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April 20, 2015

FDA approves ivabradine for treatment of HF
A drug already available in Europe has been approved by the US Food and Drug Administration for reducing the risk for hospitalization from worsening heart failure. The agent, ivabradine, is indicated for stable patients with heart failure and a heart rate of >70 per minute on maximally tolerated beta-blockers. The approval is based on the international, placebo-controlled SHIFT trial, published in 2010, which randomized >6500 patients in New York Heart Association class II-IV heart failure and left ventricular ejection fraction ≤35%. The trial saw a highly significant 18% drop in risk for cardiovascular death or hospitalization for worsening heart failure over an average of 23 months in patients treated with ivabradine.

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FDA Advisory Panel Gives the green light for Cangrelor in PCI
The Cardiovascular and Renal Drugs Advisory Committee of the US Food and Drug Administration (FDA) voted 9 to 2, with one member abstaining, that the injectable antiplatelet agent cangrelor should be approved for reducing thrombotic events in PCI. Last year, the committee voted 7 to 2 against recommending cangrelor for PCI because of data problems and they felt that the risk/benefit profile was not sufficiently strong enough. The Medicines Company then underwent further sensitivity analyses and supplied a more simplified application. Earlier this week, FDA reviewers gave a favorable review that the agent now be approved "in patients in whom treatment with an oral P2Y12 platelet inhibitor prior to PCI is not feasible and when glycoprotein IIb/IIIa receptor antagonists are not anticipated to be used." They also noted that PHOENIX was sufficient enough as a stand-alone trial to warrant approval of cangrelor.

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Micra Miniature Leadless Pacemaker Gains CE Mark Approval
European physicians will now have access to a second leadless pacemaker, as Medtronic announced today the Micra transcatheter pacing system (TPS) has gained CE Mark approval in Europe. The Micra, which is not much larger than a one Euro coin (or nickel) at one-tenth the size of a traditional pacemaker, was approved in Europe as part of the Micra TPS Global Clinical Trial, a larger ongoing study. For the CE Mark approval, European regulators approved the device on safety and efficacy outcomes of 60 patients who had the tiny pacemaker implanted and were followed for 3 months. The device, which is delivered via catheter and eliminates the traditional surgical "pocket," is not approved in the US, but researchers plan to enroll as many as 780 patients from 50 clinical centers as part of the ongoing global trial.

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LDL variability predicts CV events in patients with CAD
Visit-to-visit LDL variability was independently predictive of CV events in patients with CAD, according to new data from the TNT trial which published in JACC. Researchers evaluated 9,572 patients with CAD and LDL level less than 130 mg/dL who were randomly assigned atorvastatin at doses of 80 mg/day or 10 mg/day. They evaluated visit-to-visit LDL variability from 3 months after randomization to determine its potential impact on CV outcomes. LDL variability measurements included standard deviation, average successive variability, coefficient of variation and variation independent of mean. The primary outcome was incidence of any coronary event. Secondary outcomes were any CV event, death, MI and stroke. in the population studied, standard deviation and average successive variability were lower among those assigned atorvastatin 80 mg/day than in those assigned atorvastatin 10 mg/day (standard deviation, 12.03 ± 9.7 vs. 12.52 ± 7.43; P = .005; average successive variability, 12.84 ± 10.48 vs. 13.76 ± 8.69; P < .0001). The authors also found that each 1-unit standard deviation increase in LDL variability by average successive variability increased the risk of any coronary event by 16% on adjusted analysis (HR = 1.16; 95% CI, 1.1-1.23). They also observed increases in the risk for any CV event (HR = 1.11; 95% CI, 1.07-1.15), death (HR = 1.23; 95% CI, 1.14-1.34), MI (HR = 1.1; 95% CI, 1.02-1.19) and stroke (HR = 1.17; 95% CI, 1.04-1.31). These results were independent of treatment effect and achieved LDL levels, and were consistent after adjustment for medication adherence, according to the researchers.

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April 14, 2015

Lead-free cardiac pacemaker shows good safety, performance at 1 year (LEADLESS published)
Confirming a previous report, a leadless cardiac pacemaker system demonstrated stable performance and good safety results at 1 year, according to data from the LEADLESS trial which published online in JACC. The researchers assessed 6-month and 1-year follow-up data for 31 of the 33 patients implanted with the leadless pacemaker between December 2012 and April 2013 (mean age, 76 years; 65% men). At implantation, one patient had cardiac tamponade and died due to massive cerebral artery ischemic infarct, and another required an implantable cardioverter defibrillator and underwent successful retrieval of the leadless pacemaker 7 days after implantation.
There were no pacemaker-related adverse events reported between 3 months and 1 year, the researchers wrote.
Mean pacing threshold at a 0.4-ms pulse width was 0.4 V at 6 months and 0.43 V at 1 year, R-wave amplitude was 10.6 mV at 6 months and 10.3 mV at 1 year, and impedance was 625 ohms at 6 months and 627 ohms at 1 year, according to the researchers.
At 1 year, the rate response sector was activated in 61% of patients, all of whom had an adequate rate response, the researchers found.

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EMA Committee Warns of Cardiovascular Risk With High-Dose Ibuprofen
The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) is warning of an increased risk of cardiovascular events in patients who take high doses of the anti-inflammatory ibuprofen. The committee, states there is a small increase in the risk of MI and stroke with ibuprofen when taken at doses of 2400 mg/day or higher. The risk, according to the committee, is similar to the risk observed with other nonsteroidal anti-inflammatory drugs (NSAIDs), such as COX-2 inhibitors and diclofenac.
The committee is recommending physicians assess patients' risk factors for cardiovascular conditions before starting them on long-term high-dose ibuprofen. Overall, PRAC says the benefits of high-dose ibuprofen outweigh the small increased risk of cardiovascular events, but physicians should use caution when prescribing and avoid high-dose ibuprofen in select patients. High doses of ibuprofen (2400 mg per day or higher) should be avoided in patients with serious underlying heart or circulatory conditions, such as heart failure, heart disease, and circulatory problems or in those who have previously had a heart attack or stroke," according to PRAC. With 1200 mg of ibuprofen, the most commonly used over-the-counter dose of ibuprofen in the European Union, there is no signal of harm, according to PRAC. The recommendations of the committee also extend to dexibuprofen, which is similar to ibuprofen. A high-dose of dexibuprofen is 1200 mg/day or more.
The recommendations of PRAC will now be sent to the Coordination Group for Mutual Recognition for Decentralized Procedures—Human (CMDh). The CMDh reviews the recommendations of PRAC and will adopt a final position.

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Bivalirudin Bests Heparin for Fewer Bleeding Events During PCI (BRIGHT study)
Publication of the multicenter Chinese BRIGHT study has reopened the bivalirudin-heparin debate on treatment for patients undergoing PCI. The randomized trial showed that patients who received bivalirudin after an acute MI had significantly fewer net adverse clinical events (NACE) and bleeding events at 30 days and 1 year than those receiving heparin plus the GP IIb/IIIa inhibitor tirofiban and those receiving heparin alone.
There were no between-group differences in major cardiac events or stroke, in rates of stent thrombosis or acute stent thrombosis, or acquired thrombocytopenia.
The results, are published in the Journal of the American Medical Association.
A total of 2194 adult patients with acute MI were enrolled between August 2012 and June 2013 at 82 centers in China. All were randomly assigned to one of three treatment arms upon arrival in the cath lab for emergency PCI: bivalirudin (n=735; 82.7% men; mean age 57.3 years), heparin (n=729; 81.6% men; mean age 58.1 years), or heparin/tirofiban (n=730; 82.1% men; mean age 58.2 years).
Bivalirudin was given as a bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg/h during the PCI procedure and for at least 30 minutes but no more than 4 hours afterward. The heparin-only group received a dose of 100 U/kg; the combination group received heparin 60 U/kg and tirofiban 10 µg/kg followed by postprocedure infusions of tirofiban at 0.15 µg/kg/min for 18 to 36 hours.
NACE at 30 days' postprocedure, the primary end point, were reported for 8.8% of the bivalirudin group vs 17% of the heparin/tirofiban group (relative risk [RR] 0.52; 95% CI 0.39–0.69; P<\0.001).NACE also occurred in 13.2% of the heparin-only group (RR 0.67; 95% CI 0.50–0.90; P=0.008).
The 30-day bleeding rate occurred in 4.1% of the patients receiving bivalirudin vs 12.3% of those receiving heparin/tirofiban vs 7.5% of those receiving heparin alone.
One-year follow-up results were similar. At that time, NACE occurred in 12.8% of the bivalirudin group vs 20.5% of the heparin/tirofiban group (P <\0.001) vs 16.5% of the heparin-only group (P=0.05). Bleeding rates at 1 year were 6.3% vs 14.2% and 9.9%, respectively.

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April 6, 2015

Dronedarone in Middle Age Linked to More Admissions
Treatment with dronedarone was associated with a higher risk for hospitalization than treatment with amiodarone or other antiarrhythmic drugs, in an observational study involving nongeriatric atrial fibrillation (AF) patients without cardiovascular disease, which published in the last issue of Circulation: Cardiovascular Quality and Outcomes.. In patients age 61 and younger (median age 56) , the risk of AF-related hospitalization was greater with dronedarone than Class Ic (propafenone and flecainide) drugs (hazard ratio 1.59, 95% CI 1.13-2.24), amiodarone (HR 2.63, 95% CI 1.77-3.89) and sotalol (HR 1.72, 95% CI 1.17-2.54). Cardiovascular hospitalization risk also was lower with amiodarone (HR 0.80, 95% CI 0.70-0.92) and sotalol (HR 0.63, 95% CI 0.53-0.75) compared with class Ic drugs.
The study included 8,562 AFpatients between the ages of 49 and 61 without known heart disease identified using health plan claims data. All were prescribed antiarrhythmic drugs (AADs) from the beginning of 2006 to the end of 2010.
The primary outcome was time from first prescription to AF hospitalization, and secondary outcomes were time to cardiovascular and all-cause hospitalization. Just 608 of the 8,562 study participants were treated with dronedarone, compared with 2,984 patients treated with class Ic drugs, 2,065 patients treated with Sotalol, and 2,905 patients treated with amiodarone.

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Smoking linked to poor outcomes after revascularization in patients with complex CAD
Cigarette smoking was associated with adverse clinical outcomes, including recurrent MI, stroke and death, in patients with complex CAD undergoing revascularization with CABG or PCI, according to 5-year follow-up data from the SYNTAX trial in a study published online in the Journal of the American College of Cardiology. Researchers analyzed data on smoking status and history collected at baseline, 6 months, 1 year, 3 years and 5 years among participants of the SYNTAX trial (n = 1,793) who underwent CABG or PCI.
At baseline, 1 in 5 patients with complex CAD reported smoking. Of those, 60% stopped smoking after revascularization. Overall, 17.9% of patients had changes in smoking status during the 5-year follow-up.
According to the results, smoking at baseline did not influence death/MI/stroke or major adverse CV and cerebrovascular events at 5-year follow-up. However, when smoking was considered a time-dependent variable, smoking increased the risk for death/MI/stroke (HR = 1.38; 95% CI, 1.02-1.86) and major adverse cardiovascular/cerebrovascular events (HR = 1.28; 95% CI, 1.01-1.61) at follow-up. Baseline smoking status was associated with increased risk for MI, specifically. During follow-up, the effect of smoking as a time-dependent covariate was predominantly on subsequent MI (adjusted HR = 2.08; 95% CI, 1.3-3.32).
During follow-up, 98 patients reported always smoking and 1,374 reported never smoking. Risk for MI and stent thrombosis/graft occlusion was significantly higher among always smokers, but this group did not have increased risk for all-cause revascularization, compared with never smokers.
Additionally, smoking was identified as an independent predictor of death/MI/stroke (HR = 1.8; 95% CI, 1.3-2.5) and major adverse cardiovascular/cerebrovascular events (HR = 1.4; 95% CI, 1.1-1.7). In subgroup analyses, smoking independent predicted poor outcomes in patients who underwent CABG (HR = 1.52; 95% CI, 1.02-2.25) and PCI (HR = 1.26; 95% CI, 0.9-1.75).

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SPYRAL HTN program to evaluate renal denervation for uncontrolled hypertension
Medtronic announced with a press release the launch of a clinical trial program that will assess the use of renal denervation in patients with uncontrolled hypertension. The SPYRAL HTN global clinical trial program comprises two prospective, randomized, sham-controlled trials: SPYRAL HTN-OFF MED and SPYRAL HTN-ON MED. The trials will be conducted simultaneously. In both, participants will undergo renal denervation by experienced operators with the Symplicity Spyral catheter and Symplicity G3 radiofrequency generator. SPYRAL HTN-OFF MED will evaluate the impact of renal denervation on BP reduction without the use of antihypertensive medications. SPYRAL HTN-ON MED will assess renal denervation in patients with uncontrolled hypertension despite treatment with three antihypertensive medications; these drugs are not required to be prescribed at maximum tolerated medication dosages, a factor which may have contributed to variability in patient adherence and the large number of medication changes during the SYMPLICITY HTN-3 trial, according to the release.
The trials will include approximately 100 patients with moderate- to high-risk hypertension, enrolled at 20 centers worldwide.

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March 23, 2015

CoreValve Bests Surgery at Two-Year Mark
Data from a U.S. pivotal trial showed patients who underwent transcatheter aortic valve replacement using CoreValve had a higher two-year survival rate than those who had their valves surgically replaced. The difference in all-cause mortality between the two groups jumped from 4.8 percent at one year to 6.5 percent at the end of the second year. Patients in the TAVR arm also had a lower stroke rate than those in the control group — 10.9 percent versus 16.6 percent. The multicenter clinical trial randomized 747 patients with advanced forms of aortic stenosis to with TAVR or open-heart surgery. The patients had an estimated mortality risk of 15 percent or greater at 30 days and preexisting surgical risk factors such as frailty and disability. The FDA approved the CoreValve system last year for patients in need of aortic valve replacement who are at high or severe risk for surgery. The device is also available in countries that recognize the CE mark

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Next-generation subcutaneous ICD system receives FDA approval, CE Mark
Boston Scientific Corporation has received FDA and CE Mark approval of the EMBLEM™ Subcutaneous Implantable Defibrillator (S-ICD) System. The EMBLEM S-ICD System is a treatment option that provides protection for patients at risk of sudden cardiac arrest (SCA), yet leaves the heart and vasculature untouched, minimizing the risk of complications associated with conventional transvenous implantable cardioverter-defibrillators (TV-ICDs). A controlled and limited market release has begun in a small number of European centers with a broad European launch scheduled for May 2015 and subsequent U.S. launch planned for the third quarter of 2015. Unlike traditional ICDs that require placement of at least one lead in or on the heart, the S-ICD System is implanted just under the skin and provides the patient the same protection from cardiac arrest without invading the heart and blood vessels. Leads in the heart may be associated with infrequent but serious complications, including lead displacement, fracture and systemic blood infections, or the need for lead extraction, which may lead to hospital readmission, increased mortality and associated costs. The new generation EMBLEM S-ICD System is 19% thinner and is projected to last 40% longer than the previous S-ICD System. These improvements will further improve patient comfort and cosmetic outcomes while reducing the number of times the device will require replacement. The EMBLEM S-ICD System is also enabled for remote patient management through the LATITUDE™ NXT Patient Management System for increased patient convenience.

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Anacetrapib lowers LDL in patients with familial hypercholesterolemia (REALIZE trial)
One-year treatment with anacetrapib in patients with heterozygous familial hypercholesterolemia was well tolerated and yielded significant decreases in LDL cholesterol. For the phase 3, multicenter, double-blind, randomized, placebo-controlled REALIZE study, researchers evaluated 306 patients with a genotype-confirmed heterozygous familial hypercholesterolemia. Patients were included if they were on a therapeutic dose of statin, such as simvastatin (Zocor, Merck) 40 mg, atorvastatin 20 mg, rosuvastatin (Crestor, AstraZeneca) 5 mg, pitavastatin (Livalo, Kowa Pharmaceuticals) 4 mg, lovastatin 80 mg, or pravastatin 80 mg or higher, or one or more additional lipid-modifying drugs for 6 or more weeks prior to screening. Patients also were required to have LDL levels ≥ 2.59 mmol/L with no history of CVD, or LDL levels ≥ 1.81 mmol/L with a history of CVD. After a 2-week placebo run-in period, patients were randomly assigned 2:1 to daily anacetrapib (Merck) 100 mg (n=204) or matching placebo (n=102) for 1 year. The patients were seen for a 12-week follow-up after the conclusion of anacetrapib treatment to evaluate patient safety when off treatment. The primary efficacy endpoint was s percentage change from baseline in LDL to 1 year. At 1 year, anacetrapib decreased mean LDL levels from 3.3 mmol/L to 2.1 mmol/L (percentage change, 36%; 95% CI, – 39.5 to – 32.5) compared with an increase in LDL with placebo from 3.4 mmol/L to 3.5 mmol/L (percentage change, 3.7%; 95% CI, – 1.2 to 8.6). The difference in percentage change between anacetrapib and placebo was – 39.7% (95% CI, – 45.7 to – 33.7; P < .0001). Patients in the anacetrapib group experienced a higher number of CV events vs. those in the placebo group (4 [2%] of 203 patients vs. 0 of 102 patients; P = .1544), but the percentage of those with adverse events that prompted discontinuation was comparable (12 (6%) of 203 patients vs. 5 [5%] of 102 patients).

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Smoking Worsens Outcomes for Patients Following PCI/CABG
Smoking is associated with worse clinical outcomes, especially MI, following coronary revascularization, indicating that there is no "smoker's paradox" when smoking status is accounted for across time, the SYNTAX trial shows. The study was published in the last issue of the Journal of the American College of Cardiology. The SYNTAX trial was a prospective, multicenter, randomized trial that compared PCI with CABG surgery in patients with complex CAD. Complex CAD included left main stem disease, triple-vessel disease, or both. A total of 1793 patients were included in the analysis. Smoking status was ascertained for all patients at baseline and at 6 months and 1, 3, and 5 years. The study end point was the impact of smoking on a composite end point of death, MI or stroke after 5 years of follow-up. Some 20% of the cohort was smoking at baseline, but this dropped to 8.6% at 6 months and was still 8.7% at 1 year. At 5 years, smoking was associated with a 38% increased risk of the composite end point of death, MI, or stroke (hazard ratio [HR] 1.38, 95% CI 1.02–1.86; P=0.035). Smoking was also associated with a 28% increased risk of major adverse cardiac and cerebrovascular (MACCE) events (HR 1.28, 95% CI 1.01–1.61; P =0.041). Patients who always smoked had significantly higher rates of MI and stent thrombosis or graft occlusion as well, although not all-cause revascularization, compared with those who had never smoked.Subgroup analysis also showed that smoking independently increased the risk of poor outcomes by 52% in CABG patients (HR 1.52; 95% CI 1.02–2.25; P =0.038) and by 26% for PCI patients (HR 1.26, 95% CI 0.90–1.75; P=0.177). Baseline smoking status was also associated with poor outcomes.

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March 16, 2015

FDA approves left atrial appendage closure device
The U.S. Food and Drug Administration (FDA) approved the WATCHMAN Left Atrial Appendage (LAA) Closure Device, a first-of-its kind treatment that gives patients with non-valvular atrial fibrillation (AF) an alternative option to long-term warfarin therapy. Watchman is indicated to reduce the risk of thromboembolism from the left atrial appendage in patients with non-valvular atrial fibrillation who are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores, are deemed by their physicians to be suitable for warfarin; and have an appropriate rationale to seek a non-pharmacologic alternative to warfarin, taking into account the safety and effectiveness of the device compared to warfarin. The PROTECT AF trial concluded that use of the watchman device for LAA ligation is feasible among patients with nonvalvular AF. The trial demonstrated a noninferior rate of cardiovascular death, stroke or systemic embolism, compared with warfarin alone, which was sustained to five years of follow-up. The PREVAIL trial found that percutaneous closure of the LAA is feasible in patients with AF. Compared with the PROTECT AF trial, there was improved procedural implant success with reduced device-related complications.

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Apixaban does not increase bleeding in patients with renal insufficiencies
Compared with conventional anticoagulants, use of apixaban resulted in a lower bleeding risk in patients with mild or moderate-to-severe renal impairment, according to results of a meta-analysis published online in Am. J. Cardiol. The researchers performed a meta-analysis and systematic review to assess this risk. They included six randomized controlled trials involving 40.145 patients in their meta-analysis. The results showed that apixaban had a statistically significant lower bleeding risk in patients with mild renal impairment compared with conventional anticoagulants (vitamin K antagonist, warfarin, aspirin, placebo) (RR = 0.80; 95% CI, 0.66-0.96, I2 = 13%). The bleeding risk was similar in patients with moderate-to-severe renal insufficiency (RR = 1.01; 95% CI, 0.49-2.10, I2 = 72%). The study did not examine severe renal impairment, which may have led to underestimation of bleeding risk in the moderate-to-severe renal impairment subgroup.

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One-Year, Real-World TAVR Data Help Identify Risks, Benefits
In a study published in the Journal of the American Medical Association, with 12.182 patients who underwent transcatheter aortic-valve replacement (TAVR) in clinical practice in the US from November 2011 through June 30, 2013, 1 year after the procedure, 23.7% had died, 4.1% had a stroke, and 26% had either died or had a stroke. Furthermore, following TAVR, 59.8% of the patients, who had a median age of 84, went home rather than to a nursing home or extended-care facility. At 1 year, 46.8% of patients who were alive had not been hospitalized again. Being very elderly, on dialysis, with severe lung disease, or a high STS Predicted Risk of Operative Mortality (STS PROM) score was linked with a higher risk of 1-year mortality, and women who underwent TAVR had a higher risk of stroke than men. Most patients (57.4%) had STS PROM scores below 8%; 30.8% had scores between 8% and 15%; and 11.9% had scores above 15%—which indicates low risk of death from surgery, high risk of death from surgery, and inoperable, respectively. The median STS PROM score was 7.1%, which was lower than in PARTNER A and PARTNER B (11.8% and 11.2%, respectively), but similar to that in the CoreValve study (7.3%), the researchers note. Most patients were either 75 to 84 years old (38.2%) or 85 to 94 years old (47%). Only 12.7% were younger than 75 and 2.1% were 95 or older. About half were women. At 30 days after TAVR, 7% of patients had died and 2.5% had had a stroke.

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Low Prevalence of Diabetes Found Among Patients With Familial Hypercholesterolemia
The prevalence of type 2 diabetes among patients with familial hypercholesterolemia is significantly lower than unaffected relatives, with the prevalence varying by the type of gene mutation, according to a study published in the last issue of JAMA. Statins have been associated with increased risk for diabetes, but the cause for this is not clear. One theory is that statins increase expression of low-density lipoprotein (LDL) receptors and increase cholesterol uptake into cells including the pancreas, which could cause pancreatic dysfunction. Familial hypercholesterolemia causes decreased LDL transport into cells. Researchers have hypothesised, in patients with familial hypercholesterolemia, decreased pancreatic LDL transport would lessen cell death and ultimately lead to lower rates of diabetes. In the study was assessed the prevalence of type 2 diabetes between patients with familial hypercholesterolemia and their unaffected relatives. The study included all individuals (n = 63,320) who underwent DNA testing for familial hypercholesterolemia in the national Dutch screening program between 1994 and 2014. The prevalence of type 2 diabetes was 1.75% in patients with familial hypercholesterolemia (n = 440/25,137) versus 2.93% in unaffected relatives (n = 1,119/38,183), with adjusted figures indicating that patients with familial hypercholesterolemia had a 51% lower odds of having type 2 diabetes. Prevalence varied by the type of gene mutation. The researchers observed an inverse dose-response relationship between the severity of the familial hypercholesterolemia causing mutation and prevalence of type 2 diabetes.

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March 09, 2015

Idarucizumab filed with EMA and Health Canada as Antidote for Dabigatran
Boehringer has submitted BI 655075 (idarucizumab) for approval of marketing authorization to the European Medicines Agency (EMA) and Health Canada, for use in patients who require rapid reversal of the anticoagulant effect of dabigatran, the active ingredient in Pradaxa. This follows filing with the FDA. The submissions are based on the results from clinical trials of idarucizumab in volunteers, including elderly and renally impaired individuals. Phase I data showed an immediate, complete and sustained reversal of the anticoagulant effect of dabigatran following the administration of idarucizumab and no pro-thrombotic effect. The submissions also include first interim data from the ongoing RE-VERSE ADTM study. RE-VERSE ADTM is an ongoing global Phase III patient study in which Boehringer Ingelheim continues to evaluate idarucizumab in patients treated with Pradaxa who are in need of emergency intervention, or experience an uncontrolled or life-threatening bleeding event.

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TAVR improves quality of life in patients at extreme surgical risk
Transcatheter aortic valve replacement yielded substantial improvements in disease-specific and health-related quality of life among patients with severe aortic stenosis at extreme surgical risk, according to new data from the CoreValve U.S. Extreme Risk Pivotal Trial which published online in JACC Intrev. Journal. The new analysis characterized health status outcomes after TAVR with a self-expanding prosthesis. Researchers assessed the health status of patients at baseline and at 1, 6 and 12 months after the procedure using the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Short Form-12 and the EuroQol-5D surveys. Death, KCCQ overall summary score less than 45 or decline in KCCQ overall summary score of 10 points at 6 months indicated poor outcome after TAVR. The transfemoral approach was used in 471 patients. Of those, 93% completed the baseline health status survey, the results of which indicated considerable impairment in all health status measures at baseline. The KCCQ overall summary scores increased by 23.9 points at 1 month, 27.4 points at 6 months and 27.4 points at 12 months (P < .001 for all comparisons). Individual KCCQ subscales that measured total symptoms, physical limitations, social limitations and quality of life showed similar results. Short Form-12 physical and mental scores improved by approximately 5 points from baseline to follow-up at 6 and 12 months (P < .001 for all comparisons). Substantial increases in EuroQOL-5D utilities from baseline to follow-up at 6 and 12 months were also reported (P < .003). The proportion of patients with large KCCQ overall summary score improvement was 58% at 1 month and 59% at 12 months. The proportion of patients with an excellent outcome, defined as survival with a large improvement in KCCQ overall summary score, was 52% at 1 month and 41% at 12 months. In contrast, the proportion of patients with a poor outcome was 39% at 6 months; 22% had died and 16% had very poor quality of life. Preprocedural factors independently associated with poor outcome included wheelchair dependency, lower aortic valve gradient, previous CABG, need for home oxygen and Society of Thoracic Surgeons mortality risk greater than 15%.

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Anacetrapib on Top of Optimal Therapy Provides Large LDL-Lowering Benefit in FH (REALIZE study)
For patients with heterozygous familial hypercholesterolemia (FH) well treated with existing medical therapy, including high-intensity statins and ezetimibe , the addition of anacetrapib for 1 year further reduced LDL-cholesterol levels and other atherogenic lipoproteins, according to the results of REALIZE study which published in Lancet. Among 204 patients who received anacetrapib, LDL-cholesterol levels were reduced from 127 mg/dL at baseline to 81 mg/dL at 1 year. For the 102 patients who received a placebo, LDL-cholesterol levels increased slightly over the 52 weeks. Treatment with anacetrapib also resulted in a significant increase in HDL-cholesterol levels, with baseline levels doubling after 1 year of treatment (up from 54 mg/dL to 108 mg/dL). The investigators say anacetrapib was well tolerated, with no reported differences in serious adverse events, drug-related adverse events, or adverse events leading to drug discontinuation between the anacetrapib- and placebo-treated patients. The researchers did not observe any changes in blood pressure among the anacetrapib-treated patients, an off-target effect that was observed with torcetrapib. This study was not powered for changes in clinical outcomes, but they did observe a numerically higher, although statistically nonsignificant, number of cardiovascular events among the anacetrapib-treated patients. In total, four patients who received anacetrapib had an adjudicated cardiovascular event (stroke, MI, or unstable angina) vs none in the placebo arm, a finding that warrants watching, say the researchers.

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Recent AF Guidelines Would Significantly Expand OAC Use
An update of the guidelines for the management of patients with atrial fibrillation (AF)—one that saw a shift from the CHADS2 score to the CHA2DS2-VASc score for stroke risk assessment—significantly increases the number of patients eligible for oral anticoagulant therapy, according to the results of a new analysis published in JAMA: Internal Medicine. Using data from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF), the researchers found that the overall proportion of patients recommended for oral anticoagulation increased from 71.8% under the 2011 American Heart Association (AHA)/American College of Cardiology (ACC)/Heart Rhythm Society (HRS) guidelines to 90.8% with the 2014 AHA/ACC/HRS clinical recommendations. Using the new CHA2DS2-VASc score, researchers say that nearly every AF patient older than 65 years of age and nearly every woman with AF would be eligible for oral anticoagulation. In fact, with the 2014 recommendations guiding the management of AF, 98.5% of patients 65 years of age and older and 97.7% of women would receive a definitive recommendation for oral anticoagulant therapy.

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March 02, 2015

Heart failure patients who struggle with daily tasks are hospitalised more often and die earlier
Heart failure patients who struggle doing daily tasks are more likely to be hospitalised and die early, according to new research published online in the American Heart Association journal Circulation: Heart Failure. The risk is higher for older women, unmarried people and those with chronic conditions that affect mobility and ability, including obesity, dementia, anemia and diabetes, researchers said. Researchers reviewed questionnaires from 1,128 heart failure patients. Half were female, the average age was about 75, and half were married. Eighteen per cent were obese and most had other medical conditions including high blood pressure (87.4%), anemia (57%), diabetes (36.5%), peripheral vascular disease (26.5%) and cerebrovascular disease (almost 30%). Patients were grouped as having minimal, moderate or severe difficulty with daily activities that included getting dressed, using the bathroom, cleaning the house, climbing stairs and taking medications. Most patients had a hard time with at least one daily activity, but there was a corresponding relationship between how easily one could go about their day and overall mortality.

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Subcutaneous-ICD patients may be able to undergo MRI scans at 1.5T safely
Subcutaneous implantable cardioverter-defibrillator patients may be safe to be exposed to magnetic resonance imaging (MRI) procedures at 1.5T with a pre-specified scanning and monitoring protocol. The results of a first-of-its-kind study exploring the potential for safely imaging patients with the subcutaneous implantable cardioverter system was reported—ahead-of-print in Europace. According the authors, it is estimated that as many as 75% of active cardiac device recipients will become indicated for MRI. However, the majority of such devices are contraindicated for MRI due to potential hazards such as heating of the electrode that resides in the heart, damage to myocardium, elevation of pacing thresholds, unintended induction of ventricular tachycardia or ventricular fibrillation, pacing inhibition, permanent device malfunction, and distortion of the MRI scan. The authors note that none of the components of the S-ICD system are on or in the heart, hence heating near or around the electrode cannot harm the myocardium. However, they say, heating near the S-ICD’s electrode and can may still cause serious patient discomfort. In this single-centre prospective non-controlled study, 15 patients (12 males, mean age 53 years) were enrolled for MRI testing over a period of 18 months. They underwent a total of 22 randomised examinations, which included cardiac, brain, cervical, lumbar and knee scans. Keller et al comment that there was not a specific requirement for an MRI. The S-ICD is currently not certified for use with an MRI. For the scanning protocol, the S-ICD was programmed off to minimise the risk of inappropriate therapy and patients were monitored throughout the procedure with pulse oximetry and standard ECG to detect any arrhythmia. An external defibrillator was available. The S-ICD was evaluated prior and immediately after the scan to verify proper functioning. Patients were also asked to report immediately any pain, torqueing movement, or heating sensation in the area of pocket or electrode. They were also questioned immediately following the MRI to assess any discomfort around the can or electrode.

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Tandem Troponin-BNP Readings Predict CRT Outcomes in Heart Failure
Tandem measurements of cardiac troponin T (TnT) and brain-type natriuretic peptide (BNP) provide insight into how well patients scheduled for cardiac resynchronization therapy (CRT) will do at 12 months, suggests a multicenter, prospective study published online in Pacing and Clinical Electrophysiology Journal. Classification of patients into high-, intermediate-, and low-risk categories based on the initial biomarkers significantly predicted mortality and risk of heart-failure hospitalization. The study stratified 267 patients at 32 centers, prior to implantation of biventricular pacemakers with defibrillators (CRT-D), into three risk groups based on whether TnT was detectable and BNP elevated. A detectable TnT meant >0.01 ng/mL, whereas an elevated BNP was defined as >440 pg/mL. Patients were defined as high risk when they had both a detectable TnT and a high BNP; intermediate risk if they had either a detectable TnT or a high BNP and low-risk if they had an undetectable TnT and a low BNP. Most of the cohort consisted of men, their mean LVEF was 25%, and just over half had ischemic cardiomyopathy; their mean QRS interval was 155 ms. Within the first year of follow-up, there were 13 deaths and 25 first hospitalizations for heart-failure events among 19 patients. Patients in both the high and the intermediate categories of biomarker risk had significantly worse survival at 1 year than those categorized in the low-risk group (P <0.001). In the multivariate model containing risk group, age, NYHA class, ejection fraction, and QRS duration, the risk group into which patients had been initially categorized retained its independent predictive power for death or HF hospitalization, with a hazard ratio (HR) of 7.34 (95% CI 2.48–021.69) for the high-risk group compared with the low-risk group and 2.50 (95% CI 1.04–6.04) for the intermediate-risk group compared with the low-risk group (P =0.001 for both comparisons). Risk group at baseline was not associated with response to CRT or with likelihood of defibrillator shocks, the authors point out.

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February 24, 2015

Dabigatran, rivaroxaban contraindicated in AF patients who are on dialysis
More atrial fibrillation patients on dialysis are using dabigatran or rivaroxaban, even though these agents are contraindicated in this patient population, according to a new study published online in Circulation. Using data culled from the Fresenius Medical Care North America End-Stage Renal Disease Database (ESRD), the researchers tracked the use of dabigatran and between October 2010 and October 2014, in 29.277 patients with AF who were undergoing dialysis. In their secondary analysis, the authors followed a group of patients for 2 years to assess their bleeding and stroke outcomes. At baseline, they compared AF patients on warfarin (n = 8,064), aspirin (6,018), dabigatran (n = 281) and rivaroxaban (n = 244). Within this study group, dabigatran was first prescribed 45 days after it received FDA approval in October 2010; the first rivaroxaban prescription came 161 days after FDA approval. Over the 4-year study, 3.1% of patients received dabigatran and 2.8% received rivaroxaban. The use of both drugs increased over time. Overall, 5.9% of patients on dialysis who require anticoagulants are prescribed dabigatran or rivaroxaban. The unadjusted event rates showed that dabigatran had a major bleeding rate of 83.1 events per 100 patient years, rivaroxaban had a rate of 68.4 events, while warfarin had 35.9 events. Mortality rates from bleeding were as follows: dabigatran (19.2 deaths per 100 patient years), rivaroxaban (16.2) warfarin (10.2) and aspirin (7.7). The lowest rates for major and minor bleeding were seen in patients taking aspirin, according to the authors. Compared with warfarin, dabigatran (RR = 1.48, 95% CI, 1.21-1.81) and rivaroxaban (RR = 1.38, 95% CI 1.03-1.83) had a higher risk of major bleeding, the authors wrote. The risk of hemorrhagic death was even greater for dabigatran (RR = 1.78, 95% CI 1.18-2.68) and rivaroxaban (RR = 1.71, 95% CI 0.93-3.12) when compared with warfarin. Patients treated with aspirin had the lowest rates of major and minor bleeding and hemorrhagic death.

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Concomitant percutaneous aortic balloon balvotomy plus PCI did not improve outcomes, increased costs
Compared with percutaneous aortic balloon balvotomy alone, PCI plus percutaneous aortic balloon balvotomy performed during the same hospitalization was associated with similar in-hospital mortality and complication rates, but increased hospitalization costs among patients aged older than 60 years with aortic stenosis. The development of less-invasive endovascular therapies has yielded a resurgence in the utilization of percutaneous aortic balloon balvotomy (PABV) for high-risk patients as a bridge to transcatheter aortic valve replacement. Using the National Inpatient Sample database (1998-2010), researchers compared outcomes of PABV alone (n = 1,880) with concomitant PCI plus PAVB (n = 247) in a total of 2,127 procedures. The use of PCI plus PABV during the same hospitalization increased 225%, from 5.1% of PABVs in 1998 to 1999 to 16.6% of PABVs in 2009 to 2010 (P < .001). The in-hospital mortality rate was 10.3% in the PCI plus PABV group vs. 10.5% in the PABV alone group. The researchers found that increasing comorbidities (OR = 1.17; 95% CI, 1.01-1.35), unstable patient condition (OR = 6.19; 95% CI, 3.45-11.09), complications (OR = 2.81; 95% CI, 1.85-4.28) and weekend admission (OR = 2.12; 95% CI, 1.23-3.67) were significant predictors of in-hospital mortality after concomitant PCI plus PABV. The rate of in-hospital complications was also similar: 23.4% in the PCI plus PABV group vs. 24.7% in the PABV alone group. The most common complications were postprocedure respiratory failure (8.3%), vascular (7.5%) and cardiac (6.7%). Unstable patient condition was a significant predictor of increased complications (OR = 5.09; 95% CI, 2.97-8.7). While both groups had a similar length of stay, patients who underwent PCI plus PABV had higher costs of hospitalization ($30,089 vs. $18,421; P < 0.001).

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No difference in treatment with antiplatelets, anticoagulants after cervical artery dissection (CADISS study)
For prevention of stroke, major bleeding or death, it did not matter whether patients with cervical artery dissection were treated with antiplatelet drugs or anticoagulants, according to findings from the CADISS study which published online in Lancet Neurology. The investigators enrolled 250 patients diagnosed with cervical artery dissection (118, carotid dissection; 132, vertebral dissection) at local hospitals in the United Kingdom and Australia. Patients were randomly assigned antiplatelet agents — aspirin, dipyridamole or clopidogrel alone or in dual combination, as determined by the treating physician — or anticoagulation in the form of low–molecular-weight heparin followed by warfarin. The primary endpoint was ipsilateral stroke and death at 3 months. Four cases of ipsilateral stroke occurred: three in the antiplatelet group, one in the anticoagulant group. There was one case of major bleeding, a subarachnoid hemorrhage in the anticoagulant group. No deaths were reported during the study period. The groups did not differ in the incidence of the primary endpoint in the intention-to-treat population (OR = 0.335; 95% CI, 0.006-4.233). A central review of imaging failed to confirm dissection in 52 patients, Markus said. Therefore, the researchers conducted a per-protocol analysis of patients whose dissection was confirmed and also found no difference between the groups in the primary endpoint (OR = 0.346; 95% CI, 0.006-4.39).

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February 16, 2015

Better long-term outcomes with CABG vs. PCI, regardless of diabetes status (subanalysis of CREDO-Kyoto study)
At 5 years, patients with and without diabetes who had three-vessel and/or left main disease had better rates of cardiac death, MI and coronary revascularization after CABG compared with PCI according a subanalysis of CREDO-Kyoto PCI/CABG study which published online in Am. J. Cardiol. The multicenter Japanese CREDO-Kyoto PCI/CABG Registry Cohort-2 included 15,939 patients with first coronary revascularization. The current analysis focused on 3,982 patients with three-vessel and/or left main disease; 1,998 had diabetes (PCI, n = 1,065; CABG, n = 933) and 1,984 did not have diabetes (PCI, n = 1,123; CABG, n = 861). At 5 years, the cumulative incidence of all-cause mortality was higher for patients who underwent PCI compared with CABG. Among patients without diabetes, the 5-year cumulative incidence rate was 19.8% after PCI vs. 16.2% after CABG (P = 0.01). Among patients with diabetes, the 5-year cumulative incidence rate was 22.9% after PCI vs. 19% after CABG (P =0 .046). When the researchers adjusted for confounding factors, the increased mortality risk after PCI remained significant among patients with diabetes (P = 0.04), but was no longer significant among patients without diabetes (P = 0.29). Compared with CABG, PCI was associated with higher adjusted risks for cardiac death (HR = 1.45; 95% CI, 1-2.51), MI (HR = 2.31; 95% CI, 1.31-4.08) and any coronary revascularization (HR = 3.7; 95% CI, 2.91-4.69) among patients with diabetes. A similar trend was observed in favor of CABG in the patients without diabetes (cardiac death: HR = 1.59; 95% CI, 1.01-2.51; MI: HR = 2.16; 95% CI, 1.2-3.87; any coronary revascularization: HR = 3.3; 95% CI, 2.55-4.25).

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Elevated circulating troponin linked to AF risk in older adults (CHS study)
In ambulatory older adults, circulating troponin T levels appear to be significantly associated with incident atrial fibrillation, according to recent findings published online in Heart Rhythm Journal. In a prospective cohort study, researchers evaluated 4.262 participants in the Cardiovascular Health Study (CHS), a longitudinal analysis of adults aged 65 years or older without AF at baseline. At enrollment, participants completed a standardized questionnaire pertaining to various health and behavioral risk factors, and also underwent a physical examination. The researchers confirmed patient self-reports through baseline examination, review of medical records or surveys of treating physicians, with follow-up measurements obtained 2 to 3 years later for 2.870 patients. Patients were contacted for follow-up every 6 months after initial assessment. Incident AF was determined through ECG results, hospital discharge diagnoses and Medicare files during a median follow-up of 11.2 years. Cardiac troponin T was undetectable (< 3 ng/L) in 1,419 patients. During follow-up, incident AF occurred in 1,363 participants. Researchers observed a primarily linear association between baseline troponin levels and incident AF after adjusting for age, race, sex, AF risk factors and HF status over time, with a cutoff of 3.25 Log-ng/L, corresponding to a baseline of 24.53 ng/L (HR = 1.39; 95% CI, 1.26-1.53 per log unit increase). After adjustment for demographics, traditional risk factors and incident HF, higher baseline levels of cardiac troponin T were linked to increased risk for incident AF (HR = 1.75; 95% CI, 1.48-2.08 for third troponin T level tertile vs. undetectable levels). Further adjustment for inflammatory biomarkers and hemodynamic strain did not eliminate the significance of this association (HR = 1.38; 95% CI, 1.16-1.65).

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Sleep Apnea Signals Poor Survival in Hospitalized HF Patients
In a large study of patients who were hospitalized for HF, those who were newly diagnosed with sleep-disordered breathing (sleep apnea) were more likely to die within a few years compared with their peers. Specifically, the hazard ratio for all-cause mortality within 3 years of hospital discharge was 1.57 (95% CI 1.1–2.2; P=0.01) for HF patients with sleep apnea, after adjustment for multiple variables, in this study , published online in the European Heart Journal. Sleep-apnea treatment may improve HF outcomes, and patients who received adequate sleep-apnea treatment appeared to have better short-term survival, but this observational study was not designed to address this, they caution. The researchers performed cardiorespiratory polygraphy on 1117 patients who were hospitalized for heart failure with LVEF <45% in a single center. The screening test detected sleep apnea in 78% of the HF patients: 344 patients (31%) had central sleep apnea and 525 patients (47%) had obstructive sleep apnea. It is important to distinguish between the two types of apnea, since treatment is usually different, according to the authors. In obstructive sleep apnea, the airway collapses on inspiration, whereas in central apnea, patients lose the drive to breathe Compared with the patients without sleep apnea, those with sleep apnea were older (mean age of 60 vs 55) and more likely to be male (77% vs 56%). Of the 1096 patients in the current study who survived until hospital discharge, 110 patients with central sleep apnea (34%), 153 patients with obstructive sleep apnea (32%), and 40 patients without sleep apnea (17%) died within 3 years, mostly from congestive HF. Sleep apnea independently predicted the risk of death during follow-up.

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February 9, 2015

Long-term nitrates do not improve prognosis in patients with vasospastic angina
Chronic use of nitrate therapy in combination with calcium channel blockers was not associated with improved long-term prognosis in patients with vasospastic angina according a multicenter study published online in Eur. Heart Journal. In the study were included 1.429 patients diagnosed with vasospastic angina between April 2003 and December 2008. Treatment decisions for vasospastic angina were made at the discretion of the attending physicians. Nitrates used included nitroglycerin, isosorbide mononitrate and isosorbide dinitrate and nicorandil. In total, 49% of the cohort received chronic nitrate therapy. Concomitant calcium channel blockers were used in more than 90% of patients who received or did not receive nitrate therapy. Propensity score matching for the entire population identified 413 matched pairs of patients. There were no significant differences in baseline variables for the propensity-matched population. The primary endpoint was major adverse cardiac events, including death, nonfatal MI, hospitalization due to unstable angina and HF/appropriate ICD shocks. All-cause mortality was the secondary endpoint. During a median follow-up of 32 months, primary endpoint occurred in 5.9% of patients. Based on the propensity score-matched analysis, the cumulative incidence of major adverse cardiac events was similar between patients who received chronic nitrate therapy and those who did not (11% vs. 8%, respectively, at 5 years; HR = 1.28; 95% CI, 0.72-2.28). Nicorandil monotherapy was associated with a neutral prognostic effect on vasospastic angina outcomes (HR = 0.8; 95% CI, 0.28-2.27). However, a multivariable Cox model showed a possible hazard with the simultaneous use of conventional nitrates plus nicorandil (HR = 2.14; 95% CI, 1.02-4.47), particularly simultaneous use of nitroglycerin and nicorandil.

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High-dose atorvastatin reduced peripheral artery disease (PAD) incidence in post-MI patients (IDEAL sudy)
In patients with previous MI, therapy with high-dose atorvastatin significantly decreased the incidence of peripheral arterial disease compared with moderate-dose simvastatin, according to data from the IDEAL study. Further, patients with a history of PAD at baseline had greater risk for future CV events, but this risk was lowered with high-dose atorvastatin. The prospective, randomized, open-label, blinded–outcome-assessment trial compared atorvastatin 80 mg/day (n=4,439) with simvastatin 20 mg/day to 40 mg/day (n=4,449; Zocor, Merck) in patients aged 80 years and older with previous MI. Follow-up occurred at 12 and 24 weeks and then every 6 months. At 24 weeks, simvastatin dose could be increased to 40 mg/day if plasma total cholesterol was greater than 190 mg/dL. Atorvastatin dose could be decreased to 40 mg/day if adverse events were observed. The prespecified outcome was incident PAD. Among patients without PAD at baseline, this outcome was defined as a new clinical diagnosis necessitating diagnostic procedures or interventions. In patients with a history at baseline, this outcome was defined as recurrence of PAD requiring hospitalization. An exploratory post-hoc analysis examined the effect of baseline PAD on clinical outcomes and the benefits of high-dose vs. usual-dose statin treatment. The primary outcome for this analysis was the rate of major coronary events (coronary death, hospitalization for nonfatal MI or cardiac arrest with resuscitation). During a median follow-up of 4.8 years, incident PAD was reported in 2.2% of the high-dose atorvastatin group vs. 3.2% of the moderate-dose simvastatin group (HR = 0.7; 95% CI, 0.53-0.91). Patients with PAD at baseline had an almost twofold greater risk for major coronary events; however, this trend did not persist after researchers adjusted for adverse CV risk profile. Among patients with PAD, major coronary events were less common in the high-dose atorvastatin group (14.4% vs. 20.1%; HR = 0.68; 95% CI, 0.41-1.11). Treatment with high-dose atorvastatin yielded significant decreases in overall CV (P = .046) and coronary events (P = .007) as well as need for coronary revascularization (P = .007).

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Left atrial appendage closure reduces burden in nonparoxysmal AF
Left atrial appendage closure appears to reduce the burden of nonparoxysmal atrial fibrillation, according to recent findings of a study published in Heart Rhythm Journal. In this prospective, multicenter observational study, researchers evaluated 50 consecutive patients with nonvalvular AF and cardiac implantable electronic devices who underwent left atrial appendage (LAA) closure with the LARIAT device . The patients were enrolled from July 2010 to April 2013. Eligible patients were aged at least 18 years, had at least one risk factor for embolic stroke and were considered poor or ineligible candidates for warfarin therapy. The mean age of the patient population was 70 ± 8.4 years, and the mean duration of AF was 54 ± 40 months. All patients were followed up at three and 12 months after the LARIAT procedure. At baseline and at each follow-up visit, interrogation of cardiac implantable electronic devices was conducted to ascertain AF burden, with the devices reset at each visit to determine burden during the intervening period. Medication lists were also updated at each visit to safeguard the stability of antiarrhythmic drug regimens. Compared with the baseline AF burden of 76% ± 33%, the burden at 3 months was significantly decreased (42% ± 34%; P < .0001). This reduction persisted at the 12-month follow-up (59% ± 26%; P < .001). Results from subgroup analysis indicated a similar decrease in AF burden between patients with paroxysmal AF (n = 19) and nonparoxysmal AF (n = 31) at 3 months. At the 12 month follow-up, the decreased AF burden persisted among those with non-paroxysmal AF, but not those with paroxysmal AF. In the nine patients for whom LAA was due to triggered activity/atrial tachycardia, the AF burden was significantly decreased at 3 (52% ± 35%) and 12 months (42% ± 19%) compared with baseline (84 ± 31%, P < .0001 for both comparisons). The researchers also noted that the reduction to AF burden was significantly lower among three patients who had incomplete LAA closure at both follow-up visits.

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February 2, 2015

New permanent pacemaker implantation after TAVR linked to worse clinical outcomes
In the PARTNER trial and registry, 8.8% of patients who underwent transcatheter aortic valve replacement with a balloon-expandable valve required new permanent pacemaker implantation. In those patients, new permanent pacemaker implantation was associated with higher rates of repeat hospitalization and mortality at 1 year and a longer duration of hospitalization. Researchers evaluated 1,973 patients without a prior pacemaker who underwent TAVR with a balloon-expandable valve in the PARTNER trial and registry. The goal was to identify predictors and clinical implications of new permanent pacemaker implantation after TAVR. Predictors of permanent pacemaker implantation included right bundle branch block (OR=7.03; 95% CI, 4.92-10.06), prosthesis diameter/left ventricular outflow diameter (OR for each 0.1 increment=1.29; 95% CI, 1.1-1.51), LV end-systolic diameter (OR for each 1 cm=0.68; 95% CI, 0.53-0.87) and treatment in the continued access registry (OR=1.77; 95% CI, 1.08-2.92), according to results of a multivariable analysis. Patients who required permanent pacemaker implantation had a longer mean duration of postprocedure hospitalization compared with those who did not require a pacemaker (7.3 days vs. 6.2 days; P=.001), according to the researchers. At 1 year, compared with no pacemaker, patients who required a permanent pacemaker had higher rates of repeat hospitalization (23.9% vs. 18.2%; P=.05) and higher mortality/repeat hospitalization (42% vs. 32.6%; P=.007), the researchers wrote. However, there was no significant difference between the groups in all-cause mortality at 1 year (26.3% vs. 20.8%; P=.08). The researchers also reported no between-group differences in LV ejection fraction at 1 year.

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CABG linked to better outcomes than PCI, but at higher price
Patients who underwent CABG had improved outcomes at 4 years but at a higher overall cost compared with PCI, according to results of a cost-effectiveness analysis of the ASCERT study which published online in JACC. The cost-effectiveness analysis used data from the Society of Thoracic Surgeons and American College of Cardiology Foundation databases, which were linked to CMS claims data, and included 86,244 patients who underwent CABG and 103,549 who underwent PCI for stable ischemic heart disease. All patients were older than 65 years and had two- or three-vessel CAD. Researchers assessed costs for the index and observation periods (2004-2008) using diagnosis-related group Medicare reimbursement rates. Costs after the observation period were estimated from average Medicare participant per capita expenditure, according to the abstract. Patients who underwent CABG gained an adjusted average of 0.2525 life-years during the observation period and 0.3801 life-years during a lifetime relative to PCI, according to the results. Compared with PCI, CABG yielded higher adjusted costs for the index hospitalization ($10,670), study period ($8,145) and lifetime ($11,575). The researchers calculated that the lifetime incremental cost-effectiveness ratio of CABG vs. PCI was $30,454 quality-adjusted life-years (QALY) gained.

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Morphine associated with delayed antiplatelet activity in patients with STEMI
Use of morphine delayed the onset of action of antiplatelet agents in patients with STEMI who were undergoing PCI, according the results from a study published online in Circ. Cardiov. Interv. The study included 300 patients undergoing PCI who were receiving loading doses of prasugrel (n=95; Effient, Eli Lilly/Daiichi Sankyo) or ticagrelor (n=205; Brilinta, AstraZeneca). After the loading dose, all patients had their platelet reactivity assessed by VerifyNow. The researchers hypothesized that there was a potential drug-drug interaction between the currently recommended antiplatelet therapies and morphine in this patient population. Ninety-five patients (32%) also received morphine. Those patients had a higher incidence of vomit compared with patients who did not receive morphine (15% vs. 2%; P=.001). Two hours after the loading dose, P2Y12 reactivity unit was 187 in patients who received morphine compared with 133 in patients who did not receive morphine (P<.001). This difference in P2Y12 reactivity units persisted after the researchers excluded patients with vomit (P<.0001), according to the results. Also at 2 hours, the researchers observed high residual platelet reactivity (P2Y12 reactivity units ≥208) in 53% of patients who received morphine compared with 29% in patients who did not receive morphine (P<.001). No difference was reported based on prasugrel or ticagrelor use, according to the results. Morphine use (OR=2.91; 95% CI, 1.71-4.97) and age (OR=1.03; 95% CI, 1.01-1.05) were identified as independent predictors of high residual platelet reactivity at 2 hours. After the researchers performed propensity score adjustment, the association between morphine and high residual platelet reactivity persisted.

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January 26, 2015

Benefit of paclitaxel-coated balloon maintained at 5 years (THUNDER study)
Use of a paclitaxel-coated balloon was associated with reduced late lumen loss, binary stenosis and target lesion revascularization at 5-year follow-up according the results of THUNDER study which published in JACC Interventions. Researchers for the THUNDER trial reported 5-year follow-up data on patients with femoropopliteal arteries that were treated with paclitaxel-coated balloons (PCB), angioplasty with paclitaxel in contrast medium or no paclitaxel. The primary outcome of the trial was late lumen loss at 6 months. Freedom from TLR, binary restenosis rate and amputation served as secondary endpoints. The present study evaluated outcomes in patients treated with PCB vs. control, and analyzed late lumen loss at 6 months and TLR up to 5 years based on sex and lesion length. According to the results, the cumulative incidence of TLR was significantly lower in the PCB group compared with the control group during the 5-year follow-up (21% vs. 56%; P=.0005). The researchers also examined patients with angiographic and duplex sonographic follow-up at 5 years (n=31). In those patients, the binary restenosis rate was lower for the PCB group compared with the control group (17% vs. 54%; P=.04). Eight of 54 evaluable patients (15%) died between 24 months and 5 years (12.5% of control group, 16.7% of PCB group). Late lumen loss at 6 months was significantly lower in the PCB group (0.4 ± 1.2 mm vs. 1.7 ± 1.8 mm; P<.001). At 12 months, mean late lumen loss was determined in 69% of the PCB group and 67% of the control group. TLR was performed before 12-month re-angiography in two patients in the PCB group and 14 in the control group. The researchers reported a significant difference in favor of the PCB group (0.7 ± 1.5 mm vs. 1.9 ± 1.9 mm; P=.01). Analysis by sex revealed a similar rate of late lumen loss at 6-month follow-up between men and women in the control group (1.76 mm vs. 1.61 mm) and PCB group (0.42 mm vs. 0.37 mm). However, at 5 years, the cumulative rate of TLR was lower after treatment with a PCB in men compared with women (17% vs. 38%). The cumulative 5-year TLR rate in the control group was higher for men (71% vs. 52%).

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Statin therapy benefited real-world patients with heart failure with reduced EF
Statin use was associated with improved survival in a registry population of patients with HF with reduced ejection fraction in a study published in Circulation Heart Failure. Previously, statin use was not associated with improved outcomes in patients with HF with reduced ejection fraction (HFrEF) in randomized controlled trials, but the issue had not been studied in an unselected population, or studied in relation to ischemic heart disease, according to the study background. Researchers for the new study analyzed 21,684 patients from the Swedish Heart Failure Registry with HFrEF (mean age, 72 years; 29% women). The cohort included 47% who were treated with statins. The researchers estimated propensity scores for treatment with statins for each patient; 42 baseline characteristics served as independent variables and statin treatment served as the dependent variable. Association between statin use and outcomes were assessed in a 1:1 population match based on propensity score and age. The primary outcome was all-cause mortality. Secondary outcomes included CV mortality, hospitalization for HF and combined all-cause mortality or CV hospitalization. In the matched population, 1-year survival was better for patients treated with statins (83% vs. 79%; HR=0.81; 95% CI, 0.76-0.86). The same was true in the unmatched population after adjustment for propensity score and age (statin group, 85%; no-statin group, 79%; HR=0.84; 95% CI, 0.8-0.89). Survival rates also were higher at 3 years for patients treated with statins (unmatched population, 68% vs. 60%; matched population, 65% vs. 58%) and 5 years (unmatched population, 53% vs. 48%; matched population, 51% vs. 45%). Ischemic heart disease was the only baseline variable that interacted with statin use (P=.001). According to the researchers, patients with ischemic heart disease had better survival rates if on statin treatment (HR=0.76; 95% CI, 0.7-0.82), but statin use did not affect survival rates in those without ischemic heart disease (HR=0.95; 95% CI, 0.85-1.07). Statin use was also associated with lower CV mortality (HR=0.8; 95% CI, 0.75-0.87), HF hospitalization (HR=0.92; 95% CI, 0.86-0.97) and all-cause mortality plus CV hospitalization (HR=0.9; 95% CI, 0.86-0.95), according to the results.

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ACC announces late-breaking clinical trials slated for presentation at annual meeting
The American College of Cardiology has announced the line-up of late-breaking clinical trials and featured clinical research at the Annual Scientific Session and Expo, held March 14 to 16 in San Diego. According to the ACC, the meeting will highlight five late-breaking clinical trial sessions; two featured clinical research sessions; a “Deep Dive” session to address key elements of the late-breaking clinical trials and implications for patients and practice; and much more. Some of the late-breaking clinical trials slated for presentation include: PROMISE: A randomized comparison of anatomic vs. functional strategies for diagnostic testing in symptomatic patients with suspected CAD. PEGASUS-TIMI 54: A randomized comparison of ticagrelor vs. placebo on a background of aspirin for the prevention of CV events in patients with prior MI. OLSER-1 and 2: Two trials designed to assess the impact of evolocumab on CV outcomes. REGULATE-PCI: A randomized comparison of the REG1 anticoagulation system vs. bivalirudin in patients undergoing PCI. 5-year outcomes of the PARTNER 1 trial, which assessed transcatheter vs. surgical aortic valve replacement. 2-year outcomes of the CoreValve US Pivotal High Risk Trial, which compared self-expanding transcatheter and surgical aortic valve replacement in patients with severe aortic stenosis at high surgical risk. BEST: A comparison of everolimus-eluting stents and bypass surgery in patients with multivessel CAD. Other research scheduled for presentation during featured clinical research sessions include an assessment of dual antiplatelet therapy for longer than 1 year among patients with ACS treated with coronary stents; additional data from IMPROVE-IT on the effect of ezetimibe and simvastatin vs. simvastatin alone on CV events after ACS; the AUGMENT-HF trial of the Algisyl-LVR device with standard medical therapy among patients with advanced HF.

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January 19, 2015

Macitentan linked to decreased hospitalization risk in npatients with pulmonary hypertension (SERAPHIN stydy)
Treatment with a 10 mg dose of macitentan significantly decreased the risk for and prevalence of all-cause hospitalization among patients with symptomatic pulmonary arterial hypertension, according to findings from the SERAPHIN study which published in JACC Heart Failure Journal. This decrease was driven by a reduction in the risk and rate of hospitalizations due to pulmonary arterial hypertension (PAH) specifically according to the authors. In a multicenter, double-blind, event-driven phase 3 trial, researchers randomly assigned 742 patients aged 12 years or older with symptomatic PAH to receive placebo (n=250), macitentan 3 mg (n=250) or macitentan 10 mg (n=242) once daily until a patient experienced a primary endpoint event or a total of 285 events had occurred across the population (median 115 weeks). The researchers assessed the effects of both macitentan (Opsumit, Actelion Pharmaceuticals) doses on the risk for, rate and duration of all-cause and PAH-specific hospitalization compared with placebo. The effect on the risk for and causes of non-PAH-related hospitalizations were also evaluated. Patients were collected from a total of 151 centers across 39 countries. The cohort was 76.5% female and had a mean age of 45.6 ± 16.1 years. In the 3 mg macitentan group, researchers observed a nonsignificant decrease in the risk for all-cause hospitalization (HR=0.911; 95% CI, 0.623-1.057), while the all-cause hospitalization rate was significantly reduced by 20.5% compared with placebo (P=.0378). The mean number of hospital days for all-cause hospitalization was also 30.6% lower in this group (P=.0278) vs. placebo recipients. Risk for PAH-specific hospitalization was 42.7% lower in the 3 mg group (HR=0.573; 95% CI, 0.405-0.811), while the hospitalization rate was 44.5% lower (P=.0004) and the mean number of PAH-related hospital days decreased by 53.3% (P=.0001) compared with placebo. In the 10 mg macitentan group, risk for all-cause hospitalization was significantly lower (HR=0.677; 95% CI, 0.514-0.891), and researchers also noted a significant 33.1% reduction in the rate of all-cause hospitalization (P=.0005) compared with placebo. The mean number of hospital days decreased by 31% (P=.0336). Risk for PAH-specific hospitalization decreased by 51.6% among these patients (HR=0.484; 95% CI, 0.337-0.697), while the hospitalization rate decreased by 49.8% (P<.0001) and the number of PAH-related days in hospital were reduced by 52.3% (P=.0003) compared with placebo.

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Antidote to novel oral anticoagulant ( Factor Xa inhibitors) met primary endpoint (ANNEXA-R study)
It was announced the topline results of the phase 3 ANNEXA-R study demonstrating that andexanet alfa, an antidote to the anticoagulant effects of Factor Xa inhibitors, met the primary endpoint with high statistical significance. IV bolus of andexanet alfa was associated with significant and immediate reversal of the anticoagulant activity of rivaroxaban in the first part of the ANNEXA-R study. Andexanet alfa also was well tolerated. The first part of this study included 41 healthy volunteers aged 50 to 75 years who received 20 mg once-daily rivaroxaban for 4 days followed by random assignment to placebo (n=14) or an 800 mg IV bolus of andexanet alfa (n=27). The primary endpoint was anti-Factor Xa levels. It is expected that the full data set will presented at the American College of Cardiology Scientific Sessions in March. The second, ongoing part of the ANNEXA-R study will include 40 healthy volunteers who will receive 20 mg once-daily rivaroxaban for 4 days and will then be randomly assigned to placebo or an 800 mg IV bolus of andexanet alfa followed by a continuous infusion of 8 mg/min for 120 minutes. Data from the second part of this study are anticipated in mid-2015.

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Biomarker May Predict Best Smoking Cessation Treatment
A genetic biomarker may help predict response to specific smoking cessation treatments, new research published online in Lancet Respiratory Medicine suggests. A multicenter, randomized controlled trial (RCT) of more than 1200 smokers showed that those who had a normal nicotine metabolite ratio had significantly higher quit rates after receiving varenicline for 11 weeks than those receiving a nicotine patch. Although for those who metabolized nicotine slowly, the efficacy of both treatments was equivalent, there were significantly more overall side effects with varenicline. The investigators note that because effectiveness and adverse effects vary widely among pharmacotherapies for treating tobacco dependence, they wanted to examine whether biomarkers in individual smokers could improve outcomes. "The NMR reflects the activity of the liver enzyme CYP2A6, the major nicotine-metabolizing and cotinine-metabolizing enzyme," the researchers report, adding that NMR also reflects both environmental and genetic effects ― unlike CYP2A6 genotyping. The RCT included 1246 adult smokers seeking treatment at one of four North American sites between November 2010 and September 2014. NMR status was determined at baseline through blood samples; 662 of the participants were found to be slow metabolizers of nicotine, and 584 found to be normal metabolizers. The slow metabolizers were less likely than normal metabolizers to be white (P < .0001) and more likely to be male (P = .001), younger (P = .02), and to smoke fewer cigarettes per day (P < .001). Results showed that normal metabolizers had more success with varenicline than with the patch at end of treatment (odds ratio [OR], 2.17; 95% confidence interval, 1.38 - 3.42; P = .001) and 6 months later (OR, 1.81; 95% CI, 1.05 - 3.11; P = .03). Quit rates at end of treatment in this group were 38.5% and 22.5%, respectively; at 6 months, the rates were 22.0% and 13.6%. There was no difference between varenicline and patch for the slow metabolizers at any time point. Although the quit rates were 30.4% and 27.7%, respectively, at end of treatment and 19.1% and 21.6, respectively, at 6 months, these were not significant. However, according to NMR-by-treatment interactions, for the slow metabolizers, side effects were more severe overall with varenicline than with placebo (P = .04). These differences included increases in nausea (P = .0003) and abnormal dreams (P = .005). The NMR-by-treatment interaction was not significant for side effects from the patch vs placebo. Finally, the number needed to treat was 4.9 for varenicline and 26.0 for nicotine patch in the normal metabolizers and 8.1 vs 10.3 in the slow metabolizers

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January 12, 2015

Hospital-acquired infections after cardiac surgery linked to cost, length of stay, readmission
Hospital cost, length of stay and readmissions were strongly associated with hospital-acquired infections following cardiac surgery, according to data from a new study published in JACC. In this study was investigated the cost associated with major types of hospital-acquired infections within 2 months after cardiac surgery. The researchers prospectively collected data from an observational study in which patients (n=4,320; mean age, 64 years; 66% men) were monitored for infection for 65 days after cardiac surgery, and merged that data with routinely collected financial data. The 2.8% of patients experienced a major hospital-acquired infection during index hospitalization. The most common major infections were pneumonia (48%), sepsis (20%) and Clostridium difficile colitis (18%). The estimated annual cost associated with an infection was $38,000, with 47% of that amount related to ICU services, according to the researchers. They found that on average, the length of stay of patients who had a major hospital-acquired infection was 14 days longer than those who did not. They also found that of the 849 readmissions in the study population, 8.7% were related to major hospital-acquired infections. The cost of readmissions due to infection was approximately threefold higher than the cost of readmissions due to other reasons, according to the researchers.

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Niacin lowered PCSK9 levels
Niacin is associated with a reduction in PCSK9 levels, according to a new study published in Am. J. Cardiol and this association could help explain how niacin reduces LDL, and could offset increases in PCSK9 levels associated with other lipid-lowering therapies. The researchers conducted three studies to determine the dose-dependence effects of statins on PCSK9 levels, to assess the effect of a fibrate on PCSK9 levels when added to a statin, and to investigate the impact of niacin on PCSK9 levels on the background of statin and/or fibrate therapy. In the first study, 74 people with hyperlipidemia were randomly assigned atorvastatin 10 mg/day, atorvastatin 80 mg/day or placebo for 16 weeks. They found that PCSK9 levels were increased in a dose-dependent fashion with statin therapy compared with placebo (placebo, mean increase 7%; 95% CI, –7 to 21; atorvastatin 10 mg/day, mean increase 19%; 95% CI, –5 to 42; atorvastatin 80 mg/day, mean increase 27%; 95% CI, 12-42; P=.02 vs. placebo). In the second study, 70 patients with carotid atherosclerosis were randomly assigned simvastatin 20 mg/day, simvastatin 80 mg/day or simvastatin 20 mg/day plus extended-release niacin 2 g/day for 12 months. The researchers found that PCSK9 levels increased with statin therapy (simvastatin 20 mg/day, mean change 13%; 95% CI, –14 to 40; simvastatin 80 mg/day, mean change 41%; 95% CI, 27-76; P<.0001), but that PCSK9 decreased with combination simvastatin/niacin therapy (mean change –13%; 95% CI, –3 to –23). In a third, open-label lipid kinetics study, 19 people with dyslipidemia were treated with atorvastatin 10 mg/day for 4 weeks, followed by the addition of fenofibric acid 135 mg/day for 8 weeks, and then the further addition of extended-release niacin 2 g/day for 10 weeks. Adding fenofibric acid led to a 23% (95% CI, 10-36) increase in PCSK9 (P=.001), but the addition of niacin resulted in a subsequent 17% (95% CI, –19 to –5) decrease in PCSK9 (P=.004), according to the researchers. They also found a positive association between changes in PCSK9 levels and changes in LDL levels (P=.006) induced by the addition of niacin.

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Elevated blood glucose linked to early death, other events in patients with acute HF
Slight elevation in blood glucose was associated with early mortality, future diabetes and future hospitalization among patients with acute HF, even those without diabetes, in a recent study published in Eur. Heart J. In a competing-risk analysis, the researchers evaluated 30-day mortality, new diabetes diagnoses and hospitalization outcomes in a population-based cohort of 16,524 patients (median age, 79 years; 49% men) who presented with acute HF in Ontario, Canada, between 2004 and 2007. Patients were stratified by concentration of blood glucose at presentation: 3.9 mmol/L to 6.1 mmol/L, >6.1 mmol/L to 7.8 mmol/L, >7.8 mmol/L to 9.4 mmol/L, >9.4 mmol/L to 11.1 mmol/L and >11.1 mmol/L. Evaluated outcomes included death at 30 days and 1 year after presentation, CV readmissions, HF readmissions, diabetes-related hospitalizations among patients with pre-existing diabetes and new diabetes diagnoses in those without pre-existing diabetes. Among 9.275 patients without diabetes, blood glucose >6.1 mmol/L at presentation was associated with increased risk for all-cause mortality (HR range=1.26 [95% CI, 1.05-1.5] to 1.5 [95% CI, 1.11-2.02]) and CV-related death (HR range=1.28 [95% CI, 1.03-1.59] to 1.64 [95% CI, 1.16-2.33]). Among 7,249 patients with diabetes, blood glucose >11.1 mmol/L at presentation was associated with increased risk for all-cause mortality (HR=1.48; 95% CI, 1.1-2) and diabetes-related hospitalization (HR=1.39; 95% CI, 1.2-1.61). In all patients, blood glucose >9.4 mmol/L at presentation was associated with increased risk for HF- or CV-related hospitalization (HR range=1.09 [95% CI, 1.02-1.17] to 1.15 [95% CI, 1.07-1.24)]. Among those without diabetes at baseline, the risk for diagnosis of incident diabetes increased with the level of blood glucose at presentation (HR range=1.61 [95% CI, 1.39-1.87] for >6.1-7.8 mmol/L to 3.61 [95% CI, 2.78-4.68] for >11.1 mmol/L).

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December 21, 2014

Higher fitness level reduced hypertension risk
People with high fitness levels may be less likely to have or develop hypertension, regardless of baseline risk factors, according to new findings from a study published in Journal of American Heart Association (JAHA). The researchers analyzed the association between fitness and hypertension in 57,284 participants from the Henry Ford Exercise Testing (FIT) Project, which was conducted between 1991 and 2009. The participants’ mean age was 53 years, 49% were women and 29% were black. They measured participants’ fitness via a clinician-referred treadmill stress test. Physical fitness was expressed in metabolic equivalents (METs) and was based on the workload derived from the maximal speed and grade achieved during total treadmill time. Participants were stratified into four groups: <6 METs, 6 to 9 METs, 10 to 11 METs and ≥12 METs. The primary outcomes were prevalent hypertension, defined as prior or baseline diagnosis of hypertension and use of antihypertensive medications, and incident hypertension, defined as a new diagnosis of hypertension confirmed by at least three separate consecutive encounters. The ≥12 METs group had lower odds of prevalent hypertension compared with the <6 METs group (adjusted OR=0.73; 95% CI, 0.67-0.8). During a median follow-up period of 4.4 years (interquartile range, 2.2-7.7), 36.4% of the 22,109 participants without hypertension at baseline were diagnosed with hypertension, according to the researchers. Unadjusted 5-year incidence rates were 49% for participants with <6 METs, 41% for those with 6 to 9 METs, 30% for those with 10 to 11 METs and 21% for those with ≥12 METs. After adjustment, participants with ≥12 METs had a 20% lower risk for incident hypertension compared with those with <6 METs (HR=0.8; 95% CI, 0.72-0.89). The results were consistent across age, sex, race, obesity, resting BP and diabetes status.

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Late Post-TAVR Bleeding Linked With Significant Mortality Risks (PARTNER subanalysis)
Nearly 6% of patients undergoing transcatheter aortic-valve replacement (TAVR) will experience a late major bleeding complication, and these bleeding events are associated with a significantly increased risk of death, according to a new analysis of the PARTNER study published in JACC. Between 30 days and one year, major late bleeding complications occurred in 142 of 2401 patients (5.9%) undergoing TAVR, the most common complication being gastrointestinal bleeds, neurological bleeds, and bleeding resulting from a traumatic fall. Individuals with late bleeding were nearly four times more likely die between 30 days and 1 year, report investigators. The researchers also identified significant predictors of late bleeding. These included the presence of low hemoglobin levels at baseline, atrial fibrillation or flutter at baseline, the presence of a moderate or severe paravalvular leak at 30 days, and a larger left ventricular mass at 30 days. The median time between the procedure and the late major bleeding event was 132 days. Gastrointestinal bleeding occurred in 40.8% of patients, neurological bleeding occurred in 15.5% of patients, and falls or trauma were responsible for bleeding in 7.8% of patients. Access-site bleeding related to the procedure occurred in 2.1% of patients.

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Confounding factors may partially explain results of SYMPLICITY HTN-3
Post-hoc analyses derived from patient subgroups indicated several potential confounding factors that may help explain the unexpected BP results in the control and intervention groups from the SYMPLICITY HTN-3 trial, researchers reported. They performed post-hoc analyses to identify predictors of systolic BP change, examine the influence of medication changes, review results from selected subgroups and assess procedural factors and they published online in Eur. Heart Journal their results. They found that 39% of patients underwent medication changes between randomization and 6 months. Predictors of reduction in office systolic BP in both groups included a baseline office systolic BP ≥180 mm Hg, use of aldosterone antagonists and nonuse of vasodilators. In the renal denervation group, number of ablations also was identified as a predictor. The treatment effect of renal denervation was more pronounced in nonblack patients compared with black patients, according to the study. Nonblack patients assigned renal denervation had a greater reduction in office systolic BP at 6 months compared with nonblack patients assigned the sham procedure (–15.2 mm Hg vs. –8.6 mm Hg; P=.012). When the groups were propensity-score matched by baseline characteristics, differences in office systolic BP, ambulatory systolic BP and heart rate increased with a rising number of ablations in the treatment group; it was statistically significant for office systolic BP (P for trend=.01) and heart rate (P for trend<.01), as well as for ambulatory systolic BP in patients who received 12 or 13 ablations (P=.002). A similar but nonsignificant trend was observed in patients who had delivery of ablations in a four-quadrant pattern to at least one renal artery.

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December 15, 2014

Dual-chamber settings in ICDs reduced risk for inappropriate shock (OPTION study)
Compared with single-chamber settings, dual-chamber settings for implantable cardioverter defibrillators were associated with reduced risk for inappropriate shock without increases in morbidity and mortality, according to the results of the OPTION study which published in JACC Heart Failure Journal. According to the study background, use of dual-chamber ICDs may allow better discrimination of supraventricular arrhythmias and therefore reduce inappropriate shocks, but also may be linked to detrimental ventricular pacing. In the study were enrolled 462 patients with de novo primary or secondary prevention indications for ICD placement and left ventricular ejection fraction ≤40% despite an optimal pharmacotherapy regimen in the single blind OPTION trial. Patients received atrial leads and dual-chamber defibrillators) that were randomly assigned to programming with single- or dual-chamber settings. The primary outcomes were time to first occurrence of inappropriate ICD shock and occurrence of all-cause death or CV hospitalization, defined as hospitalization for congestive HF, symptomatic atrial fibrillation, cardioversion of AF, stroke and undetected/untreated ventricular tachycardia. Follow-up was 27 months. During the study period, time to first inappropriate shock was longer in the dual-chamber group than the single-chamber group (HR=2.5; 95% CI, 1.2-5.3). Inappropriate shocks were received by 4.3% of those in the dual-chamber group vs. 10.3% in the single-chamber group (P=.015). Rates of all-cause death or CV hospitalization were 20% for the dual-chamber group vs. 22.4% for the single-chamber group, satisfying the predefined margin for equivalence (P for equivalence <.001), according to the researchers. There were no significant differences between the groups in system-related complications.

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Higher insulin dosage for type 2 diabetes may increase mortality risk
Patients with type 2 diabetes taking exogenous insulin could be at increased risk for death from all causes, major adverse cardiovascular events and cancer with increasing dosage, according to research published in Diabetes, Obesity and Metabolism. There was an association between the dose of prescribed insulin and increased risk of all-cause mortality. A statistically significant association with major adverse cardiovascular events and cancer was also observed. Using the UK Clinical Practice Research Datalink, the researchers identified 6.484 patients (mean age at baseline, 64 years) with type 2 diabetes who progressed to insulin monotherapy from 2000 onward and followed them for an average of 3.3 years. Risks of progression to serious adverse outcomes — all-cause mortality, incident major adverse cardiovascular events (MACE) and incident cancer — were compared using Cox proportional hazards models. Insulin exposure as a cumulative, continuous, annually updated, time-dependent covariable was introduced into the model as prescribed international units per kilogram per day; results were reported in four patient groups, defined by the doses ranging from <0.5 units per kilogram of bodyweight per day, up to doses >1.5 units. The analysis of medical history showed 1,110 deaths, 342 MACE and 382 incident cancers. Unadjusted event rates, per 1,000 person-years, were 61.3 deaths, 26.4 incident MACE and 24.6 incident cancers. Adjusted HRs, relative to 1-unit increases in insulin dose, were 1.54 (95% CI, 1.32-1.78) for all-cause mortality, 1.37 (95% CI, 1.05-1.81) for MACE and 1.35 (95% CI, 1.04-1.75) for cancer. When compared to patients who received doses of less than 0.5 units, our findings indicate that patients receiving doses of between 1 to 1.5 units and more than 1.5 units were associated with a much greater death rate over time.

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Cataracts From Statins? More Signals Emerge in Analyses
Statin therapy significantly elevates the risk of developing cataracts severe enough to warrant surgery, suggests analyses of two distinct cohorts, one from Canada and another from the US, that add to a hazy landscape of prior studies variously concluding for or against such a risk for the widely used drugs. For now, the possibility of such a risk from statins and its potential mechanisms should be explored in prospective trials, "especially in light of increased statin use for primary prevention of cardiovascular disease and the importance of acceptable vision in old age, when cardiovascular disease is common," according to the report, published in the December 2014 issue of the Canadian Journal of Cardiology. One of the cohorts consisted of men and women who went to ophthalmologists from 2000 to 2007, as recorded in British Columbia Ministry of Health databases. Cases consisted of 162 501 patients who during follow-up became candidates for surgery to correct cataracts; they were matched on the basis of age and follow-up time with 650 004 control subjects with no such history of cataracts. Together, their mean age was 73 years and they were followed for about 1.7 years. For this group, the relative risk (RR) of cataracts severe enough for surgery associated with statin use for at least a year was 1.27 (95% CI 1.24–1.30) adjusted for age, follow-up time, sex, and cataract risk factors prior to cohort entry, including diabetes, hypertension, glaucoma, MI or stroke, and treatment with steroids or selective serotonin reuptake inhibitors (SSRIs). The adjusted RR for lovastatin was 1.14 (95% CI 1.04–1.26) and for rosuvastatin (Crestor, AstraZeneca) was 1.42 (95% CI 1.27–1.59), with risks for other statins falling in between. The other cohort derived from USA and included men aged 40 to 85 years (mean about 72 years) seen from 2001 to 2011; the 45 065 patients who developed cataracts made up the cases and 450 650 subjects with no history of cataracts were the controls. Follow-up averaged 1.9 years. The similarly adjusted RR for surgery-indicated cataracts associated with at least a year of statin therapy was 1.07 (95% CI 1.04–1.10). The RRs ranged from 1.03 for fluvastatin to 1.14 for lovastatin and reached significance for the latter agent and simvastatin, atorvastatin, and use of more than one statin; the risk was nonsignificant for pravastatin and rosuvastatin as well as fluvastatin.

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December 08, 2014

NSAIDs linked to bleeding, thromboembolism risk in AF
The use of nonsteroidal anti-inflammatory drugs is associated with an increased risk for serious bleeding and thromboembolism among patients with atrial fibrillation, according to recent findings of an observational cohort study which published in the Ann. Int. Med. Journal In this study, the researchers reviewed data on 150,900 patients collected from a nationwide registry in Denmark. All patients were aged at least 30 years (median age, 75 years) and had been hospitalized with a first-time diagnosis of AF between 1997 and 2011. The cohort was 47% female. Use of the following treatment regimens was recorded: single-antiplatelet therapy with aspirin or clopidogrel; monotherapy with an oral anticoagulant, or dual therapy with an oral anticoagulant and a single antiplatelet. NSAID use also was recorded. The primary outcome was serious bleeding, defined as hospitalization or death due to intracranial, gastrointestinal or respiratory/urinary tract bleeding, or anemia resulting from bleeding during a median follow-up of 6.2 years. Secondary endpoints included death or hospitalization due to thromboembolism, along with all-cause mortality. Patients received an antiplatelet or oral anticoagulant at baseline in 69.8% of cases, whereas 5% received a concomitant NSAID. During follow-up, 35.6% of the patients were prescribed an NSAID. Serious bleeding events occurred in 11.4% of patients, and 13% experienced thromboembolism. Death occurred in 48.8% of the population, and 12.4% of observed bleeding events were fatal. At 3 months, the absolute risk for serious bleeding within 14 days of taking an NSAID was 3.5 events per 1,000 patients vs. 1.5 events per 1,000 patients among those who did not take an NSAID (risk difference, 1.9 events per 1,000 patients). Among patients placed on a regimen of oral anticoagulants, the difference in absolute risk compared with those on NSAIDs was 2.5 events per 1,000 patients. Risk for serious bleeding (HR=2.27; 95% CI, 2.15-2.4) and thromboembolism (HR=1.36; 95% CI, 1.27-1.45) was associated with NSAID use compared with nonuse across all antithrombotic regimens and NSAID types. Risk for all-cause mortality was significantly increased among concomitant NSAID users. Among patients hospitalized for a nonfatal bleeding incident, prognosis was poorer among those with NSAID exposure at the time of the event (HR=1.22; 95% CI, 1.12-1.33). An NSAID dosage exceeding the minimum recommended dose further increased bleeding risk, the researchers wrote, even with short-term NSAID use.

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Early valve surgery did not affect mortality in S. aureus endocarditis
Early valve surgery did not reduce 1-year mortality among patients with Staphylococcus aureus prosthetic valve infective endocarditis, according to recent study published in Clinical Infectious Diseases Journal. The researchers examined data from the International Collaboration on Endocarditis – Prospective Cohort Study. There were 5,668 cases prospectively recorded from January 2000 to December 2006. The researchers excluded cases in IV drug users, cases of right-sided valve infective endocarditis or native valve infective endocarditis and cases with missing data. Among the 747 patients with left-sided prosthetic valve infective endocarditis (PVIE), 168 were due to S. aureus and underwent evaluation. Patients who had early valve surgery (44.3%) showed lower 1-year mortality rate than patients who did not receive early valve surgery (33.8% vs. 59.1%; P=.001). However, the association did not persist in a multivariate, propensity-adjusted model (RR=0.67; 95% CI, 0.39-1.15). The researchers identified three variables associated with 1-year mortality: age (per 1-year increment, HR=1.03; 95% CI, 1.01-1.05), stroke (time-dependent HR=2.56; 95% CI, 1.62-4.05) and congestive heart failure (HR=2.06; 95% CI, 1.29-3.3).

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Rosuvastatin failed to reduce fracture risk in JUPITER analysis
Rosuvastatin was not associated with a reduced risk for fracture in men and women with elevated high-sensitivity C-reactive protein enrolled in the JUPITER trial according to a new study published online in JAMA Int. Med. Previous observational studies have suggested a link between statin use and reduced risk for fractures, possibly because inflammation can play a role in both CVD and osteoporosis; however, there was little evidence from randomized trials, according to the study background. The researchers analyzed participants from the JUPITER trial, which enrolled 17,802 men aged 50 years or older and women aged 60 years or older with high-sensitivity CRP ≥2 mg/L. Participants were randomly assigned rosuvastatin (Crestor, AstraZeneca) 20 mg/day or placebo and were observed for up to 5 years. Median follow-up was 1.9 years. Incident fracture was a prespecified secondary endpoint of the JUPITER trial. Overall, 431 incident fractures occurred during the study period. Of those, 221 occurred in the rosuvastatin group and 210 in the placebo group. The incidence of fracture was 1.2 per 100 person-years in the rosuvastatin group vs. 1.14 per 100 person-years in the placebo group (adjusted HR=1.06; 95% CI, 0.88-1.28).

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December 01, 2014

Non–infarct-related artery disease common in patients with STEMI
Results from a retrospective pooled analysis of eight clinical trials which published in JAMA suggest that obstructive non–infarct-related artery disease is common in patients who present with STEMI, and it may increase the risk for 30-day mortality. Researchers evaluated data on 68,765 patients extracted from eight independent, international, randomized clinical trials of STEMI published from 1993 to 2007. They examined demographics, clinical risk factors, comorbidities, cardiac manifestations, hemodynamic status and left ventricular function, angiographic information regarding infarct-related artery disease and non–infarct-related artery disease for each vessel territory, in-hospital medications and mortality data. Angiographic data were available for 28,282 patients. The primary outcome was all-cause mortality within 30 days after STEMI. Obstructive non–infarct-related artery disease was found in 52.8% of patients (n=14,929). Of those, 29.6% involved a single vessel and 18.8% involved two vessels, according to the results. The researchers reported no difference in the degree or distribution of non–infarct-related artery disease based on the infarct-related artery territory. In unadjusted and adjusted analyses, patients with non–infarct-related artery disease had significantly higher rates of 30-day mortality compared with patients without non–infarct-related artery disease (unadjusted: 4.3% vs. 1.7%; P<.001; adjusted: 3.3% vs. 1.9%; P<.001).

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Cardiac troponin I levels predicted STEMI outcomes (PROTECTION AMI study)
In a new analysis published online in Circulation, researchers reported an independent association between measurement of cardiac troponin I levels after primary PCI for STEMI and clinical outcomes and cardiac function. Circulating levels of cardiac troponin I after STEMI have been linked to infarct size and chronic left ventricular dysfunction; however, there are fewer data on how cardiac troponin I levels affect clinical endpoints and biochemical markers of global cardiac function, according to background information in the study.The post-hoc analysis included 1,066 participants who received primary PCI in the PROTECTION AMI trial. Cardiac troponin I levels were measured at several points during the index hospitalization. At 3 months, the patients were reassessed for N-terminal pro–B-type natriuretic peptide and LV ejection fraction. Upon admission, the median cardiac troponin I level was 0.4 mcg/L. This increased to 33.1 mcg/L after 16 to 24 hours and 9.1 mcg/L at 70 to 80 hours, according to the results. Adjusted analysis indicated independent associations between all post-PCI single-points, peak and area under the curve with clinical events, NT-proBNP >118 pmol/L and LVEF <40% (P<.001 for all). The researchers added circulating cardiac troponin I to the baseline risk model with the aim of predicting clinical events. This addition was associated with an improvement in C-statistic of 0.779 to 0.846 at 16 to 24 hours and 0.859 at 70 to 80 hours. When the researchers quantified the improvement by integrated discrimination improvement, they observed a significant increase in predictive ability (relative integrated discrimination improvement: 44% to 154%; P<.001) with the addition of cardiac troponin I to the model. They also reported significant improvements in discrimination of NT-proBNP >118 pmol/L and LVEF <40%, according to the results.

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Beta-blockers lowered all-cause mortality in patients with heart failure with preserved ejection fraction
Patients with HF with preserved ejection fraction who received treatment with beta-blockers had lower rates of all-cause mortality, according to new study data which published in JAMA. However, the same trend was not observed with beta-blocker use and combined all-cause mortality and hospitalization for HF in this patient population. The researchers reviewed data on 41.976 consecutive patients with clinician-judged HF enrolled in the Swedish Heart Failure Registry from July 1, 2005, to Dec. 30, 2012. For this study, HFpEF was defined as EF of ≥40%. In total, 19.083 patients had HFpEF. Patients with HFpEF were matched 2:1 for beta-blocker use.The overall patient population was followed for a median of 755 days and the matched cohort was followed for a median of 709 days. Among the patients with HFpEF, those treated with beta-blockers had a 1-year survival rate of 80% compared with 79% for those who were untreated. The 5-year survival rate was 45% in the treated group vs. 42% in the untreated group. Overall, 2.279 total deaths (41%; 177 per 1,000 patient-years) occurred in patients with HFpEF treated with beta-blockers vs. 1,244 total deaths (42%; 191 per 1,000 patient-years) in the patients who were untreated (HR=0.93; 95% CI, 0.86-0.996). The researchers found no reduction in combined mortality or HF hospitalization related to beta-blocker use. The treated group experienced 3,368 (61%) total first events vs. 1,753 (64%) total first events in the untreated group. There were 371 first events per 1,000 patient-years in the treated group vs. 378 first events per 1,000 patient-years in the untreated group (HR=0.98; 95% CI, 0.92-1.04). The authors also studied 22,893 patients with HF with reduced EF (HFrEF) for a positive-control consistency analysis. Of those, 6,081 were matched (4,054 treated patients, 2,027 untreated patients). In the matched group of patients with HFrEF, the researchers observed an association between beta-blocker use and decreased mortality (HR=0.89; 95% CI, 0.82-0.97) and with reduced combined mortality or HF hospitalization (HR=0.89; 95% CI, 0.84-0.95).

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November 24, 2014

Η Γερουσία των ΗΠΑ διεξάγει έρευνα για την απότομη αύξηση της τιμής των γενοσήμων φαρμάκων
Η απότομη αύξηση του κόστους των γενόσημων φαρμάκων κατά τη διάρκεια των τελευταίων 18 μηνών είναι στο επίκεντρο ομοσπονδιακής έρευνας και αφορμή για την κατάθεση ενός νέου νομοσχεδίου που κατατέθηκε από ειδική επιτροπή της Γερουσίας των ΗΠΑ. Τον Οκτώβριο, τα μέλη του Κογκρέσου είχαν στείλει επιστολές σε 14 κατασκευαστές γενοσήμων φαρμάκων απαιτώντας μια εξήγηση για την άνοδο των τιμών. Είναι χαρακτηριστικό ότι το κόστος που καλείται να πληρώσει ο ασθενής για την αγορά διγοξίνης οχταπλασιάστηκε, αυξανόμενο από 15$ το περασμένο έτος σε 120$ το 2014. Όπως ανέφερε Αμερικανός αξιωματούχος ένας στους τέσσερις Αμερικανούς δεν μπορεί να λάβει την φαρμακευτική του αγωγή, επειδή δεν μπορεί να αντέξει το κόστος. Σύμφωνα με τα ομοσπονδιακά αρχεία που παρουσιάστηκαν τεκμηριώνεται ότι από τον Ιούλιο του 2013 μέχρι τον Ιούλιο του 2014 σχεδόν στο 10% των γενόσημων φαρμάκων η τιμή υπερδιπλασιάστηκε. Κατά την ίδια περίοδο σε 1.215 γενόσημα φάρμακα η τιμή αυξήθηκε κατά 448%.


CABG outperformed PCI in patients with diabetes
PCI was associated with increases in mortality and a composite of adverse events compared with CABG in patients with diabetes, leading researchers to conclude that CABG may be the preferred revascularization technique in this patient population.Researchers of the retrospective analysis, which was published in the Annals of Internal Medicine, reviewed several databases for randomized controlled trials comparing PCI with drug-eluting or bare-metal stents and CABG in patients with diabetes and multivessel or left main CAD. Forty studies conducted between Jan. 1, 1990 and June 1, 2014 underwent analysis for study design, quality, patient characteristics, follow-up duration and patient outcomes. According to the researchers, the studies were combined using a Bayesian network meta-analysis, which accounted for the variation in stent choice. A composite of all-cause death, non-fatal MI and stroke served as the primary outcome measure. PCI was associated with an increase in this composite outcome (OR=1.33; 95% credible interval [CrI], 1.01-1.65). Mortality also increased with PCI (OR=1.44; 95% CrI, 1.05-1.91), but there was no significant difference in the frequency of MI (OR=1.33; 95% CrI, 0.86-1.95). In addition, there were fewer strokes in the PCI group (OR=0.56; 95% CrI, 0.36-0.88). The researchers noted heterogeneity in study design as a limitation, along with the fact that the mortality findings were largely driven by a single study, and that cost and nonvascular complications did not undergo analysis.

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Co-trimoxazole linked to sudden death in older patients on renin-angiotensin inhibitors
The use of co-trimoxazole increased risk for sudden death among older patients on a regimen of ACE inhibitors or angiotensin receptor blockers, according to recent findings. In a population-based, nested case-control study, researchers evaluated data from 1.601.542 Ontario, Canada, residents aged at least 66 years who had been on a regimen of ACE inhibitor or angiotensin receptor blocker from 1994 to 2011. Researchers reviewed prescription drug claims from the Ontario drug benefit database and acquired hospital admission data from the Canadian Institute for Health Information discharge abstract database. Among 39.879 patients who experienced sudden death within this population, 1.027 occurred within 7 days of receiving one of the following antibiotics: co-trimoxazole, ciprofloxacin, norfloxacin, nitrofurantoin and amoxicillin. For each case of sudden death, up to four age-matched controls were selected who were alive at the index date and had received one of the evaluated antibiotics in the 7 days before the index date (n=3,733). The primary outcome measure was the odds ratio for the correlation between sudden death and exposure to each antibiotic in relation to amoxicillin, which served as the reference drug. Compared with amoxicillin, co-trimoxazole was associated with an increased risk for sudden death within 7 days (adjusted OR=1.38; 95% CI, 1.09-1.76), whereas a weaker association with increased risk for sudden death was observed with ciprofloxacin (adjusted OR=1.29; 95% CI, 1.03-1.62), but not with norfloxacin (adjusted OR=0.74; 95% CI, 0.53-1.02). Researchers noted a reduced risk for sudden death among nitrofurantoin recipients compared with amoxicillin recipients (adjusted OR=0.64; 95% CI, 0.46-0.88). In a supplementary analysis in which sudden death was defined as death within 14 days of antibiotic prescription, 1,827 cases of sudden death were matched to 6,771 controls. The association between sudden death and co-trimoxazole prescription persisted (adjusted OR=1.54; 95% CI, 1.29-1.84 vs. amoxicillin), but no associations were observed with the other evaluated antibiotics. According to the researchers, the link between co-trimoxazole and sudden death may be attributable to co-trimoxazole–induced hyperkalemia in a particularly susceptible population.

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WOSCOPS at 20 Years: Study Shows Lifetime Benefit With 5 Years of Statin Therapy
Twenty-year follow-up of the West of Scotland Coronary Prevention Study (WOSCOPS) has shown that treatment with a statin for 5 years provides a "persistent reduction in cardiovascular disease outcomes" over the course of 2 decades. In the follow-up study, which was presented at the American Heart Association (AHA) 2014 Scientific Sessions, Dr Chris Packard (University of Glasgow, Scotland) suggested that just 5 years of treatment with pravastatin might provide a legacy effect over the course of an individual's lifetime. For the primary end point, by the time 20 years had passed, we could see that it's actually taking an extra 5 years for the statin-treated group to reach the same level of risk as the placebo-treated group. In other words, there is a 5-year gain in event-free years if you start LDL lowering at the age we started, which is around 50 years old. The study shows a "remarkable persistence" in terms of cardiovascular risk reduction over such a long period of time, suggesting that statin treatment alters the natural history of the disease in some way by lowering LDL cholesterol. The 20-year follow-up data are based on a 5-year difference in LDL-cholesterol lowering with pravastatin. In the trial, pravastatin lowered LDL-cholesterol levels by 26% and total-cholesterol levels by 20%. For clinical outcomes, the reduction in the primary end point in WOSCOPS was sustained over the 20-year follow-up period. At 20 years, coronary heart disease mortality was reduced 27% and all-cause mortality by 13%. Also, the need for coronary revascularization was reduced by 19%, heart failure by 31%; there was no effect on stroke. Importantly, the investigators observed no signal of cancer with statin therapy, a finding that would have been uncovered over such a long follow-up period if one existed. There was a significant reduction in the number of days patients were hospitalized for any cardiovascular event over the two decades, including a reduction in days hospitalized for MI.

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November 17, 2014

Beta-Blockers Reduce Mortality in Diastolic Heart Failure
The use of beta-blockers in patients with heart failure and preserved ejection fraction (HFPEF) is associated with a lower risk of all-cause mortality but not the combined end point of all-cause mortality or first hospitalization for heart failure according to a new study published in JAMA. The authors found that after a median of 755 days, 36% of patients who received a beta-blocker had died compared with 46% of those who did not receive one (P<0.001). Of those who received a beta-blocker, 84% were still alive at 1 year compared with 78% of those who did not. At 5 years, 51% of those who received a beta-blocker were still alive compared with 41% of those who did not (P<0.001). The unadjusted hazard ratio (HR) for all-cause mortality throughout follow-up was 0.73 (P<0.001). Investigators identified 19 083 patients with HFPEF; 15 786 had received beta-blockers and 3297 did not. Of these patients, 8244 patients with HFPEF were matched using a 2:1 ratio based on age and propensity scores for beta-blocker use. In this propensity-matched cohort, 5496 patients had received beta-blockers and 2748 had not. In the propensity-score–matched HFPEF cohort, all-cause mortality at a median follow-up of 709 days was also lower, at 41% in the beta-blocker group compared with 45% in the non–beta-blocker group (P=0.04). At 1 year, 80% of the beta-blocker group were still alive compared with 79% of those who did not receive beta-blockers. At 5 years, 45% of the beta-blocker group vs 42% of the non-beta-blocker group were alive. The HR throughout follow-up for all-cause mortality in the propensity-score–matched HFPEF was 0.93 (P=0.04). Of the overall cohort who received beta-blockers, 62% were also free from heart-failure hospitalization at 1 year compared with 58% of the non-beta-blocker group. In the propensity-score matched cohort, 58% of the beta-blocker group were free from heart failure hospitalization at 1 year compared with 59% of those who did not receive beta-blockers.

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Atrial fibrillation before TAVR linked with poorer outcomes
Among patients undergoing transcatheter aortic valve replacement, prior atrial fibrillation was associated with a nearly threefold increase in risk for adverse outcomes, according to recent findings in a study published in Am. J. Cardiol. The researchers aimed to evaluate the extent to which AF impacts procedural outcomes in TAVR in a cohort of 137 patients with severe aortic stenosis. The researchers assessed factors that predicted new-onset AF, including post-procedural outcomes and adverse events with a focus on the presence or absence of previous or post-procedural AF. Forty-nine percent of the cohort demonstrated AF before TAVR. New-onset AF was reported in 21% of patients after TAVR. The cumulative incidence of post-procedural AF was 60%, according to the results. Half of the episodes of new-onset AF occurred within 24 hours of TAVR. New-onset AF occurred more frequently among patients who underwent transapical TAVR (adjusted OR=5.05; 95% CI, 1.40-18.20). Patients with prior AF were significantly more likely to experience the composite outcome of all-cause death, stroke, vascular complications and repeat hospitalizations at 1 month than patients who did not previously have AF (adjusted OR=2.60; 95% CI, 1.22-5.54). Patients who experienced AF after TAVR stayed in the ICU an average of 70 hours longer than patients without AF (95% CI, 25-114.7). Patients with AF also stayed in the hospital longer, with an increased duration of 6.7 days (95% CI, 4.69-8.73).

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Most Patients With CKD Should Take Statins, but Only Half Do
At least 92.0% of patients aged 50 to 79 years with chronic kidney disease (CKD) should be taking statins, according to two different sets of guidelines, researchers report in an article published online in the Journal of the American Society of Nephrology. Although the American College of Cardiology/American Heart Association (ACC/AHA) guidelines do not consider CKD a risk factor for heart disease, the investigators found that most patients with CKD fit at least one of the criteria. Only 50.0% of the patients studied were already taking statins. In the current study, the researchers analyzed data from 4726 patients with CKD from the Reasons for Geographic and Racial Differences in Stroke (REGARDS) study to determine how many patients fall into a category in which one guideline recommends they receive statins and the other does not. (The REGARDS study was originally designed to compare stroke risk factors across the United States.) The included patients were not receiving dialysis and were in the age range of 50 to 79 years; the KDIGO guidelines recommend statins for all patients aged 50 years and older, whereas the ACC/AHA guidelines do not recommend initiating statins for primary prevention past age 79 years. Among the patients, 50.0% were already taking statins, 35.5% had a history of atherosclerotic cardiovascular disease, 39.9% had diabetes, and 3.2% had low-density lipoprotein cholesterol levels of at least 190 mg/dL. Overall, just 8.0% of the patients did not meet the ACC/AHA criteria to recommend statins. (These patients, because of their age and kidney disease, would all be recommended statins under the KDIGO guidelines.) For 19.8% of the patients, the recommendation to take statins comes from their 10-year risk, as calculated by Pooled Cohort equations.

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November 10, 2014

European Medicines Agency Recommends Closer Monitoring of Ivabradine-Treated Patients
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed a review of ivabradine and has made recommendations aimed at reducing the risk of heart problems, including heart attack and bradycardia, in patients taking the medicine.
The PRAC made recommendations about the resting heart rate of patients before starting treatment or when the dose is adjusted, recommendations on when treatment should be stopped andrecommendations regarding use with other medicines. Because patients treated with ivabradine are at an increased risk of developing atrial fibrillation the PRAC recommended monitoring for this condition in patients treated with ivabradine. In addition, the PRAC recommended that, when used for angina, the drug should only be used to alleviate symptoms as the available data do not indicate that the medicine provides benefits on outcomes such as reducing heart attack or cardiovascular death . These recommendations follow a review of the final data from the SIGNIFY study, which evaluated whether treatment with ivabradine in patients with coronary heart disease
without heart failure reduces the rate of events such as heart attacks when compared with placebo (a dummy treatment). The study showed that in a subgroup of patients who had symptomatic angina (Canadian Cardiovascular Society class II - IV) there was a small but significant increase in the combined risk of cardiovascular death or non-fatal heart attack with Corlentor/Procoralan compared with placebo (3.4% vs 2.9% yearly incidence rates). The data also indicated a higher risk of bradycardia with ivabradine compared with placebo (17.9% vs. 2.1%).
In its evaluation the PRAC also assessed other available data on the safety and effectiveness of ivabradine which showed that the risk of atrial fibrillation is increased in patients treated with ivabradine compared with controls (4.86% vs 4.08%).
The PRAC considered that the higher dose used in the study did not fully explain the findings. However, the Committee reiterated that the starting dose for angina should not exceed 5 mg twice a day and that the maximum dose should not exceed 7.5 mg twice a day. The PRAC recommendations will now be forwarded to the Committee for Medicinal Products for Human Use (CHMP), which will adopt the Agency’s final opinion and provide clear guidance to patients and healthcare professionals.

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HbA1c Levels, Not Fasting Plasma Glucose, Predict LV Dysfunction After STEMI
HbA1c levels are predictive of left ventricular diastolic dysfunction and impaired filling pressures following ST-segment-elevation MI (STEMI), whereas fasting plasma glucose levels had poor prognostic value, according to the results of a new report published in the Canadian Journal of Cardiology. The study also showed that HbA1c levels identified previously undiagnosed diabetic patients and that the concordance between HbA1c and fasting plasma glucose levels was poor. Researchers say the reason for the poor concordance between HbA1c and fasting plasma glucose as criteria for diagnosing diabetes in the study is likely the result of "stress hyperglycemia" that can develop in the setting of acute illnesses.
Of the 142 STEMI patients, the mean fasting plasma glucose and HbA1c levels were 7.7 mmol/L and 6.5%, respectively. In this population, there were 33 patients already known to be diabetic. Of the 109 patients not known to be diabetic at the time of admission, HbA1c levels identified another 18 patients as having diabetes. For these 109 patients, 31 had a fasting plasma glucose >7.0 mmol/L, but only 29% had an HbA1c >6.5%. The kappa, which measures the degree to which HbA1c and fasting plasma glucose levels agreed with each other in the diagnosis of new diabetics, was 0.27, which the researchers say is poor.
In their analysis, left ventricular function was was measured as the average septal and lateral early diastolic velocities. In a multivariable analysis, impaired left ventricular function was independently associated with HbA1c levels but not with fasting plasma glucose. Similarly, filling pressure was independently associated with HbA1c but not fasting glucose levels. An HbA1c cutoff of 6.4% was associated with increased filling pressures, report investigators.

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Real-World Analysis Supports Culprit-Lesion Over Multivessel PCI in STEMI Patients
A real-world analysis of ST-segment-elevation MI (STEMI) patients undergoing primary PCI has shown that treating the culprit lesion only is associated with a lower rate of in-hospital major adverse cardiovascular events (MACE) and lower mortality at 30 days and 1 year compared with individuals who undergo a more comprehensive multivessel intervention. For those undergoing culprit-lesion primary PCI, the in-hospital MACE, 30-day mortality, and 1-year mortality rates were 4.6%, 4.7%, and 7.4%, respectively, whereas the corresponding event rates were 7.2%, 7.7%, and 10.1% for patients undergoing multivessel PCI. These differences were statistically significant and support the current European practice guidelines that recommend culprit-lesion PCI in STEMI patients, according to the researchers.
For the analysis of the London Heart Attack Center Group, included 3984 STEMI patients with multivessel disease undergoing primary PCI at eight tertiary cardiac centers in London, UK. Of these, 3429 patients underwent culprit-lesion revascularization and 555 patients were treated with complete revascularization. In their analysis, culprit-lesion PCI was associated with lower mortality at 30 days and 1 year. For in-hospital outcomes, treating the culprit lesion resulted only in lower in-hospital MACE, a reduction that was driven by significant reductions in reinfarction, reintervention, and mortality. In a multivariate-adjusted model, culprit-lesion PCI was an independent predictor of death at 30 days (hazard ratio 0.45; P<0.001) and 1 year (hazard ratio 0.65; P=0.011). For the in-hospital outcomes, culprit-lesion PCI was an independent predictor of MACE, as well as in-hospital reinfarction and in-hospital mortality. In a propensity-matched analysis adjusted for differences in demographics and clinical, anatomic, and procedural variables, the results were consistent with the overall findings.

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November 3, 2014

Cotrimoxazole Combined With ACE Inhibitor or ARB Could Raise Risk of Sudden Death
The risk of sudden death went up by more than a third in older patients taking ACE inhibitors or angiotensin-receptor blockers (ARBs) who were also put on the antibacterial agent cotrimoxazole, compared with those who were instead given amoxicillin, in a case-control studyb published in BMJ. The finding was independent of comorbidities, other medications, recent procedures, and other potential influencers of sudden-death risk. he elevated risk with cotrimoxazole, a combination of sulfamethoxazole and trimethoprim widely used for decades, was likely caused by its capacity for raising serum potassium, which became fatal on top of other medications known for causing hyperkalemia.
Tapping data from patients aged 66 or older who received ACE inhibitors or ARBs in Ontario from 1994 to 2012, the researchers identified outpatients who died of sudden death within 7 days of being prescribed cotrimoxazole, amoxicillin, ciprofloxacin, norfloxacin, or nitrofurantoin. Those 1027 cases were matched to 3733 controls alive within that time frame relative to the antibiotic prescriptions, based on, among other things, age, sex, chronic kidney disease, and diabetes. The adjusted odds ratios (95% CI) for sudden death within 7 days of an antibiotic prescription on top of an ACE inhibitor or ARB, by antibiotic, relative to amoxicillin (which does not pose a hyperkalemia risk itself or prolong the QT interval) were: 1.38 (1.09–1.76) for cotrimoxazole, 1.29 (1.03–1.62) for ciprofloxacin, 0.74 (0.53–1.02) for norfloxacin and 0.64 (0.46–0.88) for nitrofurantoin. When they looked at the adjusted odds of sudden death within 2 weeks of the antibiotic prescription, rather than 7 days, the OR with cotrimoxazole went up slightly to 1.54 (95% CI 1.29–1.84). But the elevated OR with ciprofloxacin seen over 7 days had attenuated over the longer time window to 1.18 (1.00–1.39).

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Platelet activation linked to MI in patients with pneumonia
Myocardial infarction (MI) appears to be an early complication of pneumonia and is associated with in vivo platelet reactivation, according to study data published in the Journal of the American College of Cardiology. Researchers investigated the relationship between troponin elevation and in vivo biomarkers of platelet activation, including plasma soluble P-selectin, soluble CD40 ligand and serum thromboxane B2, in the early phase of hospitalization. The study included 278 patients with community-acquired pneumonia. Serum high-sensitivity cardiac troponin T levels were obtained every 12 hours and ECGs were taken every 24 hours. Patients were followed until end of hospital stay. The primary endpoint was MI. Of the 144 patients with elevated high-sensitivity cardiac troponin T levels, defined as >0.14 mcg/L, 31 had signs of MI and 113 did not.
Compared with patients who did not develop signs of MI, those who developed signs of MI had higher baseline levels of soluble P-selectin (P<.001), soluble CD40 ligand (P<.001) and serum thromboxane B2 (P=0.004). When the researchers performed logistic regression analysis, plasma soluble CD40 ligand (P<0.001), soluble P-selectin (P<0.001), serum thromboxane B2 (P=0.03), mean platelet volume (P=0.037), pneumonia severity index score (P=.03) and ejection fraction (P=.001) were identified as independent predictors of MI. The researchers found no difference in rate of MI between patients taking aspirin (12%) and those not taking aspirin (10%; P=ns). However, among those treated with aspirin, those with MI had higher serum thromboxane B2 compared with those without MI (P=0.005).

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PFO closure may be cost-effective in long term
Percutaneous patent foramen ovale closure was more cost effective than medical therapy during the long term in a recent study published in the American Journal of Cardiology. The researchers conducted a cost effectiveness analysis of PFO closure using outcome and complication rates from a number of sources, including randomized controlled trials, Medicare cost tables and wholesale drug prices. Outcomes included cost for each life year gained and each quality-adjusted life-year (QALY) gained by use of PFO closure. The cost-effectiveness threshold was defined as <$50,000 per QALY gained.
The mean duration of follow-up in the randomized trials was 2.6 years. At this point, it was determined that PFO closure cost $16,213 (95% CI, 15,753-16,749) per patient. The cost per life-year gained was $103,607 (95% CI, 5,826-2,544,750) at this time point. Other results indicated a cost of $1.09 million (95% CI, 1.04 million-1.20 million) required to prevent one combined endpoint of transient ischemic attack, stroke or death at 2.6 years follow-up.
When the researchers prospectively modeled the cost of the intervention, PFO closure reached the endpoint of <$50,000 per QALY gained at 2.6 years (95% CI, 1.5-44.2).
The per-patient mean cost of medical therapy was greater than the cost of PFO closure by 30.2 years (95% CI, 28.2-36.2).

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October 27, 2014

Multivessel PCI outperformed culprit-vessel PCI in STEMI
Among patients with acute STEMI and multivessel disease, multivessel PCI significantly reduced the risk for MACE when compared with culprit-vessel PCI, according to a meta-analysis which published online in the Cardiovascular Revascularization Medicine Journal.

Currently, the American College of Cardiology Foundation/American Heart Association guidelines recommend culprit-vessel PCI for patients with acute STEMI and multivessel disease in the absence of hemodynamic instability. To better understand the role of multivessel PCI in this patient population, researchers from four US institutions searched PubMed, Embase and Central databases for publications from inception to December 2013. They culled four randomized controlled trials that included 840 patients with STEMI and multivessel disease. The primary outcome measure was MACE, defined as a composite of MI, revascularization and all-cause mortality. Compared with culprit-vessel PCI, multivessel PCI significantly reduced the risk for MACE (RR=0.46; P<.00001), which was driven by reductions in MI (RR=0.35; P=.004) and revascularization (RR=0.35; P<.00001). There were no significant reductions reported in all-cause mortality (RR=0.69; P=.19). In other results, multivessel PCI when compared with staged PCI led to similar rates of MACE (RR=0.96; P=.87), as well as its individual components: MI (RR=0.6; P=.36); revascularization (RR=0.86; P=.6); and all-cause mortality (RR=1.5; P=.57).

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NICE Advisors Recommend Rivaroxaban for Secondary Prevention in ACS Patients
An independent appraisal committee for the UK's National Institute for Health and Care Excellence (NICE) is supporting the use of rivaroxaban as part of a secondary-prevention strategy in acute coronary syndrome (ACS) patients. In its review of the data, the NICE appraisal committee states that rivaroxaban 2.5 mg twice daily with aspirin alone or aspirin plus clopidogrel or ticlopidine is an option for biomarker-confirmed ACS patients without a prior history of stroke or transient ischemic attack. Before starting treatment, clinicians should carefully assess the patient's risk of bleeding, according to the review. In their conclusions, the committee states that rivaroxaban is a "cost-effective" use of the National Health Service (NHS) resources. The NICE decision is not yet final—it is only the opinion of the independent committee—but a final appraisal determination is expected soon. In the UK, the department of health asks NICE for guidance on using drugs, treatments, and technologies within the NHS.

Rivaroxaban, an oral factor Xa inhibitor, was approved for the ACS indication throughout Europe after the European Commission gave its approval in May 2013. The approval was based on the ATLAS ACS 2-TIMI 51 study.

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Treating Sleep Apnea in HF May Cut 30-Day Readmissions
Undiagnosed sleep-disordered breathing (SDB) is common in patients hospitalized for heart failure or other heart issues and should be looked for with in-hospital sleep studies in those showing signs of it, according to a prospective study published in the last issue of the Journal of Clinical Sleep Medicine . It further suggests that prescribing continuous-positive-airway-pressure (CPAP) therapy after discharge in such patients who test positive for sleep apnea cuts the risk of 30-day readmission, at least among those who comply fully with CPAP therapy. Using a portable sleep monitor, the researchers identified sleep-disordered breathing in 79% of patients with HF, arrhythmias, or acute MI who had not been diagnosed with sleep apnea but showed SDB symptoms, such as snoring. Of the 19 patients discharged with a CPAP machine and confirmed to be fully compliant, none were readmitted within a month. That compared with a readmission rate of 29% for the 17 discharged with the machine who didn't use it. A group that used CPAP only some of the time didn't fare much better.

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October 20, 2014

Restenosis after coronary stenting predicted 4-year mortality  Restenosis detected by angiography independently predicted 4-year mortality in a large cohort of patients undergoing coronary stenting, according the findings of a study published online in Eur. Heart Journal.

In the study, investigators aimed to determine 4-year survival outcomes in a cohort of 10,004 patients (15,004 treated lesions) undergoing routine control angiography in the setting of coronary stenting. Eligible participants included all individuals who underwent successful coronary stenting for de novo lesions between 1998 and 2009 in Germany. The cohort also included individuals who underwent routine control angiography after 6 to 8 months at two centers in Munich. Clinicians defined restenosis as diameter stenosis ≥50% in the in-segment area when angiography was conducted at follow-up. Results indicated a restenosis rate of 26.4%. The researchers reported that 702 deaths occurred during the follow-up period. Restenosis was found in 218 of the patients who died, while no restenosis was reported for 484 deaths (unadjusted HR=1.19; 95% CI, 1.02-1.40).

Multivariate analysis results showed that restenosis independently predicted 4-year mortality (HR=1.23; 95% CI, 1.03-1.46).

Each 10-year increase in age (HR=2.34; 95% CI, 2.12-2.60), diabetes (HR=1.68; 95% CI, 1.41-1.99), current smoking habit (HR=1.39; 95% CI, 1.09-1.76) and each 5% decrease in left ventricular ejection fraction (HR=1.39; 95% CI, 1.31-1.48) also independently predicted 4-year mortality.

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Atherosclerosis risk increased among men with diabetes and low testosterone   A greater risk for developing atherosclerosis is found among middle-aged men with low testosterone and type 2 diabetes, according to recent study findings published in the Journal of Clinical Endocrinology & Metabolism.

This cross-sectional prospective study among 115 men younger than 70 years with type 2 diabetes and no history of CVD was determined the effect of testosterone levels on the development of atherosclerosis. Participants were divided into either normal (≥12.1 nmol/L; n=79) or low (≤12.1 nmol/L; n=36) total testosterone levels, whereas free testosterone levels <70 pg/mL were present in 48 participants. All participants underwent measurements for highly sensitive C-reactive protein (Hs-CRP), carotid artery carotid intima-media thickness (IMT) and atherosclerotic plaque, as well as being assessed for endothelial function.

The normal testosterone level group had higher HDL cholesterol levels (P<.002). The low total testosterone group had lower mean total testosterone levels, free testosterone levels and sex hormone-binding globulin. Participants with low and normal testosterone had similar treatments for type 2 diabetes and other pharmacological treatments. The most common treatment was metformin (55%), followed by insulin secretagogues (approximately 30%), DPP-IV (10%) and insulin (5.5%). Forty-five percent of the low and normal testosterone groups used statins, whereas 48.6% of those in the low testosterone group and 53% in the normal testosterone group used angiotensin-converting enzyme inhibitors.

Patients with low testosterone had higher IMT compared with those with normal testosterone (P<0.0001). Compared with the normal free testosterone group, those in the low free testosterone group had higher IMT (P<0.0001). More patients in the low testosterone group (80%) had an IMT of ≥0.1 cm compared with those with low testosterone (39%). Atherosclerotic plaques were found more often among participants with low testosterone (68.5%) vs. those with normal testostero0ne (44.8%; P<.02). Participants with normal or low free testosterone had similar plaque presence (P<0.65).

Participants with positive endothelial function had serum total testosterone levels of 13.52 nmol/L and free testosterone levels of 96.5 pg/mL, whereas participants without endothelial dysfunction had serum total testosterone levels of 18 nmol/L and free testosterone levels of 66.1 pg/mL (P<0.001). The low total testosterone group had significantly higher Hs-CRP concentrations compared with the normal testosterone group (P<0.0001). A higher risk for vascular disease was found among 54% of participants with low total testosterone and 10% with normal testosterone.

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Hemodynamically guided HF management reduced hospitalization rates (CHAMPION study)  Hemodynamically guided HF management was associated with approximately 50% fewer hospitalizations than standard HF management, according to findings from the CHAMPION trial which published in Circulation. The prospective, single-blinded, randomized controlled trial was conducted to determine treatment options for 550 patients with HF and preserved ejection fraction. Specifically, the researchers aimed to test the hypothesis that hemodynamically guided management of HF can decrease compensation that results in hospitalization. The analysis included 119 patients with left ventricular ejection fraction (LVEF) ≥40% (mean, 50.6%), 430 patients with LVEF <40% (mean, 23.3%) and one patient with undocumented LVEF. All patients underwent catheter-based implantation of a microelectromechanical systems pressure sensor during right heart catheterization. Patients were then randomly assigned in a single-blind fashion to the treatment or control group.

Treatment involved daily uploaded pressures that were used for HF management, while controls underwent standard HF management with weight monitoring. Pressures were uploaded for controls but not used by the investigators.

The rate of HF hospitalization during 6 months for patients with preserved ejection fraction served as the primary outcome measure.

Patients in the treatment group experienced a 46% lower rate of the primary endpoint compared with controls (95% CI, 0.38-0.70; P<0.0001).

The follow-up duration lasted an average of 17.6 months. During that period, hospitalization among patients in the treatment arm was 50% lower than in the control arm (95% CI, 0.35-0.70; P<0.0001).

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  1. Vicencio JM, Yellon DM, Sivaraman V et al. Plasma Exosomes Protect the Myocardium From Ischemia-Reperfusion Injury. J Am Coll Cardiol. 2015;65:1525-1536 … more More
  2. Fordyce CB, Roe MT, Ahmad T et al. Cardiovascular Drug Development: Is it Dead or Just Hibernating? J Am Coll Cardiol. 2015;65:1567-1582 … more More
  3. Totaro S, Khoury PR, Kimball TR et al. Arterial stiffness is increased in young normotensive subjects with high central blood pressure. JASH 2015;9:285-292 … more More
  4. Tan JTM, Ng MKC, Bursill CA. The role of high-density lipoproteins in the regulation of angiogenesis. Cardiovasc Res 2015; 106: 184-193 … more More
  5. Sun J, Nguyen T, Aponte AM et al. Ischaemic preconditioning preferentially increases protein S-nitrosylation in subsarcolemmal mitochondria. Cardiovasc Res 2015; 106: 227-236 … more More
  6. Chikwe J, Chiang YP, Egorova NN et al.Survival and Outcomes Following Bioprosthetic vs Mechanical Mitral Valve Replacement in Patients Aged 50 to 69 Years. JAMA 2015;313:1435-1442-1450 … more More
  7. Shore S, Ho PM, Lambert-Kerzner A et al. Site-Level Variation in and Practices Associated With Dabigatran Adherence. JAMA. 2015;313:1443-1450 … more More
  8. Sakata Y, Shiba N, Takahashi J et al. Clinical impacts of additive use of olmesartan in hypertensive patients with chronic heart failure: the supplemental benefit of an angiotensin receptor blocker in hypertensive patients with stable heart failure using olmesartan (SUPPORT) trial. Eur Heart J 2015;36:915-923 … more More
  9. Gonçalves A, Claggett B, Jhund PS et al. Alcohol consumption and risk of heart failure: the Atherosclerosis Risk in Communities Study. Eur Heart J 2015;36:939-945 … more More
  10. D’Onofrio G, Safdar B, LichtmanJH et al. Sex Differences in Reperfusion in Young Patients With ST-Segment–Elevation Myocardial Infarction: Results From the VIRGO Study Circulation. 2015;131:1324-1332 … more More

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