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News from ACC 2010

March 22, 2010. Summaries by S. Pastromas & H. Anninos

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The ACCORD lipid study enrolled 5518 patients with type 2 diabetes who were being treated with open-label simvastatin and they were randomly assigned to receive either masked fenofibrate or placebo. The two study arms were compared over a primary endpoint of first occurrence of nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular causes. The mean follow-up duration was 4.7 years. No statistically significant differences were noted between the two groups (rate of the primary outcome was 2.2% in the fenofibrate arm and 2.4% in the placebo arm, p=0.32). Pre-specified subgroup analyses indicated a benefit for men and possible harm for women (p=0.01 for interaction), and a trend towards a possible benefit for patients with both a high baseline triglyceride level and a low baseline level of high-density lipoprotein cholesterol (p=0.057 for interaction).

The ACCORD blood pressure study evaluated whether therapy targeting normal systolic blood pressure (SBP) of less than 120 mm Hg would reduce cardiovascular events in people with type 2 diabetes at high risk for CV events in comparison to therapy targeting the standard goal of less than 140 mm Hg for these patients. A total of 4733 patients were randomised to receive intensive or standard therapy and they were followed up for 4.7 years. The primary composite outcome was non-fatal myocardial infarction, non-fatal stroke, or death from any cardiovascular cause. The blood pressure target was achieved, and the study found that aggressive blood pressure management had no significant effect on the combined rates of non-fatal myocardial infarction (MI), non-fatal stroke or CV mortality. The annual rates of stroke, were 0.32% and 0.53% in the two groups, respectively (p=0.01) and notably serious adverse events attributed to antihypertensive treatment occurred in 3.3 of the participants in the intensive-therapy group and in 1.3% of those in the standard-therapy group (p<0.001).


The investigators of International Verapamil SR-Trandolapril Study (INVEST), found that tight blood pressure control in patients with diabetes and coronary artery disease is no more effective in preventing myocardial infarction (MI), stroke or all-cause mortality than standard antihypertensive therapy, and in some times may be harmful. The investigators randomly assigned 6400 patients with diabetes and coronary artery disease (CAD) to blood pressure (BP) lowering therapy with either a calcium channel blocker or a beta-blocker plus an ACE inhibitor and/or a thiazide diuretic. The study targeted a BP of less than 130/85 mmHg. Patients were categorised according to the degree of BP control they actually achieved: Patients who achieved a systolic blood pressure (SBP) of less than 130 mmHg were classified in a "tight control" group, those with a SBP from 130 to 140 mmHg were in a "usual control" group, and those with a SBP of 140 mmHg or higher were in a "not controlled" group (almost one third of all patients). Patients with uncontrolled SBP had the worst outcomes. Tight control of SBP was not associated with improved CV outcomes compared with normal control, and there was an increased risk for mortality in the tight control group, which persisted during extended follow up. Moreover, systolic blood pressure less than 115 mmHg was associated with an increase in risk for mortality.


In The Endovascular Valve Edge-to-Edge Repair Study (EVEREST II), 279 patients with significant mitral valve regurgitation were randomised 2:1 to percutaneous edge-to-edge valve repair with the MitraClip® device or to surgical repair or replacement. The primary safety endpoint—the major adverse event rate at 30 days—was 9.6% in the device group and 57% in the surgery group (p<0.0001). The primary efficacy endpoint was clinical success, defined as freedom from the combined outcome of mortality, mitral valve surgery or re-operation and mitral regurgitation greater than 2+/4+ at 12 months. Clinical success was 72% in the device group and 88 percent in the surgery group (p=0.0012).


The Nateglinide And Valsartan in Impaired Glucose Tolerance Outcomes Research (NAVIGATOR) trial randomised 9306 patients with impaired glucose tolerance and established cardiovascular disease or cardiovascular risk factors (55 years or older with at least one risk factor for CV disease) to either valsartan (up to 160 mg daily) or placebo (and nateglinide or placebo) in addition to lifestyle modification. The participants were followed for a median of 5.0 years for the development of diabetes (6.5 years for vital status). The effects of valsartan were studied on the development of diabetes, an extended composite outcome of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, hospitalisation for heart failure, arterial revascularisation, or hospitalisation for unstable angina and a core composite outcome that excluded unstable angina and revascularisation. The cumulative incidence of diabetes was 33.1% in the valsartan group, as compared with 36.8% in the placebo group (p<0.001). The drug did not significantly reduce the incidence of either the extended or the core cardiovascular outcome. Nateglinide on the other hand showed no effect neither in the development of diabetes nor in cardiovascular outcomes.


Cryoballoon Ablation of Pulmonary Veins for Paroxysmal Atrial Fibrillation (STOP-AF) trial was designed to assess the safety and effectiveness of a novel cryoballoon ablation technology designed to achieve pulmonary vein isolation with a continuous cryolesion. A total of 245 patients with early permanent AF or paroxysmal AF were enrolled, 163 to the cryoballoon arm, having previously failed at least one antiarrhythmic drug, and 82 to antiarrhythmic drug therapy (AAD) arm. The incidence of the primary endpoint of treatment success was significantly better in the cryoablation arm, as compared with the AAD arm (69.9% vs. 7.3%, p<0.001). A single ablation procedure was associated with success in 60.1% of the patients. In addition, 57.7% of patients in the cryoballoon arm were on no AADs at the end of follow-up and only 24% were still on warfarin at 12 months. The overall rate of procedural complications with cryoballoon ablation was 6.3% and included PV stenosis (3.1% vs. 2.4%), and phrenic nerve palsy (13.5% vs. 7.3%).

CABANA Pilot Study

The Catheter Ablation vs. Antiarrhythmic Drug Therapy for Atrial Fibrillation (CABANA Pilot Study) tested the hypothesis that catheter ablation would be superior to medical management in the treatment of recurrent AF in high-risk patients. A total of 60 patients were randomised, 29 patients to catheter ablation and 31 to medical management. The incidence of freedom from symptomatic AF (primary endpoint) was significantly higher in the catheter ablation arm, as compared with AAD (65% vs. 41%, p=0.03). However, the incidence of any AF, atrial flutter, or atrial tachycardia episodes was similar in the two arms (66% vs. 72%, p=0.26). One patient developed moderate PV stenosis, while no cases of severe PV stenosis or atrial oesophageal fistulas were noted.


First Report of the PERSEUS Randomised Controlled Trial Comparison of a Novel Platinum-Chromium, Thin-Strut TAXUS Element Stent vs. the TAXUS Express Stent in de novo Coronary Stenoses. The PERSEUS trials include two parallel studies of the TAXUS Element stent in single, de novo CAD lesions. The PERSEUS Workhorse study (n=1262) is a prospective, randomised (3:1), single-blind, non-inferiority trial comparing TAXUS Element to TAXUS Express DES in patients with lesion length ≤28 mm and vessel diameter 2.75 mm to 4.0 mm over a primary endpoint of 12-month clinical target lesion failure. This clinical endpoint occurred in 5.6% and 6.1%, (p=0.78) for TAXUS Element and TAXUS Express, respectively. In-stent late loss and in-segment late loss were similar between the two stents. PERSEUS Small Vessel (n=224) is a prospective, single-arm, open-label, superiority study comparing TAXUS Element to BMS historical controls in patients with lesion length ≤20 mm and vessel diameter 2.25 mm to <2.75 mm. The primary endpoint was 9-month angiographic in-stent late loss and TAXUS Element was superior (0.38 mm vs. 0.80 mm, p<0.001).


The Influence of Cilostazol-based Triple Anti-Platelet Therapy on Ischaemic Complication After Drug-Eluting Stent Implantation (CILON-T) study was performed to address the issue of triple antiplatelet therapy (TAT) superiority over to dual antiplatelet therapy (DAT) in reducing clopidogrel hypo- or non-responsiveness (as assessed by the VerifyNow assay), as well as clinical events, in patients undergoing PCI. A total of 915 patients were randomised, 457 to TAT, and 458 to DAT. Triple therapy included cilostazol 200 mg loading dose and 100 mg twice daily maintenance dose, on top of the well established double antiplatelet therapy with aspirin (100-200 mg/day) and clopidogrel (300-600 mg loading dose and 75 mg/day thereafter). The mean P2Y12 reaction unit (PRU), as assessed by the VerifyNow assay, was significantly reduced with TAT as compared with DAT, both at discharge and after 6 months (p<0.001 for both). The primary endpoint of cardiovascular death, nonfatal myocardial infarction, ischaemic stroke, and target vessel revascularisation (TLR) was similar between the TAT and DAT arms as were also the secondary outcomes, including all-cause mortality, nonfatal MI, ischaemic stroke, TLR and definite stent thrombosis.


In the Optimal Duration of Dual Antiplatelet Therapy After Drug-Eluting Stents Implantation: A Randomised, Multi-Centre Trial, patients who had been on DAT for at least 12 months following DES PCI were randomised to continuing DAT for another 2 years, or stopping clopidogrel, and continuing aspirin only. The investigators found no difference in the incidence of any of the endpoints studied, including stent thrombosis. They did note a trend towards harm for the composite endpoint of death, MI, or stroke with DAT. It should be pointed out, however, that patients who had experienced a major adverse cardiac event or bleeding since implantation were excluded from this trial.

MAINCOMPARE Registry: 5-year results

MAIN-COMPARE is a registry study comparing PCI and CABG for patients with unprotected left main coronary artery (LMCA) disease. At three years, the composite of death, Q-wave myocardial infarction, or stroke was similar between PCI and CABG treated patients, although patients undergoing the former therapy had a significantly increased rate of target vessel revascularisation (TVR). 2240 patients were followed for a median 5.2 years. PCI was performed in 1102 patients. Bare-metal stents were implanted in 318 and drug-eluting stents in 784 patients. CABG was performed in 1138 patients. At five-year follow up, PCI for unprotected LMCA disease showed similar rates of death, myocardial infarction, or stroke compared to CABG but was associated with more repeat revascularisations (p<0.001).


The Clinical evaluation Of remote NotificatioN to rEduCe Time to clinical decision (CONNECT) study is a randomised controlled trial which evaluated the clinical and health care utilisation impact of wireless remote monitoring versus routine care. In a population of 1997 patients a Medtronic wireless ICD or CRT-D device was implanted; 1014 of them were randomised to remote monitoring and 983 to routine office care. The monitored data included atrial tachycardia (AT) and atrial fibrillation (AF) daily burden, rapid ventricular response during AT/AF, and defibrillation shocks. Both groups had lead and device integrity (including lead impedance out of range, VF detection, low battery voltage, and excessive charge time) alerts on. The post implantation follow up duration was 15 months in both groups. Patients in the remote monitoring group had office visits at only one month and 15 months post-implant. Patients in the routine care arm had office visits at one, three, six, nine, 12, and 15 months post-implant. The primary objective was to compare time to clinical decision between patients managed remotely and patients managed with routine in-office care. The key secondary objective was to assess the impact of remote monitoring and early notification on healthcare utilisation. A total of 317 events (172 in remote monitoring arm and 145 in routine in-office care) were recorded triggering clinical decisions. The majority of the events were high AT/AF burden, fast ventricular response rate, and ICD shocks. The median time from event to clinical decision was significantly shorter for the remote monitoring arm (4.6 vs. 22 days, p<0.001). The total yearly clinic visits per patient were 3.9 and 6.3 for remote monitoring and routine care groups, respectively. The length of stay per hospitalisation for remote monitoring and routine care groups was 3.3 and 4.0 days, p=0.002, respectively. All these data further support the use of remote device monitoring in daily practice.

PASSION: 5-year follow up

The goal of the trial was to compare paclitaxel-eluting stents to bare-metal stents among patients undergoing primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI). A total of 629 patients undergoing primary PCI were randomised to paclitaxel-eluting Express2 stent (n=309) or bare-metal stents (n=310) with either the Express2 or Liberte platform. Use of the glycoprotein IIb/IIIa inhibitors abciximab or tirofiban was at the discretion of the treating physician. The follow up in this study included only clinical events. The left anterior descending artery was the culprit in 50% of patients, and 45% of patients had multi-vessel disease. Procedural success was 95% and the mean duration from the symptoms onset to the coronary angiogram was 3 hours. An average of 1.3 stents was used in both arms. The primary endpoint of death, re-infarction, or target lesion revascularisation (TLR) at 1 year did not differ between treatment groups (8.8% for paclitaxel-eluting stent group vs. 12.8% for bare-metal stent group, p=0.12). Cardiac death or MI occurred in 5.5% of the paclitaxel-eluting stent group and 7.2% of the bare-metal stent group (p=0.40). There was also no difference in TLR (5.3% vs. 7.8%, p=0.23). There were three cases of stent thrombosis in each group. At 5 years, cardiac death, myocardial infarction (MI), or TLR was 18.3% vs. 22.0% (p=0.24), cardiac death was 8.9% versus 11.5% (p=0.28), MI was 6.5% versus 4.3% (p=0.28), and TLR was 7.3% versus 10.5% (p= 0.16), respectively, for paclitaxel-eluting stents versus bare-metal stents. Cumulative definite stent thrombosis was 3.6% versus 1.7% (p=0.20), definite or probable stent thrombosis was 3.9% versus 3.4% (p=0.85), and possible stent thrombosis was 6.8% versus 6.7% (p=0.93), respectively. Censoring events that occurred within 30 days, the 5-year incidence of definite stent thrombosis, was 2.9% versus 0.8% (p=0.06), respectively.

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