News from ESC 2009
August 29 - September 2, 2009, Barcelona - Spain. Summaries by D. Sakellariou
CURRENT OASIS 7
The CURRENT OASIS-7 study is a 2x2 factorial, randomised trial studying the optimal dose of clopidogrel and aspirin in ACS patients presenting to an emergency department and scheduled to undergo an early invasive strategy with intent to perform PCI no later than 72 hours after randomisation. The study enrolled 25,087 patients. Patients assigned to high-dose clopidogrel received a 600 mg loading dose on day 1 and then 150 mg once daily for the next seven days, followed by 75 mg once daily until 30 days. Patients in the standard clopidogrel arm received a 300 mg loading dose on day 1, followed by 75 mg once daily until 30 days. Patients were also assigned in an open-label manner to 300 to 325 mg of aspirin once daily or 75 to 100 mg aspirin once daily. There were no significant differences in the overall cohort of patients who received the higher loading and maintenance doses. In the subanalysis of 17,232 patients who underwent PCI, there was a significant 15% reduction in cardiovascular events, death, myocardial infarction (MI), and stroke, and this reduction was driven by a significant 22% reduction in the risk of MI. In addition, there was a significant 42% reduction in the risk of definite stent thrombosis. In bleeding risks, there was no difference between the standard and doubled clopidogrel doses when the TIMI major bleeding definition was used. However, there was a significant increase in bleeding when the CURRENT major and severe bleeding definition was used, and this was driven by an increased need for red blood cell transfusions. There was no difference in fatal bleeding, intracranial haemorrhage (ICH), or CABG-related major bleeding. Compared with low-dose aspirin, use of aspirin 300 to 325 mg did not result in any significant differences in major bleeding. The researchers concluded that for every 1000 patients with ACS receiving PCI, doubling the loading and maintenance dose of clopidogrel will prevent an additional six MIs and seven stent thromboses with an excess of three severe bleeds and no increase in fatal, CABG-related, or TIMI major bleedings.
In this multi-centre, double-blind, randomised trial, Ticagrelor (an oral, reversible, direct-acting inhibitor of the adenosine diphosphate receptor P2Y12 that has a more rapid onset and more pronounced platelet inhibition than clopidogrel) was compared with clopidogrel for the prevention of cardiovascular events in 18,624 patients admitted to the hospital with an acute coronary syndrome, with or without ST-segment elevation. Ticagrelor was used at a loading dose of 180 mg and thereafter 90 mg twice daily, and clopidogrel at a 300-to-600-mg loading dose and 75 mg daily thereafter. After the follow-up period (12 months) the primary endpoint (a composite of death from vascular causes, myocardial infarction, or stroke) had occurred in 9.8% of patients receiving ticagrelor as compared with 11.7% of those receiving clopidogrel (hazard ratio, 0.84, p<0.001). The rate of myocardial infarction alone was lower in the ticagrelor group (5.8% vs. 6.9%, p=0.005) as was death from vascular causes (4.0% vs. 5.1%, p=0.001), but not stroke alone (1.5% vs. 1.3%, p=0.22). Furthermore, death from any cause was also reduced with ticagrelor (4.5%, vs. 5.9% , p<0.001). No significant difference in the rates of major bleeding was found between the ticagrelor and clopidogrel groups (11.6% and 11.2%, respectively, p=0.43), but ticagrelor was associated with a higher rate of major bleeding not related to coronary artery bypass grafting (4.5% vs. 3.8%, p=0.03), including more instances of fatal intracranial bleeding and fewer of fatal bleeding of other types. The researchers concluded that in patients who have an acute coronary syndrome, with or without ST-segment elevation, treatment with ticagrelor as compared with clopidogrel significantly reduced the rate of death from vascular causes, myocardial infarction, or stroke, without an increase in the rate of overall major bleeding but with an increase in the rate of non-procedure-related bleeding. Published online at NEJM site. ClinicalTrials.gov number, NCT00391872
This noninferiority trial compared Dabigatran (a new oral direct thrombin inhibitor) with warfarin in the prevention of stroke in patients with atrial fibrillation. A total of 18,113 patients with atrial fibrillation and a risk of stroke were randomly assigned to receive, in a blinded fashion, fixed doses of dabigatran (110 mg or 150 mg twice daily ) or, in an unblinded fashion, adjusted-dose warfarin. The median duration of the follow-up period was 2.0 years. The primary outcome was stroke or systemic embolism. Rates of the primary outcome were 1.69% per year in the warfarin group, as compared with 1.53% per year in the group that received 110 mg of dabigatran (relative risk with dabigatran, p<0.001 for noninferiority) and 1.11% per year in the group that received 150 mg of dabigatran (relative risk, 0.66; p<0.001 for superiority). The rate of major bleeding was 3.36% per year in the warfarin group and 2.71% per year in the group receiving 110 mg of dabigatran (p=0.003) and 3.11% per year in the group receiving 150 mg of dabigatran (p:0.31). The investigators concluded that in patients with atrial fibrillation, dabigatran given at a dose of 110 mg was associated with rates of stroke and systemic embolism that were similar to those associated with warfarin, as well as lower rates of major haemorrhage. Dabigatran administered at a dose of 150 mg, as compared with warfarin, was associated with lower rates of stroke and systemic embolism but similar rates of major hemorrhage. Published online at NEJM site. ClinicalTrials.gov number, NCT00262600
SEPIA-ACS1 TIMI 42 STUDY
This double-blind, phase 2 trial examined the efficacy and safety of otamixaban (an intravenous direct factor Xa inhibitor) in patients with non-ST-elevation acute coronary syndromes. A total of 3241 patients with non-ST-elevation acute coronary syndromes were randomly assigned to one of five doses of otamixaban (0.08 mg/kg bolus followed by infusions of 0.035, 0.070, 0.105, 0.140, or 0.175 mg/kg/h) or to a control of unfractionated heparin (60 IU/kg intravenous bolus followed by an infusion of 12 IU/kg/h) plus eptifibatide (180 μg/kg intravenous bolus followed by an infusion of 1.0 to 2.0 μg/kg/min ). The primary efficacy endpoint was a composite of death, myocardial infarction, urgent revascularisation, or bailout glycoprotein IIb/IIIa inhibitor use up to 7 days. The primary safety endpoint was TIMI major or minor bleeding not related to coronary-artery bypass grafting.
Rates of the primary efficacy endpoint in the five otamixaban doses were 7.2% with 0.035 mg/kg/h, 4.6% with 0.070 mg/kg/h, 3.8% with 0.105 mg/kg/h, 3.6% with 0.140 mg/kg/h, and 4.3% with 0.175 mg/kg/h. In the control group, the rate was 6.2%, yielding relative risks for the five otamixaban doses of 1.16, 0.74, 0.61, 0.58 and 0.69, respectively. Rates of the primary safety endpoint in the five otamixaban doses were 1.6%, 1.6%, 3.1%, 3.4% and 5.4%, respectively. The rate in the control group was 2.7%. The investigators concluded that, in patients with non-ST-elevation acute coronary syndromes, otamixaban infusions of 0.100-0.140 mg/kg/h might reduce ischaemic events and have a safety profile similar to unfractionated heparin plus eptifibatide. ClinicalTrials.gov, number NCT00317395.
ISAR TEST 4 STUDY
The ISAR-TEST-4 study was a randomised trial which assessed the efficacy and safety of a biodegradable polymer DES in a non-selected cohort of patients undergoing PCI in de novo native-vessel coronary lesions. The stent platform consists of a sand-blasted, stainless-steel stent that is coated on-site with a mixture of rapamycin, biodegradable polymer, and shellac resin. A cohort of 2603 patients were enrolled in the study. Patients were randomly assigned to receive either a biodegradable polymer DES (n=1299) or a permanent polymer DES (Cypher, n=652, or Xience, n=652). The primary endpoint was a composite of cardiac death, myocardial infarction (MI) related to the target vessel, or revascularisation related to the target lesion (TLR) at one year. Primary endpoint results showed that the biodegradable polymer DES was non-inferior to the permanent polymer DES (a rate of 13.8% vs 14.4%, non-inferiority p:0.005, superiority p:0.66). No significant difference was observed between the biodegradable and permanent polymer DES according to cardiac death or MI (6.3% vs 6.2%, p=0.94), TLR (8.8% vs. 9.4%, p=0.58) or stent thrombosis (definite/probable: 1.0% vs. 1.5%, p=0.29). Thus, the first results of the study indicate that safety and efficacy outcomes at one year are comparable with those of permanent polymer-based drug-eluting stents.
The NORwegian study on DIstrict treatment of ST-Elevation Myocardial Infarction (NORDISTEMI) was a randomised, open, multi-centre study conducted in Norway between February 2005 and April 2009. It compared two different strategies after fibrinolysis in a region with long transfer distances to PCI (100-400 km): to transfer all patients for immediate coronary angiography and intervention, or to manage the patients more conservatively. A total of 266 STEMI patients received thrombolytic therapy and were randomised to either immediate transfer for angiography/PCI or to standard management in the community hospitals with urgent transfer only for a rescue indication or with clinical deterioration. The results showed a reduction in the primary composite endpoint of death, reinfarction, stroke or new ischaemia within 12 months in the early invasive group, but the reduction did not reach statistical significance (hazard ratio 0.72, p=0.19). However, the composite of death, reinfarction or stroke at 12 months was significantly reduced in the early invasive group compared to the conservative group (6.0% versus 15.9%, hazard ratio 0.36, p=0.01). No significant differences in bleeding or infarct size were observed, and transfer-related complications were few. The investigators concluded that patients presenting with acute ST-elevation myocardial infarction (STEMI) in rural areas have a better treatment outcome with thrombolysis followed by immediate transfer for angiography than with thrombolysis and conservative, community-hospital follow up.
Predictors of Response to Cardiac Resynchronization Therapy (PROSPECT) trial was the first large-scale, multi-centre clinical trial that evaluated the ability of several echocardiographic measures of mechanical dyssynchrony to predict response to CRT. A subanalysis of this trial, which aimed to investigate the relationship between baseline characteristics and measures of response to CRT, was presented at ESC 2009. A total of 286 patients were grouped according to relative reduction in left ventricular end-systolic volume (LVESV) after 6 months of CRT: super-responders (reduction in LVESV 30%), responders (reduction in LVESV 15-29%), non-responders (reduction in LVESV 0-14%), and negative responders (increase in LVESV). In addition, three subgroups were formed according to clinical and/or echocardiographic response: +/+ responders (clinical improvement and a reduction in LVESV 15%), +/- responders (clinical improvement or a reduction in LVESV 15%), and -/- responders (no clinical improvement and no reduction in LVESV 15%). Differences in clinical and echocardiographic baseline characteristics between these subgroups were analysed. Super-responders were more frequently females, had non-ischaemic heart failure (HF), and had a wider QRS complex and more extensive mechanical dyssynchrony at baseline. On the other hand, negative responders were more frequently in New York Heart Association class IV and had a history of ventricular tachycardia (VT). Combined positive responders after CRT (+/+ responders) had more non-ischaemic aetiology, more extensive mechanical dyssynchrony at baseline, and no history of VT.
GISSI HF (ancillary results)
In Barcelona this ancillary analysis was presented of the GISSI-HF database, aiming at assessing the effect of rosuvastatin on the occurrence of atrial fibrillation (AF) in patients with chronic heart failure (HF) who were not in AF at study entry. GISSI-HF was a double-blind, placebo-controlled trial testing n-3 PUFA and rosuvastatin vs. corresponding placebos in patients with chronic HF. Atrial fibrillation occurrence was defined as the presence of AF in the electrocardiogram (ECG) performed at each visit during the trial or AF as a cause of worsening HF or hospital admission or as an event during hospitalisation. Among the 3690 patients (80.7%) without AF on their baseline ECG, 15.0% developed AF during a median follow-up period of 3.7 years, 258 randomised to rosuvastatin (13.9%) vs. 294 allocated to placebo (16.0%). Although the difference was not significant at unadjusted analysis (p=0.097) and multivariable analysis adjusting for clinical variables (p=0.067), it became significant after adjustment for clinical variables and laboratory examinations (p=0.039), and for clinical variables, laboratory examinations, and background therapies (p=0.038). As the investigators concluded, there is some evidence of a beneficial effect of rosuvastatin in terms of reduction of AF occurrence in patients with HF.
This randomised, controlled, open-labelled, non-inferiority trial compared beta-blockade continuation vs. discontinuation during acutely decompensated heart failure (ADHF) in patients with LVEF below 40% previously receiving stable beta-blocker therapy. A total of 147 patients were included(mean age 72 ± 12 years). After 3 days, 92.8% of patients pursuing beta-blockade improved in terms of both dyspnoea and general well-being (according to a physician blinded to therapy) vs. 92.3% of patients stopping beta-blocker. This was the main endpoint and the upper limit for unilateral 95% CI (6.6%) is lower that of the predefined upper limit (12.5%), indicating non-inferiority. Similar findings were obtained at 8 days and when evaluation was made by the patient. Plasma BNP at Day 3, length of hospital stay, re-hospitalisation rate, and death rate after 3 months were also similar. Beta-blocker therapy at 3 months was given to 90% of patients vs. 76% (p<0.05). In conclusion, during ADHF, continuation of beta-blocker therapy is not associated with delayed or lesser improvement, but with a higher rate of chronic prescription of beta-blocker therapy after 3 months, the benefit of which is well established.
Unprotected left main revascularisation in patients with acute coronary syndromes.
This subanalysis of 1799 patients (4% of the total cohort of GRACE study) with unprotected left main coronary disease (ULMCD) described the practice of ULMCD revascularisation and its evolution over an 8-year period, analysed the prognosis of this population and determined the effect of revascularisation on outcome. The patients underwent percutaneous coronary intervention (PCI) alone (n=514), coronary artery bypass graft (CABG) alone (n=612), or no revascularization (n=673). Mortality was 7.7% in hospital and 14% at 6 months. Over the 8-year study, the GRACE risk score remained constant, but there was a steady shift to more PCI than CABG over time. Forty-eight per cent (48%) of PCI patients underwent revascularisation on the day of admission vs. 5.1% in the CABG group. After adjustment, revascularisation was associated with an early hazard of hospital death vs. no revascularisation, significant for PCI. From discharge to 6 months, both PCI (HR 0.45, 95% CI 0.23-0.85) and CABG (0.11, 0.04-0.28) were significantly associated with improved survival in comparison with an initial strategy of no revascularisation. Coronary artery bypass graft revascularisation was associated with a five-fold increase in stroke compared with the other two groups. The investigators concluded that ULMCD in acute coronary syndromes is associated with high mortality, especially in patients with STEMI and/or haemodynamic or arrhythmic instability. Percutaneous coronary intervention is now the most common revascularisation strategy and is preferred in higher risk patients. Coronary artery bypass graft is often delayed and performed in lower risk patients, leading to good 6-month survival and the two approaches therefore appear complementary.
Results from the TRITON-TIMI 38 Trial
The risk of cardiovascular event for patients treated with clopidogrel or prasugrel in combination with a Proton Pump Inhibitor
The TRITON-TIMI 38 trial randomised 13,608 subjects with ACS and planned PCI to prasugrel or clopidogrel, in addition to standard therapy. The primary endpoint of the trial was cardiovascular death, MI or stroke. The decision to treat with a proton pump inhibitor was left to the discretion of the treating physician and was captured on the case-report forms. A multivariable Cox proportional hazards model was used to evaluate the association between use of a PPI at randomisation and the risk of long-term clinical outcomes. Of the 13,608 subjects enrolled in TRITON-TIMI 38, 33% of subjects were being treated with a PPI at randomisation. For patients randomised to clopidogrel, the rate of the primary endpoint through long-term follow-up was 11.8% in subjects on a PPI and 12.2% in subjects not on a PPI (HR 0.98, p=0.80). For patients randomised to prasugrel, the rate of the primary endpoint was 10.2% in subjects on a PPI and 9.7% in subjects not on a PPI (HR 1.05, p=0.58). Similarly, the use of a PPI was not associated with an increased risk of MI, stent thrombosis, or urgent revascularisation, or a decreased risk of bleeding, for patients treated with either clopidogrel or prasugrel.
Survival in patients with heart failure and preserved versus impaired left ventricular ejection fraction: an individual patient data meta-analysis.
This meta-analysis of 29 studies investigated the survival of patients with heart failure and preserved LV ejection fraction (HF-PEF). A total cohort of 46,596 patients was recruited. Of these patients 25,796 (59%) had HF-lowEF (<50%), 8571 (20%) HF-PEF (EF=50%), while for 9006 (21%) patients LVEF data were unavailable. For the whole group, 52% had a history of ischaemic heart disease and 40% a history of hypertension. The patients with HF-PEF were older (72±12 vs. 66±12), more were women (51% vs. 28%), more had a history of hypertension (47% vs. 38%) and fewer had ischaemic etiology (41% vs. 57%) compared with patients with HF-lowEF. During the 3 years' follow up, 2154 (25%) patients with HF-PEF died compared with 6988 (27%) patients with HF-lowEF. Using a Cox proportional hazards model (adjusting for age and gender and stratifying by study) the HF-PEF group had better survival than the HF-lowEF group (HR 0.68, 95% CI 0.65, 0.72). This meta-analysis suggests that patients with HF-PEF appear to have better survival than patients with HF-lowEF.
SYNTAX TRIAL (2-year outcome results)
At the ESC Congress 2009 the results of the two years outcomes of SYNTAX Trial were presented. The SYNTAX trial was designed to compare percutaneous coronary intervention (PCI) with coronary artery bypass surgery (CABG) for the treatment of de novo three-vessel (3VD) and/or left main coronary disease (LM). After two years' follow up in the 1800 patients MACCE (analysed in a time-to-event manner) was significantly increased in PCI patients (CABG 16.3% vs. PCI 23.4%, p=0.0002). However, the composite safety endpoint of death/stroke/MI was comparable between the 2 groups (CABG 9.6% vs. PCI 10.8%, p=0.44). Similar to outcomes after the first year of follow-up, the increase in MACCE at 2 years was mainly attributable to an increased rate of repeat revascularisation in PCI-treated patients (CABG 8.6% vs. PCI 17.4%, p<0.0001). The rate of MI was significantly increased in PCI patients (CABG 3.3% vs. PCI 5.9%, p=0.01), whereas stroke remained significantly higher in CABG patients (CABG 2.8% vs. PCI 1.4%, p=0.03) after 2 years of follow up. The impact of lesion complexity on 2-year clinical outcomes was estimated by examining patient outcomes relative to SYNTAX Score tercile. The rates of MACCE were not significantly different between patients with low SYNTAX Scores treated with either PCI or CABG (CABG 17.4% vs. PCI 19.4%, p=0.63). In patients with intermediate SYNTAX Scores, there was a trend towards increased MACCE with PCI (CABG 16.4% vs. PCI 22.8%, p=0.06). In the most complex patients (SYNTAX Scores =33), MACCE was significantly increased in patients treated with PCI (CABG 15.4% vs PCI 28.2%; p=0.0001). Thus, the 2-year SYNTAX results suggest that CABG remains the standard of care for patients with complex 3VD and/or LM (high SYNTAX Scores, cutoff point =33) However, PCI may be an acceptable alternative revascularisation method to CABG when treating patients with less complex (low or intermediate SYNTAX Score) 3VD and/or LM disease. The SYNTAX patients will be followed for 5 years.
This individual patient-data pooled analysis aimed to assess the long-term clinical outcome in STEMI patients randomised to percutaneous coronary intervention (PCI) with or without thrombectomy. Individual data of 2686 patients enrolled in 11 trials entered the pooled analysis. Median clinical follow-up period was 365 days. Kaplan-Meier analysis showed that allocation to thrombectomy was associated with reduced all-cause mortality (log-rank p=0.049). Furthermore, Kaplan-Meier analyses showed that allocation to thrombectomy was associated with significantly fewer MACE (log-rank p=0.011) and death/MI (log-rank p=0.015), but non-significant differences in MI (log-rank p=0.126) or in TLR/TVR (log-rank p=0.126).
This trial was designed to determine whether cardiac resynchronisation therapy would reduce mortality and heart failure events in patients with mild cardiac symptoms, reduced ejection fraction, and wide QRS complex. The study cohort consisted of 1820 patients with ischaemic or non-ischaemic cardiomyopathy, ejection fraction 0.30 or less, QRS 130 ms or more, and New York Heart class I or II symptoms. Patients were randomly assigned in a 3:2 ratio to receive cardiac resynchronisation therapy with defibrillator (1089 patients) or an implanted defibrillator (731 patients). The primary endpoint was all-cause mortality or heart failure event, whichever occurred first. During an average follow up of 2.4 years, 17.2% of patients in the resynchronisation group and 25.3% in the defibrillator group experienced a primary endpoint (HR:0.66 p=0.001). The benefit was similar in patients with ischaemic and non-ischaemic cardiomyopathy. Superiority of cardiac resynchronisation therapy was driven by a 41% reduction in the risk of a first heart failure event, a finding that was evident primarily in patients with QRS of 150 ms or more. Thus, cardiac resynchronisation therapy seems to decrease the risk of heart failure events in relatively asymptomatic patients with a low ejection fraction and a wide QRS complex.
KYOTO HEART STUDY
The objective of this multi-centre prospective trial from Japan was to assess the add-on effect of valsartan on top of the conventional treatment for high risk hypertension in terms of morbidity and mortality. In the trial, 3031 patients with uncontrolled hypertension were randomised to either valsartan add-on or non-ARB treatment. Median follow-up period was 3.27 years. In both groups, blood pressure was 157/88 mmHg at baseline and 133/76 mmHg at the end of study. Compared with the non-ARB arm, the valsartan add-on arm had fewer primary endpoints (HR 0.55, p=0.00001).
This multi-centre, randomised (rolofylline vs placebo in a 2:1 ratio), double-blind, placebo-controlled trial examined the efficacy and safety of rolofylline (selective adenosine A1 antagonist) in patients hospitalised with acute decompensated heart failure (ADHF). The 2023 patients were randomised to take rolofylline 30 mg/day IV or matching placebo. The composite endpoint of death or cardiovascular or renal hospitalisation occurred in 30.7% of rolofylline patients and 31.9% of placebo patients (p=0.86). Rolofylline did not reduce the incidence of renal impairment compared to placebo (15.0% vs. 13.7%, respectively, p=0.44). However, more patients on rolofylline experienced nervous system disorders, with 11 patients (0.8%) experiencing seizure and 16 patients (1.2%) experiencing stroke on rolofylline, with no patients experiencing seizure and 3 patients (0.5%) experiencing stroke on placebo. Thus, rolofylline failed to prove its efficacy and safety in ADHF patients.
The ESC Congress 2009 featured a presentation of the observed effects of rosuvastatin in participants aged 70 years or older, in the JUPITER study, based on intention-to-treat analyses, for the composite primary endpoint and the pre-specified secondary endpoints of total mortality, venous thromboembolism, and incident diabetes. From the 17802 apparently healthy men and women randomised in the JUPITER trial, 5695 were initially aged 70 years or older. The rates of the primary endpoint in this age group were 1.22 and 1.99 per 100 person-years of follow up in the rosuvastatin and placebo groups, respectively (hazard ratio 0.61, p<0.001). Corresponding rates of secondary endpoints in this age group were 1.63 and 2.04 for any death (hazard ratio 0.80, p=0.090), 0.24 and 0.41 for venous thromboembolism (hazard ratio 0.58, p=0.096), and 1.20 and 0.98 for diabetes (hazard ratio 1.21, p=0.27). Thus, relative effects observed in older participants were quite similar to those reported for the overall trial. However, because absolute risks were substantially higher in this age group, the estimated number needed to treat (NNT) for 5 years to prevent 1 primary end point was 19, compared with the estimated NNT of 25 for the overall trial.
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