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Highlights from the 60th ACC Meeting: Late-breaking Trials
By Michael H. Crawford, MD
Dr. George Dourgas presented the results of the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS AMI) analysis of predictors of stent thrombosis in more than 3,600 patients, and showed that higher doses of clopidogrel (600 mg) pharmacologic therapy, lesion characteristics, and the length of stents were predictors of early-stent thrombosis. Patient-related factors such as smoking and diabetes were the most important predictors of late thrombosis. The type of stent was not related to stent thrombosis at any time for up to one year (3.3% drug eluting vs. 3.4% bare metal). Thus, fears of high rates of late-stent thrombosis with drug-eluting stents seem unfounded.
Dr. Eric Bonnefoy presented the AGIR-2 study comparing pre-hospital tirofiban to cath lab administration for primary percutaneous coronary intervention (PCI) and found no difference in the angiographic results of PCI or initial clinical outcomes. However, a similar German study (ON-TIME-2) found that one-year mortality trended lower with pre-hospital tirofibran, especially in those > age 65. Thus, pre-hospital platelet glycoprotein 11b/111a inhibition remains controversial.
The STICH trial tested the hypothesis that adding ventricular reconstruction surgery to coronary bypass surgery (CABG) in patients with anteroapical LV dysfunction would improve outcomes. Dr. Robert Jones presented the results, which showed that although the left ventricular end-systolic volume was smaller, four-year mortality was not different. Thus, routine left-ventricular reconstruction during CABG for post-anterior MI patients is not indicated.
Dr. Luc Eurlings presented the results of the PRIMA study, which assessed the value of pro-BNP measurements for managing patients with heart failure as compared to usual hospital care and found no difference in mortality or rehospitalization over a two-year follow-up. However, patients who achieved and maintained a target pro-BNP level did do better. Thus, repeated BNP levels should not be a routine part of hospitalized heart failure patient's management.
Dr. Robert Glynn presented an analysis of the JUPITER trial secondary endpoint of venous thromboembolism, which occurred in 94 of 17,802 participants in this primary prevention trial. The rosuvastatin group had 34 and the placebo group 60 (RR 0.57, p < .01). If this result was due to an anticoagulant effect of rosuvastatin, there was no increased bleeding in this group. Thus, statins may decrease venous thromboembolism rates in certain individuals, for unclear reasons. (N Engl J Med. online.)
Dr. Carlo Brigerori presented the NAPLES-11 trial of 668 patients undergoing elective PCI who were not on statin therapy. They were randomized to atorvastatin 80 mg or placebo 24 hours pre-procedure and monitored for periprocedural MI (pp MI) based upon symptoms, ECG and CK-MB. PPMI was reduced from 16% to 10% in the atorvastatin group. This is another study demonstrating the ability of statins to reduce cardiovascular events in selected patients.
Dr. Germano Di Sciascio presented the ARMYDA-RECAPTURE study and showed that when atorvastatin therapy was given in high doses before PCI in patients on statins, there was a 48% relative risk reduction in 30-day major adverse cardiac events (MACE). He concluded that our practice should change to loading all patients with high-dose statins before PCI.
Dr. Jochen Senges presented the OMEGA trial which showed that omega-3 fatty acids were of no benefit to post-MI patients, as compared to an olive oil control group. The primary endpoint was sudden cardiac death, and neither it nor any of the secondary endpoints were significantly affected by omega-3 fatty acids in this study. Other than for treating hypertriglyceridemia, the role of omega-3 fatty acids remains controversial.
Dr. Kristan Newby presented the EARLY-ACS study of 4,722 patients with non ST-elevation acute coronary syndromes (ACS) who were randomized to eptifibatide administered early after non-ST elevation ACS vs. elective administration at the time of PCI. Early therapy did not affect MACE, and bleeding complications were more common in the early group. Thus, early use of glycoprotein 11b/111a agents in non-ST elevation ACS does not seem useful and may increase bleeding. (N Engl J Med. online).
Dr. Bengt Fellstrom presented the AURORA study, which randomized end-stage renal disease patients on hemodialysis to rosuvastatin vs. placebo. LDL-cholesterol was reduced 43% in the rosuvastatin group, but time to the first major adverse cardiac or cerebrovascular event (MACCE) was not altered. The authors concluded that statins do not prevent cardiovascular disease (CVD) in dialysis patients. This study is now published in full. (N Engl J Med. 2009;360:1395-1407.) (N Engl J Med. online.)
The Indian polycaps study (TIPS) was presented by Salin Yusuf. The capsule contained aspirin 100 mg, simvastatin 20 mg, atenolol 50 mg, ramipril 5 mg, and HCTZ 12.5 mg. The polycap was compared to its component drugs and their combinations in 2,400 subjects aged 45-80 years with one risk factor for CVD but no overt CVD. No outcome data were presented, but blood pressure and LDL cholesterol were lower on the polycap. Unfortunately, compliance was not good, with 18% discontinuing therapy in three months. Dr. Yusuf concluded that giving the polycap to everyone over the age of 50 could reduce CVD risk by half.
Dr. Stuart Connolly presented the results of the ACTIVE-A study comparing aspirin plus clopidogrel to aspirin alone in atrial fibrillation patients at high risk of a vascular event, but unable to take warfarin. The primary endpoint of MACCE was reduced 11% (RR 0.89) on combination therapy, mainly due to a 28% (RR 0.72) reduction in stroke. This effect was mainly on ischemic stroke. There was an increase in major bleeding. Thus, in patients with atrial fibrillation at risk of stroke, but who cannot take warfarin, aspirin plus clopidogrel may be more effective than aspirin alone at preventing ischemic stroke, but at a cost of more major bleeding.