Plavix plus aspirin more effective than aspirin alone in preventing major vascular events in patients with atrial fibrillation who cannot take oral anticoagulants.
Greatest benefit seen in reducing stroke, the highest risk for atrial fibrillation patients.
Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) and Bristol-Myers Squibb Company (NYSE: BMY) announced new findings from a landmark investigational study that demonstrated that, for patients with atrial fibrillation who were at increased risk for stroke and could not take an oral anticoagulant (OAC) medication, taking Plavix? (clopidogrel bisulfate) in addition to aspirin significantly reduced major vascular events by 11% over aspirin alone, at a median of 3.6 years of follow-up (6.8% vs. 7.6% per year, p=0.01).
The greatest benefit was seen in the reduction of stroke, by 28% (2.4% vs. 3.3% per year, p<0.001), which is the primary goal of physicians treating patients with atrial fibrillation.Other components of major vascular events -- non-CNS systemic embolism (a blood clot in the bloodstream but not in the brain), heart attack or vascular death -- did not reach statistical significance.Compared to aspirin alone, taking Plavix in addition to aspirin significantly and as expected increased the rate of major bleeding (2.0% vs. 1.3% per year, RR=1.57, p < 0.001). The study results, from the trial called ACTIVE A, were presented today at a late-breaking session during the 58th Annual Scientific Session of the American College of Cardiology."For patients with atrial fibrillation who are at increased risk for stroke but cannot take oral anticoagulants, these findings suggest a potential change in clinical practice," said ACTIVE A principal investigator Stuart Connolly, MD, Department of Medicine, McMaster University, Hamilton, Ontario, Canada. "Stroke is a major concern since it results in significant morbidity and mortality."In atrial fibrillation (AF), the most common heart arrhythmia, blood can pool in the upper chambers of the heart (the atria) and form clots, which can be released into the bloodstream and cause a vascular event. With a five-fold greater risk for stroke, AF patients account for about 15% of all strokes. Thus, in addition to therapies to normalize heart rhythm, treatment guidelines recommend AF patients at moderate-to-high risk for stroke also receive OAC therapy, which is effective in preventing vascular events in these patients. However, there are many patients who cannot take OACs or cannot maintain their blood coagulation inhibition within the narrow therapeutic range required to reduce the risk of vascular events without increasing the risk of life-threatening bleeding complications such as intracranial hemorrhage. Studies show that less than half of AF patients overall use OACs."Sanofi-aventis and Bristol-Myers Squibb Company sponsored ACTIVE A as part of our ongoing commitment to investigate the full potential of Plavix? through major clinical trials, covering a broad spectrum of patients at risk of cardiovascular events early and long-term," said Brian Daniels, Senior Vice President, Global Development and Medical Affairs, Bristol-Myers Squibb."These results are of major interest for people with atrial fibrillation and at increased risk for vascular events, particularly stroke, who cannot take OACs," said Jean-Pierre Lehner, Chief Medical Officer, sanofi-aventis.Source: Bristol Myers Squibb, USA