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| |  Clopidogrel Plus Aspirin Improves Outcomes in Patients With Atrial Fibrillation Not Taking Warfarin: Presented at ACC By Ed Susman ORLANDO, Fla -- March 31, 2009 -- Addition of clopidogrel to daily aspirin therapy in patients with atrial fibrillation who are not candidates for warfarin therapy reduces the risk of stroke by 28% over a 4-year period compared with aspirin alone, researchers reported here at the American College of Cardiology (ACC) 58th Annual Scientific Session. Overall, the dual platelet combination reduced by 11% the risk of major vascular events: stroke, myocardial infarction, noncentral nervous system embolism, and vascular death. This difference in outcomes reached statistical significance (P = .014). "We really are impressed with the reduction in stroke," said lead investigator Stuart Connolly, MD, McMaster University, Hamilton, Ontario, in a late-breaking clinical trials session on March 31. "The strokes caused by atrial fibrillation are big strokes, fatal strokes, and disabling strokes. We think this is a very important outcome," Dr. Connolly said. In the Clopidogrel Plus Aspirin Versus Aspirin Alone for Prevention of Vascular Events in Patients With Atrial Fibrillation at High Risk of Stroke (ACTIVE A) study, patients who were unsuitable for treatment with warfarin due to bleeding risk or due to patient or doctor decision were randomly assigned to receive aspirin alone -- the standard treatment for warfarin-intolerant atrial fibrillation patients -- or aspirin plus clopidogrel. Oral anticoagulants, such as warfarin and aspirin, are the only proven effective therapies for patients with atrial fibrillation and warfarin has proved to be the more effective of the two. Guidelines recommend warfarin for high-risk patients with atrial fibrillation, but as many as 50% of patients do not take it because of the associated risk of bleeding or because their physician does not recommend it, so their only alternative is aspirin, Dr. Connolly said. "The purpose of the ACTIVE-A trial was to determine if the addition of clopidogrel to aspirin would reduce major vascular events and stroke in patients with atrial fibrillation." "We determined that if you treated 1,000 patients over the course of 3 years by adding clopidogrel to aspirin, you would prevent 28 strokes, 17 of which would be fatal or disabling, and you would prevent 6 heart attacks. This would occur at a cost of 20 major haemorrhages, 3 of which would be fatal." In the double-blind, placebo-controlled ACTIVE-A study, the effect of adding clopidogrel to aspirin was directly evaluated in 7,554 patients with documented atrial fibrillation and at least 1 stroke risk factor. All patients were treated with aspirin 75 to 100 mg/day and randomised to receive either clopidogrel 75 mg/day or matching placebo. Results showed that clopidogrel increased the risk of major haemorrhage by 58% from 1.27% to 2%/year. "Addition of clopidogrel to aspirin in many patients with AF [who are] unsuitable for warfarin will provide an overall benefit at an acceptable risk," said Salim Yusuf, MD, McMaster University, Hamilton, Ontario, and one of the principal investigators. "When compared to aspirin alone, warfarin is more effective than clopidogrel plus aspirin against stroke in AF. However, clopidogrel provides only about three-quarters of the benefit of warfarin over aspirin, but with only about three-quarters of the increased risk of major and intracranial haemorrhage," Dr. Yusuf added.
[Presentation title: Clopidogrel Plus Aspirin Versus Aspirin Alone for Prevention of Vascular Events in Patients With Atrial Fibrillation at High Risk of Stroke: The Results of ACTIVE A.]
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