Aspirin and Stroke
In patients with atrial fibrillation (AF) who cannot take warfarin, the combination of clopidogrel (Plavix, Bristol-Myers Squibb/Sanofi-Aventis) and aspirin reduced major vascular events, particularly stroke, compared with placebo, although at the expense of an increase in major bleeding [1].
Although warfarin and vitamin-K antagonists are the treatment of choice for AF patients at high risk for stroke, up to 50% are not treated with either because they are judged as unsuitable candidates by their physician, and for these patients who are treated only with aspirin, "there is a major unmet medical need," lead author Dr Stuart J Connolly (McMaster University, Hamilton, ON) told the meeting here.
"The results of ACTIVE-A, which is the largest trial ever performed of an antithrombotic therapy in atrial fibrillation, with more than three times as many strokes as any other trial, have clearly shown that clopidogrel reduces major vascular events, primarily due to a reduction in stroke," Connolly concluded. "This occurs at a cost that is acceptable in terms of major bleeding. Overall, clopidogrel provides an important benefit to a majority of patients at an acceptable risk."
He presented a risk/benefit analysis suggesting that in 1000 AF patients treated for three years, 28 strokes would be prevented, 17 of which would be fatal or disabling, and six MIs, at the cost of 20 nonstroke major bleeds, three of which would be fatal. Total days in the hospital would also be reduced, from about 34,000 to just over 30,000 total days, he noted.
The results are published online March 31, 2009 in the New England Journal of Medicine to coincide with their presentation here at the American College of Cardiology 58th Annual Scientific Session. They will appear in the May 14 issue.
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