Combined Aspirin, Rx Antiplatelet Therapy Trial "May Be Warranted" - Study
This article was originally published in The Tan Sheet
Executive Summary
A randomized trial to determine the efficacy of long-term combined therapy with aspirin and the Rx antiplatelet therapy clopidogrel in patients with a history of cardiac surgery is suggested by researchers in the Jan. 23 issue of Circulation.
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A randomized trial to determine the efficacy of long-term combined therapy with aspirin and the Rx antiplatelet therapy clopidogrel in patients with a history of cardiac surgery is suggested by researchers in the Jan. 23 issue of Circulation. "The combination of aspirin plus an ADP [adenosine diphosphate] antagonist decreases fibrinogen binding and platelet aggregation significantly more than either agent alone," Deepak Bhatt, MD, Cleveland Clinic Foundation, et al., report in a study comparing clopidogrel with aspirin therapy. "The present study shows that long-term therapy with clopidogrel is superior to aspirin in patients who have had previous cardiac surgery, without an increase in bleedings risks," Bhatt, et al. say. "Therefore, a randomized trial of long-term therapy with clopidogrel plus aspirin versus aspirin (or clopidogrel) alone after [coronary artery bypass graft] may be warranted." The Clopidogrel Versus Aspirin in Patients at Risk of Ischemic Events (CAPRIE) study was a large-scale, multi-center, blinded, randomized trial comparing Plavix - co-marketed by Bristol-Myers Squibb and Sanofi - with aspirin in 19,185 patients. The results showed modest superiority of clopidogrel for reducing recurrent ischemic events, with fewer bleeding complications. Plavix received FDA approval in November 1997 based on the original CAPRIE results. In December 1998, the agency issued letters objecting to claims made by both aspirin maker Bayer Consumer Care and Sanofi regarding the CAPRIE results (1 (Also see "Bayer Aspirin MI, Stroke Prevention Comparative Claims Targeted By FDA" - Pink Sheet, 11 Jan, 1999.)). In their recent analysis, Bhatt, et al., examined whether clopidogrel is more effective than aspirin in reducing recurrent ischemic events in 1,480 of the CAPRIE subjects with previous cardiac surgery. The researchers found the event rate per year of vascular death, myocardial infarction, stroke or rehospitalization was 22.3% in the 705 aspirin patients, compared to 15.9% in the 775 patients receiving clopidogrel. Bhatt and colleagues note a consistent reduction in events among the clopidogrel group "was seen across a variety of different end points, including all-cause mortality, vascular death, MI, stroke, rehospitalization for ischemic events or bleeding, and all-cause rehospitalization." |