(HealthDay News) — Treating patients with recent lacunar strokes with dual antiplatelet therapy (clopidogrel plus aspirin) is not associated with a reduction in the risk of recurrent stroke, and correlates with significant increases in the risk of major hemorrhage and death, according to research published in the Aug. 30 issue of the New England Journal of Medicine.
Oscar R. Benavente, M.D., of the University of British Columbia in Vancouver, Canada, and the SPS3 trial investigators conducted a randomized, double-blind, multicenter trial involving 3,020 patients with recent symptomatic lacunar infarcts identified using magnetic resonance imaging (MRI). Patients received either 75 mg of clopidogrel plus aspirin or placebo plus aspirin each day.
During an average follow-up of 3.4 years, the researchers found that dual antiplatelet therapy with aspirin and clopidogrel did not significantly reduce the risks of recurrent stroke, recurrent ischemic stroke, or disabling or fatal stroke. Dual antiplatelet therapy correlated with nearly double the risk of major hemorrhage compared with aspirin alone (2.1 versus 1.1 percent per year; hazard ratio, 1.97). All-cause mortality was significantly higher in patients receiving dual antiplatelet therapy compared with aspirin alone (113 versus 77 deaths; hazard ratio, 1.52). Fatal hemorrhages did not account for this difference (nine in dual antiplatelet group versus four in the aspirin group).
“In conclusion, in this clinical trial of clopidogrel and aspirin, as compared with aspirin alone, in patients with a recent lacunar stroke identified on MRI, we found that the anticipated increase in the risk of major hemorrhage with dual anti-platelet therapy was not offset by a reduction in the risk of stroke recurrence, and there was an unexpected increase in mortality,” the authors write.
Sanofi-Aventis and Bristol-Myers Squibb donated the clopidogrel and matching placebo used in this study; several authors disclosed financial ties to these and other pharmaceutical companies.