Adding aspirin to clopidogrel failed to prevent recurrent strokes
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Combining clopidogrel with aspirin did not appear to reduce the risk for recurrent stroke in patients with recurrent lacunar stroke, although the combination was associated with a significant increase in the risk for bleeding and death.
Researchers for the Secondary Prevention of Small Subcortical Strokes (SPS3) trial randomly assigned 3,020 patients (mean age, 63 years; 63% men) with recurrent symptomatic lunar infarcts to receive clopidogrel 75 mg (Plavix, Sanofi-Aventis) or placebo in addition to aspirin 325 mg daily. Mean follow-up was 3.4 years.
One hundred twenty-five strokes occurred at a rate of 2.5% per year in the aspirin with clopidogrel group vs. 138 strokes at 2.7% per year in the aspirin alone group These data suggested that adding aspirin to clopidogrel did not significantly decrease the risk for recurrent stroke (HR=0.92; 95% CI, 0.72-1.16), recurrent ischemic stroke (HR=0.82; 95% CI, 0.63-1.09), or disabling or fatal stroke (HR=1.06; 95% CI, 0.69=1.64), according to the researchers. Seventy-one percent of classifiable recurrent ischemic strokes (133 of 187) were lacunar strokes.
Risk for major hemorrhage, however, doubled with the use of clopidogrel and aspirin (105 hemorrhages, 2.1% per year) vs. aspirin alone (56 hemorrhages, 1.1% per year), with an HR of 1.97 (95% CI, 1.41-2.71).
With 113 deaths in the clopidogrel and aspirin group and 77 deaths in the aspirin alone group, all-cause mortality also appeared to be higher in the dual antiplatelet therapy group (HR=1.52; 95% CI, 1.14-2.04).
Results from the SPS3 trial were previously reported at the International Stroke Conference 2012.
Disclosure: This study was supported by a grant from the National Institute of Neurological Disorders and Stroke and by Sanofi-Aventis and Bristol-Myers Squibb, which donated the clopidogrel and matching placebo used in the study. See the study for a full list of researchers’ disclosures.