Frequency of primary end point, bleeding risks similar for those not undergoing revascularization
MONDAY, Aug. 27 (HealthDay News) -- For patients with unstable angina or myocardial infarction without ST-segment elevation who do not undergo revascularization, intensified platelet inhibition with prasugrel does not reduce the frequency of the primary end point (death from cardiovascular causes, myocardial infarction, or stroke) and has similar risks of bleeding as clopidogrel, according to a study published online Aug. 26 in the New England Journal of Medicine to coincide with presentation at the annual European Society of Cardiology Congress, held from Aug. 25 to 29 in Munich.
Matthew T. Roe, M.D., M.H.S., from the Duke University Medical Center in Durham, N.C., and colleagues compared the effect of prasugrel with clopidogrel for patients with unstable angina or myocardial infarction without ST-segment elevation who did not undergo revascularization. In a primary analysis, 7,243 patients younger than 75 years receiving aspirin were randomized to 10 mg prasugrel or 75 mg clopidogrel daily for 30 months. In a secondary analysis, 2,083 patients aged 75 years and older were randomized to 5 mg prasugrel or 75 mg clopidogrel.
After a median follow-up of 17 months, the researchers found that there was no significant difference in the primary end point of death from cardiovascular causes, myocardial infarction, or stroke in the primary analysis (13.9 percent of the prasugrel group versus 16.0 percent of the clopidogrel group; hazard ratio, 0.91; P = 0.21). Results were similar in the overall population. In patients of all age groups, the rates of severe and intracranial bleeding were similar between the groups.
"Our findings highlight the need for further study of differences in the response to intensified platelet inhibition for patients receiving medical therapy without revascularization, as compared with those undergoing revascularization, for treatment of an index cardiac event," the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including Eli Lilly and Daiichi Sankyo, which funded the study and jointly market prasugrel.