Prasugrel versus clopidogrel for acute coronary syndromes without revascularization.
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Roe Matthew T, Armstrong Paul W, Fox Keith A A, White Harvey D, Prabhakaran Dorairaj, Goodman Shaun G, Cornel Jan H, Bhatt Deepak L, Clemmensen Peter, Martinez Felipe, Ardissino Diego, Nicolau Jose C, Boden William E, Gurbel Paul A, Ruzyllo Witold, Dalby Anthony J, McGuire Darren K, Leiva-Pons Jose L, Parkhomenko Alexander, Gottlieb Shmuel, Topacio Gracita O, Hamm Christian, Pavlides Gregory, Goudev Assen R, Oto Ali, Tseng Chuen-Den, Merkely Bela, Gasparovic Vladimir, Corbalan Ramon, Cinteză Mircea, McLendon R Craig, Winters Kenneth J, Brown Eileen B, Lokhnygina Yuliya, Aylward Philip E, Huber Kurt, Hochman Judith S, Ohman E Magnus, TRILOGY ACS Investigators
Аннотация
METHODS: In this double-blind, randomized trial, in a primary analysis involving 7243 patients under the age of 75 years receiving aspirin, we evaluated up to 30 months of treatment with prasugrel (10 mg daily) versus clopidogrel (75 mg daily). In a secondary analysis involving 2083 patients 75 years of age or older, we evaluated 5 mg of prasugrel versus 75 mg of clopidogrel.
RESULTS: At a median follow-up of 17 months, the primary end point of death from cardiovascular causes, myocardial infarction, or stroke among patients under the age of 75 years occurred in 13.9% of the prasugrel group and 16.0% of the clopidogrel group (hazard ratio in the prasugrel group, 0.91; 95% confidence interval [CI], 0.79 to 1.05; P=0.21). Similar results were observed in the overall population. The prespecified analysis of multiple recurrent ischemic events (all components of the primary end point) suggested a lower risk for prasugrel among patients under the age of 75 years (hazard ratio, 0.85; 95% CI, 0.72 to 1.00; P=0.04). Rates of severe and intracranial bleeding were similar in the two groups in all age groups. There was no significant between-group difference in the frequency of nonhemorrhagic serious adverse events, except for a higher frequency of heart failure in the clopidogrel group.
CONCLUSIONS: Among patients with unstable angina or myocardial infarction without ST-segment elevation, prasugrel did not significantly reduce the frequency of the primary end point, as compared with clopidogrel, and similar risks of bleeding were observed. (Funded by Eli Lilly and Daiichi Sankyo; TRILOGY ACS ClinicalTrials.gov number, NCT00699998.).