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Prasugrel versus clopidogrel for acute coronary syndromes without revascularization.
- Source :
-
The New England journal of medicine [N Engl J Med] 2012 Oct 04; Vol. 367 (14), pp. 1297-309. Date of Electronic Publication: 2012 Aug 25. - Publication Year :
- 2012
-
Abstract
- Background: The effect of intensified platelet inhibition for patients with unstable angina or myocardial infarction without ST-segment elevation who do not undergo revascularization has not been delineated.<br />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.<br />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.<br />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.).
- Subjects :
- Aged
Aspirin therapeutic use
Cardiovascular Diseases mortality
Cardiovascular Diseases prevention & control
Clopidogrel
Double-Blind Method
Drug Therapy, Combination
Female
Follow-Up Studies
Humans
Kaplan-Meier Estimate
Male
Middle Aged
Myocardial Infarction epidemiology
Piperazines adverse effects
Platelet Aggregation Inhibitors adverse effects
Prasugrel Hydrochloride
Purinergic P2 Receptor Antagonists adverse effects
Purinergic P2 Receptor Antagonists therapeutic use
Stroke epidemiology
Thiophenes adverse effects
Ticlopidine adverse effects
Ticlopidine therapeutic use
Acute Coronary Syndrome drug therapy
Angina, Unstable drug therapy
Myocardial Infarction drug therapy
Piperazines therapeutic use
Platelet Aggregation Inhibitors therapeutic use
Thiophenes therapeutic use
Ticlopidine analogs & derivatives
Subjects
Details
- Language :
- English
- ISSN :
- 1533-4406
- Volume :
- 367
- Issue :
- 14
- Database :
- MEDLINE
- Journal :
- The New England journal of medicine
- Publication Type :
- Academic Journal
- Accession number :
- 22920930
- Full Text :
- https://doi.org/10.1056/NEJMoa1205512