Authors
Roe MT, Armstrong PW, Fox KA, et al.
Title
Prasugrel versus clopidogrel for acute coronary syndromes without revascularization.
References
N Engl J Med 2012;367:1297-309
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.
Purpose
To evaluate whether aspirin plus prasugrel is superior to aspirin plus clopidogrel for long-term therapy without revascularization in patients with unstable angina or myocardial infarction without ST-segment elevation who are under the age of 75 years.
Design
  • Randomized, double-blind, double-dummy, active- control, event-driven trial
  • In 7243 patients under the age of 75 years receiving aspirin, up to 30 months of treatment with prasugrel (10 mg daily) versus clopidogrel (75 mg daily) were evaluated. In a secondary analysis involving 2083 patients 75 years of age or older, 5 mg of prasugrel versus 75 mg of clopidogrel were evaluated.
  • Primary end point of death from cardiovascular causes, myocardial infarction, or stroke
Exclusion Criteria
  • History of transient ischemic attack or stroke,
  • PCI or CABG within the previous 30 days,
  • Renal failure requiring dialysis
  • Concomitant treatment with an oral anticoagulant.
Follow-Up
Median follow-up of 17 months
Treatment Regimen
Up to 30 months of treatment with prasugrel (10 mg daily) versus clopidogrel (75 mg daily)
Results
Primary Endpoints:
  • 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).

Secondary Endpoints:

  • 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 non-hemorrhagic serious adverse events, except for a higher frequency of heart failure in the clopidogrel group.
Summary
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.
Implications
Prasugrel offers no advantage over clopidogrel in the treatment of NSTEMI in non-revascularized patients under 75 years of age.
Related Figures
None.