Authors
Bhatt DL, Fox KA, Hacke W, et al.
Title
Clopidogrel and Aspirin versus Aspirin Alone for the Prevention of Atherothrombotic Events
References
N Engl J Med 2006;354:1706-1717.
Background
Dual antiplatelet therapy decreases ischemic events in patients with acute coronary syndrome and in percutaneous coronary intervention with stenting.
Purpose
To determine whether there is benefit in treating high risk stable patients with the combination of clopidogrel and aspirin.
Design
Multicenter, randomised, double-blind, placebo-controlled study 15, 603 patients, aged ≥45 years and at least one of the following conditions: multiple atherothrombotic risk factors, coronary artery disease, cerebrovascular disease, or symptomatic peripheral vascular disease.
Exclusion Criteria
None.
Follow-Up
28 months (median)
Treatment Regimen
Clopidogrel 75 mg once daily plus aspirin (75-162 mg/day) versus Placebo plus aspirin (75-162 mg/day)
Results
Primary Endpoint: First occurrence of myocardial infarction, stroke (of any cause), or death from cardiovascular causes (including hemorrhage) The primary endpoint was not significantly different between the two groups: 6.8% (clopidogrel plus aspirin) versus 7.3% (aspirin); p=0.22. Severe bleeding (GUSTO definition) was 1.7% (clopidogrel plus aspirin) vs 1.3% (aspirin); p=0.09 In a pre-defined subgroup of patients with cardiovascular disease, there was a 12% risk reduction in the primary endpoint with the addition of clopiodgrel (6.9% vs 7.9%, p=0.046), with no excess of severe bleeding. Secondary Efficacy Endpoint: first occurrence of myocardial infarction, stroke, death from cardiovascular causes, or hospitalization for unstable angina, a transient ischemic attack, or a revascularization procedure (coronary, cerebral, or peripheral)
Summary
In a broad group of patients with stable atherosclerotic vascular disease or with multiple cardiovascular risk factors, clopidogrel plus aspirin was no better than aspirin alone in reducing the risk of myocardial infarction, stroke, or death from cardiovascular causes.
Implications
None.
Related Figures
[5, 7, 8]