Patients with peripheral arterial disease in the CHARISMA trial
Why the study?
Does clopidogrel plus aspirin reduce the composite of cardiovascular death, MI, or stroke in patients with peripheral arterial disease compared to aspirin alone?
Population
3,096 patients with symptomatic or asymptomatic peripheral arterial disease from the CHARISMA trial
Comparison
Clopidogrel plus aspirin vs Placebo plus aspirin
Design
Cohort
Authors
Discussion
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Implication
Does not support routine dual antiplatelet therapy in PAD; leaves open whether MI reduction justifies minor bleeding risk in dedicated trials.
Key Points
- To assess whether adding clopidogrel to aspirin provides greater cardiovascular protection than aspirin alone in patients with peripheral arterial disease (PAD).
- Post hoc analysis of 3,096 patients with symptomatic (n=2,838) or asymptomatic (n=258) PAD enrolled in the CHARISMA trial.
- Patients were randomized to receive either clopidogrel plus aspirin or placebo plus aspirin to evaluate ischemic and bleeding outcomes.
- The primary endpoint of cardiovascular death, MI, or stroke occurred in 7.6% of the clopidogrel plus aspirin group versus 8.9% of the placebo plus aspirin group (HR, 0.85; 95% CI, 0.66-1.08; P = 0.18).
- Dual therapy significantly reduced myocardial infarction (2.3% vs. 3.7%; HR, 0.63; 95% CI, 0.42-0.96; P = 0.029) and hospitalizations for ischemic events (16.5% vs. 20.1%; HR, 0.81; 95% CI, 0.68-0.95; P = 0.011).
- Severe bleeding rates were comparable between groups, but minor bleeding was significantly higher with clopidogrel (34.4% vs. 20.8%; OR, 1.99; 95% CI, 1.69-2.34; P < 0.001).
Structured PICO
Does clopidogrel plus aspirin reduce the composite of cardiovascular death, MI, or stroke in patients with peripheral arterial disease compared to aspirin alone?
P
Population
3,096 patients with symptomatic (n=2,838) or asymptomatic (n=258) peripheral arterial disease (PAD) from the CHARISMA trial
I
Intervention
Clopidogrel plus aspirin
C
Comparator
Placebo plus aspirin
O
Outcome
Composite of cardiovascular death, myocardial infarction (MI), or strokecomposite
In patients with peripheral arterial disease, adding clopidogrel to aspirin did not significantly reduce the primary composite of cardiovascular death, MI, or stroke, but did reduce MI and ischemic hospitalizations at the cost of increased minor bleeding.
Limitations
- Post hoc analysis
Cite This Study
Cacoub et al. (2008) studied this question.