European Heart Journal Advance Access originally published online on January 9, 2009
European Heart Journal 2009 30(2):192-201; doi:10.1093/eurheartj/ehn534
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Patients with peripheral arterial disease in the CHARISMA trial
1 Department of Internal Medicine, La Pitié-Salpêtrière Hospital, AP HP, 47-83 Boulevard de l'Hôpital, F-75651 Paris Cedex 13, France
2 UMR CNRS 7087, Université Pierre et Marie Curie-Paris 6, Paris, France
3 VA Boston Healthcare System and Brigham and Women’s Hospital, Boston, MA, USA
4 Department of Cardiology, Bichat Hospital, AP HP and INSERM U-698 Université Paris 7, Paris, France
5 Scripps Translational Science Institute, Scripps Clinic, and Scripps Health, La Jolla, CA 92037, USA
6 Division of Cardiovascular Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA, USA
Received 31 March 2008; revised 3 November 2008; accepted 18 November 2008.
* Corresponding author. Tel: +33 142 17 80 27, Fax: +33 142 17 80 33, Email: patrice.cacoub{at}psl.aphp.fr
See page 131 for the editorial comment on this article (doi:10.1093/eurheartj/ehn565)
Aims: The aim of this study was to determine whether clopidogrel plus aspirin provides greater protection against major cardiovascular events than aspirin alone in patients with peripheral arterial disease (PAD).
Methods and results: This is a post hoc analysis of the 3096 patients with symptomatic (2838) or asymptomatic (258) PAD from the CHARISMA trial. The rate of cardiovascular death, myocardial infarction (MI), or stroke (primary endpoint) was higher in patients with PAD than in those without PAD: 8.2% vs. 6.8% [hazard ratio (HR), 1.25; 95% CI 1.08, 1.44; P = 0.002]. Among the patients with PAD, the primary endpoint occurred in 7.6% in the clopidogrel plus aspirin group and 8.9% in the placebo plus aspirin group (HR, 0.85; 95% CI, 0.66–1.08; P = 0.18). In these patients, the rate of MI was lower in the dual antiplatelet arm than the aspirin alone arm: 2.3% vs. 3.7% (HR, 0.63; 95% CI, 0.42–0.96; P = 0.029), as was the rate of hospitalization for ischaemic events: 16.5% vs. 20.1% (HR, 0.81; 95% CI, 0.68–0.95; P = 0.011). The rates of severe, fatal, or moderate bleeding did not differ between the groups, whereas minor bleeding was increased with clopidogrel: 34.4% vs. 20.8% (odds ratio, 1.99; 95% CI, 1.69–2.34; P < 0.001).
Conclusion: Dual therapy provided some benefit over aspirin alone in PAD patients for the rate of MI and the rate of hospitalization for ischaemic events, at the cost of an increase in minor bleeding.
Key Words: Peripheral vascular disease • Aspirin • Clopidogrel • Prognosis
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Related articles in EHJ:
- The peripheral arterial disease subgroup in the CHARISMA trial: does it tell us anything new?
- Paolo Gresele and Rino Migliacci
EHJ 2009 30: 131-132.[Extract] [Full Text]
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