Original Paper

Clopidogrel and Aspirin versus Aspirin Alone for the Prevention of Stroke in Patients with a History of Atrial Fibrillation: Subgroup Analysis of the CHARISMA Randomized Trial
Robert G. Hart^a, Deepak L. Bhatt^b, Werner Hacke^e, Keith A.A. Fox^f, Graeme J. Hankey^g, Peter B. Berger^c, Tingfei Hu^b, Eric J. Topol^d, for the CHARISMA Investigators

^aUniversity of Texas Health Science Center at San Antonio, San Antonio, Tex.,
^bCleveland Clinic, Cleveland, Ohio,
^cGeisinger Center for Health Research, Danville, Pa.,
^dScripps Clinic, La Jolla, Calif., USA;
^eUniversity of Heidelberg, Heidelberg, Germany;
^fUniversity and Royal Infirmary of Edinburgh, Edinburgh, UK;
^gUniversity of Western Australia, Perth, W.A., Australia

Address of Corresponding Author

Cerebrovasc Dis 2008;25:344-347 (DOI: 10.1159/000118380)

  Key Words

• Atrial fibrillation
• Clopidogrel
• Aspirin
• Antiplatelet
• Stroke

  Abstract

Background: Aspirin offers modest reduction in stroke in patients with atrial fibrillation. Whether combination of aspirin with clopidogrel offers additional protection is unclear. Methods: Post-hoc subgroup analysis of 593 participants with a history of atrial fibrillation in the Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management, and Avoidance (CHARISMA) randomized trial testing clopidogrel 75 mg per day plus aspirin (75-162 mg per day) vs. aspirin alone in patients with stable cardiovascular disease or multiple cardiovascular risk factors. Results: Mean patient age was 70 years, 78% were men, and hypertension, heart failure and diabetes were present in 78, 20 and 44%, respectively. During a median follow-up of 2.3 years, stroke (ischemic and hemorrhagic) occurred in 15 of 298 assigned to clopidogrel plus aspirin and in 14 of 285 given aspirin alone (hazard ratio, HR, 1.03, 95% CI 0.49-2.1). There was no difference in all-cause mortality (HR 1.1, 95% CI 0.6-1.9) or in the composite of stroke, myocardial infarction, or vascular death (HR = 1.2, 95% CI 0.7-2.0). Severe/fatal extracranial hemorrhage occurred in 6 patients with combination vs. 3 with aspirin alone. Conclusions: This post-hoc subgroup analysis does not support the use of this combination over aspirin alone in patients with a history of atrial fibrillation pending results of ongoing larger randomized trials.

Copyright © 2008 S. Karger AG, Basel

  Author Contacts

Robert G. Hart, MD
Department of Neurology, University of Texas Health Science Center
7703 Floyd Curl Drive MC# 7883
San Antonio, TX 78229-3900 (USA)
Tel. +1 210 592 0404, Fax +1 210 592 0552, E-Mail hartr@uthscsa.edu

  Article Information

Received: October 15, 2007
Accepted: October 17, 2007
Published online: February 27, 2008
Number of Print Pages : 4
Number of Figures : 0, Number of Tables : 2, Number of References : 13