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David G. Sherman, MD; Soo G. Kim, MD; Bradley S. Boop, MD; Scott D. Corley, MD; John P. DiMarco, MD; Robert G. Hart, MD; L. Julian Haywood, MD; Keith Hoyte, MD; Elizabeth S. Kaufman, MD; Michael H. Kim, MD; Elaine Nasco, MD; Albert L. Waldo, MD; for the National Heart, Lung, and Blood Institute AFFIRM Investigators

Arch Intern Med. 2005;165:1185-1191.

Background  Atrial fibrillation (AF) is a risk factor for stroke, especially when accompanied by other high-risk cardiovascular predictors. The Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) Study was a multicenter comparison of high-risk patients with AF who were randomized to either a sinus rhythm control or a rate control strategy.

Methods  Physicians were encouraged to continue anticoagulation therapy for their patients. Patients in the sinus rhythm control group could stop warfarin sodium therapy after 4 (preferably a minimum of 12) weeks if they maintained sinus rhythm while receiving an antiarrhythmic drug.

Results  The AFFIRM Study enrolled 4060 patients. Mortality was the same in both groups. Two hundred eleven patients (8.2%) had a stroke event. Ischemic stroke occurred in 157 patients (6.3%), primary intraparenchymal hemorrhage in 34 (1.2%), and subdural or subarachnoid hemorrhage in 24 (0.8%). The most frequently determined ischemic stroke mechanism was cardioembolic (35/71 [49%]). Treatment assignment had no significant effect on the occurrence of ischemic stroke. Patients in AF at the time of the stroke event had a 60% greater chance of having an ischemic stroke, and those taking warfarin at the time of follow-up had a 69% decrease in the risk of having an ischemic stroke.

Conclusions  In the AFFIRM Study, stroke rates were not significantly different in the rate control and sinus rhythm control arms. However, several clinical and therapeutic variables were associated with stroke risk. In patients with a history of AF at high risk for stroke or death, the presence of AF increases the risk of having a stroke, and warfarin therapy reduces the risk of having a stroke. The beneficial effect of warfarin therapy is seen not only in patients in AF but also in patients with a history of AF but who presumably remain in sinus rhythm.

Author Affiliations: University of Texas Health Science Center, San Antonio (Drs Sherman and Hart); Montefiore Medical Center, Bronx, NY (Dr S. G. Kim); Little Rock, Ark (Dr Boop); Axio Reseach Corp, Seattle, Wash (Drs Corley and Nasco); University of Virginia, Charlottesville, Va (Dr DiMarco); Keck School of Medicine, University of Southern California, Los Angeles, Calif (Dr Haywood); University of Calgary, Calgary, Alberta (Dr Hoyte); Case Western Reserve, Cleveland, Ohio (Drs Kaufman and Waldo); Rush-Presbyterian–St Luke’s Medical Center, Chicago, Ill (Dr M. H. Kim).
Group Information: A complete listing of the members of the AFFIRM Study was previously published (Am Heart J. 2002;143:991-1001).

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