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The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
Published on: February 28, 2012
Occurrence and characteristics of stroke events in the Atrial Fibrillation Follow-up Investigation of Sinus Rhythm
David G Sherman1, Soo G Kim, Bradley S Boop
1University of Texas Health Science Center, San Antonio, USA. Sherman@uthscsa.edu
Insights
The AFFIRM study found no difference in stroke rates between rate and rhythm control for atrial fibrillation (AF). However, warfarin significantly reduced stroke risk in high-risk AF patients.
Area of Science:
- Cardiology
- Neurology
- Clinical Trials
Background:
- Atrial fibrillation (AF) is a significant risk factor for stroke, particularly in patients with co-existing cardiovascular conditions.
- The Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) Study compared rhythm control versus rate control strategies in high-risk AF patients.
Purpose of the Study:
- To compare the efficacy of sinus rhythm control versus rate control strategies in managing high-risk patients with atrial fibrillation.
- To identify factors influencing stroke risk in patients with atrial fibrillation.
Main Methods:
- The AFFIRM Study randomized 4060 high-risk patients with AF to either a sinus rhythm control or a rate control strategy.
- Physicians were encouraged to maintain anticoagulation therapy; patients in the rhythm control group could discontinue warfarin after 4-12 weeks if maintaining sinus rhythm.
Main Results:
- Mortality rates were similar between the rate control and sinus rhythm control groups.
- Overall stroke incidence was 8.2% (211 patients), with ischemic stroke in 6.3% (157 patients).
- Warfarin therapy was associated with a 69% reduction in ischemic stroke risk, and active AF at the time of stroke increased risk by 60%.
Conclusions:
- Stroke rates did not significantly differ between the rate and rhythm control arms in the AFFIRM Study.
- Active atrial fibrillation increases stroke risk, while warfarin therapy significantly reduces this risk.
- Warfarin's protective effect against stroke extends to patients with a history of AF, even if in sinus rhythm.
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.
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