Atrial Fibrillation Follow-Up Investigation of Rhythm Management—The AFFIRM Study Design

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Abstract

The Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) Study is a randomized evaluation of treatment of atrial fibrillation by 1 of 2 strategies: ventricular rate control and anticoagulation versus rhythm control and anticoagulation. The primary end point is total mortality, analyzed by intention-to-treat. Secondary end points are composite end points (total mortality, disabling intracranial bleed [subdural and/or subarachnoid hemorrhage], stroke [embolus, thrombosis, hemorrhage], disabling anoxic encephalopathy, cardiac arrest, major noncentral nervous system bleed), cost of therapy, and quality of life. AFFIRM will randomize therapy and follow 5,300 patients for an average of 3.5 years (minimum 2 years) at 200 sites in the United States and Canada.

The AFFIRM Study is a randomized evaluation of treatment of atrial fibrillation by 1 of 2 strategies: rate control and anticoagulation versus rhythm control and anticoagulation. AFFIRM will randomize therapy and follow 5,300 patients for an average of 3.5 years at 200 sites in the United States and Canada.

Section snippets

Primary Objective

AFFIRM will test the null hypothesis that antiarrhythmic drug therapy administered to maintain normal sinus rhythm has no effect on total mortality when compared with therapy that controls the heart rate.

Secondary Objectives

Because stroke is such an important end point in trials of patients with AF, AFFIRM will compare the effects of the 2 treatment strategies on the following composite end points: (1) total mortality, disabling stroke (embolic, thrombotic, hemorrhagic), disabling anoxic encephalopathy, and

Therapeutic Approach to Maintenance of Sinus Rhythm

In clinical practice, management to maintain sinus rhythm is highly individualized. Except in the major substudy, the order of drugs used in AFFIRM will not be specified. The choice of drugs will be left to the primary treating physician, to be chosen from: amiodarone, sotalol, propafenone, flecainide, quinidine, moricizine, disopyramide, procainamide, and combinations of these drugs. Atrioventricular nodal blocking drugs will also be administered unless contraindicated. The major substudy for

Acknowledgements

This study was supported by the National Heart, Lung, and Blood Institute, Bethesda, Maryland, under contract NO1-HC-55139.

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