AFFIRM Trial

Trial details:

Acronym: Atrial Fibrillation Follow-up Investigation of Rhythm Management

Purpose: Evaluated a rate control vs. a rhythm control strategy in patients with atrial fibrillation.

Format: Randomized, multi-center comparison

Treatment group 1: Cardioversion and rhythmn-control therapy

Treatment group 2: Rate-control therapy

Number of patients: 4,060

Primary endpoint: Overall mortality

Summary:

The composite endpoint of death from cardiovascular causes, heart failure, thromboembolic complications, bleeding, need for pacemaker and adverse reaction to antiarrhythmic drugs was not different in the two groups. Subanalysis showed increased mortality for rhythm control strategy in the elderly, coronary disease patients and systolic heart failure patients. Anticoagulation was recommended for all patients as thromboembolic risk was similar in the two groups, even if rhythm control strategy was undertaken.

Original Publication:

Wyse DG, et al. N Engl J Med. 2002;doi:10.1056/NEJMoa021328.
Van Gelder IC, et al. N Engl J Med. 2002;doi:10.1056/NEJMoa021375.
Bardy GH, et al. N Engl J Med. 2005;doi:10.1056/NEJMoa043399.