Clinical Trials
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.