AFFIRM
Trial question
What is the role of rhythm control strategy in patients with AF and a high risk of stroke or death?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
39.0% female
61.0% male
N = 4060
4060 patients (1594 female, 2466 male)
Inclusion criteria: patients with AF and a high risk of stroke or death
Key exclusion criteria: unsuccessful cardioversion, contraindication to certain therapies in the study, congestive HF, or renal abnormality
Interventions
N=2033 rhythm control (antiarrhythmic drugs, cardioversion as necessary to maintain sinus rhythm)
N=2027 rate control (target to control heart-rate control < 80 beats/min at rest and < 110 beats/min during six-minute walk test)
Primary outcome
Death at 5 years
23.8
21.3
23.8 %
17.9 %
11.9 %
6.0 %
0.0 %
Rhythm control
Rate control
No significant difference ↔
No significant difference in death at 5 years (23.8% vs. 21.3%; HR 1.15, 95% CI 0.99 to 1.34)
Secondary outcomes
No significant difference in death, disabling stroke, disabling anoxic encephalopathy, major bleeding, and cardiac arrest (32% vs. 32.7%; RR 0.98, 95% CI -0.97 to 2.93)
No significant difference in CNS events (8.9% vs. 7.4%; RR 1.2, 95% CI -23.34 to 25.74)
Safety outcomes
Significant differences in hospitalization during follow-up (80.1% vs. 73.0%, p < 0.001) and adverse drug effects leading to discontinuation (more common in rhythm-control group), including pulmonary events, gastrointestinal events, bradycardia, and prolongation of corrected QT interval (p < 0.001 for all comparisons).
Conclusion
In patients with AF and a high risk of stroke or death, rhythm control was not superior to rate control with respect to death at 5 years.
Reference
Wyse DG, Waldo AL, DiMarco JP et al. A comparison of rate control and rhythm control in patients with atrial fibrillation. N Engl J Med. 2002 Dec 5;347(23):1825-33.
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