6/28/23, 12:05 AM AFFIRM Pathway Feedback Search Clinical Topics Home Studies AFFIRM AFFIRM Disease Disease Disease Acute ischemic stroke Atrial fibrillation Transient 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 N = 4060 61.0% male 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 https://web.pathway.md/studies/rec0eshIzaTolhbhK 1/2 6/28/23, 12:05 AM AFFIRM Pathway Death at 5 years 23.8 % 23.8 21.3 17.9 % 11.9 % 6.0 % No significant difference 0.0 % Rhythm control Rate control 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. Open reference URL https://web.pathway.md/studies/rec0eshIzaTolhbhK 2/2