6/29/23, 12:42 AM RACE II Pathway Feedback Search Clinical Topics Home Studies RACE II RACE II Disease Atrial fibrillation Trial question Is lenient rate control noninferior to strict rate control in patients with AF? Study design Multi-center Open label RCT Population Characteristics of study participants 34.0% female N = 614 66.0% male 614 patients (211 female, 403 male) Inclusion criteria: patients with permanent AF Key exclusion criteria: paroxysmal AF, previous adverse effects on negative chronotropic drugs, unstable HF defined as NYHA IV HF or HF necessitating hospital admission < 3 months before inclusion, cardiac surgery < 3 months, or any stroke Interventions N=311 lenient rate control (resting HR < 110 beats/min) N=303 strict rate control (resting HR < 80 beats/min and HR during exercise < 110 beats/min) Primary outcome https://web.pathway.md/studies/recvQSaRxtRS6PQg0 1/2 6/29/23, 12:42 AM RACE II Pathway Death from cardiovascular causes, hospitalization for heart failure, and stroke, systemic embolism, bleeding, and life-threatening arrhythmic events at 3 years 14.9 % 14.9 12.9 11.2 % 7.5 % Difference not exceeding nonferiority margin 3.7 % 0.0 % Lenient rate control Strict rate control Difference not exceeding nonferiority margin in death from cardiovascular causes, hospitalization for HF, and stroke, systemic embolism, bleeding, and life-threatening arrhythmic events at 3 years (12.9% vs. 14.9%; HR 0.8, 90% CI 0.55 to 1.17) Secondary outcomes Significant decrease in stroke (1.6 vs. 3.9; HR 0.35, 90% CI 0.13 to 0.92) Significant decrease in death at 3 years (5.6% vs. 6.6%; HR 0.91, 90% CI 0.52 to 1.59) Safety outcomes No significant difference in frequencies of symptoms and adverse events. Conclusion In patients with permanent AF, lenient rate control was noninferior to strict rate control with respect to death from cardiovascular causes, hospitalization for HF, and stroke, systemic embolism, bleeding, and life-threatening arrhythmic events at 3 years. Reference Van Gelder IC, Groenveld HF, Crijns HJ et al. Lenient versus strict rate control in patients with atrial fibrillation. N Engl J Med. 2010 Apr 15;362(15):1363-73. Open reference URL https://web.pathway.md/studies/recvQSaRxtRS6PQg0 2/2