RACE II
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
66.0% male
N = 614
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
Death from cardiovascular causes, hospitalization for heart failure, and stroke, systemic embolism, bleeding, and life-threatening arrhythmic events at 3 years
12.9
14.9
14.9 %
11.2 %
7.5 %
3.7 %
0.0 %
Lenient rate
control
Strict rate
control
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority 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.
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