RACE-II

RACE-II

Is lenient rate control noninferior to strict rate control in patients with AF?

Study design

Population

• 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

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.