- Question
- Is lenient heart-rate control noninferior to strict rate control for preventing cardiovascular morbidity and mortality in patients with permanent atrial fibrillation?
- Design
- Randomized, noninferiority trial of 614 patients, with no masking (per the registry). Follow-up was at least 2 years and a maximum of 3 years.
- Population
- Patients with permanent atrial fibrillation.
- Intervention
- Lenient rate control: resting heart rate below 110 beats per minute.
- Control
- Strict rate control: resting heart rate below 80 beats per minute and below 110 beats per minute during moderate exercise.
- Primary outcome
- Composite of cardiovascular death, hospitalization for heart failure, stroke, systemic embolism, bleeding, and life-threatening arrhythmic events.
- Results
- The estimated cumulative incidence of the primary outcome at 3 years was 12.9% with lenient control and 14.9% with strict control, an absolute difference of -2.0 percentage points (90% CI, -7.6 to 3.5; P<0.001 for the prespecified noninferiority margin). The heart-rate target was met by 97.7% in the lenient group versus 67.0% in the strict group, with fewer visits in the lenient group.
- Safety
- The frequencies of symptoms and adverse events were similar in the two groups.
- Conclusion
- In permanent atrial fibrillation, lenient rate control is as effective as strict control and easier to achieve.
- Why it matters
- It challenged the recommendation for strict rate control, which was not based on clinical evidence, and supported a simpler strategy requiring fewer follow-up visits.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 10, 2026