Robby Nieuwlaat, PhD; Stuart J. Connolly, MD
Is lenient rate control as effective as strict rate control for preventing cardiovascular events in patients with permanent atrial fibrillation (AF)?
Randomized noninferiority trial (Rate Control Efficacy in Permanent Atrial Fibrillation: a Comparison between Lenient versus Strict Rate Control II [RACE II] study). ClinicalTrials.gov NCT00392613.
Blinded (outcome adjudication committee).*
≥ 2 years and ≤ 3 years.
33 centers in the Netherlands.
614 patients ≤ 80 years of age (mean age 68 y, 66% men) who had permanent AF for ≤ 12 months, had mean resting heart rate > 80 beats/min, and were currently using oral anticoagulation therapy (or aspirin if at low risk).
311 patients were allocated to lenient rate control (target resting heart rate < 110 beats/min), and 303 were allocated to strict rate control (target resting heart rate < 80 beats/min and < 110 beats/min during moderate exercise). During an initial dose-adjustment phase, patients received ≥ 1 negative dromotropic drugs, alone or in combination, until heart rate targets were achieved.
Primary outcome was a composite of cardiovascular mortality, hospitalization for heart failure, stroke, systemic embolism, major bleeding, and arrhythmic events.
Lenient and strict rate control did not differ for the primary outcome (Table). The criterion for noninferiority was met because the upper limit of the 90% CI for the absolute difference in the primary outcome between groups at 3 years (−2%, 90% CI −7.6 to 3.5) was < 10%. Results for select components of the primary outcome are also presented in the Table.
Lenient rate control was as effective as strict rate control for preventing cardiovascular events in permanent atrial fibrillation.
Lenient vs strict rate control in patients with permanent atrial fibrillation†
†Abbreviations defined in Glossary. Composite endpoint estimates based on first event for each patient; all other outcomes based on all events.
‡Cardiovascular mortality, hospitalization for heart failure, stroke, systemic embolism, major bleeding, and arrhythmic events.
Nieuwlaat R, Connolly SJ. Lenient rate control is as effective as strict rate control for preventing cardiovascular events in AF. Ann Intern Med. ;153:JC2–4. doi: 10.7326/0003-4819-153-4-201008170-02004
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Published: Ann Intern Med. 2010;153(4):JC2-4.
Cardiology, Rhythm Disorders and Devices.
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