Problem Atrial fibrillation
Format -
Treatment Lenient rate control (HR<110)
Control Strict rate control (HR<80)
Population 614 patients
Inclusion criteria Permanent atrial fibrillation for up to 12 months
Age of 80 years or younger
Mean resting heart rate above 80 beats per minute
Current use of oral anticoagulation therapy (or aspirin, if no risk factors for thromboembolic complications were present)
Exclusion criteria -
Follow-up 2-3 years
Primary endpoint Composite of
-Death from cardiovascular causes
-Hospitalization for heart failure
-Systemic embolism
-Life-threatening arrhythmic events
Secondary endpoint(s) Components of the primary outcome
Death from any cause
Functional status
Details Paroxysmal AF
Known contraindications for either strict or lenient rate control (eg, previous adverse effects on negative chronotropic drugs)
Unstable heart failure defined as NYHA IV heart failure or heart failure necessitating hospital admission within 3 months before inclusion
Cardiac surgery within 3 months
Any stroke,
Current or foreseen pacemaker
Internal cardioverter defibrillator, and/or cardiac resynchronization therapy,
Signs of sick sinus syndrome or AV conduction disturbances (ie, symptomatic bradycardia or asystole >3 seconds or escape rate b40 bpm in awake symptom-free patients)
Untreated hyperthyroidism or <3 months euthyroidism
Inability to walk or bike.
Discontinuation of rate control drugs before inclusion to meet the inclusion criteria is not allowed.
Brief summary: Strict rate control (<80) no better than lenient (<110) control
PAPER: Lenient versus strict rate control in patients with atrial fibrillation.
Date 15 Apr 2010
Journal N Engl J Med. 2010 Apr 15;362(15):1363-73. Epub 2010 Mar 15.
Information Lenient (resting HR<110) vs. strict (resting HR<80; mod. exercise HR<110)
-Lenient rate control non-inferior to strict control (p<0.001)
-Components of outcome similar in 2 groups
-Decreased clinic visits for lenient control