AFFIRM. NEJM 2002; 347(23): 1825.
Randomization: 7401 eligible, 4060 enrolled. 2027 in rate-control group, 2033 in rhythm-control group.
Baseline: Mean age 69.7y, 40% women, 11% ethnic minorities, 71% HTN, 38% CAD, 5% valvular disease, 23% CHF, 35% had first episode of afib, 90% had afib in last 6wks, 69% had afib > 2d.
Therapy:
Rate-control: Initial treatment was 49% digoxin, 47% beta-blockers, 30% diltiazem, 10% verapamil. 70% had used digoxin at least once. At five years 35% in sinus rhythm, 80% in afib had rate control, and 15% had crossover to rhythm-control. Continuous anticoagulation with goal INR 2-3.
Rhythm-control: Initial treatment was 33% digoxin, 22% beta-blockers, 38% amiodarone, & 31% sotalol. 63% had used amiodarone at least once. At five years, 63% were in sinus rhythm and 37.5% had crossover to rate-control. Anticoagulation could be stopped if NSR > 4 wks, preferably > 12 wks. Goal INR 2-3.
Primary Outcome: rate vs rhythm
Overall mortality: 25.9% vs 26.7%, ARR 0.8%, NNT 125, p = 0.08
Secondary Outcomes: rate vs rhythm
Composite death, disabling stroke, encephalopathy, bleed, arrest: 32.7 vs 32.0%, p = 0.33
Cardiac arrest: no difference
Encephalopathy: no difference
Ischemic stroke: 5.5 vs 7.1%, p = 0.79
Myocardial infarction: 4.9 vs 6.1%, p = 0.60
Pulmonary embolism: no difference
Adverse Events:
Hemorrhage not involving CNS: 7.7 vs 6.9%, p = 0.44
No Data Zone: comparing rate control with long term anticoagulation with rhythm control with long term anticoagulation.
this study compares rate control with long term anticoagulation with rhythm control with SHORT TERM anticoagulation.
It could be possible that when long term anticoagulation is added to rhythm control, pts do better than anticoagulated rate control...or maybe they dont.
That would be the next study in the long-term management of atrial fibrillation. Although, the AFFIRM and RACE trial have shown benefit to rate control with long-term anticoagulation, the question you raised has yet to be answered.
We know that patients with LA size > 4.5 to 5cm, CHF, no reversible underlying disorder (hyperthyroidism, pericarditis, PE, or cardiac surgery), HTN, and hypertensive heart disease have an increased risk of recurrent AF.
in the SAFE-T trial that compared amiodarone, sotalol, and placebo in patients with persistent AF, maintenance of sinus rhythm was significantly higher in amiodarone compared to sotalol or placebo (52 v 32 & 13, respectively). However, in that study we know that recurrence will happen with the median time being 487, 74, and 6 days in the three groups. (re: NEJM 2005; 352: 1861)