Randomized Ablation-Based Rhythm-Control Versus Rate-Control Trial in Patients with Heart Failure and Atrial Fibrillation: Results from the RAFT-AF trial

Background: Atrial fibrillation (AF) and heart failure (HF) frequently coexist and can be challenging to treat. Pharmacologic based rhythm-control of AF has not proven to be superior to rate-control. Ablation-based rhythm-control was compared to rate-control to evaluate if clinical outcomes in patients with HF and AF could be improved. Methods: This was a multicenter, open-label trial with blinded outcome evaluation using a central adjudication committee. Patients with high burden paroxysmal (>4 episodes in six months) or persistent (duration < three years) AF, New York Heart Association class II-III HF, and elevated NT-proBNP were randomized to ablation-based rhythm-control or rate-control. The primary outcome was a composite of all-cause mortality and all HF events, with a minimum follow up of two years. Secondary outcomes included left ventricular ejection fraction (LVEF), six-minute walk test and NT-proBNP. Quality of life was measured using the Minnesota Living with Heart Failure Questionnaire (MLHFQ) and the AF Effect on quality of life (AFEQT). The primary analysis was time-to-event using Cox proportional hazards modeling. The trial was stopped early due to a determination of apparent futility by the Data Safety Monitoring Committee. Results: From December 1, 2011, to January 20, 2018, 411 patients were randomized to ablation-based rhythm-control (n=214) or rate-control (n=197). The primary outcome occurred in 50 (23.4%) patients in the ablation-based rhythm-control group and 64 (32.5%) patients in the rate-control group (hazard ratio 0.71 95% CI (0.49, 1.03), p=0.066). LVEF increased in the ablation-based group (10.1±1.2% vs 3.8±1.2%, p=0.017); six-minute walk distance improved (44.9±9.1 meters 27.5±9.7 meters, p=0.025) and NT-proBNP demonstrated a decrease (mean change -77.1% vs -39.2%, p<0.0001). MLHFQ demonstrated greater improvement in the ablation-based rhythm-control group (LSMD of -5.4, 95%CI (-10.5, -0.3), p=0.0036), as did the AFEQT score (LSMD of 6.2, 95%CI (1.7, 10.7), p=0.0005). Serious adverse events were observed in 50% of patients in both treatment groups. Conclusions: In patients with high burden AF and HF, there was no statistical difference in all-cause mortality or HF events with ablation-based rhythm-control versus rate-control, however, there was a non-significant trend for improved outcomes with ablation-based rhythm control over rate-control.