randomized ablation-based af rhythm-control versus rate-control in patients with hf and high-burden af extend

Conditions: Atrial Fibrillation; Heart Failure

Summary: this is an extended follow up study of the original raft-af study. the raft-af study was a multi-centre randomized controlled trial with a prospective randomized open blinded endpoint trial (probe) design. patients were randomized to either catheter ablation-based rhythm control of af as compared to rate control of af

the raft-af extend trial is a continued follow up of patients enrolled in the original raft-af study (clinicaltrials.gov, nct01420393), which evaluated whether ablation-based rhythm-control compared to rate-control improves clinical outcomes in patients with heart failure and atrial fibrillation. it was a randomised, open-label clinical trial, with blinded endpoint adjudication, conducted in 21 institutions in four countries. patients with atrial fibrillation, new york heart association class ii-iii heart failure, and elevated nt-probnp were included. patients were randomized (1:1) to ablation-based rhythm-control or rate-control, stratified by left ventricular ejection fraction (≤45% and \>45%). ablation-based rhythm-control consisted of pulmonary vein isolation in paroxysmal atrial fibrillation, and additional ablation for persistent atrial fibrillation. rate-control included av-nodal blocking agents and av node ablation with permanent pacing. the primary outcome was a composite of mortality and heart failure events, with a minimum follow up of two years. secondary outcomes included left ventricular ejection fraction, quality of life, six-minute walk test and nt-probnp. the primary analysis was intention-to-treat. from december 1, 2011, to january 20, 2018, 411 patients were randomised 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). quality of life, six-minute walk distance, left ventricular ejection fraction, and nt-probnp demonstrated greater improvements in the ablation-based rhythm-control group. in patients with high burden atrial fibrillation and heart failure, there was no statistically significant reduction of all-cause mortality or heart failure events with ablation-based rhythm-control versus rate-control. with the hazard ratio equivalent to the minimal clinically important difference and the result near statistical significance, there is a probable clinically important benefit of ablation-based rhythm-control over rate-control. this raft-af extend study is to extend follow up in raft-af patients for an additional 24 months in order to have sufficient power to definitely determine if ablation-based rhythm control of atrial fibrillation is superior to rate control for the reduction of the primary outcome of all-cause mortality or heart failure event in patient with atrial fibrillation and heart failure.

Eligibility criteria:
inclusion criteria: all patients previously enrolled and randomized in the raft-af study that are eligible to enroll exclusion criteria: * did not participate in the original raft-af study

Keywords: atrial fibrillation heart failure long-term follow up