RAFT-AF clinical trial review

RAFT-AF clinical trial review

RAFT-AF trial (Randomized Ablation-Based Rhythm-Control Versus Rate-Control Trial in Patients with Heart Failure and Atrial Fibrillation) checked whether ablation based rhythm control improved clinical outcome in patients with heart failure and atrial fibrillation, compared to rate control [1]. It was a multicenter, open label trial with blinded outcome evaluation using a central adjudication committee. Persons with high burden of paroxysmal AF of more than 4 episodes in six months or persistent AF of less than 3 years duration and heart failure were included. Heart failure was New York Heart Association class II-III with elevated NT-proBNP. The study had enrolled 411 patients, of which 214 were in ablation group and 197 in rate control group.

Primary outcome measured in the RAFT-AF trial was a composite of all-cause mortality and all heart failure events with a minimum follow up of two years. Secondary outcomes measured  in the trial were left ventricular ejection fraction, six-minute walk test and NT-proBNP. Quality of life was measured using the Minnesota Living with Heart Failure Questionnaire and the AF Effect on quality of life. RAFT-AF trial was stopped early due to an apparent futility by the Data Safety Monitoring Committee. The final report concluded that in patients with high AF burden and heart failure, there was no statistical difference in all-cause mortality or heart failure events with ablation based rhythm control strategy vs rate control. But there was a non-significant trend for improved outcomes with ablation based rhythm control [1].

Interestingly a meta-analysis published in January 2019 had concluded that catheter ablation was superior to conventional drug therapy for improving all-cause mortality, heart failure hospitalization, LVEF, 6 minute walk distance, VO2 max and quality of life. They also mentioned that there was no statistically significant increase in serious adverse events. But they had mentioned in the limitations of the analysis that the results were driven primarily by one clinical trial, possible patient selection bias in ablation group, open-label trial designs, heterogenous follow up lengths among trials and lack of patient-level data [2].

But, AMICA Trial (Catheter Ablation Versus Best Medical Therapy in Patients With Persistent Atrial Fibrillation and Congestive Heart Failure) which was published in December 2019 was also terminated early for futility [3]. In the AMICA trial also catheter ablation did not show any benefits in patients with AF and advanced heart failure. LVEF increased in ablation patients to a similar extent as with best medical therapy. AMICA trial had 68 patients in ablation group and 72 patients in medical therapy group for final analysis. The study had enrolled patients with persistent or long standing persistent AF and LVEF of 35% or less. Primary end point was an increase in LVEF from baseline at 1 year. Secondary end points were 6 minute walk test, quality of life and NT-proBNP. Best medical therapy was rate control and all patients were discharged after index hospitalization with cardioverter-defibrillator or cardiac resynchronization therapy with defibrillator implanted. Device recorded AF burden was lower in the ablation group at 1 year. Pulmonary vein isolation was the basic ablation strategy.

References

1. Parkash R, Wells GA, Rouleau J, Talajic M, Essebag V, Skanes A, Wilton SB, Verma A, Healey JS, Sterns L, Bennett M, Roux JF, Rivard L, Leong-Sit P, Jensen-Urstad M, Jolly U, Philippon F, Sapp JL, Tang ASL. Randomized Ablation-Based Rhythm-Control Versus Rate-Control Trial in Patients with Heart Failure and Atrial Fibrillation: Results from the RAFT-AF trial. Circulation. 2022;145:1693–1704. doi: 10.1161/CIRCULATIONAHA.121.057095. Epub ahead of print. PMID: 35313733.
2. Turagam MK, Garg J, Whang W, Sartori S, Koruth JS, Miller MA, Langan N, Sofi A, Gomes A, Choudry S, Dukkipati SR, Reddy VY. Catheter Ablation of Atrial Fibrillation in Patients With Heart Failure: A Meta-analysis of Randomized Controlled Trials. Ann Intern Med. 2019 Jan 1;170(1):41-50. doi: 10.7326/M18-0992. Epub 2018 Dec 25. Erratum in: Ann Intern Med. 2019 May 7;170(9):668-669. PMID: 30583296.
3. Kuck KH, Merkely B, Zahn R, Arentz T, Seidl K, Schlüter M, Tilz RR, Piorkowski C, Gellér L, Kleemann T, Hindricks G. Catheter Ablation Versus Best Medical Therapy in Patients With Persistent Atrial Fibrillation and Congestive Heart Failure: The Randomized AMICA Trial. Circ Arrhythm Electrophysiol. 2019 Dec;12(12):e007731. doi: 10.1161/CIRCEP.119.007731. Epub 2019 Nov 25. PMID: 31760819.