Randomized Ablation-Based Rhythm-Control Versus Rate-Control Trial in Patients With Heart Failure and Atrial Fibrillation: Results from the RAFT-AF trial
Authors: Parkash Ratika , Wells George A. , Rouleau Jean , Talajic Mario , Essebag Vidal , Skanes Allan , Wilton Stephen B. , Verma Atul , Healey Jeffrey S. , Sterns Laurence , Bennett Matthew , Roux Jean-Francois , Rivard Lena , Leong-Sit Peter , Jensen-Urstad Mats , Jolly Umjeet , Philippon Francois , Sapp John L. , Tang Anthony S.L. , MacDonald Paul , Bennett Matthew , Chakrabarti Santabhanu , Yeung-Lai-Wah John , Ignaszewski Andrew , Tung Stanley , Virani Shahnawaz , Deyell Marc , Krahn Andrew , Andrade Jason , Straatman Lynn , Toma Mustafa , Wong Graham , Wei Matthew , Greiss Isabelle , Raymond Jean-Marc , Coutu Benoit , Costi Paolo , Mansour Fadi , Saint-Phard Wouter , Denis Isabelle , Fleury Julie , Roux Jean-Francois , Ayala-Paredes Felix , Badra-Verdu Mariano , Dussault Charles , Vachon Nadia , Dagenais Véronique , Lamoureux Caroline , Healey Jeff , Connolly Stuart , Ribas C. Sebastien , Divakaramenon Syamkumar , Wong Jorge , Amit Guy , Meyer Wendy , Nault Isabelle , Champagne Jean , Sarrazin Jean-Francois , O’Hara Gilles , Philippon Francois , Blier Louis , Plourde Benoit , Steinburg Christian , Roy Karine , Banville Paule , Ottinger Brigitte , Boucher Marie-Eve , Sanchez Marina , Rivard Lena , Dubuc Marc , Guerra Peter , Dyrda Katia , Khairy Paul , Macle Laurent , Mondesert Blandine , Roy Denis , Talajic Mario , Thibault Bernard , Tadros Rafik , Roy Véronique , Redfearn Damian , Abdollah Hoshiar , Baranchuk Adrian , Michael Kevin , Simpson Christopher , Hammond Sharlene , Wilton Stephen B. , Clarke Brian , Morillo Carlos , Kuriachan Vikas , Veenhuyzen George , Quinn Russell , Exner Derek , Howlett Jonathan , McKeage Jennifer , Leong-Sit Peter , Gula Lorne , Skanes Allan , Manlucu Jaimie , Tang Anthony , Klein George , Wall Sabrina , El-Sakka Yomna , Essebag Vidal , Hadjis Tom , Bernier Martin , Joza Jacqueline , Roux Jean- Francois , Omelchenko Alexander , Nascimento Thais , Rafti Fiorella , DiStefano Ida , Parkash Ratika , Sapp John , Gray Chris , Gardner Martin , Abdel-Wahab Amir , MacIntyre Ciorsti J , Rajda Miroslaw , O’Regan Patrick , Levins-Lamont Mary Lee , Lockwood Evan , Hruczkowski Tom , Valtuille Lucas , Chan Michael , Halenar Jennifer , McLean Samantha , Verma Atul , Khaykin Yaariv , Nyman Lynn , Wulffhart Zaev , Pantano Alfredo , Tsang Bernice , Patterson Sherri , Nath Annette , Nyman Lynn , Jolly Umjeet , Rinne Clause , Janzen Irene , Crystal Eugene , Lashevsky Ilan , Singh Sheldon , Tiong Irving , Syeda Ambreen , Tremblay Anyur , Ha Andrew C. T. , Chauhan Vijay , Hill Ann , Nery Pablo , Birnie David , Redpath Calum , Green Martin , Nair Girish , Lemery Robert , Sadek Mouhannad , MacDonald Karen , Sterns Laurence , Novak Paul , Leather Richard , Swiggum Elizabeth , Sikkel Markus , Lane Chris , Rakochey Tanner , Patterson Caitlin , Luz Leiria Tiago Luiz , Glotz de Lima Gustavo , Sant’Anna Roberto , Dutz Eduardo , Klein Weber Cristina , Peixoto Deiro Aline , Hoscheidt Laís Machado , Jensen-Urstad Mats , Linde Cecile , Saluveer Ott , Carnlof Carina , Yu Chih-Chieh , Chiu Fu-Chun , Lin Jiunn-Lee , Huang Cheng-Yu , Wells George A. , Theoret-Patrick Patricia , Ryan Janine , Tran My-Linh , Chen Li , Singh Sarah , Tang Anthony , Wells George , Talajic Mario , Rouleau Jean , Parkash Ratika , Tang Anthony , Wells George , Talajic Mario , Rouleau Jean , Parkash Ratika , Verma Atul , Essebag Vidal , Birnie David , Healey Jeff , Macle Laurent , Newton Gary , Coyle Doug , Skanes Allan , Wilton Stephen B. , Wyse George , Cassidy Dennis , Thabane Lehana , Verma Atul , Morillo Carlos , Healey Jeff , Newton Gary , Sapp John , Philippon Francois , Gula Lorne , Swiggum Elizabeth , Mielniczuk Lisa , Nery Pablo , Nault Isabelle , Wilton Stephen B. , Ha Andrew , Rivard Lena , Luz Leiria TIago Luiz , Tung Stanley , Tzemos Niko , Mathew Andrew , Thain De , Wall Sabrina , Parkash Ratika , MacDonald Anita , Shields Marcia 
Published: March 2022

Background:
Atrial fibrillation (AF) and heart failure (HF) frequently coexist and can be challenging to treat. Pharmacologically based rhythm control of AF has not proven to be superior to rate control. Ablation-based rhythm control was compared with 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 6 months) or persistent (duration <3 years) AF, New York Heart Association class II to III HF, and elevated NT-proBNP (N-terminal pro brain natriuretic peptide) were randomly assigned 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 2 years. Secondary outcomes included left ventricular ejection fraction, 6-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. The primary analysis was time-to-event using Cox proportional hazards modeling. The trial was stopped early because of a determination of apparent futility by the Data Safety Monitoring Committee.

Results:

From December 1, 2011, to January 20, 2018, 411 patients were randomly assigned 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). Left ventricular ejection fraction increased in the ablation-based group (10.1±1.2% versus 3.8±1.2%,
P
=0.017), 6-minute walk distance improved (44.9±9.1 m versus 27.5±9.7 m,
P
=0.025), and NT-proBNP demonstrated a decrease (mean change –77.1% versus –39.2%,
P
<0.0001). Minnesota Living With Heart Failure Questionnaire demonstrated greater improvement in the ablation-based rhythm-control group (least-squares mean difference of –5.4 [95% CI, –10.5 to –0.3];
P
=0.0036), as did the AF Effect on Quality of Life score (least-squares mean difference 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 nonsignificant trend for improved outcomes with ablation-based rhythm control over rate control.

Registration:

URL:
https://www.clinicaltrials.gov
; Unique identifier: NCT01420393.