Randomized Ablation-Based Rhythm-Control Versus Rate-Control Trial in Patients With Heart Failure and Atrial Fibrillation: Results from the RAFT-AF trial
Authors: Ratika Parkash, George A. Wells, Jean Rouleau, Mario Talajic, Vidal Essebag, Allan Skanes, Stephen B. Wilton, Atul Verma, Jeffrey S. Healey, Laurence Sterns, Matthew Bennett, Jean-Francois Roux, Lena Rivard, Peter Leong-Sit, Mats Jensen-Urstad, Umjeet Jolly, Francois Philippon, John L. Sapp, Anthony S.L. Tang, Paul MacDonald, Matthew Bennett, Santabhanu Chakrabarti, John Yeung-Lai-Wah, Andrew Ignaszewski, Stanley Tung, Shahnawaz Virani, Marc Deyell, Andrew Krahn, Jason Andrade, Lynn Straatman, Mustafa Toma, Graham Wong, Matthew Wei, Isabelle Greiss, Jean-Marc Raymond, Benoit Coutu, Paolo Costi, Fadi Mansour, Wouter Saint-Phard, Isabelle Denis, Julie Fleury, Jean-Francois Roux, Felix Ayala-Paredes, Mariano Badra-Verdu, Charles Dussault, Nadia Vachon, Véronique Dagenais, Caroline Lamoureux, Jeff Healey, Stuart Connolly, C. Sebastien Ribas, Syamkumar Divakaramenon, Jorge Wong, Guy Amit, Wendy Meyer, Isabelle Nault, Jean Champagne, Jean-Francois Sarrazin, Gilles O’Hara, Francois Philippon, Louis Blier, Benoit Plourde, Christian Steinburg, Karine Roy, Paule Banville, Brigitte Ottinger, Marie-Eve Boucher, Marina Sanchez, Lena Rivard, Marc Dubuc, Peter Guerra, Katia Dyrda, Paul Khairy, Laurent Macle, Blandine Mondesert, Denis Roy, Mario Talajic, Bernard Thibault, Rafik Tadros, Véronique Roy, Damian Redfearn, Hoshiar Abdollah, Adrian Baranchuk, Kevin Michael, Christopher Simpson, Sharlene Hammond, Stephen B. Wilton, Brian Clarke, Carlos Morillo, Vikas Kuriachan, George Veenhuyzen, Russell Quinn, Derek Exner, Jonathan Howlett, Jennifer McKeage, Peter Leong-Sit, Lorne Gula, Allan Skanes, Jaimie Manlucu, Anthony Tang, George Klein, Sabrina Wall, Yomna El-Sakka, Vidal Essebag, Tom Hadjis, Martin Bernier, Jacqueline Joza, Jean- Francois Roux, Alexander Omelchenko, Thais Nascimento, Fiorella Rafti, Ida DiStefano, Ratika Parkash, John Sapp, Chris Gray, Martin Gardner, Amir Abdel-Wahab, Ciorsti J MacIntyre, Miroslaw Rajda, Patrick O’Regan, Mary Lee Levins-Lamont, Evan Lockwood, Tom Hruczkowski, Lucas Valtuille, Michael Chan, Jennifer Halenar, Samantha McLean, Atul Verma, Yaariv Khaykin, Lynn Nyman, Zaev Wulffhart, Alfredo Pantano, Bernice Tsang, Sherri Patterson, Annette Nath, Lynn Nyman, Umjeet Jolly, Clause Rinne, Irene Janzen, Eugene Crystal, Ilan Lashevsky, Sheldon Singh, Irving Tiong, Ambreen Syeda, Anyur Tremblay, Andrew C. T. Ha, Vijay Chauhan, Ann Hill, Pablo Nery, David Birnie, Calum Redpath, Martin Green, Girish Nair, Robert Lemery, Mouhannad Sadek, Karen MacDonald, Laurence Sterns, Paul Novak, Richard Leather, Elizabeth Swiggum, Markus Sikkel, Chris Lane, Tanner Rakochey, Caitlin Patterson, Tiago Luiz Luz Leiria, Gustavo Glotz de Lima, Roberto Sant’Anna, Eduardo Dutz, Cristina Klein Weber, Aline Peixoto Deiro, Laís Machado Hoscheidt, Mats Jensen-Urstad, Cecile Linde, Ott Saluveer, Carina Carnlof, Chih-Chieh Yu, Fu-Chun Chiu, Jiunn-Lee Lin, Cheng-Yu Huang, George A. Wells, Patricia Theoret-Patrick, Janine Ryan, My-Linh Tran, Li Chen, Sarah Singh, Anthony Tang, George Wells, Mario Talajic, Jean Rouleau, Ratika Parkash, Anthony Tang, George Wells, Mario Talajic, Jean Rouleau, Ratika Parkash, Atul Verma, Vidal Essebag, David Birnie, Jeff Healey, Laurent Macle, Gary Newton, Doug Coyle, Allan Skanes, Stephen B. Wilton, George Wyse, Dennis Cassidy, Lehana Thabane, Atul Verma, Carlos Morillo, Jeff Healey, Gary Newton, John Sapp, Francois Philippon, Lorne Gula, Elizabeth Swiggum, Lisa Mielniczuk, Pablo Nery, Isabelle Nault, Stephen B. Wilton, Andrew Ha, Lena Rivard, TIago Luiz Luz Leiria, Stanley Tung, Niko Tzemos, Andrew Mathew, De Thain, Sabrina Wall, Ratika Parkash, Anita MacDonald, Marcia Shields
Journal: Circulation (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 (&gt;4 episodes in 6 months) or persistent (duration &lt;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 &lt;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.