Nassir F Marrouche1, Johannes Brachmann1, Dietrich Andresen1, Jürgen Siebels1, Lucas Boersma1, Luc Jordaens1, Béla Merkely1, Evgeny Pokushalov1, Prashanthan Sanders1, Jochen Proff1, Heribert Schunkert1, Hildegard Christ1, Jürgen Vogt1, Dietmar Bänsch1. 1. From the Comprehensive Arrhythmia Research and Management Center, Division of Cardiovascular Medicine, School of Medicine, University of Utah Health, Salt Lake City (N.F.M.); Klinikum Coburg, Coburg (J.B.), Kardiologie an den Ev. Elisabeth-Kliniken (D.A.) and Biotronik (J.P., H.S.), Berlin, Klinik Rotes Kreuz, Frankfurt/Main (J.S.), Klinikum Links der Weser, Bremen (L.B.), Deutsches Herzzentrum München, Munich (H.C.), Institute of Medical Statistics and Computational Biology, Cologne (D.B.), and KMG Klinikum, Güstrow (J.V.) - all in Germany; Antonius Ziekenhuis Nieuwegein, Nieuwegein (L.J.), and the Erasmus University Medical Center, Rotterdam (B.M.) - both in the Netherlands; Semmelweis Medical University, Budapest, Hungary (E.P.); and the State Research Institute of Circulation Pathology, Novosibirsk, Russia (P.S.).
Abstract
BACKGROUND:Mortality and morbidity are higher among patients with atrial fibrillation and heart failure than among those with heart failure alone. Catheter ablation for atrial fibrillation has been proposed as a means of improving outcomes among patients with heart failure who are otherwise receiving appropriate treatment. METHODS: We randomly assigned patients with symptomatic paroxysmal or persistent atrial fibrillation who did not have a response to antiarrhythmic drugs, had unacceptable side effects, or were unwilling to take these drugs to undergo eithercatheter ablation (179 patients) or medical therapy (rate or rhythm control) (184 patients) for atrial fibrillation in addition to guidelines-based therapy for heart failure. All the patients had New York Heart Association class II, III, or IV heart failure, a left ventricular ejection fraction of 35% or less, and an implanted defibrillator. The primary end point was a composite of death from any cause or hospitalization for worsening heart failure. RESULTS: After a median follow-up of 37.8 months, the primary composite end point occurred in significantly fewer patients in the ablation group than in the medical-therapy group (51 patients [28.5%] vs. 82 patients [44.6%]; hazard ratio, 0.62; 95% confidence interval [CI], 0.43 to 0.87; P=0.007). Significantly fewer patients in the ablation group died from any cause (24 [13.4%] vs. 46 [25.0%]; hazard ratio, 0.53; 95% CI, 0.32 to 0.86; P=0.01), were hospitalized for worsening heart failure (37 [20.7%] vs. 66 [35.9%]; hazard ratio, 0.56; 95% CI, 0.37 to 0.83; P=0.004), or died from cardiovascular causes (20 [11.2%] vs. 41 [22.3%]; hazard ratio, 0.49; 95% CI, 0.29 to 0.84; P=0.009). CONCLUSIONS:Catheter ablation for atrial fibrillation in patients with heart failure was associated with a significantly lower rate of a composite end point of death from any cause or hospitalization for worsening heart failure than was medical therapy. (Funded by Biotronik; CASTLE-AF ClinicalTrials.gov number, NCT00643188 .).
RCT Entities:
BACKGROUND: Mortality and morbidity are higher among patients with atrial fibrillation and heart failure than among those with heart failure alone. Catheter ablation for atrial fibrillation has been proposed as a means of improving outcomes among patients with heart failure who are otherwise receiving appropriate treatment. METHODS: We randomly assigned patients with symptomatic paroxysmal or persistent atrial fibrillation who did not have a response to antiarrhythmic drugs, had unacceptable side effects, or were unwilling to take these drugs to undergo either catheter ablation (179 patients) or medical therapy (rate or rhythm control) (184 patients) for atrial fibrillation in addition to guidelines-based therapy for heart failure. All the patients had New York Heart Association class II, III, or IV heart failure, a left ventricular ejection fraction of 35% or less, and an implanted defibrillator. The primary end point was a composite of death from any cause or hospitalization for worsening heart failure. RESULTS: After a median follow-up of 37.8 months, the primary composite end point occurred in significantly fewer patients in the ablation group than in the medical-therapy group (51 patients [28.5%] vs. 82 patients [44.6%]; hazard ratio, 0.62; 95% confidence interval [CI], 0.43 to 0.87; P=0.007). Significantly fewer patients in the ablation group died from any cause (24 [13.4%] vs. 46 [25.0%]; hazard ratio, 0.53; 95% CI, 0.32 to 0.86; P=0.01), were hospitalized for worsening heart failure (37 [20.7%] vs. 66 [35.9%]; hazard ratio, 0.56; 95% CI, 0.37 to 0.83; P=0.004), or died from cardiovascular causes (20 [11.2%] vs. 41 [22.3%]; hazard ratio, 0.49; 95% CI, 0.29 to 0.84; P=0.009). CONCLUSIONS: Catheter ablation for atrial fibrillation in patients with heart failure was associated with a significantly lower rate of a composite end point of death from any cause or hospitalization for worsening heart failure than was medical therapy. (Funded by Biotronik; CASTLE-AF ClinicalTrials.gov number, NCT00643188 .).
Authors: Alexander C Perino; George C Leef; Andrew Cluckey; Fahd N Yunus; Mariam Askari; Paul A Heidenreich; Sanjiv M Narayan; Paul J Wang; Mintu P Turakhia Journal: Am Heart J Date: 2018-10-29 Impact factor: 4.749