医学
危险系数
心房颤动
心脏病学
临床终点
内科学
射血分数
烧蚀
心力衰竭
心脏再同步化治疗
中期分析
导管消融
随机对照试验
置信区间
QRS波群
外科
作者
Michele Brignole,Francesco Pentimalli,Pietro Palmisano,Maurizio Landolina,Fabio Quartieri,Eraldo Occhetta,Leonardo Calò,Giuseppe Mascia,Lluís Mont,Kevin Vernooy,Vincent F. van Dijk,Cor Allaart,Laurent Fauchier,Maurizio Gasparini,Gianfranco Parati,Davide Soranna,Michiel Rienstra,Isabelle C. Van Gelder
标识
DOI:10.1093/eurheartj/ehab569
摘要
In patients with atrial fibrillation (AF) and heart failure (HF), strict and regular rate control with atrioventricular junction ablation and biventricular pacemaker (Ablation + CRT) has been shown to be superior to pharmacological rate control in reducing HF hospitalizations. However, whether it also improves survival is unknown.In this international, open-label, blinded outcome trial, we randomly assigned patients with severely symptomatic permanent AF >6 months, narrow QRS (≤110 ms) and at least one HF hospitalization in the previous year to Ablation + CRT or to pharmacological rate control. We hypothesized that Ablation + CRT is superior in reducing the primary endpoint of all-cause mortality. A total of 133 patients were randomized. The mean age was 73 ± 10 years, and 62 (47%) were females. The trial was stopped for efficacy at interim analysis after a median of 29 months of follow-up per patient. The primary endpoint occurred in 7 patients (11%) in the Ablation + CRT arm and in 20 patients (29%) in the Drug arm [hazard ratio (HR) 0.26, 95% confidence interval (CI) 0.10-0.65; P = 0.004]. The estimated death rates at 2 years were 5% and 21%, respectively; at 4 years, 14% and 41%. The benefit of Ablation + CRT of all-cause mortality was similar in patients with ejection fraction (EF) ≤35% and in those with >35%. The secondary endpoint combining all-cause mortality or HF hospitalization was significantly lower in the Ablation + CRT arm [18 (29%) vs. 36 (51%); HR 0.40, 95% CI 0.22-0.73; P = 0.002].Ablation + CRT was superior to pharmacological therapy in reducing mortality in patients with permanent AF and narrow QRS who were hospitalized for HF, irrespective of their baseline EF.ClinicalTrials.gov Identifier: NCT02137187.
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