Cardiac resynchronization therapy with or without atrioventricular node ablation in atrial fibrillation: the CAAN-AF trial.

Observational data suggest that atrioventricular node ablation (AVNA) may enhance CRT efficacy in this population.

观察数据表明，房室结消融（AVNA）可能增强这一人群的CRT疗效。

This trial aimed to evaluate the effect of AVNA compared with medical rate control therapy (MRCT) on CRT outcomes in patients with HFrEF and permanent AF.

本试验旨在评估AVNA与药物性心率控制治疗（MRCT）相比，对HFrEF和永久性AF患者CRT结果的影响。

Methods

The CAAN-AF trial was an international, prospective, multicentre, randomized controlled trialevaluating the impact of AVNA in patients with HFrEF, permanent AF, and CRT-defibrillators (CRT-D).

CAAN-AF试验是一项国际性的前瞻性多中心随机对照试验，评估了AVNA对HFrEF、永久性AF和CRT除颤器（CRT-D）患者的影响。

Participants were randomly assigned (1:1) to AVNA or MRCT targeting a resting heart rate <90 bpm.

参与者被随机分配（1:1）到AVNA或MRCT，目标是静息心率<90次/分钟。

All participants received device optimization.

所有参与者均接受了设备优化。

The primary endpoint was a composite of all-cause mortality and nonfatal heart failure events.

主要终点是全因死亡和非致命性心力衰竭事件的复合终点。

Secondary endpoints included cardiovascular mortality, unplanned hospitalizations, ventricular arrhythmias requiring device therapy, 6-min walk distance (6MWD), and quality of life.

次要终点包括心血管死亡、计划外住院、需要设备治疗的室性心律失常、6分钟步行距离（6MWD）和生活质量。

Results

With early termination of the trial due to futility, a total of 143 patients were randomized (67 to AVNA, 76 to MRCT).

由于无效性提前终止试验，共有143名患者被随机分配（67名接受AVNA治疗，76名接受MRCT治疗）。

Baseline characteristics were similar across groups.

各组基线特征相似。

No significant difference was found in the primary endpoint [47 vs. 46 events; incident rate ratio (IRR), 1.16; 95% confidence interval(CI), 0.60-2.24].

主要终点事件无显著差异[47比46事件；发生率比（IRR），1.16；95%置信区间（CI），0.60-2.24]。

Secondary outcomes, including cardiovascular mortality (odds ratio, 1.93; 95% CI 0.60-6.20), unplanned hospitalizations (IRR, 1.01; 95% CI 0.71-1.74), ventricular arrhythmias requiring device therapy (IRR, 0.68; 95% CI 0.17-2.63), 6MWD, and SF-36 scores, also showed no significant differences.

次要结果，包括心血管死亡率（比值比，1.93；95% CI 0.60-6.20）、非计划住院（发生率比，1.01；95% CI 0.71-1.74）、需要设备治疗的室性心律失常（发生率比，0.68；95% CI 0.17-2.63）、6分钟步行距离和SF-36评分，也未显示出显著差异。

Conclusions

This randomized trial of patients with permanent AF and CRT-D found no evidence of a reduction in all-cause mortality and nonfatal heart failure events with AVNA compared with MRCT.

这项针对永久性房颤和CRT-D患者的随机试验发现，与MRCT相比，AVNA并未显示出减少全因死亡率和非致命性心力衰竭事件的证据。

trial_registration

NCT01522898.

NCT01522898。