Department of Cardiology, Ospedali del Tigullio, Lavagna, Italy.
Department of Cardiology, IRCCS Istituto Auxologico Italiano, Ospedale San Luca, Piazzale Brescia 20, 20149 Milan, Italy.
Eur Heart J. 2021 Dec 7;42(46):4731-4739. doi: 10.1093/eurheartj/ehab569.
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.
在心房颤动（AF）和心力衰竭（HF）患者中，房室结消融和双心室起搏器（消融+CRT）的严格和规律的心率控制已被证明优于药物心率控制，可降低 HF 住院率。然而，它是否也能改善生存率尚不清楚。
在这项国际性、开放标签、盲法结局试验中，我们将严重症状性永久性 AF>6 个月、QRS 波群狭窄（≤110ms）且前一年至少有一次 HF 住院史的患者随机分为消融+CRT 组或药物心率控制组。我们假设消融+CRT 在降低全因死亡率这一主要终点方面更优。共有 133 例患者被随机分配。平均年龄为 73±10 岁，62 例（47%）为女性。中位随访时间为每位患者 29 个月后，在中期分析时因疗效停止试验。主要终点在消融+CRT 组发生 7 例（11%），药物组发生 20 例（29%）[风险比（HR）0.26，95%置信区间（CI）0.10-0.65；P=0.004]。2 年时的估计死亡率分别为 5%和 21%；4 年时分别为 14%和 41%。在射血分数（EF）≤35%和>35%的患者中，消融+CRT 对全因死亡率的获益相似。消融+CRT 组全因死亡率或 HF 住院的次要终点显著降低[18 例（29%）vs.36 例（51%）；HR 0.40，95%CI 0.22-0.73；P=0.002]。
在因 HF 住院的永久性 AF 和 QRS 波群狭窄的患者中，消融+CRT 优于药物治疗，可降低死亡率，无论其基线 EF 如何。
ClinicalTrials.gov 标识符：NCT02137187。
