无除颤器心脏再同步化治疗对发病率和死亡率的影响：COMPANION 和 CARE-HF 的个体患者数据荟萃分析。
The effect of cardiac resynchronization without a defibrillator on morbidity and mortality: an individual patient data meta-analysis of COMPANION and CARE-HF.
机构信息
Robertson Centre for Biostatistics & Clinical Trials, University of Glasgow & National Heart & Lung Institute, Imperial College, London, UK.
University of Colorado Cardiovascular Institute, Aurora and Boulder, Aurora, CO, USA.
出版信息
Eur J Heart Fail. 2022 Jun;24(6):1080-1090. doi: 10.1002/ejhf.2524. Epub 2022 May 22.
AIMS
Cardiac resynchronization therapy (CRT) reduces morbidity and mortality for patients with heart failure, reduced left ventricular ejection fraction, QRS duration >130 ms and in sinus rhythm. The aim of this study was to identify patient characteristics that predict the effect, specifically, of CRT pacemakers (CRT-P) on all-cause mortality or the composite of hospitalization for heart failure or all-cause mortality.
METHODS AND RESULTS
We conducted an individual patient data meta-analysis of the Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) and Cardiac Resynchronization-Heart Failure (CARE-HF) trials. Only patients assigned to CRT-P or control (n = 1738) were included in order to avoid confounding from concomitant defibrillator therapy. The influence of baseline characteristics on treatment effects was investigated. Median age was 67 (59-73) years, most patients were men (70%), 68% had a QRS duration of 150-199 ms and 80% had left bundle branch block. Patients assigned to CRT-P had lower rates for all-cause mortality (hazard ratio [HR] 0.68, 95% confidence interval [CI] 0.56-0.81; p < 0.0001) and the composite outcome (HR 0.67, 95% CI 0.58-0.78; p < 0.0001). No pre-specified characteristic, including sex, aetiology of ventricular dysfunction, QRS duration (within the studied range) or morphology or PR interval significantly influenced the effect of CRT-P on all-cause mortality or the composite outcome. However, CRT-P had a greater effect on the composite outcome for patients with lower body surface area and those prescribed beta-blockers.
CONCLUSIONS
Cardiac resynchronization therapy-pacemaker reduces morbidity and mortality in appropriately selected patients with heart failure. Benefits may be greater in smaller patients and in those receiving beta-blockers. Neither QRS duration nor morphology independently predicted the benefit of CRT-P.
CLINICAL TRIAL REGISTRATION
COMPANION, NCT00180258; CARE-HF, NCT00170300.
目的
心脏再同步治疗（CRT）可降低左心室射血分数降低、QRS 持续时间>130ms 且窦性节律的心力衰竭患者的发病率和死亡率。本研究的目的是确定预测 CRT 起搏器（CRT-P）对全因死亡率或心力衰竭住院和全因死亡率复合终点的影响的患者特征。
方法和结果
我们对心力衰竭的药物治疗、起搏和除颤比较（COMPANION）和心脏再同步心力衰竭（CARE-HF）试验进行了个体患者数据荟萃分析。仅纳入被分配至 CRT-P 或对照组的患者（n=1738），以避免因同时进行除颤器治疗而产生混杂。研究了基线特征对治疗效果的影响。中位年龄为 67（59-73）岁，大多数患者为男性（70%），68%的 QRS 持续时间为 150-199ms，80%为左束支传导阻滞。与对照组相比，被分配至 CRT-P 的患者全因死亡率（风险比[HR]0.68，95%置信区间[CI]0.56-0.81；p<0.0001）和复合终点（HR 0.67，95%CI 0.58-0.78；p<0.0001）的发生率较低。没有预设的特征，包括性别、心室功能障碍的病因、QRS 持续时间（在研究范围内）或形态或 PR 间隔，显著影响 CRT-P 对全因死亡率或复合终点的疗效。然而，对于身体表面积较小和接受β受体阻滞剂治疗的患者，CRT-P 对复合终点的疗效更大。
结论
心脏再同步治疗起搏器可降低适当选择的心力衰竭患者的发病率和死亡率。对于较小的患者和接受β受体阻滞剂治疗的患者，益处可能更大。QRS 持续时间和形态均不能独立预测 CRT-P 的获益。
临床试验注册
COMPANION，NCT00180258；CARE-HF，NCT00170300。
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