Continuous automatic optimisation of cardiac resynchronisation therapy (CRT), stimulating only the left ventricle to fuse with intrinsic right bundle conduction (synchronised left ventricular stimulation), might offer better outcomes than conventional CRT in patients with heart failure, left bundle branch block, and normal atrioventricular conduction. This study aimed to compare clinical outcomes of adaptive CRT versus conventional CRT in patients with heart failure with intact atrioventricular conduction and left bundle branch block. This global, prospective, randomised controlled trial was done in 227 hospitals in 27 countries across Asia, Australia, Europe, and North America. Eligible patients were aged 18 years or older with class 2–4 heart failure, an ejection fraction of 35% or less, left bundle branch block with QRS duration of 140 ms or more (male patients) or 130 ms or more (female patients), and a baseline PR interval 200 ms or less. Patients were randomly assigned (1:1) via block permutation to adaptive CRT (an algorithm providing synchronised left ventricular stimulation) or conventional biventricular CRT using a device programmer. All patients received device programming but were masked until procedures were completed. Site staff were not masked to group assignment. The primary outcome was a composite of all-cause death or intervention for heart failure decompensation and was assessed in the intention-to-treat population. Safety events were collected and reported in the intention-to-treat population. This study is registered with , , and is closed to accrual. Between Aug 5, 2014, and Jan 31, 2019, of 3797 patients enrolled, 3617 (95·3%) were randomly assigned (1810 to adaptive CRT and 1807 to conventional CRT). The futility boundary was crossed at the third interim analysis on June 23, 2022, when the decision was made to stop the trial early. 1568 (43·4%) of 3617 patients were female and 2049 (56·6%) were male. Median follow-up was 59·0 months (IQR 45–72). A primary outcome event occurred in 430 of 1810 patients (Kaplan-Meier occurrence rate 23·5% [95% CI 21·3–25·5] at 60 months) in the adaptive CRT group and in 470 of 1807 patients (25·7% [23·5–27·8] at 60 months) in the conventional CRT group (hazard ratio 0·89, 95% CI 0·78–1·01; p=0·077). System-related adverse events were reported in 452 (25·0%) of 1810 patients in the adaptive CRT group and 440 (24·3%) of 1807 patients in the conventional CRT group. Compared with conventional CRT, adaptive CRT did not significantly reduce the incidence of all-cause death or intervention for heart failure decompensation in the included population of patients with heart failure, left bundle branch block, and intact AV conduction. Death and heart failure decompensation rates were low with both CRT therapies, suggesting a greater response to CRT occurred in this population than in patients in previous trials. Medtronic.

中文翻译：

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心力衰竭患者的适应性与传统心脏再同步治疗（AdaptResponse）：一项全球性、前瞻性、随机对照试验

心脏再同步治疗 (CRT) 的连续自动优化，仅刺激左心室与固有右束传导融合（同步左心室刺激），对于心力衰竭、左束支传导阻滞和正常患者来说，可能会比传统 CRT 提供更好的结果房室传导。本研究旨在比较房室传导完整且左束支传导阻滞的心力衰竭患者自适应 CRT 与传统 CRT 的临床结果。这项全球性、前瞻性、随机对照试验在亚洲、澳大利亚、欧洲和北美 27 个国家的 227 家医院进行。符合条件的患者年龄为 18 岁或以上，患有 2-4 级心力衰竭、射血分数为 35% 或更低、QRS 持续时间为 140 毫秒或更长（男性患者）或 130 毫秒或更长（女性患者）的左束支传导阻滞，基线 PR 间期为 200 毫秒或更短。使用设备编程器，通过块排列将患者随机分配 (1:1) 至自适应 CRT（一种提供同步左心室刺激的算法）或传统双心室 CRT。所有患者都接受了设备编程，但在手术完成之前都被掩盖。现场工作人员没有被隐藏到小组分配中。主要结局是全因死亡或心力衰竭失代偿干预的综合结果，并在意向治疗人群中进行评估。收集并报告意向治疗人群中的安全事件。这项研究已在 、 、 注册，并且已停止计提。2014年8月5日至2019年1月31日期间，入组的3797名患者中，3617名（95·3%）被随机分配（1810名接受自适应CRT，1807名接受传统CRT）。2022 年 6 月 23 日的第三次中期分析跨越了无效边界，当时决定提前停止试验。3617 名患者中，1568 名 (43·4%) 为女性，2049 名 (56·6%) 为男性。中位随访时间为 59·0 个月 (IQR 45–72)。主要结局事件发生在适应性 CRT 组 1810 名患者中的 430 名（60 个月时 Kaplan-Meier 发生率为 23·5% [95% CI 21·3–25·5]）和 1807 名患者中的 470 名（25·5%）。传统 CRT 组为 7% [23·5–27·8]（60 个月时）（风险比 0·89，95% CI 0·78–1·01；p=0·077）。适应性 CRT 组 1810 名患者中有 452 名 (25·0%) 报告了系统相关不良事件，而传统 CRT 组 1807 名患者中有 440 名 (24·3%) 报告了系统相关不良事件。与传统 CRT 相比，适应性 CRT 并未显着降低心力衰竭、左束支传导阻滞和房室传导完整患者群体的全因死亡或心力衰竭失代偿干预的发生率。两种 CRT 疗法的死亡和心力衰竭失代偿率均较低，表明该人群对 CRT 的反应比之前试验中的患者更大。美敦力。