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心脏再同步治疗改善伴有室内传导延迟但无右束支传导阻滞患者的结局:一项随机对照试验的患者水平荟萃分析。

Cardiac Resynchronization Therapy Improves Outcomes in Patients With Intraventricular Conduction Delay But Not Right Bundle Branch Block: A Patient-Level Meta-Analysis of Randomized Controlled Trials.

机构信息

Division of Cardiology (D.J.F., S.M.A-K., M.F.), Duke University School of Medicine, Durham, NC.

Duke Clinical Research Institute (D.J.F, S.M.A-K., F.D., M.F, G.D.S., F.A-A.), Duke University School of Medicine, Durham, NC.

出版信息

Circulation. 2023 Mar 7;147(10):812-823. doi: 10.1161/CIRCULATIONAHA.122.062124. Epub 2023 Jan 26.

Abstract

BACKGROUND

Benefit from cardiac resynchronization therapy (CRT) varies by QRS characteristics; individual randomized trials are underpowered to assess benefit for relatively small subgroups.

METHODS

The authors analyzed patient-level data from pivotal CRT trials (MIRACLE [Multicenter InSync Randomized Clinical Evaluation], MIRACLE-ICD [Multicenter InSync ICD Randomized Clinical Evaluation], MIRACLE-ICD II [Multicenter InSync ICD Randomized Clinical Evaluation II], REVERSE [Resynchronization Reverses Remodeling in Systolic Left Ventricular Dysfunction], RAFT [Resynchronization-Defibrillation for Ambulatory Heart Failure], BLOCK-HF [Biventricular Versus Right Ventricular Pacing in Heart Failure Patients with Atrioventricular Block], COMPANION [Comparison of Medical Therapy, Pacing and Defibrillation in Heart Failure], and MADIT-CRT [Multicenter Automatic Defibrillator Implantation Trial - Cardiac Resynchronization Therapy]) using Bayesian Hierarchical Weibull survival regression models to assess CRT benefit by QRS morphology (left bundle branch block [LBBB], n=4549; right bundle branch block [RBBB], n=691; and intraventricular conduction delay [IVCD], n=1024) and duration (with 150-ms partition). The continuous relationship between QRS duration and CRT benefit was also examined within subgroups defined by QRS morphology. The primary end point was time to heart failure hospitalization (HFH) or death; a secondary end point was time to all-cause death.

RESULTS

Of 6264 patients included, 25% were women, the median age was 66 [interquartile range, 58 to 73] years, and 61% received CRT (with or without an implantable cardioverter defibrillator). CRT was associated with an overall lower risk of HFH or death (hazard ratio [HR], 0.73 [credible interval (CrI), 0.65 to 0.84]), and in subgroups of patients with QRS ≥150 ms and either LBBB (HR, 0.56 [CrI, 0.48 to 0.66]) or IVCD (HR, 0.59 [CrI, 0.39 to 0.89]), but not RBBB (HR 0.97 [CrI, 0.68 to 1.34]; <0.001). No significant association for CRT with HFH or death was observed when QRS was <150 ms (regardless of QRS morphology) or in the presence of RBBB. Similar relationships were observed for all-cause death.

CONCLUSIONS

CRT is associated with reduced HFH or death in patients with QRS ≥150 ms and LBBB or IVCD, but not for those with RBBB. Aggregating RBBB and IVCD into a single "non-LBBB" category when selecting patients for CRT should be reconsidered.

REGISTRATION

URL: https://www.

CLINICALTRIALS

gov; Unique identifiers: NCT00271154, NCT00251251, NCT00267098, and NCT00180271.

摘要

背景

心脏再同步治疗(CRT)的获益因 QRS 特征而异;个别随机试验的效力不足以评估相对较小亚组的获益。

方法

作者使用贝叶斯分层威布尔生存回归模型分析了来自主要 CRT 试验(MIRACLE [多中心同步随机临床评估]、MIRACLE-ICD [多中心同步 ICD 随机临床评估]、MIRACLE-ICD II [多中心同步 ICD 随机临床评估 II]、REVERSE [再同步逆转左心室收缩功能障碍的重构]、RAFT [心力衰竭患者的再同步除颤治疗]、BLOCK-HF [房室传导阻滞心力衰竭患者的双心室与右心室起搏]、COMPANION [心力衰竭的药物治疗、起搏和除颤比较]和 MADIT-CRT [多中心自动除颤器植入试验-心脏再同步治疗])的患者水平数据,以评估 QRS 形态(左束支传导阻滞 [LBBB],n=4549;右束支传导阻滞 [RBBB],n=691;和室内传导延迟 [IVCD],n=1024)和持续时间(150-ms 分区)对 CRT 获益的影响。还在 QRS 形态定义的亚组内检查了 QRS 持续时间与 CRT 获益之间的连续关系。主要终点是心力衰竭住院(HFH)或死亡时间;次要终点是全因死亡时间。

结果

在纳入的 6264 名患者中,25%为女性,中位年龄为 66 [四分位间距,58 至 73]岁,61%接受了 CRT(伴或不伴植入式心脏复律除颤器)。CRT 与 HFH 或死亡的总体风险降低相关(风险比 [HR],0.73 [可信区间(CrI),0.65 至 0.84]),并且在 QRS ≥150 ms 且 QRS 形态为 LBBB(HR,0.56 [CrI,0.48 至 0.66])或 IVCD(HR,0.59 [CrI,0.39 至 0.89])的患者亚组中,而不是 RBBB(HR 0.97 [CrI,0.68 至 1.34];<0.001)。当 QRS<150 ms 时(无论 QRS 形态如何)或存在 RBBB 时,CRT 与 HFH 或死亡之间没有观察到显著关联。对于全因死亡,也观察到了类似的关系。

结论

在 QRS ≥150 ms 且存在 LBBB 或 IVCD 的患者中,CRT 与 HFH 或死亡减少相关,但在存在 RBBB 的患者中则不然。在为 CRT 选择患者时,应重新考虑将 RBBB 和 IVCD 合并为单个“非 LBBB”类别。

注册

网址:https://www.。

临床试验

NCT00271154、NCT00251251、NCT00267098 和 NCT00180271。

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