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日本心脏器械治疗登记数据库分析:心脏再同步治疗伴或不伴除颤器的原发性预防对心力衰竭患者的生存和住院的影响

Survival and Heart Failure Hospitalization in Patients With Cardiac Resynchronization Therapy With or Without a Defibrillator for Primary Prevention in Japan - Analysis of the Japan Cardiac Device Treatment Registry Database.

机构信息

Department of Cardiovascular Medicine, Hokkaido University Graduate School of Medicine.

Faculty of Health Sciences, Yamaguchi Graduate School of Medicine.

出版信息

Circ J. 2017 Nov 24;81(12):1798-1806. doi: 10.1253/circj.CJ-17-0234. Epub 2017 Jun 13.

DOI:10.1253/circj.CJ-17-0234
PMID:28626201
Abstract

BACKGROUND

Randomized control trials comparing the effectiveness of cardiac resynchronization therapy devices, with (CRT-D) or without (CRT-P) a defibrillator, are scarce in heart failure patients with no prior sustained ventricular tachyarrhythmias.Methods and Results:The Japan Cardiac Device Treatment Registry (JCDTR) has data for 2714 CRT-D and 555 CRT-P recipients for primary prevention with an implantation date between January 2011 and August 2015. Of these patients, follow-up data were available for 717. Over the mean follow-up period of 21 months, Kaplan-Meier curves of survival free of combined events for all-cause death or heart failure hospitalization (whichever came first) diverged between the CRT-D (n=620) and CRT-P (n=97) groups with a rate of 22% vs. 42%, respectively, at 24 months (P=0.0011). However, this apparent benefit of CRT-D over CRT-P was no longer significant after adjustment for covariates. With regard to mortality, including heart failure death or sudden cardiac death, there was no significant difference between the 2 groups.

CONCLUSIONS

In patients without sustained ventricular tachyarrhythmias enrolled in the JCDTR, there was no significant difference in mortality between the CRT-D and CRT-P groups, despite a lower trend in CRT-D recipients. This study was limited by large clinical and demographic differences between the 2 groups.

摘要

背景

比较具有或不具有除颤器的心脏再同步治疗装置(CRT-D 与 CRT-P)疗效的随机对照试验在无既往持续性室性心动过速/心室颤动的心力衰竭患者中较为少见。

方法和结果

日本心脏器械治疗注册研究(JCDTR)纳入了 2011 年 1 月至 2015 年 8 月间植入的 2714 例 CRT-D 和 555 例 CRT-P 的用于一级预防的患者数据。这些患者中,717 例可获得随访数据。在平均 21 个月的随访期间,全因死亡或心力衰竭住院(以先发生者为准)复合终点的无事件生存 Kaplan-Meier 曲线在 CRT-D(n=620)和 CRT-P(n=97)组之间出现分离,24 个月时的发生率分别为 22%和 42%(P=0.0011)。然而,在调整协变量后,CRT-D 优于 CRT-P 的这种明显获益不再显著。至于死亡率,包括心力衰竭死亡或心源性猝死,两组间无显著差异。

结论

在 JCDTR 纳入的无持续性室性心动过速/心室颤动的患者中,尽管 CRT-D 组的死亡率呈下降趋势,但 CRT-D 与 CRT-P 组间死亡率无显著差异。本研究受到两组间较大的临床和人口统计学差异的限制。

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