Department of Cardiovascular Medicine, Hokkaido University Graduate School of Medicine.
Faculty of Health Sciences, Yamaguchi Graduate School of Medicine.
Circ J. 2017 Nov 24;81(12):1798-1806. doi: 10.1253/circj.CJ-17-0234. Epub 2017 Jun 13.
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.
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.
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。
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。
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。