N Engl J Med:心脏再同步除颤治疗心力衰竭的长期预后

2024-01-20 来源:N Engl J Med

本文由小咖机器人翻译整理

期刊来源:N Engl J Med

原文链接:https://doi.org/10.1056/NEJMoa2304542

摘要内容如下:

背景

非卧床心力衰竭再同步除颤试验(RAFT)显示,接受心脏再同步治疗(CRT)的患者比接受植入式心律转复除颤器(ICD)的患者在5年死亡率方面获益更大。然而,CRT对长期生存的影响尚不清楚。

方法

我们将纽约心脏协会(NYHA)II或III级心力衰竭、左心室射血分数为30%或更低、固有QRS持续时间为120毫秒或更长(或起搏QRS持续时间为200毫秒或更长)的患者随机分配接受单独的ICD或CRT除颤器(CRT-D)。我们评估了8个登记人数最多的参与地点的患者的长期结果。主要结局是任何原因导致的死亡;次要转归是任何原因导致的死亡、心脏移植或心室辅助装置植入的复合转归。

结果

该试验共纳入1798例患者,其中1050例纳入长期生存试验;1050名患者的中位随访时间为7.7年(四分位间距为3.9至12.8),存活者的中位随访时间为13.9年(四分位间距为12.8至15.7)。ICD组530例患者中有405例(76.4%)死亡,CRT-D组520例患者中有370例(71.2%)死亡。接受CRT-D的患者死亡时间似乎比接受ICD的患者更长(加速因子,0.80;95%置信区间,0.69至0.92;P=0.00 2)。ICD组和CRT-D组分别有412例(77.7%)和392例(75.4%)患者发生了次要结局事件。

结论

在射血分数降低、QRS波群增宽和NYHA II级或III级心力衰竭的患者中,与ICD相比,接受CRT-D的生存获益似乎在中位数近14年的随访期间持续存在。(RAFT ClinicalTrials.gov编号,NCT00251251。)

英文原文如下:

Abstracts

BACKGROUND  The Resynchronization-Defibrillation for Ambulatory Heart Failure Trial (RAFT) showed a greater benefit with respect to mortality at 5 years among patients who received cardiac-resynchronization therapy (CRT) than among those who received implantable cardioverter-defibrillators (ICDs). However, the effect of CRT on long-term survival is not known.

METHODS  We randomly assigned patients with New York Heart Association (NYHA) class II or III heart failure, a left ventricular ejection fraction of 30% or less, and an intrinsic QRS duration of 120 msec or more (or a paced QRS duration of 200 msec or more) to receive either an ICD alone or a CRT defibrillator (CRT-D). We assessed long-term outcomes among patients at the eight highest-enrolling participating sites. The primary outcome was death from any cause; the secondary outcome was a composite of death from any cause, heart transplantation, or implantation of a ventricular assist device.

RESULTS  The trial enrolled 1798 patients, of whom 1050 were included in the long-term survival trial; the median duration of follow-up for the 1050 patients was 7.7 years (interquartile range, 3.9 to 12.8), and the median duration of follow-up for those who survived was 13.9 years (interquartile range, 12.8 to 15.7). Death occurred in 405 of 530 patients (76.4%) assigned to the ICD group and in 370 of 520 patients (71.2%) assigned to the CRT-D group. The time until death appeared to be longer for those assigned to receive a CRT-D than for those assigned to receive an ICD (acceleration factor, 0.80; 95% confidence interval, 0.69 to 0.92; P = 0.002). A secondary-outcome event occurred in 412 patients (77.7%) in the ICD group and in 392 (75.4%) in the CRT-D group.

CONCLUSIONS  Among patients with a reduced ejection fraction, a widened QRS complex, and NYHA class II or III heart failure, the survival benefit associated with receipt of a CRT-D as compared with ICD appeared to be sustained during a median of nearly 14 years of follow-up. (RAFT ClinicalTrials.gov number, NCT00251251.).

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