现在的位置: 首页时讯速递, 进展交流>正文
[NEJM最新论文]:VEST研究显示,可穿戴ICD不能减少心梗后心率失常导致的死亡
2018年10月10日 时讯速递, 进展交流 暂无评论

ORIGINAL ARTICLE

Wearable Cardioverter–Defibrillator after Myocardial Infarction

Jeffrey E. Olgin, Mark J. Pletcher, Eric Vittinghoff, et al.

N Engl J Med 2018; 379:1205-1215

DOI: 10.1056/NEJMoa1800781

Abstract

BACKGROUND 背景

Despite the high rate of sudden death after myocardial infarction among patients with a low ejection fraction, implantable cardioverter–defibrillators are contraindicated until 40 to 90 days after myocardial infarction. Whether a wearable cardioverter–defibrillator would reduce the incidence of sudden death during this high-risk period is unclear.

尽管低射血分数患者心梗后猝死发生率很高,但在心梗后40-90天禁忌使用植入式心律转复除颤器(ICD)。可穿戴ICD能否降低高危阶段猝死发生率尚不清楚。

METHODS 方法

We randomly assigned (in a 2:1 ratio) patients with acute myocardial infarction and an ejection fraction of 35% or less to receive a wearable cardioverter–defibrillator plus guideline-directed therapy (the device group) or to receive only guideline-directed therapy (the control group). The primary outcome was the composite of sudden death or death from ventricular tachyarrhythmia at 90 days (arrhythmic death). Secondary outcomes included death from any cause and nonarrhythmic death.

我们将急性心梗且射血分数不超过35%的患者按照2:1的比例随机分组,接受可穿戴ICD及指南指导治疗(装置组)或仅接受指南指导治疗(对照组)。主要预后终点为复合终点,包括90天内猝死或室性快速性心律失常导致死亡(心率失常死亡)。次要预后终点包括全因死亡及非心率失常死亡。

RESULTS 结果

Of 2302 participants, 1524 were randomly assigned to the device group and 778 to the control group. Participants in the device group wore the device for a median of 18.0 hours per day (interquartile range, 3.8 to 22.7). Arrhythmic death occurred in 1.6% of the participants in the device group and in 2.4% of those in the control group (relative risk, 0.67; 95% confidence interval [CI], 0.37 to 1.21; P=0.18). Death from any cause occurred in 3.1% of the participants in the device group and in 4.9% of those in the control group (relative risk, 0.64; 95% CI, 0.43 to 0.98; uncorrected P=0.04), and nonarrhythmic death in 1.4% and 2.2%, respectively (relative risk, 0.63; 95% CI, 0.33 to 1.19; uncorrected P=0.15). Of the 48 participants in the device group who died, 12 were wearing the device at the time of death. A total of 20 participants in the device group (1.3%) received an appropriate shock, and 9 (0.6%) received an inappropriate shock.

总共2302名入选患者中,1524名随机分至装置组,778名分至对照组。装置组患者每天佩戴装置中位时间18.0小时(四分位区间3.8-22.7)。装置组患者心率失常死亡发生率1.6%,对照组为2.4%(相对危险度,0.67; 95%可信区间 [CI], 0.37 to 1.21; P=0.18)。装置组患者全因死亡率3.1%,对照组为4.9%(相对危险度,0.64; 95% CI, 0.43 to 0.98; 未校正 P=0.04),非心率失常死亡比例分别为1.4% 和 2.2%(相对危险度,0.63; 95% CI, 0.33 to 1.19; 未校正 P=0.15)。在装置组死亡的48名患者中,12名死亡时佩戴装置。装置组共20名患者(1.3%)接受了恰当的除颤,9例(0.6%)接受了不恰当的除颤。

CONCLUSIONS 结论

Among patients with a recent myocardial infarction and an ejection fraction of 35% or less, the wearable cardioverter–defibrillator did not lead to a significantly lower rate of the primary outcome of arrhythmic death than control.

在近期心梗且射血分数不超过35%的患者,与对照相比,可穿戴ICD不能显著降低主要预后终点即心率失常死亡比例。

(Funded by the National Institutes of Health and Zoll Medical; VEST ClinicalTrials.gov number, NCT01446965.)

给我留言

您必须 [ 登录 ] 才能发表留言!

×
腾讯微博