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植入式除颤器可提高冠心病合并室性心律失常高危患者的生存率。多中心自动除颤器植入试验研究者。

Improved survival with an implanted defibrillator in patients with coronary disease at high risk for ventricular arrhythmia. Multicenter Automatic Defibrillator Implantation Trial Investigators.

作者信息

Moss A J, Hall W J, Cannom D S, Daubert J P, Higgins S L, Klein H, Levine J H, Saksena S, Waldo A L, Wilber D, Brown M W, Heo M

机构信息

Department of Medicine, University of Rochester School of Medicine and Dentistry, NY 14642, USA.

出版信息

N Engl J Med. 1996 Dec 26;335(26):1933-40. doi: 10.1056/NEJM199612263352601.

Abstract

BACKGROUND

Unsustained ventricular tachycardia in patients with previous myocardial infarction and left ventricular dysfunction is associated with a two-year mortality rate of about 30 percent. We studied whether prophylactic therapy with an implanted cardioverter-defibrillator, as compared with conventional medical therapy, would improve survival in this high-risk group of patients.

METHODS

Over the course of five years, 196 patients in New York Heart Association functional class I, II, or III with prior myocardial infarction; a left ventricular ejection fraction < or = 0.35; a documented episode of asymptomatic unsustained ventricular tachycardia; and inducible, nonsuppressible ventricular tachyarrhythmia on electrophysiologic study were randomly assigned to receive an implanted defibrillator (n = 95) or conventional medical therapy (n=101). We used a two-sided sequential design with death from any cause as the end point.

RESULTS

The base-line characteristics of the two treatment groups were similar. During an average follow-up of 27 months, there were 15 deaths in the defibrillator group (11 from cardiac causes) and 39 deaths in the conventional-therapy group (27 from cardiac causes) (hazard ratio for overall mortality, 0.46; 95 percent confidence interval, 0.26 to 0.82; P=0.009). There was no evidence that amiodarone, beta-blockers, or any other antiarrhythmic therapy had a significant influence on the observed hazard ratio.

CONCLUSIONS

In patients with a prior myocardial infarction who are at high risk for ventricular tachyarrhythmia, prophylactic therapy with an implanted defibrillator leads to improved survival as compared with conventional medical therapy.

摘要

背景

既往有心肌梗死且左心室功能不全的患者发生非持续性室性心动过速,其两年死亡率约为30%。我们研究了与传统药物治疗相比,植入式心脏复律除颤器预防性治疗能否改善这一高危患者群体的生存率。

方法

在五年的时间里,196例纽约心脏协会心功能I级、II级或III级的患者,既往有心肌梗死;左心室射血分数≤0.35;记录到无症状非持续性室性心动过速发作;且在电生理检查中可诱导出不可抑制的室性快速心律失常,将这些患者随机分为植入除颤器组(n = 95)或传统药物治疗组(n = 101)。我们采用双侧序贯设计,以任何原因导致的死亡作为终点。

结果

两个治疗组的基线特征相似。在平均27个月的随访期间,除颤器组有15例死亡(11例死于心脏原因),传统治疗组有39例死亡(27例死于心脏原因)(总体死亡率的风险比为0.46;95%置信区间为0.26至0.82;P = 0.009)。没有证据表明胺碘酮、β受体阻滞剂或任何其他抗心律失常治疗对观察到的风险比有显著影响。

结论

对于有既往心肌梗死且室性快速心律失常高危的患者,与传统药物治疗相比,植入式除颤器预防性治疗可提高生存率。

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