A randomized study of the prevention of sudden death in patients with coronary artery disease
A randomized study of the prevention of sudden death in patients with coronary artery disease
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DOI：
10.1056/nejm199912163412503
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发表时间：
1999-12-16
影响因子：
158.5
通讯作者：
Hafley, G
中科院分区：
文献类型：
--
作者：
Buxton, AE;Lee, KL;Hafley, G
背景：经验性抗心律失常治疗并未降低冠状动脉疾病和无症状室性心律失常患者的死亡率。先前的研究表明，以电生理学检测为指导的抗心律失常治疗可能会降低猝死的风险。方法：我们进行了一项随机对照试验，以检验以下假设：电生理学指导的抗心律失常治疗可以降低患有冠状动脉疾病、左心室射血分数为 40% 或更低以及无症状、非持续性室性心动过速的患者的猝死风险。由程序刺激诱发持续性室性快速心律失常的患者被随机分配接受抗心律失常治疗，包括药物和植入式除颤器（如电生理测试结果所示）或不接受抗心律失常治疗。如果患者能够耐受，则给予血管紧张素转换酶抑制剂和β-肾上腺素能阻滞剂。结果：共有704例诱发性、持续性室性快速性心律失常患者被随机分配到治疗组。 Kaplan-Meier 估计，接受电生理引导治疗的患者中心脏骤停或心律失常死亡的主要终点发生率为 25%，未接受抗心律失常治疗的患者为 32%（相对风险为 0.73；95% 置信区间为 0.53 至 0.99），这意味着风险降低了 27%。总体死亡率的五年估计值分别为 42% 和 48%（相对风险，0.80；95% 置信区间，0.64 至 1.01）。接受除颤器治疗的患者心脏骤停或心律失常死亡的风险显着低于未接受除颤器治疗的出院患者（相对风险，0.24；95%置信区间，0.13至0.45；P
Background: Empirical antiarrhythmic therapy has not reduced mortality among patients with coronary artery disease and asymptomatic ventricular arrhythmias. Previous studies have suggested that antiarrhythmic therapy guided by electrophysiologic testing might reduce the risk of sudden death.Methods: We conducted a randomized, controlled trial to test the hypothesis that electrophysiologically guided antiarrhythmic therapy would reduce the risk of sudden death among patients with coronary artery disease, a left ventricular ejection fraction of 40 percent or less, and asymptomatic, unsustained ventricular tachycardia. Patients in whom sustained ventricular tachyarrhythmias were induced by programmed stimulation were randomly assigned to receive either antiarrhythmic therapy, including drugs and implantable defibrillators, as indicated by the results of electrophysiologic testing, or no antiarrhythmic therapy. Angiotensin-converting-enzyme inhibitors and beta-adrenergic-blocking agents were administered if the patients could tolerate them.Results: A total of 704 patients with inducible, sustained ventricular tachyarrhythmias were randomly assigned to treatment groups. Five-year Kaplan-Meier estimates of the incidence of the primary end point of cardiac arrest or death from arrhythmia were 25 percent among those receiving electrophysiologically guided therapy and 32 percent among the patients assigned to no antiarrhythmic therapy (relative risk, 0.73; 95 percent confidence interval, 0.53 to 0.99), representing a reduction in risk of 27 percent. The five-year estimates of overall mortality were 42 percent and 48 percent, respectively (relative risk, 0.80; 95 percent confidence interval, 0.64 to 1.01). The risk of cardiac arrest or death from arrhythmia among the patients who received treatment with defibrillators was significantly lower than that among the patients discharged without receiving defibrillator treatment (relative risk, 0.24; 95 percent confidence interval, 0.13 to 0.45; P