Epstein A E, Hallstrom A P, Rogers W J, Liebson P R, Seals A A, Anderson J L, Cohen J D, Capone R J, Wyse D G
Department of Medicine, University of Alabama at Birmingham.
JAMA. 1993 Nov 24;270(20):2451-5.
To test the hypothesis that in survivors of myocardial infarction, the suppression of ventricular premature depolarizations improves survival free of cardiac arrest and arrhythmic death.
International, prospective, multicenter, randomized, placebo-controlled trial.
University and community hospitals.
A total of 3549 patients with myocardial infarction and left ventricular dysfunction.
Administration of encainide, flecainide, moricizine, or placebo to suppress ventricular premature depolarizations.
Overall survival and survival free of cardiac arrest or arrhythmic death were compared in patients randomized to long-term, active antiarrhythmic drug therapy vs corresponding placebo, using the stratified log rank statistic.
At 1 year from the time of randomization to blinded therapy, 95% of placebo-treated patients vs 90% of active drug-treated patients remained alive (P = .0006). Similarly, at 1 year, 96% of placebo-treated patients vs 93% of active drug-treated patients remained free of cardiac arrest or arrhythmic death (P = .003).
The suppression of asymptomatic or mildly symptomatic ventricular arrhythmias after myocardial infarction does not improve survival and can increase mortality. Treatment strategies designed solely to suppress these arrhythmias should no longer be followed.
验证如下假设,即心肌梗死幸存者中,室性早搏的抑制可改善无心脏骤停和心律失常性死亡的生存率。
国际性、前瞻性、多中心、随机、安慰剂对照试验。
大学及社区医院。
共3549例心肌梗死伴左心室功能障碍患者。
给予恩卡胺、氟卡尼、莫雷西嗪或安慰剂以抑制室性早搏。
采用分层对数秩统计量,比较随机接受长期、活性抗心律失常药物治疗的患者与相应安慰剂治疗患者的总生存率以及无心脏骤停或心律失常性死亡的生存率。
从随机分组至盲法治疗1年时,接受安慰剂治疗的患者中有95%存活,而接受活性药物治疗的患者中有90%存活(P = 0.0006)。同样,在1年时,接受安慰剂治疗的患者中有96%无心脏骤停或心律失常性死亡,而接受活性药物治疗的患者中有93%无此类情况(P = 0.003)。
心肌梗死后无症状或轻度症状性室性心律失常的抑制并不能改善生存率,反而可能增加死亡率。不应再遵循仅旨在抑制这些心律失常的治疗策略。