Epstein A E, Bigger J T, Wyse D G, Romhilt D W, Reynolds-Haertle R A, Hallstrom A P
Department of Medicine, University of Alabama, Birmingham.
J Am Coll Cardiol. 1991 Jul;18(1):14-9. doi: 10.1016/s0735-1097(10)80210-4.
To test the hypothesis that suppression of ventricular arrhythmias by antiarrhythmic drugs after myocardial infarction improves survival, the Cardiac Arrhythmia Suppression Trial (CAST) was initiated. Suppression was evaluated before randomization during an open label titration period. Patients whose arrhythmias were suppressed were randomized in the main study and those whose arrhythmias were partially suppressed were randomized in a substudy. Overall survival and survival free of arrhythmic death or cardiac arrest were lower [corrected] in patients treated with encainide or flecainide than in patients treated with placebo. However, the death rate in patients randomized to placebo therapy was lower than expected. This report describes the survival experience of all patients enrolled in CAST and compares it with mortality in other studies of patients with ventricular arrhythmias after myocardial infarction. As of April 18, 1989, 2,371 patients had enrolled in CAST and entered prerandomization, open label titration: 1,913 (81%) were randomized to double-blind, placebo-controlled therapy (1,775 patients whose arrhythmias were suppressed and 138 patients whose arrhythmias were partially suppressed during open label titration); and 458 patients (19%) were not randomized because they were still in titration, had died during titration or had withdrawn. Including all patients who enrolled in CAST, the actuarial (Kaplan-Meier) estimate of 1-year mortality was 10.3%. To estimate the "natural" mortality rate of patients enrolled in CAST, an analysis was done that adjusted for deaths that might be attributable to encainide or flecainide treatment either during prerandomization, open label drug titration or after randomization. Because the censoring procedure excluded patients treated with encainide or flecainide after randomization, the mortality estimate will be less than the unadjusted mortality estimate of 10.3%.(ABSTRACT TRUNCATED AT 250 WORDS)
为了验证心肌梗死后抗心律失常药物抑制室性心律失常可提高生存率这一假说，开展了心律失常抑制试验（CAST）。在开放标签滴定期随机分组前对抑制情况进行评估。心律失常被抑制的患者在主要研究中随机分组，心律失常被部分抑制的患者在一项子研究中随机分组。与接受安慰剂治疗的患者相比，接受恩卡尼或氟卡尼治疗的患者总生存率以及无心律失常死亡或心脏骤停的生存率更低[校正后]。然而，随机接受安慰剂治疗的患者死亡率低于预期。本报告描述了所有纳入CAST患者的生存情况，并将其与其他心肌梗死后室性心律失常患者研究中的死亡率进行比较。截至1989年4月18日，2371例患者纳入CAST并进入随机分组前的开放标签滴定阶段：1913例（81%）被随机分配至双盲、安慰剂对照治疗组（1775例在开放标签滴定期间心律失常被抑制的患者和138例心律失常被部分抑制的患者）；458例患者（19%）未被随机分组，原因是他们仍在滴定阶段、在滴定期间死亡或已退出。包括所有纳入CAST的患者，1年死亡率的精算（Kaplan-Meier）估计值为10.3%。为了估计纳入CAST患者的“自然”死亡率，进行了一项分析，对随机分组前、开放标签药物滴定期间或随机分组后可能归因于恩卡尼或氟卡尼治疗的死亡进行校正。由于截尾程序排除了随机分组后接受恩卡尼或氟卡尼治疗的患者，死亡率估计值将低于未校正的10.3%的死亡率估计值。（摘要截短至250字）
