Capone R J, Pawitan Y, el-Sherif N, Geraci T S, Handshaw K, Morganroth J, Schlant R C, Waldo A L
Department of Biostatistics, University of Washington, Seattle.
J Am Coll Cardiol. 1991 Nov 15;18(6):1434-8. doi: 10.1016/0735-1097(91)90671-u.
Patients randomized to placebo in the encainide and flecainide arms of the Cardiac Arrhythmia Suppression Trial (CAST) have been found to have a relatively low 1-year mortality rate of 3.9% in comparison with previous studies of patients in the postmyocardial infarction period. To determine the comparability of CAST with previous studies, baseline variables were examined in the 743 patients randomized to placebo in the flecainide and encainide arms of CAST. Twenty-three baseline characteristics were correlated with major outcome events: arrhythmic death (16 events), total mortality (26 events) and congestive heart failure (51 events). On multivariate analysis the risk of new or worsening congestive heart failure was significantly associated with diuretic use, diabetes, high New York Heart Association functional class, age, prolonged QRS duration and low ejection fraction. The risk of arrhythmic death or resuscitated cardiac arrest was significantly associated with an index Q wave myocardial infarction, history of heart failure, use of digitalis, diabetes and prolonged QRS duration. Total mortality or resuscitated cardiac arrest was significantly associated with an index Q wave myocardial infarction, diabetes, ST segment depression, high functional class, prolonged QRS duration and low ejection fraction. The variables at baseline associated with mortality from all causes or arrhythmic death or resuscitated cardiac arrest and heart failure in the CAST placebo-treated patients are similar to those identified in previous postmyocardial infarction studies. Thus, the observation of increased mortality in CAST associated with the administration of encainide and flecainide for suppression of ventricular premature depolarizations is probably applicable to any comparably defined group of patients in the postmyocardial infarction period.
在心律失常抑制试验(CAST)中,被随机分配到恩卡尼和氟卡尼组服用安慰剂的患者,与既往心肌梗死后患者的研究相比,其1年死亡率相对较低,为3.9%。为了确定CAST与既往研究的可比性,对CAST中被随机分配到氟卡尼和恩卡尼组服用安慰剂的743例患者的基线变量进行了检查。23项基线特征与主要结局事件相关:心律失常性死亡(16例)、总死亡率(26例)和充血性心力衰竭(51例)。多因素分析显示,新发或加重充血性心力衰竭的风险与使用利尿剂、糖尿病、纽约心脏协会心功能分级高、年龄、QRS时限延长和射血分数低显著相关。心律失常性死亡或心脏骤停复苏的风险与指数Q波心肌梗死、心力衰竭病史、使用洋地黄、糖尿病和QRS时限延长显著相关。总死亡率或心脏骤停复苏与指数Q波心肌梗死、糖尿病、ST段压低、心功能分级高、QRS时限延长和射血分数低显著相关。CAST安慰剂治疗患者中与全因死亡率、心律失常性死亡或心脏骤停复苏以及心力衰竭相关的基线变量与既往心肌梗死后研究中确定的变量相似。因此,在CAST中观察到的与使用恩卡尼和氟卡尼抑制室性早搏相关的死亡率增加,可能适用于心肌梗死后任何具有类似定义的患者群体。