Friedman L M, Byington R P, Capone R J, Furberg C D, Goldstein S, Lichstein E
J Am Coll Cardiol. 1986 Jan;7(1):1-8. doi: 10.1016/s0735-1097(86)80250-9.
The Beta-Blocker Heart Attack Trial was a placebo-controlled, randomized, double-blind clinical trial of the long-term administration of propranolol hydrochloride to patients who had had at least one myocardial infarction. Among 3,837 patients followed up for an average of 25 months, 3,290 (85.7%) had 24 hour ambulatory electrocardiograms performed at the baseline examination. Four classifications of arrhythmia were examined. One of these, the presence of complex ventricular arrhythmias (at least 10 ventricular premature beats/h, or at least one pair or run of ventricular premature beats or multiform ventricular premature beats) was the subgroup of major interest. Regardless of the classification, the presence of arrhythmia identifies a group of patients with a higher risk of total mortality, coronary heart disease mortality, sudden cardiac death and instantaneous cardiac death. The a priori subgroup hypothesis that sudden death would be preferentially reduced by propranolol in patients with complex ventricular arrhythmias was not supported. The relative benefit of propranolol in reducing sudden death for this subgroup was 28 versus 16% for the subgroup without ventricular arrhythmia (relative risk of 0.72 versus 0.84, a nonsignificant relative difference of 14%). There were similar findings for two of the three other classifications of arrhythmia and for the other response variables. Although propranolol does not appear to be of special relative benefit in patients with ventricular arrhythmia, the presence of the arrhythmia does identify a high-risk group. The mechanism by which propranolol reduces mortality is still unclear, but is probably not solely an antiarrhythmic one.
β受体阻滞剂心肌梗死试验是一项安慰剂对照、随机、双盲的临床试验,旨在对至少发生过一次心肌梗死的患者长期给予盐酸普萘洛尔。在平均随访25个月的3837例患者中,3290例(85.7%)在基线检查时进行了24小时动态心电图检查。对心律失常的四种分类进行了检查。其中之一,复杂性室性心律失常(至少10次室性早搏/小时,或至少一对或一阵室性早搏或多形性室性早搏)的存在是主要关注的亚组。无论分类如何,心律失常的存在都确定了一组全因死亡率、冠心病死亡率、心源性猝死和即时心源性死亡风险较高的患者。预先设定的亚组假设,即普萘洛尔可优先降低复杂性室性心律失常患者的心源性猝死,未得到支持。普萘洛尔对该亚组降低心源性猝死的相对益处为28%,而无室性心律失常亚组为16%(相对风险为0.72对0.