Implications of the Cardiac Arrhythmia Suppression Trial for antiarrhythmic drug treatment.
Implications of the Cardiac Arrhythmia Suppression Trial for antiarrhythmic drug treatment.
复制标题
心律失常抑制试验对抗心律失常药物治疗的影响。
DOI：
10.1016/0002-9149(90)91410-8
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发表时间：
1990
期刊：
影响因子：
--
通讯作者：
BiggerJr,JT
中科院分区：
文献类型：
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作者：
BiggerJr,JT
心脏心律失常抑制试验(CAST)是一项随机、安慰剂对照、双盲、多中心临床试验，涉及北美和欧洲的27个中心和100多家医院，以检验单尾假设，即心肌梗死后左心功能不全患者抑制室性心律失常将减少心律失常死亡。自1989年4月18日以来，CAST招募了年龄为80岁、≥6室性早搏和左心室射血分数≤为40%的患者。持续性室性心动过速、IV级充血性心力衰竭或IV级心绞痛是排除标准。在预随机期间，对抗心律失常药物进行滴定以抑制室性心律失常。如果在开放标记滴定过程中实现了≥80%的抑制，患者将被随机分配到有效剂量或匹配的安慰剂。如果只实现了部分抑制(1%到79%)，患者有资格参加一项子研究，该研究将他们随机分配到开放标记滴定过程中发现的最佳剂量或服用安慰剂。唯一没有随机接受治疗的患者是那些在滴定过程中心律失常或药物不耐受增加的患者。1989年4月18日，恩卡胺和氟卡胺被从石膏中移除，因为这些药物使死亡率增加了2.5倍。在恩卡胺/氟卡胺组和安慰剂组之间，基线风险变量没有不平衡，这可能可以解释不良治疗效果。在所有亚组中，不良反应都有显著的一致性。没有从治疗中受益的亚组；所有的亚组要么受到伤害，要么无法评估。莫里西津继续在演员阵容中，因为它有很大的机会显示出好处。CAST仍然有机会通过确定是否预防或治疗症状性心律失常是合适的方法，对心肌梗死后无症状或轻微症状性室性心律失常的未来处理产生重大影响。演员阵容的招募工作正在积极进行中，并鼓励医生推荐参加。
The Cardiac Arrhythmia Suppression Trial (CAST) is a randomized, placebo-controlled, double-blind, multicenter clinical trial involving 27 centers and more than 100 hospitals in North America and Europe to test the 1-tailed hypothesis that suppression of ventricular arrhythmias in patients with left ventricular dysfunction after myocardial infarction will reduce arrhythmic death. Since April 18, 1989, the CAST is enrolling patients aged <80 years with ≥6 ventricular premature complexes and left ventricular ejection fraction ≤40%. Sustained ventricular tachycardia, class IV congestive heart failure or class IV angina pectoris are exclusion criteria. During a prerandomization period, antiarrhythmic drugs are titrated to suppress ventricular arrhythmias. If ≥80% suppression is achieved during open-label titration, patients are randomized to the effective dose or to a matched placebo. If only partial suppression (1 to 79%) is achieved, patients are eligible for a substudy that randomizes them to the best dose found during open-label titration or to placebo. The only patients not randomized to treatment are those with increased arrhythmias or drug intolerance during titration. On April 18, 1989, encainide and flecainide were removed from the CAST because these drugs increased the death rate 2.5-fold. There were no imbalances in baseline risk variables between the encainide/flecainide group and the placebo group that might explain the adverse treatment effect. There was remarkable uniformity of the adverse effect across all subgroups. There were no subgroups that benefited from treatment; all were either harmed or not evaluable. Moricizine was continued in the CAST because it has a significant chance of showing benefit. The CAST still has the opportunity to make a major impact on the future management of asymptomatic or minimally symptomatic ventricular arrhythmias after myocardial infarction by determining whether prophylaxis or treatment of symptomatic arrhythmias is the appropriate approach. Enrollment for the CAST is actively underway and physicians are encouraged to recommend participation.