Klein H, Auricchio A, Reek S, Geller C
Division of Cardiology, University Hospital Magdeburg, Germany.
Am J Cardiol. 1999 Mar 11;83(5B):91D-97D. doi: 10.1016/s0002-9149(99)00040-5.
Primary prevention of sudden arrhythmic death in patients with organic heart disease with poor left ventricular function and/or heart failure is currently a major challenge in cardiology. Amiodarone (with or without beta blockers) and the implantable cardioverter defibrillator (ICD) are considered the 2 major therapeutic tools to prevent sudden arrhythmic death in these patients. Two large trials have been launched to define the prophylactic benefit of the ICD or amiodarone on total mortality in patients that receive optimal heart failure and anti-ischemic treatment but remain at high risk of dying suddenly. The Sudden Cardiac Death in Heart Failure Trial (SCD-Heft) is designed to determine whether amiodarone or the ICD will decrease overall mortality in patients with coronary artery disease or nonischemic cardiomyopathy who are in heart failure New York Heart Association (NYHA) class II or III and have a left ventricular ejection fraction < 35%. The primary endpoint is total mortality; secondary objectives are comparison of arrhythmic and nonarrhythmic mortality and morbidity in the 3 arms as well as quality of life, cost-effectiveness, and incidence of episodes of ventricular tachyarrhythmias. The Multicenter Automatic Defibrillator Implantation Trial (MADIT) II is a follow-up study to the MADIT trial. It examines the prophylactic benefit in coronary artery disease patients with a left ventricular ejection fraction of < 30%, who have had at least 1 myocardial infarction but require no further risk stratification. MADIT II is a sequential design trial that compares ICD versus no ICD therapy. Programmed electrical stimulation to test inducibility of ventricular tachycardia is performed during ICD implantation, and various noninvasive risk markers are tested after randomization. Primary endpoint is total mortality, and secondary objectives are quality-of-life issues as well as cost-effectiveness ratio.
对于左心室功能不佳和/或心力衰竭的器质性心脏病患者，心律失常性猝死的一级预防目前是心脏病学中的一项重大挑战。胺碘酮（联合或不联合β受体阻滞剂）和植入式心脏复律除颤器（ICD）被认为是预防这些患者心律失常性猝死的两大治疗手段。已开展两项大型试验，以确定ICD或胺碘酮对接受最佳心力衰竭和抗缺血治疗但仍有猝死高风险患者的总死亡率的预防益处。心力衰竭猝死试验（SCD-Heft）旨在确定胺碘酮或ICD是否会降低纽约心脏协会（NYHA）II或III级心力衰竭、左心室射血分数<35%的冠心病或非缺血性心肌病患者的总死亡率。主要终点是总死亡率；次要目标是比较三组中心律失常性和非心律失常性死亡率及发病率，以及生活质量、成本效益和室性快速心律失常发作的发生率。多中心自动除颤器植入试验（MADIT）II是MADIT试验的一项后续研究。它研究左心室射血分数<30%、至少有1次心肌梗死但无需进一步风险分层的冠心病患者的预防益处。MADIT II是一项序贯设计试验，比较ICD治疗与非ICD治疗。在植入ICD期间进行程控电刺激以测试室性心动过速的诱发性，并在随机分组后测试各种非侵入性风险标志物。主要终点是总死亡率，次要目标是生活质量问题以及成本效益比。
