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抗心律失常药物与植入式除颤器(AVID)——基本原理、设计与方法

Antiarrhythmics Versus Implantable Defibrillators (AVID)--rationale, design, and methods.

作者信息

Hallstrom A P, Greene H L, Wyse D G, Zipes D, Epstein A E, Domanski M J, Schron E B

机构信息

AVID Clinical Trial Center, University of Washington, Seattle., USA.

出版信息

Am J Cardiol. 1995 Mar 1;75(7):470-5.

PMID:7863991
Abstract

The Antiarrhythmics Versus Implantable Defibrillators (AVID) study compares a strategy of initial treatment with an implantable cardioverter-defibrillator (ICD) to a strategy of initial treatment with an antiarrhythmic drug to prevent death in patients with a history of ventricular fibrillation or hemodynamically compromising ventricular tachycardia, or both. Neither arrhythmia can have been due to a transient or correctable cause. The principle exclusions are a contraindication to amiodarone therapy and inability to undergo ICD implantation. Antiarrhythmic drug therapy includes empiric amiodarone and guided sotalol. The ICDs allowed are advanced generation devices, and most are implanted transvenously. The primary end point of the study is total mortality. Secondary end points are cost and quality of life. The study was designed in 2 phases. The pilot phase enrolled 200 patients between June 1993 and June 1994. Data collected during the pilot phase confirmed that the trial is feasible. An additional 1,000 patients will be enrolled between June 1994 and March 1997. It is anticipated that all 1,200 patients will be followed until September 1998, and will be included in the intention-to-treat analysis.

摘要

抗心律失常药物与植入式除颤器(AVID)研究比较了采用植入式心脏复律除颤器(ICD)进行初始治疗的策略和采用抗心律失常药物进行初始治疗的策略,以预防有室颤病史或血流动力学不稳定的室性心动过速病史或两者兼有的患者死亡。两种心律失常均不能归因于短暂性或可纠正的原因。主要排除标准是对胺碘酮治疗有禁忌证以及无法进行ICD植入。抗心律失常药物治疗包括经验性使用胺碘酮和指导性使用索他洛尔。允许使用的ICD是先进一代的设备,大多数通过静脉植入。该研究的主要终点是总死亡率。次要终点是成本和生活质量。该研究分两个阶段设计。试点阶段在1993年6月至1994年6月期间招募了200名患者。试点阶段收集的数据证实该试验是可行的。1994年6月至1997年3月期间将再招募1000名患者。预计所有1200名患者都将随访至1998年9月,并将纳入意向性分析。

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