ANTIARRHYTHMICS VERSUS IMPLANTABLE DEFIBRILLATORS (AVID) - RATIONALE,DESIGN, AND METHODS

The Antiarrhythmics Versus Implantable Defibrillators (AVID) study com pares a strategy of initial treatment with an implantable cardioverter -defibrillator (ICD) to a strategy of initial treatment with an antiar rhythymic drug to prevent death in patients with a history of ventricu lar fibrillation or hemodynamically compromising ventricular tachycard ia, or both. Neither arrhythmia can have been due to a transient or co rrectable cause. The principle exclusions are a contraindication to am iodarone therapy and inability to undergo ICD implantation. Antiarrhyt hmic drug therapy includes empiric amiodarone and guided sotalol. The ICDs allowed are advanced generation devices, and most are implanted t ransvenously. The primary end point of the study is total mortality. S econdary end points are cost and quality of life. The study was design ed in 2 phases. The pilot phase enrolled 200 patients between June 199 3 and June 1994. Data collected during the pilot phase confirmed that the trial is feasible. An additional 1,000 patients will be enrolled b etween June 1994 and March 1997. It is anticipated that all 1,200 pati ents will be followed until September 1998, and will be included in th e intention-to-treat analysis.