Antiarrhythmic drugs versus implantable defibrillators: the need for a randomized controlled study.

The implantable cardiac defibrillator was first used in 1980 and has gained widespread acceptance. However, no randomized controlled trials have been reported that compare the implantable cardiac defibrillator with antiarrhythmic drugs. Most published studies have used historical control subjects or nonrandomized concurrent patients for comparison with patients who received an implantable defibrillator. To reduce bias, studies are needed that compare therapies randomized between antiarrhythmic drugs and implantable defibrillators. The Antiarrhythmics Versus Implantable Defibrillators (AVID) Study was designed to evaluate the nonthoracotomy, tiered-therapy implantable defibrillator compared with drug therapy (amiodarone or sotalol). Patients are eligible for randomization if they have a history of recent cardiac arrest caused by ventricular fibrillation or have hemodynamically serious ventricular tachycardia. A pilot study to enroll 200 patients began on June 1, 1993, before the start of the main study of 1000 patients. Analysis of the main study by intention to treat will assess the primary endpoint of total mortality.