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Antiarrhythmic drugs versus implantable defibrillators: the need for a randomized controlled study
1Division of Cardiology, University of Washington, Harborview Medical Center, Seattle, WA 98104-2499.
Insights
The Antiarrhythmics Versus Implantable Defibrillators (AVID) study compares implantable cardiac defibrillators with antiarrhythmic drugs. This trial aims to reduce bias by randomizing patients with serious ventricular tachycardia or cardiac arrest.
Area of Science:
- Cardiology
- Clinical Trials
- Medical Devices
Background:
- Implantable cardiac defibrillators (ICDs) have been widely adopted since 1980.
- Previous studies comparing ICDs with antiarrhythmic drugs lacked randomized controlled trials, often using historical or nonrandomized controls.
- A need exists for randomized studies to minimize bias in comparing ICD therapy with antiarrhythmic drugs.
Purpose of the Study:
- To evaluate the efficacy of nonthoracotomy, tiered-therapy implantable defibrillators compared to drug therapy.
- To assess total mortality as the primary endpoint in patients at high risk for sudden cardiac death.
Main Methods:
- The Antiarrhythmics Versus Implantable Defibrillators (AVID) Study is a randomized controlled trial.
- Eligible patients have a history of recent cardiac arrest due to ventricular fibrillation or hemodynamically serious ventricular tachycardia.
- The study involves a pilot phase (200 patients) and a main study (1000 patients), with intention-to-treat analysis.
Main Results:
- The abstract does not contain specific results, as the study was ongoing.
- The primary endpoint for analysis is total mortality.
Conclusions:
- The AVID study is designed to provide unbiased, randomized data on ICDs versus antiarrhythmic drugs.
- Findings will inform clinical practice regarding the optimal treatment for patients with life-threatening ventricular arrhythmias.
Abstract:
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.