Comparison of β-Blockers, Amiodarone Plus β-Blockers, or Sotalol for Prevention of Shocks From Implantable Cardioverter Defibrillators: The OPTIC Study: A Randomized Trial

• Published in: JAMA : the journal of the American Medical Association 2006-01, Vol.295 (2), p.165-171
• Main Authors: Connolly, Stuart J, Dorian, Paul, Roberts, Robin S, Gent, Michael, Bailin, Steven, Fain, Eric S, Thorpe, Kevin, Champagne, Jean, Talajic, Mario, Coutu, Benoit, Gronefeld, Gerian C, Hohnloser, Stefan H, Optimal Pharmacological Therapy in Cardioverter Defibrillator Patients (OPTIC) Investigators, for the
• Format: Article
• Language: English
• Subjects: Adrenergic beta-Antagonists - administration & dosage; Adrenergic beta-Antagonists - therapeutic use; Aged; Amiodarone - administration & dosage; Amiodarone - therapeutic use; Anti-Arrhythmia Agents - administration & dosage; Anti-Arrhythmia Agents - therapeutic use; Biological and medical sciences; Defibrillators, Implantable - adverse effects; Equipment Failure; Female; General aspects; Humans; Male; Medical sciences; Middle Aged; Proportional Hazards Models; Sotalol - administration & dosage; Sotalol - therapeutic use; Ventricular Fibrillation - etiology; Ventricular Fibrillation - prevention & control
• ISSN: 0098-7484; 1538-3598
• DOI: 10.1001/jama.295.2.165

CONTEXT Implantable cardioverter defibrillator (ICD) therapy is effective but is associated with high-voltage shocks that are painful. OBJECTIVE To determine whether amiodarone plus β-blocker or sotalol are better than β-blocker alone for prevention of ICD shocks. DESIGN, SETTING, AND PATIENTS A randomized controlled trial with blinded adjudication of events of 412 patients from 39 outpatient ICD clinical centers located in Canada, Germany, United States, England, Sweden, and Austria, conducted from January 13, 2001, to September 28, 2004. Patients were eligible if they had received an ICD within 21 days for inducible or spontaneously occurring ventricular tachycardia or fibrillation. INTERVENTION Patients were randomized to treatment for 1 year with amiodarone plus β-blocker, sotalol alone, or β-blocker alone. MAIN OUTCOME MEASURE Primary outcome was ICD shock for any reason. RESULTS Shocks occurred in 41 patients (38.5%) assigned to β-blocker alone, 26 (24.3%) assigned to sotalol, and 12 (10.3%) assigned to amiodarone plus β-blocker. A reduction in the risk of shock was observed with use of either amiodarone plus β-blocker or sotalol vs β-blocker alone (hazard ratio [HR], 0.44; 95% confidence interval [CI], 0.28-0.68; P