American College of Cardiology Presented by Dr. Stuart J. Connolly OPTIC Trial Optimal Pharmacological Therapy in Implantable Cardioverter Defibrillator Patients Trial Presented at American College of Cardiology Scientific Sessions 2005 Presented by Dr. Stuart J. Connolly

Beta-Blocker Alone Metoprolol, Carvedolol, or Bisoprolol OPTIC Trial 412 patients receiving a St. Jude Medical dual chamber ICD, with presence of one of the following: 1) spontaneous ventricular tachycardia (VT); or 2) left ventricular (LV) ejection fraction ≤40% with either spontaneous ventricular fibrillation (VF) or inducible VT or VF. Randomized Beta-Blocker Alone Metoprolol, Carvedolol, or Bisoprolol Sotalol 160 mg/day Beta-Blocker plus Amiodarone 800 mg load plus 200 mg/day Endpoints (1 year): Occurrence of shock (appropriate or inappropriate) Presented at ACC Scientific Sessions 2005

Excluding Shocks During First 21 Days OPTIC Trial Any Shock at 1 Year Any Shock at 1 Year Excluding Shocks During First 21 Days p<0.0001 p<0.0001 p=0.055 p=0.014 p=0.015 p=0.0057 Beta-blocker Sotalol Beta-Blocker w/ Amiodarone Beta-blocker Sotalol Beta-Blocker w/ Amiodarone Baseline clinical characteristics were similar between the treatment groups, with 80% of patients having had a prior MI, 29% having inducible VT or VF and 71% spontaneous VT or VF. Presented at ACC Scientific Sessions 2005

OPTIC Trial Appropriate Shocks Inappropriate Shocks Beta-blocker Sotalol Beta-Blocker w/ Amiodarone Beta-blocker Sotalol Beta-Blocker w/ Amiodarone Mean number of shocks per patient was 4.32 in the beta-blocker alone group, 0.93 in the sotalol group, and 0.51 of the amiodarone plus beta-blocker group. Adverse events were similar in the three groups. Presented at ACC Scientific Sessions 2005

OPTIC Trial: Summary Among patients receiving a dual chamber ICD for spontaneous or inducible VT or VF, sotalol therapy and amiodarone plus beta-blocker therapy were associated with reductions in shocks at 1 year compared with beta-blocker therapy alone. The reductions in the amiodarone plus beta-blocker group were greater than the sotalol group. The addition of amiodarone or sotalol was associated with reductions in shock without an increase in adverse events, suggesting these therapies may improve the quality of life in patients implanted with an ICD. Presented at ACC Scientific Sessions 2005