Sudden Cardiac Death in Heart Failure Trial Presented at American College of Cardiology Scientific Sessions 2004 Presented by Dr. Gust H. Bardy SCD-HeFTSCD-HeFT

www. Clinical trial results.org Endpoints (median 45.5 months): All-cause mortality Endpoints (median 45.5 months): All-cause mortality SCD-HeFT Presented at ACC Scientific Sessions ,521 patients with moderately symptomatic CHF (NYHA Class II or III) and LVEF ≤35% Randomized, double-blind, multicenter 2,521 patients with moderately symptomatic CHF (NYHA Class II or III) and LVEF ≤35% Randomized, double-blind, multicenter Conventional CHF Treatment + Placebo Conventional CHF Treatment + ICD Single lead implantable cardioverter defibrillator programmed for ventricular fibrillation (VF) treatment only Conventional CHF Treatment + ICD Single lead implantable cardioverter defibrillator programmed for ventricular fibrillation (VF) treatment only Treatment Conventional CHF Treatment + Amiodarone Antiarrhythmic agent  800 mg Week 1, 400 mg Week 2-4  Chronic therapy:  200 mg/day if <150 lbs  300 mg/day if lbs  400 mg/day if >200 lbs Conventional CHF Treatment + Amiodarone Antiarrhythmic agent  800 mg Week 1, 400 mg Week 2-4  Chronic therapy:  200 mg/day if <150 lbs  300 mg/day if lbs  400 mg/day if >200 lbs

www. Clinical trial results.org All-cause mortality at 5 years Amiodarone vs placebo HR 1.06, p=0.529 ICD vs placebo HR 0.77, p=0.007 Medication use at end of follow-up included 72% ACE- inhibitors, 78% beta-blockers, 80% loop diuretics, and 55% ASA Prior duration of CHF was 24.5 months at baseline No difference in all-cause mortality between amiodarone and placebo arm Mortality was lower in ICD arm vs placebo Presented at ACC Scientific Sessions 2004 % Mortality SCD-HeFTSCD-HeFT

www. Clinical trial results.org Among patients with NYHA Class II or Class III CHF and reduced left ventricular ejection fraction, treatment with an implantable ICD was associated with a reduction in all-cause mortality compared with placebo, but there was no difference between amiodarone and placebo Secondary endpoint data not yet reported Among patients with NYHA Class II or Class III CHF and reduced left ventricular ejection fraction, treatment with an implantable ICD was associated with a reduction in all-cause mortality compared with placebo, but there was no difference between amiodarone and placebo Secondary endpoint data not yet reported SCD-HeFTSCD-HeFT