Sudden Cardiac Death Sudden Cardiac Death in Heart Failure Trialin Heart Failure Trial

Sudden Cardiac Death Sudden Cardiac Death in Heart Failure Trialin Heart Failure Trial

Presented atPresented atAmerican College of CardiologyAmerican College of Cardiology

Scientific Sessions 2004Scientific Sessions 2004

Presented by Dr. Gust H. BardyPresented by Dr. Gust H. Bardy

SCD-HeFTSCD-HeFTSCD-HeFTSCD-HeFT

www. Clinical trial results.org

Endpoints (median 45.5 months):All-cause mortality

Endpoints (median 45.5 months):All-cause mortality

SCD-HeFTSCD-HeFTSCD-HeFTSCD-HeFT

Presented at ACC Scientific Sessions 2004Presented at ACC Scientific Sessions 2004

2,521 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 + PlaceboConventional CHF

Treatment + PlaceboConventional 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

TreatmentTreatment

Conventional CHF Treatment + Amiodarone

Antiarrhythmic agent 800 mg Week 1, 400 mg Week 2-4Chronic therapy:

200 mg/day if <150 lbs300 mg/day if 150-200 lbs400 mg/day if >200 lbs

Conventional CHF Treatment + Amiodarone

Antiarrhythmic agent 800 mg Week 1, 400 mg Week 2-4Chronic therapy:

200 mg/day if <150 lbs300 mg/day if 150-200 lbs400 mg/day if >200 lbs

www. Clinical trial results.org

All-cause mortality at 5 yearsAmiodarone vs placebo

HR 1.06, p=0.529ICD vs placebo

HR 0.77, p=0.007

28.9%

34.1%35.8%

0%

5%

10%

15%

20%

25%

30%

35%

40%

ICD Amiodarone Placebo

28.9%

34.1%35.8%

0%

5%

10%

15%

20%

25%

30%

35%

40%

ICD Amiodarone Placebo

•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 2004Presented at ACC Scientific Sessions 2004

% M

ort

alit

y

SCD-HeFTSCD-HeFTSCD-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-HeFTSCD-HeFTSCD-HeFT