SCD-HeFT

Published

Bardy GH, et al. "Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure". The New England Journal of Medicine. 2005. 252(3):225-37.
PubMed • Full text • PDF

Clinical Question

In patients with HFrEF and NYHA II-III symptoms, how does amiodarone or ICD implantation compare to placebo in reducing all-cause mortality?

Bottom Line

SCD-HeFT demonstrated that ICDs reduced mortality compared to conventional therapy or amiodarone among patients with HFrEF.

Major Points

Prophylactic ICD placement in post-MI patients with LVEF ≤30% was shown to improve survival in MADIT-II (2002). The role of ICDs and the antiarrhythmic amiodarone was unclear in those with heart failure with reduced EF regardless of MI history.

Single-lead, shock-only ICD therapy reduces mortality by 23% compared to conventional therapy or amiodarone in stable NYHA class II or III HF with EF <35%. Amiodarone conferred no survival benefit compared to placebo.

Guidelines

AHA/ACCF Heart Failure Guidelines (2013, adapted)

• ICD if nonischemic dilated cardiomyopathy or ICM ≥40 days post MI with LVEF ≤35% and NYHA class II or III symptoms on OMT with expected survival >1 year (class I, level A)
• ICD for ICM >40 days post MI with LVEF ≤30%, NYHA class I symptoms on OMT with expected survival >1 year (class I level B)

Design

• Multicenter, double-blinded, parallel-group, randomized, placebo-controlled trial
• N=2,521
  • Amiodarone (n=845)
  • Shock-only ICD (n=829)
  • Placebo (n=847)
• Enrollment: 1997-2001
• Median follow up: 45.5 months
• Primary outcome: All-cause mortality

Population

Inclusion Criteria

• Age >18 years
• NYHA class II-III chronic stable HF (ischemic or nonischemic)

Baseline Characteristics

• Median LVEF: 25%
• NYHA class II: 30%
• NYHA class III: 30%
• Ischemic CHF: 52%
• ACE inhibitor: 85%
• ACE inhibitor or ARB: 96%
• Beta-blocker: 69%
• Spironolactone: 19%
• Loop diuretics: 82%
• Aspirin: 56%
• Statin: 38%

Interventions

• Randomized to ICD vs. amiodarone vs. placebo; all patients received conventional medical therapy as well
• All patients had EKG, 6-minute walk test, 24h Holter monitoring, LFTs, TFTs, and CXR

Outcomes

Primary Outcomes

All-cause mortality

ICD vs. placebo

22% vs. 29% (HR 0.77; 97.5% CI 0.62-0.96; P=0.007)

Amiodarone vs. placebo

28% vs. 29% (HR 1.06; 97.5% CI 0.86-1.30; P=0.53)

Funding

Funding from NHLBI, NIH, Medtronic, Wyeth–Ayerst Laboratories, and Knoll Pharmaceuticals.

Further Reading

• Concurrent editorial
• NEJM Letters to the Editor