Long-Term Outcomes of Implantable Cardioverter-Defibrillator Therapy in the SCD-HeFT

J Am Coll Cardiol. 2020 Jul 28;76(4):405-415. doi: 10.1016/j.jacc.2020.05.061.

Abstract

Background: The SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial) randomized 2,521 patients with moderate heart failure (HF) to amiodarone, placebo drug, or implantable cardioverter-defibrillator (ICD) therapy. Original trial follow-up ended October 31, 2003. Over a median 45.5-month follow-up, amiodarone, compared with placebo, did not affect survival, whereas randomization to an ICD significantly decreased all-cause mortality by 23%.

Objectives: This study sought to describe the extended treatment group survival of the SCD-HeFT cohort.

Methods: Mortality outcomes for the 1,855 patients alive at the end of the SCD-HeFT trial were collected between 2010 and 2011. These data were combined with the 666 deaths from the original study to compare long-term outcomes overall and for key pre-specified subgroups.

Results: Median (25th to 75th percentiles) follow-up was 11.0 (10.0 to 12.2) years. On the basis of intention-to-treat analysis, the ICD group had overall survival benefit versus placebo drug (hazard ratio [HR]: 0.87; 95% confidence interval [CI]: 0.76 to 0.98; p = 0.028). When treatment benefit was examined as a function of time from randomization, attenuation of the ICD benefit was observed after 6 years (p value for the interaction = 0.0015). Subgroup analysis revealed long-term ICD benefit varied according to HF etiology and New York Heart Association (NYHA) functional class: ischemic HF HR: 0.81; 95% CI: 0.69 to 0.95; p = 0.009; nonischemic HF HR: 0.97; 95% CI: 0.79 to 1.20; p = 0.802; NYHA functional class II HR: 0.76; 95% CI: 0.65 to 0.90; p = 0.001; NYHA functional class III HR: 1.06; 95% CI: 0.86 to 1.31; p = 0.575.

Conclusions: Follow-up of SCD-HeFT patients to 11 years demonstrated heterogenous treatment-related patterns of long-term survival with ICD benefit most evident at 11 years for ischemic HF patients and for those with NYHA functional class II symptoms at trial enrollment. (SCD-HeFT 10 Year Follow-up [SCD-HeFT10 Yr]; NCT01058837).

Keywords: heart failure; implantable cardioverter-defibrillator; sudden cardiac death.

Publication types

  • Randomized Controlled Trial
  • Research Support, American Recovery and Reinvestment Act
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Amiodarone* / administration & dosage
  • Amiodarone* / adverse effects
  • Anti-Arrhythmia Agents / administration & dosage
  • Anti-Arrhythmia Agents / adverse effects
  • Death, Sudden, Cardiac / etiology
  • Death, Sudden, Cardiac / prevention & control
  • Defibrillators, Implantable / statistics & numerical data*
  • Electric Countershock* / adverse effects
  • Electric Countershock* / methods
  • Female
  • Heart Failure* / etiology
  • Heart Failure* / mortality
  • Heart Failure* / therapy
  • Humans
  • Long Term Adverse Effects* / diagnosis
  • Long Term Adverse Effects* / etiology
  • Long Term Adverse Effects* / mortality
  • Male
  • Middle Aged
  • Severity of Illness Index
  • Survival Analysis

Substances

  • Anti-Arrhythmia Agents
  • Amiodarone

Associated data

  • ClinicalTrials.gov/NCT01058837