Jeanne E Poole1, Brian Olshansky2, Daniel B Mark3, Jill Anderson4, George Johnson4, Anne S Hellkamp5, Linda Davidson-Ray3, Daniel P Fishbein6, Robin E Boineau7, Kevin J Anstrom5, Per G Reinhall8, Douglas L Packer9, Kerry L Lee5, Gust H Bardy10. 1. Department of Medicine, Division of Cardiology, University of Washington, Seattle, Washington. Electronic address: jpoole@u.washington.edu. 2. Department of Medicine, Division of Cardiology, University of Iowa, Iowa City, Iowa. 3. Department of Medicine, Division of Cardiology, Duke University, Durham, North Carolina. 4. Seattle Institute for Cardiac Research, Seattle, Washington. 5. Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina. 6. Department of Medicine, Division of Cardiology, University of Washington, Seattle, Washington. 7. National Center for Complementary and Integrative Health, National institutes of Health, Bethesda, Maryland. 8. Department of Mechanical Engineering, University of Washington, Seattle, Washington. 9. Department of Cardiology, Division of Cardiac Electrophysiology, Mayo Clinic, Rochester, Minnesota. 10. Department of Medicine, Division of Cardiology, Seattle Institute for Cardiac Research, Seattle, Washington.
Abstract
BACKGROUND: The SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial) randomized 2,521 patients with moderate heart failure (HF) toamiodarone, 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).
RCT Entities:
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 HFpatients and for those with NYHA functional class II symptoms at trial enrollment. (SCD-HeFT 10 Year Follow-up [SCD-HeFT10 Yr]; NCT01058837).
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