PMID- 32703511 OWN - NLM STAT- MEDLINE DCOM- 20210125 LR - 20210125 IS - 1558-3597 (Electronic) IS - 0735-1097 (Linking) VI - 76 IP - 4 DP - 2020 Jul 28 TI - Long-Term Outcomes of Implantable Cardioverter-Defibrillator Therapy in the SCD-HeFT. PG - 405-415 LID - S0735-1097(20)35525-X [pii] LID - 10.1016/j.jacc.2020.05.061 [doi] AB - 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). CI - Copyright (c) 2020 American College of Cardiology Foundation. All rights reserved. FAU - Poole, Jeanne E AU - Poole JE AD - Department of Medicine, Division of Cardiology, University of Washington, Seattle, Washington. Electronic address: jpoole@u.washington.edu. FAU - Olshansky, Brian AU - Olshansky B AD - Department of Medicine, Division of Cardiology, University of Iowa, Iowa City, Iowa. FAU - Mark, Daniel B AU - Mark DB AD - Department of Medicine, Division of Cardiology, Duke University, Durham, North Carolina. FAU - Anderson, Jill AU - Anderson J AD - Seattle Institute for Cardiac Research, Seattle, Washington. FAU - Johnson, George AU - Johnson G AD - Seattle Institute for Cardiac Research, Seattle, Washington. FAU - Hellkamp, Anne S AU - Hellkamp AS AD - Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina. FAU - Davidson-Ray, Linda AU - Davidson-Ray L AD - Department of Medicine, Division of Cardiology, Duke University, Durham, North Carolina. FAU - Fishbein, Daniel P AU - Fishbein DP AD - Department of Medicine, Division of Cardiology, University of Washington, Seattle, Washington. FAU - Boineau, Robin E AU - Boineau RE AD - National Center for Complementary and Integrative Health, National institutes of Health, Bethesda, Maryland. FAU - Anstrom, Kevin J AU - Anstrom KJ AD - Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina. FAU - Reinhall, Per G AU - Reinhall PG AD - Department of Mechanical Engineering, University of Washington, Seattle, Washington. FAU - Packer, Douglas L AU - Packer DL AD - Department of Cardiology, Division of Cardiac Electrophysiology, Mayo Clinic, Rochester, Minnesota. FAU - Lee, Kerry L AU - Lee KL AD - Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina. FAU - Bardy, Gust H AU - Bardy GH AD - Department of Medicine, Division of Cardiology, Seattle Institute for Cardiac Research, Seattle, Washington. CN - SCD-HeFT Investigators LA - eng SI - ClinicalTrials.gov/NCT01058837 GR - U01 HL054496/HL/NHLBI NIH HHS/United States GR - U01 HL055297/HL/NHLBI NIH HHS/United States PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, American Recovery and Reinvestment Act PT - Research Support, N.I.H., Extramural PT - Research Support, Non-U.S. Gov't PL - United States TA - J Am Coll Cardiol JT - Journal of the American College of Cardiology JID - 8301365 RN - 0 (Anti-Arrhythmia Agents) RN - N3RQ532IUT (Amiodarone) SB - IM CIN - J Am Coll Cardiol. 2020 Jul 28;76(4):416-418. PMID: 32703512 MH - Aged MH - *Amiodarone/administration & dosage/adverse effects MH - Anti-Arrhythmia Agents/administration & dosage/adverse effects MH - Death, Sudden, Cardiac/etiology/prevention & control MH - Defibrillators, Implantable/*statistics & numerical data MH - *Electric Countershock/adverse effects/methods MH - Female MH - *Heart Failure/etiology/mortality/therapy MH - Humans MH - *Long Term Adverse Effects/diagnosis/etiology/mortality MH - Male MH - Middle Aged MH - Severity of Illness Index MH - Survival Analysis OTO - NOTNLM OT - heart failure OT - implantable cardioverter-defibrillator OT - sudden cardiac death EDAT- 2020/07/25 06:00 MHDA- 2021/01/26 06:00 CRDT- 2020/07/25 06:00 PHST- 2019/07/27 00:00 [received] PHST- 2020/05/24 00:00 [revised] PHST- 2020/05/28 00:00 [accepted] PHST- 2020/07/25 06:00 [entrez] PHST- 2020/07/25 06:00 [pubmed] PHST- 2021/01/26 06:00 [medline] AID - S0735-1097(20)35525-X [pii] AID - 10.1016/j.jacc.2020.05.061 [doi] PST - ppublish SO - J Am Coll Cardiol. 2020 Jul 28;76(4):405-415. doi: 10.1016/j.jacc.2020.05.061.