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Randomized Controlled Trial Multicenter Study Comparative Study
Long-Term Outcomes of Resynchronization-Defibrillation for Heart Failure.
- John L Sapp, Soori Sivakumaran, Calum J Redpath, Habib Khan, Ratika Parkash, Derek V Exner, Jeff S Healey, Bernard Thibault, Laurence D Sterns, Nhat Hung N Lam, Jaimie Manlucu, Ahmed Mokhtar, Glen Sumner, Stuart McKinlay, Shane Kimber, Blandine Mondesert, Mario Talajic, Jean Rouleau, C Elizabeth McCarron, George Wells, TangAnthony S LASLFrom QEII Health Sciences Centre, Dalhousie University, Halifax, NS (J.L.S., R.P.), the Mazankowski Alberta Heart Institute, University of Alberta, Edmonton (S.S., S.K.), the University of Ottawa Heart Institute, Ottawa (C.J.R., N.H.N.L., and RAFT Long-Term Study Team.
- From QEII Health Sciences Centre, Dalhousie University, Halifax, NS (J.L.S., R.P.), the Mazankowski Alberta Heart Institute, University of Alberta, Edmonton (S.S., S.K.), the University of Ottawa Heart Institute, Ottawa (C.J.R., N.H.N.L., G.W.), Schulich School of Medicine and Dentistry, Western University, London, ON (H.K., J.M., C.E.M., A.S.L.T.), Libin Cardiovascular Institute, Calgary, AB (D.V.E., G.S.), McMaster University, Hamilton, ON (J.S.H.), Montreal Heart Institute, Montreal (B.T., B.M., M.T., J.R.), Royal Jubilee Hospital, Victoria, BC (L.D.S.), and the University of Toronto, Toronto (S.M.) - all in Canada; and King Abdulaziz University, Jeddah, Saudi Arabia (A.M.).
- N. Engl. J. Med. 2024 Jan 18; 390 (3): 212220212-220.
BackgroundThe Resynchronization-Defibrillation for Ambulatory Heart Failure Trial (RAFT) showed a greater benefit with respect to mortality at 5 years among patients who received cardiac-resynchronization therapy (CRT) than among those who received implantable cardioverter-defibrillators (ICDs). However, the effect of CRT on long-term survival is not known.MethodsWe randomly assigned patients with New York Heart Association (NYHA) class II or III heart failure, a left ventricular ejection fraction of 30% or less, and an intrinsic QRS duration of 120 msec or more (or a paced QRS duration of 200 msec or more) to receive either an ICD alone or a CRT defibrillator (CRT-D). We assessed long-term outcomes among patients at the eight highest-enrolling participating sites. The primary outcome was death from any cause; the secondary outcome was a composite of death from any cause, heart transplantation, or implantation of a ventricular assist device.ResultsThe trial enrolled 1798 patients, of whom 1050 were included in the long-term survival trial; the median duration of follow-up for the 1050 patients was 7.7 years (interquartile range, 3.9 to 12.8), and the median duration of follow-up for those who survived was 13.9 years (interquartile range, 12.8 to 15.7). Death occurred in 405 of 530 patients (76.4%) assigned to the ICD group and in 370 of 520 patients (71.2%) assigned to the CRT-D group. The time until death appeared to be longer for those assigned to receive a CRT-D than for those assigned to receive an ICD (acceleration factor, 0.80; 95% confidence interval, 0.69 to 0.92; P = 0.002). A secondary-outcome event occurred in 412 patients (77.7%) in the ICD group and in 392 (75.4%) in the CRT-D group.ConclusionsAmong patients with a reduced ejection fraction, a widened QRS complex, and NYHA class II or III heart failure, the survival benefit associated with receipt of a CRT-D as compared with ICD appeared to be sustained during a median of nearly 14 years of follow-up. (RAFT ClinicalTrials.gov number, NCT00251251.).Copyright © 2024 Massachusetts Medical Society.
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