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Type: Journal article
Title: Cardiac-resynchronization therapy for mild-to-moderate heart failure
Author: Tang, A.
Sanders, P.
Citation: New England Journal of Medicine, 2010; 363(25):2385-2395
Issue Date: 2010
ISSN: 1533-4406
Statement of
Anthony S.L. Tang, George A. Wells, Mario Talajic, Malcolm O. Arnold, Robert Sheldon, Stuart Connolly, Stefan H. Hohnloser, Graham Nichol, David H. Birnie, John L. Sapp, Raymond Yee, Jeffrey S. Healey, and Jean L. Rouleau
Abstract: BACKGROUND Cardiac-resynchronization therapy (CRT) benefits patients with left ventricular systolic dysfunction and a wide QRS complex. Most of these patients are candidates for an implantable cardioverter–defibrillator (ICD). We evaluated whether adding CRT to an ICD and optimal medical therapy might reduce mortality and morbidity among such patients. METHODS We 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 an ICD plus CRT. The primary outcome was death from any cause or hospitalization for heart failure. RESULTS We followed 1798 patients for a mean of 40 months. The primary outcome occurred in 297 of 894 patients (33.2%) in the ICD–CRT group and 364 of 904 patients (40.3%) in the ICD group (hazard ratio in the ICD–CRT group, 0.75; 95% confidence interval [CI], 0.64 to 0.87; P<0.001). In the ICD–CRT group, 186 patients died, as compared with 236 in the ICD group (hazard ratio, 0.75; 95% CI, 0.62 to 0.91; P=0.003), and 174 patients were hospitalized for heart failure, as compared with 236 in the ICD group (hazard ratio, 0.68; 95% CI, 0.56 to 0.83; P<0.001). However, at 30 days after device implantation, adverse events had occurred in 124 patients in the ICD-CRT group, as compared with 58 in the ICD group (P<0.001). CONCLUSIONS Among patients with NYHA class II or III heart failure, a wide QRS complex, and left ventricular systolic dysfunction, the addition of CRT to an ICD reduced rates of death and hospitalization for heart failure. This improvement was accompanied by more adverse events. (Funded by the Canadian Institutes of Health Research and Medtronic of Canada; number, NCT00251251.)
Keywords: Resynchronization-Defibrillation for Ambulatory Heart Failure Trial Investigators
Ventricular Dysfunction, Left
Cardiac Pacing, Artificial
Severity of Illness Index
Double-Blind Method
Defibrillators, Implantable
Middle Aged
Heart Failure
Intention to Treat Analysis
Kaplan-Meier Estimate
Description: For the Resynchronization–Defibrillation for Ambulatory Heart Failure Trial (RAFT) Investigators
Rights: Copyright © 2010 Massachusetts Medical Society.
DOI: 10.1056/NEJMoa1009540
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