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Background This trial was designed to determine whether cardiac-resynchronization therapy (CRT) with biventricular pacing would reduce the risk of death or heart-failure events in patients with mild cardiac symptoms, a reduced ejection fraction, and a wide QRS complex.
Methods During a 4.5-year period, we enrolled and followed 1820 patients with ischemic or nonischemic cardiomyopathy, an ejection fraction of 30% or less, a QRS duration of 130 msec or more, and New York Heart Association class I or II symptoms. Patients were randomly assigned in a 3:2 ratio to receive CRT plus an implantable cardioverter–defibrillator (ICD) (1089 patients) or an ICD alone (731 patients). The primary end point was death from any cause or a nonfatal heart-failure event (whichever came first). Heart-failure events were diagnosed by physicians who were aware of the treatment assignments, but they were adjudicated by a committee that was unaware of assignments.
Results During an average follow-up of 2.4 years, the primary end point occurred in 187 of 1089 patients in the CRT–ICD group (17.2%) and 185 of 731 patients in the ICD-only group (25.3%) (hazard ratio in the CRT–ICD group, 0.66; 95% confidence interval [CI], 0.52 to 0.84; P=0.001). The benefit did not differ significantly between patients with ischemic cardiomyopathy and those with nonischemic cardiomyopathy. The superiority of CRT was driven by a 41% reduction in the risk of heart-failure events, a finding that was evident primarily in a prespecified subgroup of patients with a QRS duration of 150 msec or more. CRT was associated with a significant reduction in left ventricular volumes and improvement in the ejection fraction. There was no significant difference between the two groups in the overall risk of death, with a 3% annual mortality rate in each treatment group. Serious adverse events were infrequent in the two groups.
Conclusions CRT combined with ICD decreased the risk of heart-failure events in relatively asymptomatic patients with a low ejection fraction and wide QRS complex. (ClinicalTrials.gov number, NCT00180271
[ClinicalTrials.gov]
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Source Information
From the Departments of Medicine (A.J.M., H.K., M.W.B., W.Z.) and Biostatistics and Computational Biology (W.J.H.), University of Rochester Medical Center, Rochester, NY; Division of Cardiology, Hospital of the Good Samaritan, Los Angeles (D.S.C.); the Department of Medicine, Duke University Medical Center, Durham, NC (J.P.D.); New England Cardiac Arrhythmia Center, Tufts–New England Medical Center, Boston (N.A.M.E.); Cardiology Unit, University of California at San Francisco, San Francisco (E.F.); Cardiology Unit, St. Luke's–Roosevelt Hospital, New York (H.G.); the Department of Cardiology, Scripps Memorial Hospital, La Jolla, CA (S.L.H.); Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (M.A.P., S.D.S.); and the Cardiovascular Institute, Loyola University Medical Center, Chicago (D.W.).
This article (10.1056/NEJMoa0906431) was published on September 1, 2009, at NEJM.org.
Address reprint requests to Dr. Moss at the Heart Research Follow-up Program, Box 653, University of Rochester Medical Center, Rochester, NY 14642, or at heartajm{at}heart.rochester.edu.
Related Letters:
Cardiac-Resynchronization Therapy
Mariani J. A., McDonald M. A., Newton G. E., Carrigan T. P., Sipahi I., Woollett I., Wilson J. R., Owen A., Moss A. J., Hall W. J.
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N Engl J Med 2010;
362:177-179, Jan 14, 2010.
Correspondence
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