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N Engl J Med. 2009 Oct 1;361(14):1329-38. doi: 10.1056/NEJMoa0906431. Epub 2009 Sep 1.

Cardiac-resynchronization therapy for the prevention of heart-failure events.

Collaborators (167)

Desai P, Wiggins S, Greer G, Beau S, Curnis A, Katz A, Cook J, McPherson C, Rozmus G, Switzer D, Stone J, Ludmer P, Colavita P, Tomassoni G, Crevey B, Nair G, Saliba W, Corbisiero R, Gilliam F, Hranitzky P, Rashtian M, Giudici M, Thomsen P, Cannom D, Clyne C, Pena E, Lessmeier T, Schuger C, Vogt J, Kacet S, Almendral J, Quesada A, Kautzner J, Padeletti L, Delnoy P, Goel S, Berger R, Pitschner H, Martin D, Kfoury A, Klein S, Levin V, Schalij M, Chow T, Chung E, Wilber D, Greenberg Y, Lemke B, Singh J, Rea R, Gold M, Guttigoli A, Adler A, Singer I, Shinn T, Guarnieri T, Casey C, Naccarelli G, Gornick C, Thibault B, Ackerman S, Turk K, Hunter N, Jentzer J, Bartlett T, Glascock D, Tamirisa K, Goldberger J, Coman J, Sandler D, Malik R, Nair L, O'Neill P, Sharma A, Brodine W, Kargul W, Higgins S, Porter M, Merkely B, Onufer J, Eldar M, Gottipaty V, Pires L, Wilson D, Arshad A, Fischer A, Mollerus M, Dixon M, Clair W, Wang P, Cox M, Viskin S, Greenspon A, Thakur R, Link M, Goette A, Klein H, Duru F, Parker J, Stambler B, Meine M, Badhwar N, Olgin J, Knight B, Attari M, Berenbom L, Shorofsky S, Pelosi F, Mounsey J, Sanders W Jr, Barrington W, Daubert J, Huang D, Saxon L, DiMarco J, Merillat J, Bajaj R, Margolis D, Ewald G, Morgan J, Finta B, Haines D, Oakes D, Pearson T, Richeson F, Pomerantz R, Goldstein R, Haigney M, Krone R, Dwyer E Jr, Kukin M, Lichstein E, Wang P, Solomon S, Foster E, Zareba W, Hall WJ, Beck C, McNitt S, Zhang H, Bausch J, Wang H, Brown M, Andrews M, Barber D, Buermann R, Cermak P, Kremer K, Moll J, Oberer A, Palmmontalbano L, Perkins E, Pyykkonen K, Ramsell D, Moss A, Brown M, Cannom D, Daubert J, Estes NA 3rd, Foster E, Greenberg H, Hall WJ, Higgins S, Klein H, Pfeffer M, Wilber D, Zareba W.

Author information

  • 1Department of Medicine, University of Rochester Medical Center, Rochester, NY 14642, USA. heartajm@heart.rochester.edu

Abstract

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.)

2009 Massachusetts Medical Society

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PMID:
19723701
[PubMed - indexed for MEDLINE]
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