TY - JOUR
T1 - Cardiac-resynchronization therapy for the prevention of heart-failure events
AU - MADIT-CRT Trial Investigators
AU - Moss, Arthur J.
AU - Hall, W. Jackson
AU - Cannom, David S.
AU - Klein, Helmut
AU - Brown, Mary W.
AU - Daubert, James P.
AU - Estes, N. A.Mark
AU - Foster, Elyse
AU - Greenberg, Henry
AU - Higgins, Steven L.
AU - Pfeffer, Marc A.
AU - Solomon, Scott D.
AU - Wilber, David
AU - Zareba, Wojciech
AU - Desai, P.
AU - Wiggins, S.
AU - Greer, G.
AU - Beau, S.
AU - Curnis, A.
AU - Katz, A.
AU - Cook, J.
AU - McPherson, C.
AU - Rozmus, G.
AU - Switzer, D.
AU - Stone, J.
AU - Ludmer, P.
AU - Colavita, P.
AU - Tomassoni, G.
AU - Crevey, B.
AU - Nair, G.
AU - Saliba, W.
AU - Corbisiero, R.
AU - Gilliam, F.
AU - Hranitzky, P.
AU - Rashtian, M.
AU - Giudici, M.
AU - Thomsen, P.
AU - Clyne, C.
AU - Pena, E.
AU - Lessmeier, T.
AU - Schuger, C.
AU - Vogt, J.
AU - Kacet, S.
AU - Almendral, J.
AU - Quesada, A.
AU - Kautzner, J.
AU - Padeletti, L.
AU - Delnoy, P.
AU - Goldstein, R.
AU - Haigney, M.
PY - 2009/10/1
Y1 - 2009/10/1
N2 - 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.)
AB - 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.)
UR - http://www.scopus.com/inward/record.url?scp=70349625757&partnerID=8YFLogxK
U2 - 10.1056/NEJMoa0906431
DO - 10.1056/NEJMoa0906431
M3 - Article
C2 - 19723701
AN - SCOPUS:70349625757
SN - 0028-4793
VL - 361
SP - 1329
EP - 1338
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 14
ER -