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