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Original Article
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Volume 350:2140-2150 May 20, 2004 Number 21
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Cardiac-Resynchronization Therapy with or without an Implantable Defibrillator in Advanced Chronic Heart Failure
Michael R. Bristow, M.D., Leslie A. Saxon, M.D., John Boehmer, M.D., Steven Krueger, M.D., David A. Kass, M.D., Teresa De Marco, M.D., Peter Carson, M.D., Lorenzo DiCarlo, M.D., David DeMets, Ph.D., Bill G. White, Ph.D., Dale W. DeVries, B.A., Arthur M. Feldman, M.D., Ph.D., for the Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) Investigators

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ABSTRACT

Background We tested the hypothesis that prophylactic cardiac-resynchronization therapy in the form of biventricular stimulation with a pacemaker with or without a defibrillator would reduce the risk of death and hospitalization among patients with advanced chronic heart failure and intraventricular conduction delays.

Methods A total of 1520 patients who had advanced heart failure (New York Heart Association class III or IV) due to ischemic or nonischemic cardiomyopathies and a QRS interval of at least 120 msec were randomly assigned in a 1:2:2 ratio to receive optimal pharmacologic therapy (diuretics, angiotensin-converting–enzyme inhibitors, beta-blockers, and spironolactone) alone or in combination with cardiac-resynchronization therapy with either a pacemaker or a pacemaker–defibrillator. The primary composite end point was the time to death from or hospitalization for any cause.

Results As compared with optimal pharmacologic therapy alone, cardiac-resynchronization therapy with a pacemaker decreased the risk of the primary end point (hazard ratio, 0.81; P=0.014), as did cardiac-resynchronization therapy with a pacemaker–defibrillator (hazard ratio, 0.80; P=0.01). The risk of the combined end point of death from or hospitalization for heart failure was reduced by 34 percent in the pacemaker group (P<0.002) and by 40 percent in the pacemaker–defibrillator group (P<0.001 for the comparison with the pharmacologic-therapy group). A pacemaker reduced the risk of the secondary end point of death from any cause by 24 percent (P=0.059), and a pacemaker–defibrillator reduced the risk by 36 percent (P=0.003).

Conclusions In patients with advanced heart failure and a prolonged QRS interval, cardiac-resynchronization therapy decreases the combined risk of death from any cause or first hospitalization and, when combined with an implantable defibrillator, significantly reduces mortality.


Source Information

From the University of Colorado Health Sciences Center, Denver (M.R.B.); the University of Southern California, Los Angeles (L.A.S.); Milton S. Hershey Medical Center, Hershey, Pa. (J.B.); Bryan Memorial Hospital, Lincoln, Nebr. (S.K.); Johns Hopkins Hospital, Baltimore (D.A.K.); Moffit Hospital, University of California, San Francisco, San Francisco (T.D.M.); Washington, D.C., Veterans Affairs Medical Center, Washington, D.C. (P.C.); Pfizer Global Research and Development, Ann Arbor, Mich. (L.D.); University of Wisconsin–Madison Medical School, Madison (D. DeMets); Clinical Cardiovascular Research, Gaithersburg, Md. (B.G.W.); Guidant Corporation, St. Paul, Minn. (D. DeVries); and Jefferson Medical College, Philadelphia (A.M.F.).

Address reprint requests to Dr. Bristow at the Division of Cardiology, University of Colorado Health Sciences Center, 4200 E. Ninth Ave., Denver, CO 80262, or at michael.bristow{at}uchsc.edu.

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