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(Circulation. 2009;119:969-977.)
© 2009 American Heart Association, Inc.

Heart Failure

Cardiac Resynchronization Therapy Reduces the Risk of Hospitalizations in Patients With Advanced Heart Failure

Results From the Comparison of Medical Therapy, Pacing and Defibrillation in Heart Failure (COMPANION) Trial

Inder S. Anand, MD, FRCP, DPhil (Oxon); Peter Carson, MD; Elizabeth Galle, MPH; Rui Song, PhD; John Boehmer, MD; Jalal K. Ghali, MD; Brian Jaski, MD; JoAnn Lindenfeld, MD; Christopher O'Connor, MD; Jonathan S. Steinberg, MD; Jill Leigh, BS; Patrick Yong, MSEE; Michael R. Kosorok, PhD; Arthur M. Feldman, MD, PhD; David DeMets, PhD; Michael R. Bristow, MD, PhD

From the Division of Cardiology, Veterans Affairs Medical Center, Minneapolis, Minn (I.S.A.); Veterans Affairs Medical Center, Washington, DC (P.C.); Boston Scientific Corporation, St Paul, Minn (E.G., J.L., P.Y.); University of North Carolina, Chapel Hill (R.S., M.R.K.); Penn State/Hershey Medical Center, Hershey (J.B.); Detroit Medical Center, Detroit, Mich (J.K.G.); Sharp Memorial Hospital, San Diego, Calif (B.J.); University of Colorado, Denver (J.L., M.R.B.); Duke University, Durham, NC (C.O.); St Luke’s–Roosevelt Hospital, New York, NY (J.S.S.); Jefferson Medical College, Philadelphia, Pa (A.M.F.); and University of Wisconsin, Madison (D.D.).

Correspondence to Inder S. Anand, MD, FRCP, DPhil (Oxon), VA Medical Center, Cardiology 111-C, 1 Veterans Dr, Minneapolis, MN 55417. E-mail anand001{at}umn.edu

Received May 22, 2008; accepted November 7, 2008.

Background— In the Comparison of Medical Therapy, Pacing and Defibrillation in Heart Failure (COMPANION) trial, 1520 patients with advanced heart failure were assigned in a 1:2:2 ratio to optimal pharmacological therapy or optimal pharmacological therapy plus cardiac resynchronization therapy (CRT-P) or CRT with defibrillator (CRT-D). Use of CRT-P and CRT-D was associated with a significant reduction in combined risk of death or all-cause hospitalizations. Because mortality also was significantly reduced (optimal pharmacological therapy versus CRT-D only), an assessment of the true reduction in hospitalization rates must consider the competing risk of death and varying follow-up times.

Methods and Results— To overcome the challenges of comparing treatment groups, we used a nonparametric test of right-censored recurrent events that accounts for multiple hospital admissions, differential follow-up time between treatment groups, and death as a competing risk. An end-point committee adjudicated and classified all hospitalizations. Compared with optimal pharmacological therapy, CRT-P and CRT-D were associated with a 21% and 25% reduction in all-cause, 34% and 37% reduction in cardiac, and 44% and 41% reduction in heart failure hospital admissions per patient-year of follow-up, respectively. Similar reductions were seen in hospitalization days per patient-year. The reduction in hospitalization rate for heart failure in the CRT groups appeared within days of randomization and remained sustained. Noncardiac hospitalization rates were not different between groups.

Conclusion— Use of CRT with or without a defibrillator in advanced heart failure patients was associated with marked reductions in all-cause, cardiac, and heart failure hospitalization rates in an analysis that accounted for the competing risk of mortality and unequal follow-up time.

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CLINICAL PERSPECTIVE

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Clinical Summaries
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