COMPANION

Comparison of Medical Therapy, Pacing and Defibrillation in Heart Failure (COMPANION)

Status: Completed in 2002

COMPANION is the first trial to show that Cardiac Resynchronization Therapy, used in combination with Optimal Pharmacologic Therapy, can significantly improve both the quality and duration of life for a large group of heart failure patients.


Results

  • A Boston Scientific pacemaker with CRT capabilities (CRT-P), in combination with OPT, reduced the risk of all-cause mortality or first hospitalization by 19% when compared with OPT alone. (p value: 0.015)
  • A defibrillator with CRT capabilities (CRT-D), in combination with OPT, reduced the risk of all-cause mortality or first hospitalization by 20% when compared with OPT alone. (p value: 0.011)
  • CRT-D, in combination with OPT, reduced the risk of all-cause mortality by 36% when compared with OPT alone. (p value: 0.004)  

Design

Randomization (1:2:2)
20% received OPT alone
40% received OPT + CRT-P
40% received OPT + CRT-D

Patient Population

1520 Heart Failure patients

  • NYHA Class III/IV
  • EF ≤ 35%
  • QRS ≥ 120ms
  • PR interval ≥ 150 ms

128 U.S. centers

Clinical Relevance

  • The primary endpoint Combination of all-cause mortality or first hospitalization as measured by time to first event.
  • Proved for the first time that CRT-D therapy, used in combination with OPT, can significantly improve both the quality and duration of life for patients with late-stage symptomatic heart failure versus using OPT alone.
  • As a result of COMPANION, the benefits of CRT-D therapy are available to heart failure patients who otherwise do not have an ICD indication.

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