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


The COMPANION trial is the largest heart failure device trial to date. The trial shows that cardiac resynchronization therapy (CRT), used in combination with optimal pharmacologic therapy (OPT), can significantly improve both the quality and duration of life for a large group of heart failure patients.

The COMPANION trial followed more than 1500 heart failure patients from 128 US centers. The trial yielded impressive results:

A 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.1
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.2
CRT-D, in combination with OPT, reduced the risk of all-cause mortality by 36% when compared with OPT alone.3

The COMPANION trial results are published in the May 20 issue of The New England Journal of Medicine.

* Hospitalization is defined as either care provided at a hospital for any reason in which the duration is associated with a date change, or use of intravenous inotropes and/or vasoactive drugs for a duration > 4 hours (inpatient or outpatient). NOTE: Hospitalizations associated with a device implant attempt or re-attempt are excluded.

  1. Adjusted P value 0.015.
  2. Adjusted P value 0.011.
  3. Adjusted P value 0.004. P values adjusted for sequential monitoring.
    Alpha allocation: CRT-P = 0.02; CRT-D = 0.03.
COMPANION trial results

View and print The New England
Journal of Medicine article

NEW expanded indication for Guidant CRT-Ds



Update: FDA Approves COMPANION Indication » COMPANION Trial At a Glance » Slideset: Results 2004 » (PowerPoint format in a ZIP archive, 1.1 MB)

Note: This slideset is also available in PDF format on the University of Colorado Cardiovascular Institute website.

COMPANION and MADIT II: An Overview »

OTHER RESOURCES
CRT Cost-Effectiveness in COMPANION » SCD-HeFT Trial » MADIT II Trial »