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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.
References
1 Bristow MR, Saxon LA, Boehmer J, et al. Cardiac resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. N Engl J Med 2004:350:2140-2150.
Downloadable Resource
Download slide deck for the COMPANION Trial
COMPANION Trial Slides (PPT)
Important Risk Information
Access trial information
CRM10-1525-1109

ALTITUDE
COMPANION