COMPANION Trial At a Glance

Description

The Comparison of Medical Therapy, Pacing, and Defibrillation In Heart Failure (COMPANION) trial is the largest heart failure device trial to date. It was designed to study the effect of cardiac resynchronization therapy, with or without defibrillation, on death and hospitalization in heart failure patients when compared with optimal pharmacologic therapy.

Enrollment

1520 patients were randomized in the study at 128 US centers.

Trial Design

All patients were required to be on optimal pharmacologic therapy (OPT).

A second group received OPT plus cardiac resynchronization therapy (CRT) via an implantable device (CRT-P). These devices deliver pacing stimulation on both sides of the heart to synchronize the heart's pumping action. In contrast, pacemakers deliver stimulation to only one side of the heart and only affect heart rate.

A third group received OPT plus an implantable device that synchronizes the heart and also contains a defibrillator (CRT-D), to provide therapy in the event of an uncontrollably fast and/or deadly heart rhythm.

Figure 1. COMPANION Trial Design

Randomization (1:2:2)

20% received OPT alone

40% received OPT + CRT-P

40% received OPT + CRT-D

Primary Endpoint

All-cause mortality or first hospitalization*

Secondary Endpoint

All-cause mortality

Results

CRT-P and CRT-D, in combination with OPT, reduced the risk of all-cause mortality or first hospitalizations by 19% and 20% respectively vs. OPT alone (adjusted P values 0.015 and 0.011, respectively); CRT-D, in combination with OPT, reduced the risk of all-cause mortality by 36% (adjusted P value 0.004).1 P values adjusted for sequential monitoring. Alpha allocation: CRT-P = 0.02; CRT-D = 0.03.

Co-Chairs

The COMPANION trial is co-chaired by:

Michael R. Bristow, MD, PhD, University of Colorado Health Sciences Center

Arthur M. Feldman MD, PhD, Jefferson Medical College

The brief summaries above are based on clinical information consistent with current labeling and are not based on published COMPANION trial results.

* 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.

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.