User Manual Part 3

CLINICAL STUDY - COMPANION
B-9
Table B-3. CRT-D and O PT cause of de ath (continued)
Cause of Death OPT Arm
(N = 308)
CRT-D A rm
(N = 595)
Total
(N = 903)
Unknown/ Unclassi fied 8 (2.6%) 5 (0.8%) 13 (1.4%)
Total Deaths
77 (25.0%) 105 (17.6%) 182 (20.2%)
NOTE: After the stud y was stop pe d in Novemb er 2002, follo w-up for safety
continued for approximately one more year on 151 OPT and 449 CRT-D
patients with the final data cut-off on November 26, 2003. During this post-trial
follow-up period, an additional 54 deaths were reported, consisting of 14/151
(9.3%) OPT patients and 40/449 (8.9%) CRT-D patients.
The mortality rates are approximately equal during this post-trial follow-up
period. This may be because CRT devices were made available to OPT
patients. Thus, most patients w ere receiving the same therapy during this
interval.
STUDY DESIGN
The COMPANION study design and study results have been previously
described in the medical literature.
12
The COMPANION study was a prospective, randomized (1:2:2 to OPT, CRT-P
[delivered by the CONTAK TR device], or CRT-D [delivered by the CONTAK
CD device]), controlled, multi-center study. Both of these devices became
comme rcially available during the course of the study.
Randomization was stratified by centers and by b et a-b locker use to
assure proper balance between the treatment groups within each center.
Each randomized patient remained counted as a member of the original
randomization assignment (intention-to-treat) regardless of subsequent
crossover or protocol adherence.
Eligible patients were also enrolled in a sub-study designed to measure
improvement in exercise performance in p atients randomized to CRT (CRT-P
and CRT-D pooled data) therapy compared to OPT.
1. Bristow MR, Feldman AM, Saxon LA. Heart failure management using implantable devices for
ventricular resynchronization: Com parison of Med ical Therapy, Pacing, and Defibrillation in
Chronic Heart Failure (COMPANION) trial. J Card Fail. 2000;6(3):276-285.
2. 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.
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