User Manual Part 4

CLINICAL STUDY - COMPANION
B-29
6
4
2
1
3
0
5.9
3.8
OPT
(n = 308)
CRT-D
(n = 595)
Heart Failure Hospitalization Days
per Patient-Year of Follow-up
5
Figure B-11. Heart failure hospitalization d ays per patient year
DATA ANALYSIS AND RESULTS - CRT-D SYSTEM SAFETY
The system-related complication-free rate analysis was not a predefined
endpoint in the protocol. The intent of this analysis is to provide reasonable
assurance of safety of the CONTAK CD system in this patient population.
The system-related complication-free rate was defined over a six-month
follow-up period as the proportion of patients who are free of complications
attributed to:
• Any implanted component (e.g, pulse generator, coronary venous lead,
right atrial pace/sense lead, cardioversion/defibrillation lea d)
• The surgical procedure required to implant the CRT-D system
In the COMPANION study, this analysis was performed on an intention-to-treat
basis and also extends to those patients who underwent an implant procedure
but did not ultimately receive a device. Of the 595 patients analyzed, 522
(87.7%) were free of system-re lat ed co m plications.
Of the 73 (12.3%) patients who experienced a system-related complication,
the mos t common w ere loss of left ventricular capture (25 patients, 4.2%),
loss of right atria l capture (9 patients, 1.5%), and phrenic nerve/diaphragmatic
stimulation (8 patients, 1.3%).
When analyzed on a time-to-event basis, the system-related complication-free
rate was 87.7%. The safety performance of the CONTAK CD system compares
favorably with the safety performance observed in the prior CONTAK CD study
(P010012, May 2, 2002).
- DRAFT -