User Manual Part 3

B-1
CLINICAL STUDY - COMPANION
APPENDIX B
CLINICAL STUDY POPULATIONS
Guidant CRT-Ds, when compared to OPT alone, have been demonstrated with
reasonable assurance, to be safe and effective in significantly reducing: the
risk of a c omposite of all-c au s e mortality or first hospitalization by 20%, the
risk of all-cause mortality by 36%, and heart failure symptoms in patients who
have moderate to severe heart failure (NYHA III/IV) including left ventricular
dysfunction (EF ≤ 35%) and QRS duration ≥120 ms and remain symptomatic
despite stable, optimal heart failure drug therapy, based on the Guidant
sponsored COMPANION clinical study. (Guidant devices were the only devices
studied in the COMPANION clinical trial.)
SUMMARY
The COMPANION clinic al study w as designed to determine whether combined
all-cause mortality or first hospitalization in heart failure patients rece ivin g
optimal pharmacologic therapy (OPT) can be reduced by combining OPT and
either of the following:
• Biventricular pacing therapy alone (CRT-P)
• Biventricular pacing with defibrillation (CRT-D)
All-cause mortality or first hospitalization (time to first event) analyzed from the
time of randomization, was the primary endpoint of the study.
Guidant conducted the COMPANION study in part to demonstrate the safety
and effectiveness of Guidant CRT-D and CRT-P devices in the COMPANION
patient population. Trial objectives included establishing that OPT combined
with biventricular p acing with defibrillation (CONTAK CD) is superior to OPT
alone in improving exercise performance (Sub-study), reducing combined
all-cause m orta lity or first hospitalization (Primary endpoint), reducing cardiac
morbidity (Secondary endpoint) and reducing all-cause mortality (Secondary
endpoint).
The COMPANION trial utilized a Steering Com mitte e, Data Safety Monitoring
Board (DSMB), and Morbidity and Mortality Committee for study conduct,
safety, and event adjudication respectively.
- DRAFT -