User Manual Part 4

B-26
CLINICAL STUDY - COMPANION
• 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.
Those contributing to the heart failure hospitalization outcome were required
by the Morbidity and Mortality committee to meet at least one of the following
additional criteria:
•IVdiuretics
• IV inotrope/vasoactive therapy
• Other parenteral therapy for the treatment of heart failure
•Significant alterations in oral therapy for the treatment of heart failure
All-cau se Mortality or First Heart Failure Hosp italization
The Kaplan-Meier curves for all-cause mortality or first heart failure
hospitalization is shown in Figure B-8 on p age B-27. OPT and CRT-D had
annual event rates of 45% and 29%, respectively with a hazard ratio of 0.60,
95% CI (0.49-0.75), p < 0.001. Therefore, CRT-D was associated with a
40% relative reduction in t he risk of all-cause mo rta lity or firs t heart-failure
hospitalization when compared to OPT alone.
- DRAFT -