Use Instructions

60
The Bayesian Posterior Probability that ∆
3
is greater than 0 (indicating superiority of
FIX-HF-5C2 device to FIX-HF-5C control) is 1. Because this exceeds 0.975, the null
hypothesis is rejected and superiority is claimed with respect to the primary endpoint.
Frequentist Analysis
The Bayesian analysis indicates that the FIX-HF-5C2 OPTIMIZER group had a
superior increase in Peak VO2 over the FIX-HF-5C Control group with a posterior
probability which exceeds the 0.975 required for statistical significance.
A supporting, non-Bayesian analysis of Peak VO2 appears in Table 18 overall
summaries).
Eleven (11) subjects were missing evaluable Peak VO2 results at weeks 12 or 24.
Five (5) subjects were missing at both visits.
There were no deaths or missingness due to heart failure hospitalizations so there
were no imputations of zeros or lowest value in the FIX-HF-5C2 data. Previous study
results are presented for comparative purposes including differences between the
current OPTIMIZER results and results from the FIX-HF-5C study. Peak VO2 was
significantly increased at both 12 and 24 weeks in the FIX-HF-5C2 OPTIMIZER
group and the change from baseline was significantly different from the control group
in the FIX-HF-5C study. This was confirmed in the frequentist mixed model results
compared to the FIX-HF-5C study control.
In total, we observed an improvement in peak VO
2
for the device subjects in the FIX-
HF-5C2 study which was not dependent on a decrease in VO2 for the control group.