Heart failure & cardiomyopathiesRandomised controlled trial
Comprehensive clinical benefit of CCM in HFrEF patients: a win-ratio analysis of FIX-HF-5C randomized trial
- win-ratio analysis of FIX-HF-5C randomized trial
- multicentre
- hierarchical win-ratio
- re-analysis
Authors' conclusion
The win-ratio re-analysis supports and extends the original study results demonstrating a consistent clinical benefit of CCM therapy over OMT across a hierarchical framework integrating event-driven clinical endpoints with patient-centred functional outcomes. The findings, while clinically highly encouraging, are hypothesis-generating and warrant validation in future confirmatory studies.
Study context
- Population
- HFrEF patientsrandomized patients (6364 patient pairs)
- Participants
- 160 patients
- Comparison
- CCM versus OMT
- Primary endpoint
- Hierarchical composite (cardiovascular mortality, heart failure hospitalization (HFH), and patient-centred outcomes: peak oxygen consumption, Minnesota Living with Heart Failure Questionnaire score, 6-minute walk distance, NYHA functional class)
Primary result
As reported in the abstract
Win ratio
2.48
95% CI 1.76–3.64
P < 0.001
CCM vs OMT
win ratio 2.48 (95% CI 1.76–3.64); P < 0.001
Further findings
Source of wins
- Event-driven clinical endpoints, share of total wins
- 22%
- Patient-centric endpoints, share of total wins
- 56.2%
- CCM consistently outperformed OMT across all hierarchies
Sensitivity analyses
- Win ratios favouring CCM (range)
- 1.52 to 2.42
NYHA class III and IV subgroups
- Treatment effects consistent across NYHA class III and IV subgroups
Original publication
Comprehensive clinical benefit of CCM in HFrEF patients: a win-ratio analysis of FIX-HF-5C randomized trial. ESC Heart Fail. Published 23 June 2026. doi:10.1093/eschf/xvag179
Summarised from the published abstract; every number is checked against it