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Hierarchical testing of composite endpoints: applying the win ratio to percutaneous coronary intervention versus
Milan Milojevic1, Stuart J Head, Eleni-Rosalina Andrinopoulou
1Department of Cardiothoracic Surgery, Erasmus University Medical Center, Rotterdam, the Netherlands.
Insights
The win ratio analysis shows coronary artery bypass grafting (CABG) significantly reduces mortality and myocardial infarction (MI) compared to percutaneous coronary intervention (PCI). This method offers more statistical power for future clinical trials.
Area of Science:
- Cardiovascular Medicine
- Clinical Trial Analysis
- Interventional Cardiology
Background:
- Percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) are primary revascularization strategies.
- Comparing long-term outcomes requires robust statistical methods that account for composite endpoints.
- The win ratio (Rw) offers a novel approach to prioritize and analyze clinical events.
Purpose of the Study:
- To compare long-term outcomes of PCI versus CABG using the win ratio (Rw).
- To assess the clinical impact of individual components within composite endpoints.
- To evaluate the efficiency of the win ratio method in clinical trial design.
Main Methods:
- Re-analysis of the SYNTAX trial (n=1,800) data.
- Comparison of win ratio (Rw) with conventional methods (hazard ratio [HR], relative risk).
- Analysis of composite endpoints including death, stroke, and myocardial infarction (MI).
Main Results:
- The win ratio favored CABG for the composite endpoint of death/stroke/MI (Rw=1.37 matched, Rw=1.28 unmatched).
- CABG significantly reduced death (Rw=1.39 matched, Rw=1.27 unmatched) and MI.
- Win ratio analyses revealed a larger treatment effect for CABG in specific subgroups (e.g., three-vessel disease).
Conclusions:
- CABG demonstrates a significant benefit in reducing hard clinical endpoints (mortality, MI) over PCI, as shown by win ratio analysis.
- The win ratio method allows for similar statistical power with potentially smaller sample sizes in future trials.
- This approach can lead to reduced trial costs and more efficient clinical research.
Aims:
The goal of the study was to compare long-term outcomes of percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG), accounting for the clinical impact of individual components in the composite endpoints and prioritising these using the win ratio (Rw).
Methods And Results:
The win ratio was compared with conventional methods of analyses (hazard ratio [HR] and relative risk) in the SYNTAX trial (n=1,800). For the composite of death/stroke/myocardial infarction (MI), the win ratio favoured CABG and was 1.37 (95% CI: 1.10-1.77) for matched analysis, 1.28 (95% CI: 1.11-1.53) for unmatched analysis, while the conventional HR was 1.29 (95% CI: 1.11-1.53). The largest number of winners in favour of CABG over PCI were based on MI (n=39 vs. n=19, respectively). Death was significantly reduced with CABG in matched (Rw=1.39, 95% CI: 1.04-1.86) and unmatched win ratio analyses (Rw=1.27, 95% CI: 1.01-1.42) as compared with non-significant conventional analysis (HR 1.19, 95% CI: 0.92-1.56). In subgroups, matched win ratio analyses had a larger treatment effect in favour of CABG compared with conventional analyses, especially in patients with three-vessel disease and intermediate SYNTAX scores, while unmatched win ratios had a smaller point estimate, but with narrower confidence intervals than matched analyses findings.
Conclusions:
This re-analysis of the SYNTAX trial using the win ratio shows that the most important benefit of CABG treatment is the reduction of hard clinical endpoints such as mortality and MI. Future trials using this approach can expect to maintain similar statistical power with smaller sample sizes, and thereby reduce the cost of a trial.
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