Naslov (eng)

Hierarchical testing of composite endpoints

Autor

Milojević, Milan
Head, Stuart J.
Andrinopoulou, Eleni-Rosalina
Serruys, Patrick W.
Mohr, Friedrich W.
Tijssen, Jan G.
Kappetein, A. Pieter

Opis (eng)

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. ClinicalTrials.gov Identifier: NCT00114972

Jezik

engleski

Datum

2017

Licenca

© All rights reserved

Predmet

Key words: clinical trials, composite endpoints, death multivessel disease, myocardial infarction win ratio, coronary interventions, stable CAD, bypass surgery

Deo kolekcije (1)

o:2793

Radovi saradnika Instituta za kardiovaskularne bolesti "Dedinje"