Win-ratio analysis of the 1-year composite endpoint showed no significant difference between the Myval THV and contemporary THVs (win ratio 1.02; 95% CI 0.68-1.51; p=0.94).
RCT (n=768)
Sí
Does the Myval transcatheter heart valve improve outcomes compared to contemporary THVs in patients with severe native aortic valve stenosis?
Win-ratio analysis of the LANDMARK trial showed no significant difference between the Myval transcatheter heart valve and contemporary valves for a 1-year hierarchical composite endpoint.
Estimación del efecto: Win ratio 1.02 (95% CI 0.68-1.51)
Tasa de eventos absoluta: 12.1% vs 11.9%
valor p: p=0.94
Abstract Background Conventional time-to-first event analyses for composite endpoints consider only the first event, whereas win-ratio analyses account for event severity and recurrence. Methods We performed a win-ratio analysis of the 1-year composite endpoint in the LANDMARK trial, a multicentre, non-inferiority study that randomized patients with severe native aortic valve stenosis to receive either the Myval transcatheter heart valve (THV) series (n=384) or contemporary THVs (n=384), consisting of the Sapien and Evolut series (n=192 each). The 1-year composite endpoint included the following components, ranked in hierarchical order: all-cause death, disabling stroke, non-disabling stroke, and procedure- or valve-related hospitalization. For death and stroke events, wins or losses were determined according to the time-to-first-event principle. For procedure- or valve-related hospitalizations, the total number of events was compared. Win-ratio analysis was also conducted for an extended composite endpoint that also included quality-of-life outcomes. Results Among 147,456 (384x384) unmatched patient pairs, the win ratio for the primary composite endpoint was 1.02 (95% CI: 0.68–1.51; p=0.94), with 17,870 (12.1%) wins for the Myval group and 17,599 (11.9%) for the contemporary group. For the extended composite endpoint, the win ratio was 1.13 (95% CI: 0.82–1.55; p=0.45), with 27,007 (18.3%) wins for the Myval group and 23,920 (16.2%) for the contemporary group. Comparisons between the Myval and Sapien groups, and between the Myval and Evolut groups, were also not statistically significant. Conclusions Win-ratio analysis did not demonstrate a significant difference between Myval and contemporary THVs, consistent with the primary time-to-first event analysis of the LANDMARK trial.
This substudy of the LANDMARK trial applies a different statistical method (win ratio analysis) to evaluate the composite endpoint in a comparison of transcatheter heart valves. This methodological approach is gaining attention in clinical trial interpretation.
Tobe et al. (Mon,) conducted a rct in severe native aortic valve stenosis (n=768). Myval transcatheter heart valve (THV) series vs. contemporary THVs (Sapien and Evolut series) was evaluated on 1-year composite endpoint (all-cause death, disabling stroke, non-disabling stroke, and procedure- or valve-related hospitalization) analyzed by win-ratio (Win ratio 1.02, 95% CI 0.68-1.51, p=0.94). Win-ratio analysis of the 1-year composite endpoint showed no significant difference between the Myval THV and contemporary THVs (win ratio 1.02; 95% CI 0.68-1.51; p=0.94).