TCT-933 Win Ratio Analysis of the LANDMARK Trial: Myval Transcatheter Heart Valve vs Contemporary Standard Valves (Sapien and Evolut) in Patients With Severe Aortic Stenosis

Abstract

Background
The LANDMARK trial reported the noninferiority of the Myval transcatheter heart valve (THV) compared with the contemporary standard THVs (Sapien and Evolut) regarding a 30-day composite endpoint in patients with severe aortic stenosis.

Methods
The LANDMARK was a multicenter, randomized, noninferiority trial comparing the Myval series and the contemporary THV series. From January 2021 to December 2023, 768 patients were randomized 1:1 to Myval or contemporary THV group. This substudy aimed to compare the 2 groups using a win ratio analysis. A consensual ranking order of severity of the 7 items of the primary composite endpoint was obtained among 10 cardiologists by means of the Delphi method and became all-cause death, all stroke, VARC type 3 or 4 bleeding, major vascular complication, ≥ moderate prosthetic valve regurgitation (PVR), acute kidney injury (AKI) stage 2-4, and new permanent pacemaker implantation (PPI).

Results
In the win ratio analysis with 145,161 unmatched patient pairs, five events (death, stroke, vascular complications, ≥ moderate PVR, and PPI) numerically favored the Myval group, and 2 (bleeding and AKI) the contemporary group (Figure 1). Overall, there were 34,290 wins in the Myval and 30,636 in the contemporary group, such that the win ratio was not statistically significant (34,290/30,636 = 1.12; 95% CI: 0.84-1.48; P = 0.43).

Conclusions
The win ratio of the primary composite endpoint was not statistically significant, and consistent with the primary analysis of noninferiority of the Myval series to the contemporary THV series at 30 days.