Randomized study for the optimal treatment of symptomatic patients with low gradient severe aortic valve stenosis and preserved left ventricular ejection fraction (ROTAS trial)

Abstract

Background: the best management of symptomatic patients with low gradient (LG) severe aortic stenosis (AS) and preserved left ventricular ejection fraction (LVEF) has not been established in randomized controlled trials. The ROTAS trial aimed to assess the superiority of aortic valve replacement (AVR) versus optimized medical therapy (OMT) in symptomatic patients with LG severe AS and preserved LVEF. Fifty-two patients (age 79 ± 7 years; males 46%, mean aortic gradient: 31 ± 5 mmHg; aortic surface: 0.8 ± 0.1 cm2) who were randomized 1:1 to AVR or OMT. The follow-up lasted 14 ± 7 months. The study was interrupted early because of the low inclusion rate during the COVID-2019 pandemic. The AS severity was confirmed by a multimodality approach including dobutamine stress echocardiography and/or aortic calcium score. The primary end-point (overall death and/or hospitalisation for heart failure) occurred in 13 (25%) patients. Patients undergoing AVR showed a similar recurrence of events (overall death, heart failure hospitalisation) compared to patients receiving OMT (5 vs. 8 events). Patients receiving OMT did not experience worse survival compared to patients receiving AVR (HR 1.57, 95% CI: 0.51–4.83, P = 0.4275). Kaplan-Meier curves showed similar event-free survival (logrank P = 0.4236) among the 2 groups (Fig. 1). In the randomized ROTAS trial, AVR is not associated with a better prognosis in symptomatic patients with LG severe AS and preserved LVEF. .