1. Randomised study for the Optimal Treatment of symptomatic patients with low-gradient severe Aortic valve Stenosis and preserved left ventricular ejection fraction (ROTAS trial).
- Author
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Galli E, Le Ven F, Coisne A, Sportouch C, Le Tourneau T, Lavie-Badie Y, Bernard A, Eicher JC, Dreyfus J, Ternacle J, Baleynaud S, Auffret V, Le Pabic E, Pibarot P, Oger E, and Donal E
- Subjects
- Humans, Female, Male, Aged, Treatment Outcome, Aged, 80 and over, Aortic Valve diagnostic imaging, Aortic Valve surgery, Aortic Valve physiopathology, Aortic Valve Stenosis physiopathology, Aortic Valve Stenosis surgery, Aortic Valve Stenosis diagnostic imaging, Stroke Volume physiology, Severity of Illness Index, Ventricular Function, Left physiology, Echocardiography, Stress, Heart Valve Prosthesis Implantation methods
- 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. The Randomised study for the Optimal Treatment of symptomatic patients with low-gradient severe Aortic valve Stenosis (ROTAS) trial aimed to assess the superiority of aortic valve replacement (AVR) versus medical treatment (MT) in this specific group of AS patients., Methods: Patients with symptomatic LG severe AS and preserved LVEF (>50%) underwent dobutamine stress echocardiography and/or CT-aortic calcium score to confirm AS severity and were then randomised 1:1 to AVR or MT. The primary endpoint was a composite of overall death and/or cardiovascular hospitalisation., Results: The ROTAS study was stopped early because of insufficient recruitment. In the end, only 52 patients (age 79±7 years; women 54%; NYHA III-IV 27%; median STS score 3.3%) were included in the study. During follow-up (mean: 14±7 months), the primary endpoint occurred in 12 (23%) patients. Compared with MT, AVR was not associated with a significant prognostic benefit (events: 5/26 (19%) vs 7/26 (27%) (HR 0.76, 95% CI 0.24 to 2.39, p=0.63). During follow-up, 11 (42%) patients in the MT group developed class I criteria for AVR or severe symptoms justifying a cross-over to the AVR group., Conclusions: Because of the small number of included patients and short follow-up the ROTAS trial was underpowered and unable to demonstrate a difference in the study endpoint between treatment arms. In patients in the MT arm, a regular echocardiographic and clinical assessment might be useful to disclose those developing class I indications of AVR or severe AS-related symptoms., Trial Registration Number: NCT01835028., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)
- Published
- 2024
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