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  • Randomised study for the Optimal Treatment of symptomatic patients with low-gradient severe Aortic valve Stenosis and preserved left ventricular ejection fraction (ROTAS trial)

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Valvular heart disease
Original research
Randomised study for the Optimal Treatment of symptomatic patients with low-gradient severe Aortic valve Stenosis and preserved left ventricular ejection fraction (ROTAS trial)
  1. Elena Galli1,
  2. Florent Le Ven2,
  3. Augustin Coisne3,
  4. Catherine Sportouch4,
  5. Thierry Le Tourneau5,
  6. Yoan Lavie-Badie6,
  7. Anne Bernard7,
  8. Jean-Christophe Eicher8,
  9. Julien Dreyfus9,
  10. Julien Ternacle10,
  11. Serge Baleynaud11,
  12. Vincent Auffret1,
  13. Estelle Le Pabic12,
  14. Philippe Pibarot13,
  15. Emmanuel Oger12,
  16. Erwan Donal1
  1. 1 Univ Rennes, CHU Rennes, Inserm, LTSI – UMR 1099, Rennes, France
  2. 2 Hôpital Cavale Blanche, CHRU Brest, Brest, France
  3. 3 University of Lille, Inserm, CHU Lille, Institut Pasteur de Lille, Lille, France
  4. 4 Clinique du Millenaire, Montpellier, France
  5. 5 Nantes Université, CHU Nantes, CNRS, INSERM, l’Institut du Thorax, Nantes, France
  6. 6 Department of Cardiology, Rangueil University Hospital, Toulouse, France
  7. 7 Service de Cardiologie, CHU Tours, Tours, France
  8. 8 Unité de Rythmologie et Insuffisance Cardiaque, Centre de Compétences des Cardiomyopathies, Service de Cardiologie, Hôpital François Mitterrand, CHU Dijon-Bourgogne, Dijon, France
  9. 9 Cardiology Department, Centre Cardiologique du Nord, Saint Denis, France
  10. 10 Bordeaux University Hospital, Bordeaux, France
  11. 11 Department of Cardiology, Centre Hospitalier Bretagne Sud, Lorient, France
  12. 12 CHU Rennes, Inserm, CIC 1414, Rennes, France
  13. 13 Institut Universitaire de Cardiologie et de Pneumologie de Québec (Québec Heart and Lung Institute), Laval University, Quebec, Quebec, Canada
  1. Correspondence to Dr Elena Galli; gallelena{at}gmail.com

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.

  • Aortic Valve Stenosis
  • Cardiac Imaging Techniques
  • Diagnostic Imaging
  • Treatment Outcome

Data availability statement

Data are available upon reasonable request.

https://doi.org/10.1136/heartjnl-2024-324224

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    Data availability statement

    Data are available upon reasonable request.

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    Footnotes

    • X @ElenaGalli10, @juliendreyfus1, @PPibarot

    • Contributors EG: conception of the study, results interpretation, writing of the paper; FLV: results interpretation, revision of the paper; AC: results interpretation, revision of the paper; CS: results interpretation, revision of the paper; TLT: results interpretation, revision of the paper; YL-B: results interpretation, revision of the paper; AB-B: results interpretation, revision of the paper; J-CE: results interpretation, revision of the paper; JD: results interpretation, revision of the paper; JT: results interpretation, revision of the paper; SB, results interpretation, revision of the paper; VA: results interpretation, revision of the paper; ELP: statistical, analysis, results interpretation and revision of the paper; PP: conception of the study, results interpretation and revision of the paper; EO: statistical analysis, results interpretation; ED: conception of the study, results interpretation, revision of the paper. EG acted as guarantor.

    • Funding This trial was supported by the PHRC-N 2017 (National grant from 'Programme Hospitalier pour la Recherche Clinique, Direction Générale de la Santé - Ministère de la Santé, France').

    • Competing interests None declared.

    • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

    • Provenance and peer review Not commissioned; externally peer-reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.