Transcatheter or Surgical Aortic Valve Replacement in Patients with Severe Aortic Stenosis and Small Aortic Annulus: A Randomized Clinical Trial

BACKGROUND The optimal treatment in patients with severe aortic stenosis (AS) and small aortic annulus (SAA) remains to be determined. The objectives of this study were to compare the hemodynamic and clinical outcomes between transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) in patients with a SAA. METHODS Prospective multicenter international randomized trial performed in 15 university hospitals. Participants were 151 patients with severe AS and SAA (mean diameter <23 mm) were randomized (1:1) to TAVR (n=77) vs SAVR (n=74), The primary outcome was impaired valve hemodynamics (i.e. severe prosthesis patient mismatch [PPM] or moderate-severe aortic regurgitation [AR]) at 60 days as evaluated by Doppler-echocardiography and analyzed in a central echocardiography core laboratory. Clinical events were secondary outcomes. RESULTS The mean age of the participants was 75±5 years, with 93 of women, a median STS of 2.5 (1.7-3.3)%, and a mean annulus diameter of 21.1±1.2 mm. CONCLUSIONS This trial will provide clinicians with scientific evidence to determine if population with smaller aortic anatomy in the setting of severe AS maybe better suited to TAVR compared with SAVR. TRIAL REGISTRATION [Clinicaltrials.gov][1]: [NCT03383445][2] ### Competing Interest Statement Dr. Rodés-Cabau has received institutional research grants from and is consultant for Edwards Lifesciences and Medtronic. Dr. Nombela-Franco has received consulting fees from Edwards Lifesciences. Dr Conradi is a member of the Advisory Board of Medtronic, Abbott, JenaValve, and Neovase; and has received consulting fees from Edwards Lifesciences, Boston Scientific, New Valve Technology, and MicroInterventions. Dr Moris received fees as a proctor from Medtronic and Boston Scientific. Pibarot has received institutional research grants from Edwards Lifesciences, Medtronic, Pi-Cardia, and Novartis. The rest of authors do not report any significant conflict of interest with respect to the content of this article. ### Clinical Trial NCT03383445 ### Funding Statement Investigator initiated trial, with financial support from the Research Chair 'Fondation Famille Jacques Larivière' for the Development of Structural Heart Disease Interventions (Laval University, Quebec City, Canada); grant from the Foundation of the Quebec Heart & Lung Institute (Quebec City, Canada); and grant from the Research Center of the Quebec Heart & Lung Institute (Quebec City, Canada). ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Comite ethique de la recherche Institut universitaire de cardiologie et de pneumologie de Quebec-Universite Laval Ethical approval - Ethical approval was given Comissao Nacional de Etica Em Pesquisa - Plataforma Brasil - Ethical approval was given Comite de etica de investigacion con medicamentos y comision de proyectos de investigacion del hospital universitary Vall Hebron - Ethical approval was given Ottawa Health Science Network Research Ethics Board- Ethical approval was given Comite de Etica de Investigacion con medicamentos de Galicia - Ethical approval was given Comite de Etica de la investigacion con medicamentos del Principado de Asturias- Ethical approval was given Comite de Etica en Investigacion Clinica Hospital Clinico San Carlos- Ethical approval was given Comite etica de la investigacion de las Islas Baleares- Ethical approval was given Comite de Protection des Personnes Ile de France II - Ethical approval was given Ethik-Kommission Der Arztekammer Hambur- Ethical approval was given Comite de Etica de la investigaciOn con medicamentos del Principado de Asturias- Ethical approval was given ComitE de Etica en InvestigaciOn ClInica Hospital Universitario Virgen de la Victoria- Ethical approval was given I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes The data referred to in the manuscript will be available to other authors upon reasonable request and only for the purpose of patient-level meta-analyses. [1]: http://Clinicaltrials.gov [2]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT03383445&atom=%2Fmedrxiv%2Fearly%2F2023%2F10%2F12%2F2023.09.28.23296187.atom