{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,4]],"date-time":"2026-11-04T19:32:01Z","timestamp":1793820721258,"version":"4.6.1"},"reference-count":62,"publisher":"Oxford University Press (OUP)","issue":"12","license":[{"start":{"date-parts":[[2025,12,1]],"date-time":"2025-12-01T00:00:00Z","timestamp":1764547200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,12,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>To critically appraise the design of the ongoing multicentre, randomized START YOUNG trial comparing transcatheter aortic valve implantation (TAVI) with bioprosthetic surgical aortic valve replacement (SAVR) in patients aged 65-75 years with symptomatic severe aortic stenosis (AS).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Publicly available trial information (ClinicalTrials.gov: NCT06861361) was reviewed, and the design was benchmarked against the minimum expected methodological standards for generating practice-changing evidence in patients with very long life expectancy (LE) following SAVR. The appraisal domains included objectives and study endpoints; selected non-inferiority (NI) margins; adequacy of follow-up for late events; statistical analysis plans and handling of crossovers\/missing data; consistency of surgical comparators; and prespecified sub-groups.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Several major concerns were identified: (1) co-primary safety\/efficacy composites mix hard adverse events (death, stroke) with softer outcomes, with rehospitalization likely to dominate; (2) limited duration primary follow-up (30 days\/1 year), with only optional survaillance beyond 5 years, inadequate for durability and late hazards; (3) wide NI margins (7%-8%) that could accept clinically meaningful inferiority; (4) an unclear statistical analysis plan; (5) a device-specific TAVI arm versus heterogeneous SAVR comparator; and (6) up to 25% bicuspid anatomy without stratified randomization or powered analyses. Collectively, these choices markedly increase the risks of type I error, and misinterpretation in a population with likely crossing hazard curves and a long median LE comparable to that of the age-matched general population after SAVR.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>In order to generate guideline-informing evidence for extending TAVI to younger patients with severe AS, the trial should prioritise hard adverse endpoints, tighten NI margins, mandate extended follow-up, standardise the surgical comparator, and adequately power the bicuspid subgroup. Without these revisions, continuing the study under the current protocol risks yielding biased, non\u2013guideline informative results.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/ejcts\/ezaf348","type":"journal-article","created":{"date-parts":[[2025,11,6]],"date-time":"2025-11-06T13:14:19Z","timestamp":1762434859000},"source":"Crossref","is-referenced-by-count":3,"title":["Methodological Appraisal of Ongoing Trial of Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement in Younger Patients: From Incentives to Guideline-Informing Evidence"],"prefix":"10.1093","volume":"67","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0984-9011","authenticated-orcid":false,"given":"Milan","family":"Milojevic","sequence":"first","affiliation":[{"name":"Department of Cardiac Surgery and Cardiovascular Research, Dedinje Cardiovascular Institute , Belgrade,","place":["Serbia"]},{"name":"Department of Cardiac Surgery, University Hospital Zurich, University of Zurich , Zurich,","place":["Switzerland"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1768-8433","authenticated-orcid":false,"given":"Patrick O","family":"Myers","sequence":"additional","affiliation":[{"name":"Department of Cardiac Surgery, University Hospital Zurich, University of Zurich , Zurich,","place":["Switzerland"]},{"name":"La Tour Hospital, Geneva University Medical School , Geneva,","place":["Switzerland"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7911-8620","authenticated-orcid":false,"given":"Volkmar","family":"Falk","sequence":"additional","affiliation":[{"name":"Deutsches Herzzentrum der Charit\u00e9, Charit\u00e9 University Medicine Berlin ,","place":["Germany"]},{"name":"DZHK (German Center for Cardiovascular Research) partner site , Berlin,","place":["Germany"]},{"name":"Swiss Federal Institute of Technology, Department of Health Science and Technology , Zurich,","place":["Switzerland"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph E","family":"Bavaria","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Surgery, Jefferson Health , Philadelphia, PA,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1046-1364","authenticated-orcid":false,"given":"Michael A","family":"Borger","sequence":"additional","affiliation":[{"name":"University Department of Cardiac Surgery, Leipzig Heart Center, University of Leipzig , Leipzig,","place":["Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Filip P A","family":"Casselman","sequence":"additional","affiliation":[{"name":"Heart Center AZORG, Cluster Cardiovascular Surgery , Aalst,","place":["Belgium"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7916-3544","authenticated-orcid":false,"given":"Vinay","family":"Badhwar","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular and Thoracic Surgery, West Virginia University , Morgantown, WV,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sanjay","family":"Kaul","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Cedars-Sinai Medical Centre , Los Angeles, CA,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3305-9343","authenticated-orcid":false,"given":"Matthias","family":"Siepe","sequence":"additional","affiliation":[{"name":"Department of Cardiac Surgery, University Hospital Bern, University of Bern , Bern,","place":["Switzerland"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J 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