{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,23]],"date-time":"2026-09-23T18:08:04Z","timestamp":1790186884402,"version":"4.1.0"},"reference-count":18,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"7","content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["Circ: Cardiovascular Interventions"],"published-print":{"date-parts":[[2023,7]]},"abstract":"<jats:sec>\n            <jats:title>BACKGROUND:<\/jats:title>\n            <jats:p>In the SCOPE I trial (Safety and Efficacy of the Symetis ACURATE Neo\/TF Compared to the Edwards SAPIEN 3 Bioprosthesis), transcatheter aortic valve implantation with the self-expanding ACURATE neo (NEO) did not meet noninferiority compared with the balloon-expandable SAPIEN 3 (S3) device regarding a composite end point at 30 days due to higher rates of prosthetic valve regurgitation and acute kidney injury. Data on long-term durability of NEO are scarce. Here, we report whether early differences between NEO and S3 translate into differences in clinical outcomes or bioprosthetic valve failure 3 years after transcatheter aortic valve implantation.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>METHODS:<\/jats:title>\n            <jats:p>Patients with severe aortic stenosis were randomized to transfemoral transcatheter aortic valve implantation with NEO or S3 at 20 European centers. Clinical outcomes at 3 years are compared using Cox proportional or Fine-Gray subdistribution hazard models by intention-to-treat. Bioprosthetic valve failure is reported for the valve-implant cohort.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>RESULTS:<\/jats:title>\n            <jats:p>\n              Among 739 patients, 84 of 372 patients (24.3%) had died in the NEO and 85 of 367 (25%) in the S3 group at 3 years. Comparing NEO with S3, the 3-year rates of all-cause death (hazard ratio, 0.98 [95% CI, 0.73\u20131.33]), stroke (subhazard ratio, 1.04 [95% CI, 0.56\u20131.92]), and hospitalization for congestive heart failure (subhazard ratio, 0.74 [95% CI, 0.51\u20131.07]) were similar between the groups. Aortic valve reinterventions were required in 4 NEO and 3 S3 patients (subhazard ratio, 1.32 [95% CI, 0.30\u20135.85]). New York Heart Association functional class \u2264II was observed in 84% (NEO) and 85% (S3), respectively. Mean gradients remained lower after NEO at 3 years (8 versus 12 mm Hg;\n              <jats:italic>P<\/jats:italic>\n              &lt;0.001).\n            <\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>CONCLUSIONS:<\/jats:title>\n            <jats:p>Early differences between NEO and S3 did not translate into significant differences in clinical outcomes or bioprosthetic valve failure throughout 3 years.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>REGISTRATION:<\/jats:title>\n            <jats:p>\n              URL:\n              <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\">https:\/\/clinicaltrials.gov<\/jats:ext-link>\n              , Unique identifier: NCT03011346.\n            <\/jats:p>\n          <\/jats:sec>","DOI":"10.1161\/circinterventions.123.012873","type":"journal-article","created":{"date-parts":[[2023,7,7]],"date-time":"2023-07-07T09:00:22Z","timestamp":1688720422000},"update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":37,"title":["Final 3-Year Outcomes of a Randomized Trial Comparing a Self-Expanding to a Balloon-Expandable Transcatheter Aortic Valve"],"prefix":"10.1161","volume":"16","clinical-trial-number":[{"clinical-trial-number":"nct03011346","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5035-6625","authenticated-orcid":true,"given":"Jonas","family":"Lanz","sequence":"first","affiliation":[{"name":"Department of Cardiology, Inselspital, Bern University Hospital, Switzerland (J.L., S.S., S.W., T.P.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Helge","family":"M\u00f6llmann","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine I, St-Johannes-Hospital, Dortmund, Germany (H.M.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0799-7478","authenticated-orcid":true,"given":"Won-Keun","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Kerckhoff Heart and Thorax Center, Bad Nauheim, Germany (W.-K.K.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christof","family":"Burgdorf","sequence":"additional","affiliation":[{"name":"Heart and Vascular Center, Bad Bevensen, Germany (C.B.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Axel","family":"Linke","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine and Cardiology, Heart Center Dresden, Technische Universit\u00e4t Dresden, Germany (A.L.)."},{"name":"Clinical Trials Unit Bern, University of Bern, Switzerland (S.D., A.K., D.H.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1937-063X","authenticated-orcid":true,"given":"Simon","family":"Redwood","sequence":"additional","affiliation":[{"name":"Department of Cardiology, St Thomas\u2019 Hospital, London, United Kingdom (S.R., B.P.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Hilker","sequence":"additional","affiliation":[{"name":"Department of Cardiothoracic Surgery, University Medical Center, Regensburg, Germany (M.H.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2971-8310","authenticated-orcid":true,"given":"Michael","family":"Joner","sequence":"additional","affiliation":[{"name":"German Heart Centre, Technical University of Munich, Germany (M.J.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0169-998X","authenticated-orcid":true,"given":"Holger","family":"Thiele","sequence":"additional","affiliation":[{"name":"Heart Center Leipzig at University of Leipzig, Germany (H.T.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2018-6976","authenticated-orcid":true,"given":"Lars","family":"Conzelmann","sequence":"additional","affiliation":[{"name":"Department of Cardiac Surgery, Helios Klinik, Karlsruhe, Germany (L. Conzelmann)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2237-9050","authenticated-orcid":true,"given":"Lenard","family":"Conradi","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Surgery, University Heart and Vascular Center Hamburg, Germany (L. Conradi)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sebastian","family":"Kerber","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Cardio-vascular Center Bad Neustadt, Germany (S.K.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christian","family":"Thilo","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine I, RoMed Klinikum Rosenheim, Germany (C.T.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7860-0298","authenticated-orcid":true,"given":"Stefan","family":"Toggweiler","sequence":"additional","affiliation":[{"name":"Heart Center Lucerne, Luzerner Kantonsspital, Lucerne, Switzerland (S.T.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bernard","family":"Prendergast","sequence":"additional","affiliation":[{"name":"Department of Cardiology, St Thomas\u2019 Hospital, London, United Kingdom (S.R., B.P.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Oliver","family":"Husser","sequence":"additional","affiliation":[{"name":"Department of Cardiology and Intensive Care Medicine, Augustinum Klinik Munich (O.H.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5076-0177","authenticated-orcid":true,"given":"Stefan","family":"Stortecky","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Inselspital, Bern University Hospital, Switzerland (J.L., S.S., S.W., T.P.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah","family":"Deckarm","sequence":"additional","affiliation":[{"name":"Clinical Trials Unit Bern, University of Bern, Switzerland (S.D., A.K., D.H.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3115-9156","authenticated-orcid":true,"given":"Arnaud","family":"K\u00fcnzi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8766-7945","authenticated-orcid":true,"given":"Dik","family":"Heg","sequence":"additional","affiliation":[{"name":"Clinical Trials Unit Bern, University of Bern, Switzerland (S.D., A.K., D.H.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2892-8949","authenticated-orcid":true,"given":"Thomas","family":"Walther","sequence":"additional","affiliation":[{"name":"Department of Cardiac and Vascular Surgery, University Hospital Frankfurt, Germany (T.W.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2653-6762","authenticated-orcid":true,"given":"Stephan","family":"Windecker","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Inselspital, Bern University Hospital, Switzerland (J.L., S.S., S.W., T.P.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8721-4068","authenticated-orcid":true,"given":"Thomas","family":"Pilgrim","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Inselspital, Bern University Hospital, Switzerland (J.L., S.S., S.W., T.P.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"on behalf of the SCOPE I 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Interventions"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.ahajournals.org\/doi\/full\/10.1161\/CIRCINTERVENTIONS.123.012873","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,5,13]],"date-time":"2024-05-13T02:32:22Z","timestamp":1715567542000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ahajournals.org\/doi\/10.1161\/CIRCINTERVENTIONS.123.012873"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,7]]},"references-count":18,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2023,7]]}},"alternative-id":["10.1161\/CIRCINTERVENTIONS.123.012873"],"URL":"https:\/\/doi.org\/10.1161\/circinterventions.123.012873","relation":{},"ISSN":["1941-7640","1941-7632"],"issn-type":[{"value":"1941-7640","type":"print"},{"value":"1941-7632","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,7]]},"assertion":[{"value":"2023-01-06","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication 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