{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T12:02:26Z","timestamp":1792152146500,"version":"4.4.0"},"reference-count":38,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"3","license":[{"start":{"date-parts":[[2026,7,21]],"date-time":"2026-07-21T00:00:00Z","timestamp":1784592000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["Circulation"],"published-print":{"date-parts":[[2026,7,21]]},"abstract":"<jats:sec>\n                    <jats:title>BACKGROUND:<\/jats:title>\n                    <jats:p>Implantation of drug eluting stents (DESs) is currently the default approach for percutaneous coronary interventions, but long-term adverse events still exist. An approach with minimal stenting deserves to be assessed in a randomized trial. We studied a novel sirolimus-eluting balloon (SEB) that elutes sirolimus over a 90-day period using a biodegradable polymer microreservoir technology.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS:<\/jats:title>\n                    <jats:p>In a multicenter, open-label, randomized trial, we compared an SEB-based strategy with provisional DES with one of systematic DES for de novo lesions in coronary arteries between 2 and 5 mm in diameter. Subjects were randomized 1:1 before percutaneous coronary intervention. The primary end point was target vessel failure, a composite of cardiac death, target vessel\u2013related myocardial infarction, and clinically driven target vessel revascularization. It was tested for noninferiority at 1 year with the use of an absolute margin equal to 50% of the combined event rate at a significance level of 0.025. The primary analysis population included all randomized subjects with completed or attempted percutaneous revascularization, analyzed according to the intention-to-treat principle. A sensitivity analysis was performed on the per-protocol population.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS:<\/jats:title>\n                    <jats:p>\n                      Between August 27, 2021, and July 29, 2024, 3323 participants were randomized and treated in 62 sites. Among 1661 participants in the SEB strategy group, bailout stenting was performed in 343 (20.7%). Target vessel failure occurred over 365 days in 88 (5.3%) and 73 (4.4%) participants in the SEB and the systematic DES strategy groups, respectively (risk difference, 0.91% [95% CI \u20130.55% to 2.38%]; 1-sided\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      =0.02 for noninferiority with a 2.44% noninferiority margin). Clinically driven target vessel revascularization occurred more frequently in the SEB strategy group (3.3% versus 2.1%; risk difference, 1.22% [95% CI, 0.11%\u20132.33%). Safety events, including lesion thrombosis, were low and similar in both groups. Although the results of the per-protocol population (3194 participants, 96%) did not confirm noninferiority (upper boundary of the 95% CI, 2.63;\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      =0.04), they were similar to the intention-to-treat results in both magnitude and direction.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSIONS:<\/jats:title>\n                    <jats:p>At 1 year, in the primary intention-to-treat analysis population, a strategy of percutaneous coronary intervention with SEB and provisional DES was noninferior to the systematic use of DES for the primary end point of target vessel failure. The per-protocol population sensitivity analysis did not confirm noninferiority. Clinically driven target vessel revascularization occurred more frequently in the SEB strategy group. At 5 years, target vessel failure will be tested again for noninferiority and for superiority if noninferiority is achieved.<\/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:\/\/www.clinicaltrials.gov\">https:\/\/www.clinicaltrials.gov<\/jats:ext-link>\n                      ; Unique identifier: NCT04859985.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1161\/circulationaha.126.079033","type":"journal-article","created":{"date-parts":[[2026,6,15]],"date-time":"2026-06-15T09:00:52Z","timestamp":1781514052000},"page":"185-197","update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":20,"title":["Sirolimus-Eluting Balloon With Provisional Stenting Versus Systematic Drug-Eluting Stent Implantation to Treat De Novo Coronary Lesions: A Randomized, Open-Label, Noninferiority Trial"],"prefix":"10.1161","volume":"154","clinical-trial-number":[{"clinical-trial-number":"nct04859985","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1644-2079","authenticated-orcid":true,"given":"Christian","family":"Spaulding","sequence":"first","affiliation":[{"name":"Department of Cardiology, European Hospital Georges Pompidou, Assistance Publique H\u00f4pitaux de Paris, Paris-Cit\u00e9 University, INSERM Centre d\u2019investigation Clinique 1414, France (C.S., E.P.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5965-8817","authenticated-orcid":true,"given":"Florian","family":"Krackhardt","sequence":"additional","affiliation":[{"name":"Berlin Institute of Health at Charit\u00e9 Universit\u00e4tsmedizin Berlin, BIH Center for Regenerative Therapies (BCRT), Charit\u00e9 Campus Virchow-Klinikum, Germany (F.K)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0188-8665","authenticated-orcid":true,"given":"Kris","family":"Bogaerts","sequence":"additional","affiliation":[{"name":"Department of Public Health and Primary Care, I-BioStat, KU Leuven, Leuven and UHasselt, I-BioStat, Hasselt, Belgium (K.B.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eltigani","family":"Abdelaal","sequence":"additional","affiliation":[{"name":"Manchester Heart Institute, Manchester University NHS Foundation Trust, UK (E.A.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7480-2511","authenticated-orcid":true,"given":"Fernando","family":"Alfonso","sequence":"additional","affiliation":[{"name":"Cardiology Department, Hospital Universitario de La Princesa\/Universidad Autonoma de Madrid IIS-IP, CIBER-CV, Spain (F.A.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2105-8186","authenticated-orcid":true,"given":"Carlo","family":"Briguori","sequence":"additional","affiliation":[{"name":"Mediterranea Cardiocentro, Naples, Italy (C.B.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7295-5805","authenticated-orcid":true,"given":"Leonhard","family":"Bruch","sequence":"additional","affiliation":[{"name":"BG Klinikum Unfallkrankenhaus Department of Internal Medicine\/Cardiology, Berlin, Germany (L.B.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicholas","family":"Cruden","sequence":"additional","affiliation":[{"name":"Royal Infirmary of Edinburgh, UK (N.C.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-1800-5829","authenticated-orcid":true,"given":"Alexander W.","family":"Den Hartog","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Amsterdam University Medical Center, Netherlands (A.W.D.H.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-8960-7006","authenticated-orcid":true,"given":"Philippe","family":"Garot","sequence":"additional","affiliation":[{"name":"Institut Cardiovasculaire Paris Sud H\u00f4pital Jacques Cartier Ramsay-Sant\u00e9, Massy, France (P.G.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8249-9161","authenticated-orcid":true,"given":"Mathieu","family":"Godin","sequence":"additional","affiliation":[{"name":"Clinique Saint Hillaire, Rouen, France (M.G.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1147-1436","authenticated-orcid":true,"given":"David","family":"Hildick-Smith","sequence":"additional","affiliation":[{"name":"Sussex Cardiac Centre University Hospitals Sussex, Brighton, UK (D.H.-S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Johnson","sequence":"additional","affiliation":[{"name":"Bristol Heart Institute, Translational Health Sciences, University of Bristol, Bristol Royal Infirmary University, UK (T.J.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1551-0594","authenticated-orcid":true,"given":"Andrew","family":"Ladwiniec","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Sciences, University of Leicester, National Institute for Health and Care Research Leicester Biomedical Research Center, British Heart Foundation Centre of Research Excellence, Glenfield Hospital, UK (A.L.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-0173-3903","authenticated-orcid":true,"given":"Axel","family":"Linke","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine and Cardiology, Herat Center, University Clinic, University of Technology Dresden, Germany (A.L.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7508-4785","authenticated-orcid":true,"given":"Clint Anthony","family":"Maart","sequence":"additional","affiliation":[{"name":"Norfolk and Norwich University Hospital NHS Foundation Trust, Norwich Medical School, University of East Anglia, UK (C.A.M, S.E.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8119-8941","authenticated-orcid":true,"given":"Kambis","family":"Mashayekhi","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine and Cardiology, Heart Center Lahr, Germany (K.M.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8909-2180","authenticated-orcid":true,"given":"Pascal","family":"Meier","sequence":"additional","affiliation":[{"name":"Service de Cardiologie, Fribourg Hospitals HFR, Switzerland (P.M.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1929-6898","authenticated-orcid":true,"given":"Ludovic","family":"Meunier","sequence":"additional","affiliation":[{"name":"Cardiology Department, Centre Hospitalier La Rochelle, France (L.M.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenneth","family":"Morgan","sequence":"additional","affiliation":[{"name":"Northern General Hospital, Sheffield, UK (K.P.M.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5245-4547","authenticated-orcid":true,"given":"Peter","family":"O\u2019Kane","sequence":"additional","affiliation":[{"name":"Dorset Heart Centre, University Hospitals Dorset, Royal Bournemouth Hospital, UK (P.O.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0533-9682","authenticated-orcid":true,"given":"Etienne","family":"Puymirat","sequence":"additional","affiliation":[{"name":"Department of Cardiology, European Hospital Georges Pompidou, Assistance Publique H\u00f4pitaux de Paris, Paris-Cit\u00e9 University, INSERM Centre d\u2019investigation Clinique 1414, France (C.S., E.P.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1914-2282","authenticated-orcid":true,"given":"Tuomas T.","family":"Rissanen","sequence":"additional","affiliation":[{"name":"Heart Center, North Karelia Central Hospital, Siunsote, University of Eastern Finland, Kuopio (T.T.R.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2316-3705","authenticated-orcid":true,"given":"Manel","family":"Sabat\u00e9","sequence":"additional","affiliation":[{"name":"Interventional Cardiology Department, Cardiovascular Institute, Hospital Clinic de Barcelona, Institut d'Investigacions Biom\u00e8diques August Pi i Sunyer (IDIBAPS), University of Barcelona, CIBER-CV, Barcelona, Spain (M.S.)."},{"name":"University of Barcelona, CIBER-CV, Spain (M.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Schmitz","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Elisabeth Krankenhaus Essen, Germany (T.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0283-9091","authenticated-orcid":true,"given":"Gabor G.","family":"Toth","sequence":"additional","affiliation":[{"name":"Division of Cardiology, University Heart Center Graz, Medical University Graz, Germany (G.G.T.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-4831-7589","authenticated-orcid":true,"given":"Jasper","family":"Trevelyan","sequence":"additional","affiliation":[{"name":"Worcestershire Acute Hospital NHS Trust, UK (J.T.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Piotr","family":"Wanczura","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Collegium Medicum, University of Rzeszow, Poland (P.W.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4781-8064","authenticated-orcid":true,"given":"Marcus","family":"Wiemer","sequence":"additional","affiliation":[{"name":"Johannes Wesling Universit\u00e4tsklinik, Minden, Germany (M.W.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7577-4084","authenticated-orcid":true,"given":"Joanna J.","family":"Wykrzykowska","sequence":"additional","affiliation":[{"name":"Department of Cardiology, University Medical Center Groningen, Netherlands (J.W.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philip","family":"Urban","sequence":"additional","affiliation":[{"name":"Cardiovascular Department, H\u00f4pital de la Tour, Geneva, Switzerland (P.U.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6395-2389","authenticated-orcid":true,"given":"Simon","family":"Eccleshall","sequence":"additional","affiliation":[{"name":"Norfolk and Norwich University Hospital NHS Foundation Trust, Norwich Medical School, University of East Anglia, UK (C.A.M, S.E.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mathias","family":"Frick","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Clemens","family":"Steinwender","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leo\u0161","family":"Pleva","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin","family":"Poloczek","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guillaume","family":"Cayla","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicolas","family":"Delarche","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pierre","family":"Poustis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin","family":"Andrassy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ralf","family":"Birkemeyer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fabian","family":"Brunner","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frank","family":"Edelmann","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marcel","family":"Halbach","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christoph","family":"Langer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Faridun Daniel","family":"Rahimi Nedjat","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joachim","family":"Schofer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bastian","family":"Wein","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dario","family":"Bongiovanni","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maurizio","family":"d\u2019Amico","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gioel","family":"Gabrio Secco","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fabrizio","family":"Ugo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Dickinson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Madera","family":"Cambero","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maciej","family":"Lesiak","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kamil","family":"Skoczynski","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Muhammad Bin","family":"Idu Jion","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fam","family":"Jiang Ming","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Victor A.","family":"Jimenez Diaz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Diego","family":"Arroyo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonas","family":"H\u00e4ner","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juan","family":"Fernando Iglesias","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gregor","family":"Leibundgut","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Johannes","family":"Rigger","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Barbara","family":"St\u00e4hli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Freidoon","family":"Keshavarzi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nick","family":"Cruden","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nick","family":"Curzen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karim","family":"Ratib","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Neil","family":"Ruparelia","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew","family":"Peter Vanezis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stuart","family":"Watkins","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juan F.","family":"Iglesias","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Muhammad Bin","family":"Idu Jion","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maciej","family":"Lesiak","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gioel","family":"Gabrio Secco","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thierry","family":"Royer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"St\u00e9phane","family":"Carlier","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"St\u00e9phane","family":"Cook","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michal","family":"Hawranek","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean-Louis","family":"Mas","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joanna","family":"Szachniewicz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bernhard","family":"Meier","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fina","family":"Mauri","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sonia","family":"Petronio","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2019.11.058"},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2020.05.026"},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.115.019071"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2018.02.029"},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2020.08.035"},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(18)31719-7"},{"key":"e_1_3_3_8_2","doi-asserted-by":"publisher","DOI":"10.4244\/EIJ-D-19-00723"},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.4244\/EIJV9I5A98"},{"key":"e_1_3_3_10_2","doi-asserted-by":"publisher","DOI":"10.1155\/2019\/6548696"},{"key":"e_1_3_3_11_2","doi-asserted-by":"publisher","DOI":"10.4244\/EIJ-D-21-01034"},{"key":"e_1_3_3_12_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(24)01594-0"},{"key":"e_1_3_3_13_2","doi-asserted-by":"publisher","DOI":"10.4244\/EIJ-D-23-00868"},{"key":"e_1_3_3_14_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2022.01.012"},{"key":"e_1_3_3_15_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2023.09.026"},{"key":"e_1_3_3_16_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.carrev.2022.08.037"},{"key":"e_1_3_3_17_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.carrev.2025.09.001"},{"key":"e_1_3_3_18_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ahj.2023.01.007"},{"key":"e_1_3_3_19_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2020.02.043"},{"key":"e_1_3_3_20_2","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehy394"},{"key":"e_1_3_3_21_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIR.0000000000000617"},{"key":"e_1_3_3_22_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.117.029289"},{"key":"e_1_3_3_23_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.106.685313"},{"key":"e_1_3_3_24_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.110.009449"},{"key":"e_1_3_3_25_2","doi-asserted-by":"publisher","DOI":"10.1161\/01.cir.78.2.486"},{"key":"e_1_3_3_26_2","unstructured":"US Food and Drug Administration. Non-Inferiority Clinical Trials to Establish Effectiveness Guidance for Industry. Accessed December 19 2025. https:\/\/fda.gov\/media\/78504\/download"},{"key":"e_1_3_3_27_2","doi-asserted-by":"publisher","DOI":"10.1001\/jamacardio.2020.6814"},{"key":"e_1_3_3_28_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(19)31126-2"},{"key":"e_1_3_3_29_2","doi-asserted-by":"publisher","DOI":"10.3390\/jcm13102779"},{"key":"e_1_3_3_30_2","doi-asserted-by":"publisher","DOI":"10.1002\/ccd.31268"},{"key":"e_1_3_3_31_2","doi-asserted-by":"publisher","DOI":"10.15420\/ecr.2022.24"},{"key":"e_1_3_3_32_2","doi-asserted-by":"publisher","DOI":"10.1002\/ccd.30358"},{"key":"e_1_3_3_33_2","doi-asserted-by":"publisher","DOI":"10.3390\/futurepharmacol4040041"},{"key":"e_1_3_3_34_2","doi-asserted-by":"publisher","DOI":"10.1161\/JAHA.124.037214"},{"key":"e_1_3_3_35_2","doi-asserted-by":"publisher","DOI":"10.1002\/ccd.30878"},{"key":"e_1_3_3_36_2","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehaf029"},{"key":"e_1_3_3_37_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2026.03.021"},{"key":"e_1_3_3_38_2","doi-asserted-by":"publisher","DOI":"10.1001\/jamacardio.2021.5724"},{"key":"e_1_3_3_39_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacadv.2024.101021"}],"container-title":["Circulation"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.ahajournals.org\/doi\/full\/10.1161\/CIRCULATIONAHA.126.079033","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,21]],"date-time":"2026-09-21T14:11:14Z","timestamp":1789999874000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ahajournals.org\/doi\/10.1161\/CIRCULATIONAHA.126.079033"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,7,21]]},"references-count":38,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2026,7,21]]}},"alternative-id":["10.1161\/CIRCULATIONAHA.126.079033"],"URL":"https:\/\/doi.org\/10.1161\/circulationaha.126.079033","relation":{},"ISSN":["0009-7322","1524-4539"],"issn-type":[{"value":"0009-7322","type":"print"},{"value":"1524-4539","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,7,21]]},"assertion":[{"value":"2026-01-22","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-05-22","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-06-15","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}