{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,14]],"date-time":"2025-12-14T12:34:30Z","timestamp":1765715670573,"version":"3.48.0"},"reference-count":18,"publisher":"BMJ","issue":"10","license":[{"start":{"date-parts":[[2024,10,22]],"date-time":"2024-10-22T00:00:00Z","timestamp":1729555200000},"content-version":"unspecified","delay-in-days":21,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Sahajanand Medical Technologies Ltd., Surat, India","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2024,9,15]]},"published-print":{"date-parts":[[2024,10]]},"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>We evaluated the clinical safety and performance of the ultrathin strut biodegradable polymer-coated Supraflex Cruz (Sahajanand Medical TechnologiesLtd., Surat, India) sirolimus-eluting stent (SES) in an all-comer patient population requiring coronary stent implantation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Study design<\/jats:title>\n                    <jats:p>The study was a prospective, observational, multicentre, single-arm registry.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Study settings<\/jats:title>\n                    <jats:p>The study was conducted at 19 NHS Hospitals across the UK, from March 2020 to September 2021.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Study participants<\/jats:title>\n                    <jats:p>A total of 1904 patients with symptomatic coronary artery disease (age \u226518 years) who underwent percutaneous coronary intervention with at least one Supraflex Cruz SES were enrolled.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Primary and secondary outcomes measure<\/jats:title>\n                    <jats:p>The primary endpoint was target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (TV-MI) and clinically indicated target lesion revascularisation (CI-TLR), at 12 months. Safety endpoints were stent thrombosis, all-cause death and any MI. Prespecified subgroups analysis included patients with diabetes mellitus, bifurcation lesion, type B2\/C lesion defined as per ACC\/AHA (American College of Cardiology\/American Heart Association) lesion classification and long coronary lesions (&gt;20\u2009mm).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A total of 2973 Supraflex Cruz SES were implanted in 1835 patients (mean age: 65.20\u00b111.03 years). Of these, 404 patients had diabetes mellitus (491 lesions), 271 had bifurcation lesions (293 lesions), 1541 had type B2\/C lesions (1832 lesions) and 985 had long coronary lesions (&gt;20\u2009mm, 1139 lesions). Among the overall population, device success was achieved in 98.2% of lesions. TLF occurred in 12 (0.7%) patients (0.3% cardiac death, 0.2% TV-MI, 0.2% CI-TLR) at 30 days and in 43 (2.3%) patients (0.8% cardiac death, 0.8% TV-MI, 0.8% CI-TLR) at 12 months follow-up. The rate of definite stent thrombosis was 0.3% in the overall population at 12 months. The incidence of TLF and stent thrombosis was 6.2% and 1% in the diabetic, 1.8% and none in bifurcation lesion, 2.5% and 0.3% in type B2\/C lesion, and 2.7% and 0.3% in long coronary lesions (&gt;20\u2009mm) subgroups, respectively. at 12 months follow-up.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The S-FLEX UK-II registry confirms the clinical safety and performance of the ultrathin Supraflex Cruz SES in an all-comer population with complex coronary artery disease, demonstrating low rates of TLF and stent thrombosis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"isrctn\" xlink:href=\"ISRCTN39751665\">ISRCTN39751665<\/jats:ext-link>\n                      (\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/doi.org\/10.1186\/ISRCTN39751665\">https:\/\/doi.org\/10.1186\/ISRCTN39751665<\/jats:ext-link>\n                      )\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2024-084028","type":"journal-article","created":{"date-parts":[[2024,10,22]],"date-time":"2024-10-22T12:15:37Z","timestamp":1729599337000},"page":"e084028","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":1,"title":["Safety and performance of the ultrathin sirolimus-eluting coronary stent in an all-comer patient population: the S-FLEX UK-II registry"],"prefix":"10.1136","volume":"14","clinical-trial-number":[{"clinical-trial-number":"isrctn39751665","registry":"10.18810\/isrctn"}],"author":[{"given":"Vellore J","family":"Karthikeyan","sequence":"first","affiliation":[{"name":"Department of Cardiology, Wigan Hospital, Wigan, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Abdul","family":"Mozid","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Leeds General Infirmary, Leeds, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Suneil","family":"Aggarwal","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Liverpool Heart and Chest Hospital, Liverpool, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Abhishek","family":"Kumar","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Wigan Hospital, Wigan, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"Hildick-Smith","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Brighton and Sussex University Hospital, Brighton, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Richard","family":"Anderson","sequence":"additional","affiliation":[{"name":"Department of Cardiology, University Hospital of Wales, Cardiff, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Satheesh","family":"Nair","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Glan Clwyd Hospital, Rhyl, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Neil","family":"Ruparelia","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Royal Berkshire Hospital, Reading, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9651-7829","authenticated-orcid":false,"given":"Nick","family":"Curzen","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Southampton General Hospital, Southampton, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Murugu","family":"Veerasamy","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Leeds General Infirmary, Leeds, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sandra","family":"Elsheikh","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Liverpool Heart and Chest Hospital, Liverpool, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4891-8892","authenticated-orcid":false,"given":"Azfar","family":"Zaman","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Freeman Hospital and Newcastle University, Newcastle upon Tyne, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2024,10,22]]},"reference":[{"key":"2025121404323204000_14.10.e084028.1","first-page":"1324","article-title":"Ultrathin, Biodegradable-Polymer Sirolimus-Eluting 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biodegradable polymer-coated sirolimus-eluting stent implantation: SiBi optical coherence tomography study","volume":"98","author":"Abhyankar","year":"2021","journal-title":"Catheter Cardiovasc Interv"},{"key":"2025121404323204000_14.10.e084028.5","doi-asserted-by":"crossref","first-page":"706","DOI":"10.5152\/AnatolJCardiol.2021.78291","article-title":"Clinical outcomes of ultrathin biodegradable polymer-coated sirolimus-eluting stents in an all-comer population: One-year results from the T-FLEX registry including high-risk subgroups","volume":"25","author":"Pothineni","year":"2021","journal-title":"Anatol J Cardiol"},{"key":"2025121404323204000_14.10.e084028.6","first-page":"262","article-title":"Twelve months clinical outcomes of ultrathin strut sirolimus-eluting stent in real-world Indian patients with coronary artery disease","volume":"12","author":"Ajmera","year":"2022","journal-title":"Am J Cardiovasc 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EuroPCR 2022."},{"key":"2025121404323204000_14.10.e084028.18","doi-asserted-by":"crossref","first-page":"889","DOI":"10.1056\/NEJMoa2300468","article-title":"Complete or Culprit-Only PCI in Older Patients with Myocardial Infarction","volume":"389","author":"Biscaglia","year":"2023","journal-title":"N Engl J Med"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2024-084028","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,14]],"date-time":"2025-12-14T12:32:40Z","timestamp":1765715560000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2024-084028"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,10]]},"references-count":18,"journal-issue":{"issue":"10","published-online":{"date-parts":[[2024,10,22]]},"published-print":{"date-parts":[[2024,10]]}},"alternative-id":["10.1136\/bmjopen-2024-084028"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2024-084028","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"type":"print","value":"2044-6055"},{"type":"electronic","value":"2044-6055"}],"subject":[],"published":{"date-parts":[[2024,10]]}}}