{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,16]],"date-time":"2026-02-16T09:07:44Z","timestamp":1771232864712,"version":"3.50.1"},"reference-count":27,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2023,7,26]],"date-time":"2023-07-26T00:00:00Z","timestamp":1690329600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/501100005035","name":"Biotronik","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100005035","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cathet Cardio Intervent"],"published-print":{"date-parts":[[2023,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Ultrathin strut coronary drug\u2010eluting stents (DES) have demonstrated improved safety and efficacy in large contemporary trials. The evaluation of an ultrathin strut DES in a post\u2010market United States (US) patient population was undertaken.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objective<\/jats:title><jats:p>The purpose of this post\u2010approval study is to confirm that the clinical performance of an ultrathin strut bioresorbable polymer sirolimus\u2010eluting stent (BP SES) in clinical practice is similar to that observed with BP SES in the BIOFLOW V pivotal trial.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>BIOFLOW VII is a prospective, multicenter, single\u2010arm US post\u2010market approval study to confirm the clinical performance of BP SES in a real\u2010world setting. The primary endpoint of 1\u2010year target lesion failure (TLF) was compared with a performance goal of 6.9% based on an adapted BIOFLOW V trial BP SES TLF rate and TLF rates from other US\u00a0market\u2010released DES utilizing the Society for Cardiovascular Angiography and Interventions definition for peri\u2010procedural myocardial infarction (MI). Subjects undergoing percutaneous coronary intervention with BP SES were consented within 24\u2009h post\u2010index procedure with planned follow\u2010up through 5 years.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Among 556 enrolled patients, clinical demographics included: 34.7% female, 35.6% with diabetes mellitus, and 56.8% with acute coronary syndromes. The average stent length (mean\u2009\u00b1\u2009standard deviation) was 20.2\u2009\u00b1\u200911.8\u2009mm, and the mean number of stents per patient was 1.3\u2009\u00b1\u20090.6. Procedure success was 99.1% (551\/556), and device success was 99.9% (689\/690). Among 531 subjects included in the primary endpoint analysis, the 1\u2010year rate of TLF rate was 1.7% (9\/531), and the primary endpoint was met compared with the performance goal (<jats:italic>p<\/jats:italic>\u2009&lt;\u20090.0001, 95% confidence interval: 0.69%, 3.43%). Rates of target vessel MI and clinically driven target lesion revascularization were 1.3% (7\/531) and 0.9% (5\/531), with no occurrence of cardiac death. Definite stent thrombosis was observed for two cases (0.4%; 2\/556) with one acute (\u226424\u2009h) and one late (&gt;30 days and \u22641 year) event.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>In a post\u2010approval study, 1\u2010year clinical outcomes with BP SES were consistent with prior trials supporting the safety and effectiveness of ultrathin BP SES.<\/jats:p><\/jats:sec>","DOI":"10.1002\/ccd.30783","type":"journal-article","created":{"date-parts":[[2023,7,26]],"date-time":"2023-07-26T13:19:35Z","timestamp":1690377575000},"page":"464-471","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Ultrathin bioresorbable polymer sirolimus\u2010eluting stents in US\u00a0patients undergoing coronary revascularization: 1\u2010Year outcomes from the BIOFLOW VII trial"],"prefix":"10.1002","volume":"102","author":[{"given":"David E.","family":"Kandzari","sequence":"first","affiliation":[{"name":"Piedmont Heart Institute Atlanta Georgia USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hector M.","family":"Garcia\u2010Garcia","sequence":"additional","affiliation":[{"name":"Division of Interventional Cardiology, MedStar Cardiovascular Research Network MedStar Washington Hospital Center Washington DC USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robert C.","family":"Stoler","sequence":"additional","affiliation":[{"name":"Baylor Scott and White Heart and Vascular Hospital Dallas Texas USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John","family":"Wang","sequence":"additional","affiliation":[{"name":"MedStar Union Memorial Hospital MedStar Health Research Institute Baltimore Maryland USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mark","family":"Picone","sequence":"additional","affiliation":[{"name":"Austin Heart Austin Texas USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Itsik","family":"Ben\u2010Dor","sequence":"additional","affiliation":[{"name":"Division of Interventional Cardiology, MedStar Cardiovascular Research Network MedStar Washington Hospital Center Washington DC USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3715-8082","authenticated-orcid":false,"given":"Santiago A.","family":"Garcia","sequence":"additional","affiliation":[{"name":"The Christ Hospital and Lindner Center for Research and Education Cincinnati Ohio USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2023,7,26]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(17)32249-3"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2018.09.019"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2020.02.019"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2022.07.027"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(19)31877-X"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.119.040241"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.120.052766"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.118.034456"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehab280"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2020.09.014"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.117.028885"},{"issue":"134","key":"e_1_2_10_13_1","first-page":"e123","article-title":"ACC\/AHA guideline focused update on duration of dual antiplatelet therapy in patients with coronary artery disease. 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