{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,28]],"date-time":"2026-03-28T05:12:25Z","timestamp":1774674745938,"version":"3.50.1"},"reference-count":28,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2014,12,11]],"date-time":"2014-12-11T00:00:00Z","timestamp":1418256000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Fundamemntal Clinical Pharma"],"published-print":{"date-parts":[[2015,2]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>This prospective, first\u2010in\u2010man, open\u2010label multicenter study sought to assess the pharmacokinetics of sirolimus after <jats:styled-content style=\"fixed-case\">U<\/jats:styled-content>ltimaster drug\u2010eluting stent implantation (coated with sirolimus and bioabsorbable co\u2010polymer) in patients with de novo coronary artery disease (the <jats:styled-content style=\"fixed-case\">TCD<\/jats:styled-content>\u201010023 <jats:styled-content style=\"fixed-case\">PK<\/jats:styled-content> study). The primary endpoint was sirolimus concentration in peripheral whole blood at 28\u00a0days after stent implantation. In addition, safety, tolerability, therapeutic outcome and vasomotor response after stent implantation were studied. Twenty patients were enrolled in the study. Blood samples for the measurements of sirolimus concentration were collected at eight time points during first 48\u00a0h, at 7\u00a0days and 28\u00a0days after stent implantation. Patients underwent 6\u2010month angiographic and up to 12\u00a0months clinical follow\u2010up. At 28\u00a0days, only two of 20 patients had sirolimus concentrations above lower limit of quantification (20.0\u00a0pg\/mL). The highest sirolimus blood concentration was 105\u00a0pg\/mL. The median maximum concentration was 36.8\u00a0pg\/mL (range 22.9\u201341.5\u00a0pg\/mL) for stent 3.0\u00a0\u00d7\u00a015\u00a0mm and 87.2\u00a0pg\/mL (range 60.0\u2013105.0\u00a0pg\/mL) for 3\u00a0\u00d7\u00a028\u00a0mm stent. The median systemic exposure, as measured by the area under the time\u2013concentration curve, was 8.3\u00a0ng\u00a0h\/mL (range 6.47\u201328.0\u00a0ng\u00a0h\/mL). At 6\u00a0months, endothelial function was well preserved, and up to 12\u00a0months, there were no signs of sirolimus toxicity nor any other safety concerns. Our results demonstrate that implantation of <jats:styled-content style=\"fixed-case\">U<\/jats:styled-content>ltimaster stent resulted in almost nondetectable sirolimus in blood after 28\u00a0days. These findings were translated into exceptional safety profile, without any sign of systemic toxicity.<\/jats:p>","DOI":"10.1111\/fcp.12092","type":"journal-article","created":{"date-parts":[[2014,9,16]],"date-time":"2014-09-16T06:24:21Z","timestamp":1410848661000},"page":"95-105","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Reduced sirolimus systemic exposure and improved bioresorbable polymer properties: new allies for the treatment of patients with coronary artery disease"],"prefix":"10.1111","volume":"29","author":[{"given":"Sinisa","family":"Stojkovic","sequence":"first","affiliation":[{"name":"Clinic for Cardiology Clinical Center of Serbia Faculty of Medicine University of Belgrade 8 Dr Subotica Belgrade Serbia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aleksandar N.","family":"Neskovic","sequence":"additional","affiliation":[{"name":"Department of Cardiology Clinical Hospital Center 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