Early vascular healing with rapid breakdown biodegradable polymer sirolimus-eluting versus durable polymer everolimus-eluting stents assessed by optical coherence tomography.

Tada, Tomohisa; Byrne, Robert A; Schuster, Tibor; Cuni, Rezarta; Kitabata, Hironori; Tiroch, Klaus; Dirninger, Alfred; Gratze, Franz; Kaspar, Klaus; Zenker, Gerald; Joner, Michael; Schömig, Albert; Kastrati, Adnan

doi:10.1016/j.carrev.2012.12.003

journal article

Titel:: Early vascular healing with rapid breakdown biodegradable polymer sirolimus-eluting versus durable polymer everolimus-eluting stents assessed by optical coherence tomography.
Dokumenttyp:: Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
Autor(en):: Tada, Tomohisa; Byrne, Robert A; Schuster, Tibor; Cuni, Rezarta; Kitabata, Hironori; Tiroch, Klaus; Dirninger, Alfred; Gratze, Franz; Kaspar, Klaus; Zenker, Gerald; Joner, Michael; Schömig, Albert; Kastrati, Adnan
Abstract:: Differences in early arterial healing patterns after stent implantation between biodegradable and durable polymer based new generation drug-eluting stents are not well understood. The aim of this study was to compare the healing patterns of a novel rapid breakdown (<=8 weeks) biodegradable polymer sirolimus-eluting stent (BP-SES) with a durable polymer everolimus-eluting stent (EES) using intravascular optical coherence tomography (OCT) at 4 months.A total of 20 patients were randomly assigned to stenting with BP-SES (n=11) or EES (n=9). Overall intravascular imaging was available for 15 (75%) patients. The primary endpoint was the difference in rate of uncovered struts between BP-SES and EES. To account for strut-level clustering, the results in both treatment groups were compared using a generalized linear mixed model approach.Regarding the primary endpoint, BP-SES as compared to EES showed similar rates of uncovered struts (37 [6.8%] versus 167 [17.5%], odds ratio (OR) 0.45 (95% CI 0.09-2.24), p=0.33). There were no malapposed struts in BP-SES group and 14 malapposed struts in EES group (p=0.97). No difference in percent neointimal volume (14.1±8.2% vs. 11.4±6.4%, p=0.56) was observed.Although rapid-breakdown BP-SES as compared to EES showed signs of improved early tissue coverage, after adjustment for strut-level clustering these differences were not statistically significant. No differences in ability to suppress neointimal hyperplasia after stent implantation between 2 stents were observed.
Zeitschriftentitel:: Cardiovasc Revasc Med
Jahr:: 2013
Band / Volume:: 14
Heft / Issue:: 2
Seitenangaben Beitrag:: 84-9
Sprache:: eng
Volltext / DOI:: doi:10.1016/j.carrev.2012.12.003
PubMed:: http://view.ncbi.nlm.nih.gov/pubmed/23352095
Print-ISSN:: 1553-8389
TUM Einrichtung:: Institut für Medizinische Statistik und Epidemiologie; Klinik für Herz- und Kreislauferkrankungen im Erwachsenenalter (Prof. Schunkert)
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