Thin, Very Thin, or Ultrathin Strut Biodegradable or Durable Polymer-Coated Drug-Eluting Stents: 3-Year Outcomes of BIO-RESORT

Rosaly A. Buiten, Eline H. Ploumen, Paolo Zocca, Carine J.M. Doggen, Peter W. Danse, Carl E. Schotborgh, Martijn Scholte, K. Gert van Houwelingen, Martin G. Stoel, Marc Hartmann, R. Melvyn Tjon Joe Gin, Samer Somi, Gerard C. M. Linssen, Marlies M. Kok, Clemens von Birgelen*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

45 Citations (Scopus)
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Abstract

Objectives: The aim of this study was to assess the 3-year safety and efficacy of treating all-comer patients with 3 contemporary drug-eluting stents (DES). Background: The BIO-RESORT (Comparison of Biodegradable Polymer and Durable Polymer Drug-Eluting Stents in an All Comers Population) (TWENTE III) randomized trial (NCT01674803) found similar 1-year safety and efficacy for the 2 biodegradable-polymer DES (i.e., ultrathin-strut cobalt-chromium Orsiro sirolimus-eluting stent [SES] and very-thin-strut platinum-chromium Synergy everolimus-eluting stent) compared with the durable-polymer thin-strut cobalt-chromium Resolute Integrity zotarolimus-eluting stent (ZES). Two-year follow-up suggested that the SES might reduce repeat revascularizations beyond 1 year compared with the ZES. Methods: A total of 3,514 all-comer patients were treated at 4 centers for coronary intervention. The main clinical endpoint, target vessel failure, was a composite of safety (cardiac death or target vessel–related myocardial infarction) and efficacy (target vessel revascularization). Secondary endpoints included the individual components of target vessel failure and stent thrombosis. Results: Three-year follow-up data were available for 3,393 of 3,514 patients (96.6%). Target vessel failure occurred in 8.5% with SES and 10.0% with ZES (p log rank = 0.22) and in 8.8% with everolimus-eluting stents (vs. ZES, p log rank = 0.32). Rates of cardiac death, target vessel myocardial infarction, and target vessel revascularization were similar between stent groups. Landmark analyses found no statistically significant between-stent difference in repeat revascularization between 1 and 3 years. Definite or probable stent thrombosis rates were low (SES, 1.1%; everolimus-eluting stent, 1.1%; ZES, 0.9%) and similar with all 3 DES. Conclusions: Despite substantial differences in stent backbone and polymer coating, all 3 DES showed favorable 3-year safety and efficacy in all comers, without significant between-stent differences. Further follow-up is required to definitely answer the question of whether one stent might improve clinical outcomes at a later stage.

Original languageEnglish
Pages (from-to)1650-1660
Number of pages11
JournalJACC : cardiovascular interventions
Volume12
Issue number17
Early online date14 Aug 2019
DOIs
Publication statusPublished - 9 Sept 2019

Keywords

  • biodegradable polymer
  • clinical trial
  • drug-eluting stent(s)
  • percutaneous coronary intervention
  • 22/4 OA procedure

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