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

Research output: Contribution to journalArticleAcademicpeer-review

4 Citations (Scopus)

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 Sep 2019

Keywords

  • biodegradable polymer
  • clinical trial
  • drug-eluting stent(s)
  • percutaneous coronary intervention

Cite this

Buiten, Rosaly A. ; Ploumen, Eline H. ; Zocca, Paolo ; Doggen, Carine J.M. ; Danse, Peter W. ; Schotborgh, Carl E. ; Scholte, Martijn ; van Houwelingen, K. Gert ; Stoel, Martin G. ; Hartmann, Marc ; Gin, R. Melvyn Tjon Joe ; Somi, Samer ; Linssen, Gerard C. M. ; Kok, Marlies M. ; von Birgelen, Clemens. / Thin, Very Thin, or Ultrathin Strut Biodegradable or Durable Polymer-Coated Drug-Eluting Stents : 3-Year Outcomes of BIO-RESORT. In: JACC : cardiovascular interventions. 2019 ; Vol. 12, No. 17. pp. 1650-1660.
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title = "Thin, Very Thin, or Ultrathin Strut Biodegradable or Durable Polymer-Coated Drug-Eluting Stents: 3-Year Outcomes of BIO-RESORT",
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.",
keywords = "biodegradable polymer, clinical trial, drug-eluting stent(s), percutaneous coronary intervention",
author = "Buiten, {Rosaly A.} and Ploumen, {Eline H.} and Paolo Zocca and Doggen, {Carine J.M.} and Danse, {Peter W.} and Schotborgh, {Carl E.} and Martijn Scholte and {van Houwelingen}, {K. Gert} and Stoel, {Martin G.} and Marc Hartmann and Gin, {R. Melvyn Tjon Joe} and Samer Somi and Linssen, {Gerard C. M.} and Kok, {Marlies M.} and {von Birgelen}, Clemens",
year = "2019",
month = "9",
day = "9",
doi = "10.1016/j.jcin.2019.04.054",
language = "English",
volume = "12",
pages = "1650--1660",
journal = "JACC : cardiovascular interventions",
issn = "1936-8798",
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Buiten, RA, Ploumen, EH, Zocca, P, Doggen, CJM, Danse, PW, Schotborgh, CE, Scholte, M, van Houwelingen, KG, Stoel, MG, Hartmann, M, Gin, RMTJ, Somi, S, Linssen, GCM, Kok, MM & von Birgelen, C 2019, 'Thin, Very Thin, or Ultrathin Strut Biodegradable or Durable Polymer-Coated Drug-Eluting Stents: 3-Year Outcomes of BIO-RESORT' JACC : cardiovascular interventions, vol. 12, no. 17, pp. 1650-1660. https://doi.org/10.1016/j.jcin.2019.04.054

Thin, Very Thin, or Ultrathin Strut Biodegradable or Durable Polymer-Coated Drug-Eluting Stents : 3-Year Outcomes of BIO-RESORT. / Buiten, Rosaly A.; Ploumen, Eline H.; Zocca, Paolo; Doggen, Carine J.M.; Danse, Peter W.; Schotborgh, Carl E.; Scholte, Martijn; van Houwelingen, K. Gert; Stoel, Martin G.; Hartmann, Marc; Gin, R. Melvyn Tjon Joe; Somi, Samer; Linssen, Gerard C. M.; Kok, Marlies M.; von Birgelen, Clemens.

In: JACC : cardiovascular interventions, Vol. 12, No. 17, 09.09.2019, p. 1650-1660.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - Thin, Very Thin, or Ultrathin Strut Biodegradable or Durable Polymer-Coated Drug-Eluting Stents

T2 - 3-Year Outcomes of BIO-RESORT

AU - Buiten, Rosaly A.

AU - Ploumen, Eline H.

AU - Zocca, Paolo

AU - Doggen, Carine J.M.

AU - Danse, Peter W.

AU - Schotborgh, Carl E.

AU - Scholte, Martijn

AU - van Houwelingen, K. Gert

AU - Stoel, Martin G.

AU - Hartmann, Marc

AU - Gin, R. Melvyn Tjon Joe

AU - Somi, Samer

AU - Linssen, Gerard C. M.

AU - Kok, Marlies M.

AU - von Birgelen, Clemens

PY - 2019/9/9

Y1 - 2019/9/9

N2 - 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.

AB - 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.

KW - biodegradable polymer

KW - clinical trial

KW - drug-eluting stent(s)

KW - percutaneous coronary intervention

U2 - 10.1016/j.jcin.2019.04.054

DO - 10.1016/j.jcin.2019.04.054

M3 - Article

VL - 12

SP - 1650

EP - 1660

JO - JACC : cardiovascular interventions

JF - JACC : cardiovascular interventions

SN - 1936-8798

IS - 17

ER -