Two-year clinical outcome of all-comers treated with three highly dissimilar contemporary coronary drug-eluting stents in the randomised BIO-RESORT trial

Marlies M. Kok, Paolo Zocca, Rosaly A. Buiten, Peter W. Danse, Carl E. Schotborgh, Martijn Scholte, Marc Hartmann, Martin G. Stoel, K.G. van Houwelingen, Gerard C.M. Linssen, Carine Doggen, Clemens von Birgelen (Corresponding Author)

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Abstract

Aims: The aim of the study was to evaluate the two-year clinical outcome of all-comer trial participants who were treated with two very different thin-strut biodegradable polymer versus thin-strut durable polymer drug-eluting stents (DES). Prolonged clinical outcome after discontinuation of dual antiplatelet therapy is of particular interest, given the highly dissimilar polymer types, amount, distribution, and degradation speed of both biodegradable polymer DES.

Methods and results: The BIO-RESORT trial (NCT01674803) randomly assigned 3,514 patients to treatment with biodegradable polymer SYNERGY everolimus-eluting stents (EES) or Orsiro sirolimus-eluting stents (SES), or durable polymer Resolute Integrity zotarolimus-eluting stents (ZES). At two-year follow-up (available in 98.8%), the rate of the primary composite endpoint target vessel failure (TVF) was 8.3% in ZES versus 6.8% in EES (p=0.19) and 6.6% in SES (p=0.12). Landmark analyses at one year revealed differences between SES and ZES in the rates of target lesion revascularisation and target lesion failure (0.6% vs. 1.5%, p=0.04, and 1.1% vs. 2.4%, p=0.02, respectively) as well as other composite secondary endpoints that reached statistical significance.

Conclusions: At two-year follow-up, there was no significant between-DES difference in the rates of the primary endpoint. Landmark analyses provided a signal that the use of SES versus ZES might reduce the risk of repeat revascularisation after one-year follow-up.
Original languageEnglish
Pages (from-to)915-923
Number of pages9
JournalEuroIntervention
Volume14
Issue number8
Early online date23 May 2018
DOIs
Publication statusPublished - 20 Oct 2018

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Drug-Eluting Stents
Stents
Polymers
Sirolimus

Keywords

  • Clinical trials
  • Drug-eluting stent
  • NSTEMI
  • STEMI
  • Stable angina

Cite this

Kok, Marlies M. ; Zocca, Paolo ; Buiten, Rosaly A. ; Danse, Peter W. ; Schotborgh, Carl E. ; Scholte, Martijn ; Hartmann, Marc ; Stoel, Martin G. ; van Houwelingen, K.G. ; Linssen, Gerard C.M. ; Doggen, Carine ; von Birgelen, Clemens . / Two-year clinical outcome of all-comers treated with three highly dissimilar contemporary coronary drug-eluting stents in the randomised BIO-RESORT trial. In: EuroIntervention. 2018 ; Vol. 14, No. 8. pp. 915-923.
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title = "Two-year clinical outcome of all-comers treated with three highly dissimilar contemporary coronary drug-eluting stents in the randomised BIO-RESORT trial",
abstract = "Aims: The aim of the study was to evaluate the two-year clinical outcome of all-comer trial participants who were treated with two very different thin-strut biodegradable polymer versus thin-strut durable polymer drug-eluting stents (DES). Prolonged clinical outcome after discontinuation of dual antiplatelet therapy is of particular interest, given the highly dissimilar polymer types, amount, distribution, and degradation speed of both biodegradable polymer DES.Methods and results: The BIO-RESORT trial (NCT01674803) randomly assigned 3,514 patients to treatment with biodegradable polymer SYNERGY everolimus-eluting stents (EES) or Orsiro sirolimus-eluting stents (SES), or durable polymer Resolute Integrity zotarolimus-eluting stents (ZES). At two-year follow-up (available in 98.8{\%}), the rate of the primary composite endpoint target vessel failure (TVF) was 8.3{\%} in ZES versus 6.8{\%} in EES (p=0.19) and 6.6{\%} in SES (p=0.12). Landmark analyses at one year revealed differences between SES and ZES in the rates of target lesion revascularisation and target lesion failure (0.6{\%} vs. 1.5{\%}, p=0.04, and 1.1{\%} vs. 2.4{\%}, p=0.02, respectively) as well as other composite secondary endpoints that reached statistical significance.Conclusions: At two-year follow-up, there was no significant between-DES difference in the rates of the primary endpoint. Landmark analyses provided a signal that the use of SES versus ZES might reduce the risk of repeat revascularisation after one-year follow-up.",
keywords = "Clinical trials, Drug-eluting stent, NSTEMI, STEMI, Stable angina",
author = "Kok, {Marlies M.} and Paolo Zocca and Buiten, {Rosaly A.} and Danse, {Peter W.} and Schotborgh, {Carl E.} and Martijn Scholte and Marc Hartmann and Stoel, {Martin G.} and {van Houwelingen}, K.G. and Linssen, {Gerard C.M.} and Carine Doggen and {von Birgelen}, Clemens",
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Kok, MM, Zocca, P, Buiten, RA, Danse, PW, Schotborgh, CE, Scholte, M, Hartmann, M, Stoel, MG, van Houwelingen, KG, Linssen, GCM, Doggen, C & von Birgelen, C 2018, 'Two-year clinical outcome of all-comers treated with three highly dissimilar contemporary coronary drug-eluting stents in the randomised BIO-RESORT trial' EuroIntervention, vol. 14, no. 8, pp. 915-923. https://doi.org/10.4244/EIJ-D-18-00336

Two-year clinical outcome of all-comers treated with three highly dissimilar contemporary coronary drug-eluting stents in the randomised BIO-RESORT trial. / Kok, Marlies M.; Zocca, Paolo; Buiten, Rosaly A.; Danse, Peter W.; Schotborgh, Carl E.; Scholte, Martijn; Hartmann, Marc; Stoel, Martin G.; van Houwelingen, K.G.; Linssen, Gerard C.M.; Doggen, Carine; von Birgelen, Clemens (Corresponding Author).

In: EuroIntervention, Vol. 14, No. 8, 20.10.2018, p. 915-923.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - Two-year clinical outcome of all-comers treated with three highly dissimilar contemporary coronary drug-eluting stents in the randomised BIO-RESORT trial

AU - Kok, Marlies M.

AU - Zocca, Paolo

AU - Buiten, Rosaly A.

AU - Danse, Peter W.

AU - Schotborgh, Carl E.

AU - Scholte, Martijn

AU - Hartmann, Marc

AU - Stoel, Martin G.

AU - van Houwelingen, K.G.

AU - Linssen, Gerard C.M.

AU - Doggen, Carine

AU - von Birgelen, Clemens

PY - 2018/10/20

Y1 - 2018/10/20

N2 - Aims: The aim of the study was to evaluate the two-year clinical outcome of all-comer trial participants who were treated with two very different thin-strut biodegradable polymer versus thin-strut durable polymer drug-eluting stents (DES). Prolonged clinical outcome after discontinuation of dual antiplatelet therapy is of particular interest, given the highly dissimilar polymer types, amount, distribution, and degradation speed of both biodegradable polymer DES.Methods and results: The BIO-RESORT trial (NCT01674803) randomly assigned 3,514 patients to treatment with biodegradable polymer SYNERGY everolimus-eluting stents (EES) or Orsiro sirolimus-eluting stents (SES), or durable polymer Resolute Integrity zotarolimus-eluting stents (ZES). At two-year follow-up (available in 98.8%), the rate of the primary composite endpoint target vessel failure (TVF) was 8.3% in ZES versus 6.8% in EES (p=0.19) and 6.6% in SES (p=0.12). Landmark analyses at one year revealed differences between SES and ZES in the rates of target lesion revascularisation and target lesion failure (0.6% vs. 1.5%, p=0.04, and 1.1% vs. 2.4%, p=0.02, respectively) as well as other composite secondary endpoints that reached statistical significance.Conclusions: At two-year follow-up, there was no significant between-DES difference in the rates of the primary endpoint. Landmark analyses provided a signal that the use of SES versus ZES might reduce the risk of repeat revascularisation after one-year follow-up.

AB - Aims: The aim of the study was to evaluate the two-year clinical outcome of all-comer trial participants who were treated with two very different thin-strut biodegradable polymer versus thin-strut durable polymer drug-eluting stents (DES). Prolonged clinical outcome after discontinuation of dual antiplatelet therapy is of particular interest, given the highly dissimilar polymer types, amount, distribution, and degradation speed of both biodegradable polymer DES.Methods and results: The BIO-RESORT trial (NCT01674803) randomly assigned 3,514 patients to treatment with biodegradable polymer SYNERGY everolimus-eluting stents (EES) or Orsiro sirolimus-eluting stents (SES), or durable polymer Resolute Integrity zotarolimus-eluting stents (ZES). At two-year follow-up (available in 98.8%), the rate of the primary composite endpoint target vessel failure (TVF) was 8.3% in ZES versus 6.8% in EES (p=0.19) and 6.6% in SES (p=0.12). Landmark analyses at one year revealed differences between SES and ZES in the rates of target lesion revascularisation and target lesion failure (0.6% vs. 1.5%, p=0.04, and 1.1% vs. 2.4%, p=0.02, respectively) as well as other composite secondary endpoints that reached statistical significance.Conclusions: At two-year follow-up, there was no significant between-DES difference in the rates of the primary endpoint. Landmark analyses provided a signal that the use of SES versus ZES might reduce the risk of repeat revascularisation after one-year follow-up.

KW - Clinical trials

KW - Drug-eluting stent

KW - NSTEMI

KW - STEMI

KW - Stable angina

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U2 - 10.4244/EIJ-D-18-00336

DO - 10.4244/EIJ-D-18-00336

M3 - Article

VL - 14

SP - 915

EP - 923

JO - EuroIntervention

JF - EuroIntervention

SN - 1774-024X

IS - 8

ER -