5-Year Outcome Following Randomized Treatment of All-Comers With Zotarolimus-Eluting Resolute Integrity and Everolimus-Eluting PROMUS Element Coronary Stents: Final Report of the DUTCH PEERS (TWENTE II) Trial

Paolo Zocca, Marlies M. Kok, Kenneth Tandjung, Peter W. Danse, Gillian A.J. Jessurun, Raymond W.M. Hautvast, Gert K. van Houwelingen, Martin G. Stoel, Alexander R. Schramm, R. Melvyn Tjon Joe Gin, Frits H.A.F. de Man, Marc Hartmann, J. (Hans) W. Louwerenburg, Gerard C.M. Linssen, Marije M. Löwik, Carine J.M. Doggen, Clemens von Birgelen (Corresponding Author)

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Abstract

Objectives: The study sought to evaluate for the first time the 5-year outcomes after treating an all-comers population with newer-generation cobalt chromium-based Resolute Integrity zotarolimus-eluting stents (ZES) (Medtronic, Santa Rosa, California) versus platinum chromium-based PROMUS Element everolimus eluting stents (EES) (Boston Scientific, Natick, Massachusetts).

Background: The DUTCH PEERS (TWENTE II) (DUrable polymer-based sTent CHallenge of Promus ElemEnt versus ReSolute integrity: TWENTE II) trial is a randomized, multicenter, single-blinded, investigator-initiated all-comers trial that found at its main analysis similar 1-year safety and efficacy for both drug-eluting stents. It is the first randomized trial ever to investigate the Resolute Integrity ZES and the first trial to compare both devices.

Methods: In total, 1,811 patients were 1:1 randomized to ZES versus EES. We performed a pre-specified assessment of the 5-year clinical outcomes in terms of safety and efficacy. The main endpoint target vessel failure (TVF) is a composite of cardiac death, target vessel–related myocardial infarction, or target vessel revascularization. Secondary endpoints included the individual components of TVF, and stent thrombosis. The study was independently monitored, and adverse clinical events were independently adjudicated.

Results: Five-year clinical follow-up data was available in 1,798 (99.3%) patients. The ZES and EES groups showed favorable outcomes, with similar 5-year incidence of TVF (13.2% vs. 14.2%; plog-rank = 0.62) and its individual components: cardiac death (4.5% vs. 4.9%; plog-rank = 0.69), target vessel–related myocardial infarction (3.1% vs. 2.6%; plog-rank = 0.47), and target vessel revascularization (7.6% vs. 8.6%; plog-rank = 0.46). The 5-year incidence of definite or probable stent thrombosis was similar (1.5% vs. 1.3%; plog-rank = 0.83).

Conclusions: At 5-year follow-up, the Resolute Integrity ZES and PROMUS Element EES showed similar and sustained results in terms of safety and efficacy for treating a broad population of all-comers.

Original languageEnglish
Pages (from-to)462-469
Number of pages8
JournalJACC : cardiovascular interventions
Volume11
Issue number5
DOIs
Publication statusPublished - 12 Mar 2018

Fingerprint

Stents
Therapeutics
Chromium
Safety
zotarolimus
Everolimus
Thrombosis
Myocardial Infarction
Drug-Eluting Stents
Incidence
Cobalt
Platinum
Population
Polymers
Research Personnel
Equipment and Supplies

Keywords

  • Long-term outcome
  • Newer-generation drug-eluting stent(s)
  • PCI
  • Percutaneous coronary intervention
  • PROMUS Element everolimus-eluting stent(s)
  • Resolute Integrity zotarolimus-eluting stent(s)
  • DES

Cite this

Zocca, Paolo ; Kok, Marlies M. ; Tandjung, Kenneth ; Danse, Peter W. ; Jessurun, Gillian A.J. ; Hautvast, Raymond W.M. ; van Houwelingen, Gert K. ; Stoel, Martin G. ; Schramm, Alexander R. ; Tjon Joe Gin, R. Melvyn ; de Man, Frits H.A.F. ; Hartmann, Marc ; Louwerenburg, J. (Hans) W. ; Linssen, Gerard C.M. ; Löwik, Marije M. ; Doggen, Carine J.M. ; von Birgelen, Clemens. / 5-Year Outcome Following Randomized Treatment of All-Comers With Zotarolimus-Eluting Resolute Integrity and Everolimus-Eluting PROMUS Element Coronary Stents : Final Report of the DUTCH PEERS (TWENTE II) Trial. In: JACC : cardiovascular interventions. 2018 ; Vol. 11, No. 5. pp. 462-469.
@article{217e7c705d284771a0de0edba7fdb1a0,
title = "5-Year Outcome Following Randomized Treatment of All-Comers With Zotarolimus-Eluting Resolute Integrity and Everolimus-Eluting PROMUS Element Coronary Stents: Final Report of the DUTCH PEERS (TWENTE II) Trial",
abstract = "Objectives: The study sought to evaluate for the first time the 5-year outcomes after treating an all-comers population with newer-generation cobalt chromium-based Resolute Integrity zotarolimus-eluting stents (ZES) (Medtronic, Santa Rosa, California) versus platinum chromium-based PROMUS Element everolimus eluting stents (EES) (Boston Scientific, Natick, Massachusetts).Background: The DUTCH PEERS (TWENTE II) (DUrable polymer-based sTent CHallenge of Promus ElemEnt versus ReSolute integrity: TWENTE II) trial is a randomized, multicenter, single-blinded, investigator-initiated all-comers trial that found at its main analysis similar 1-year safety and efficacy for both drug-eluting stents. It is the first randomized trial ever to investigate the Resolute Integrity ZES and the first trial to compare both devices.Methods: In total, 1,811 patients were 1:1 randomized to ZES versus EES. We performed a pre-specified assessment of the 5-year clinical outcomes in terms of safety and efficacy. The main endpoint target vessel failure (TVF) is a composite of cardiac death, target vessel–related myocardial infarction, or target vessel revascularization. Secondary endpoints included the individual components of TVF, and stent thrombosis. The study was independently monitored, and adverse clinical events were independently adjudicated.Results: Five-year clinical follow-up data was available in 1,798 (99.3{\%}) patients. The ZES and EES groups showed favorable outcomes, with similar 5-year incidence of TVF (13.2{\%} vs. 14.2{\%}; plog-rank = 0.62) and its individual components: cardiac death (4.5{\%} vs. 4.9{\%}; plog-rank = 0.69), target vessel–related myocardial infarction (3.1{\%} vs. 2.6{\%}; plog-rank = 0.47), and target vessel revascularization (7.6{\%} vs. 8.6{\%}; plog-rank = 0.46). The 5-year incidence of definite or probable stent thrombosis was similar (1.5{\%} vs. 1.3{\%}; plog-rank = 0.83).Conclusions: At 5-year follow-up, the Resolute Integrity ZES and PROMUS Element EES showed similar and sustained results in terms of safety and efficacy for treating a broad population of all-comers.",
keywords = "Long-term outcome, Newer-generation drug-eluting stent(s), PCI, Percutaneous coronary intervention, PROMUS Element everolimus-eluting stent(s), Resolute Integrity zotarolimus-eluting stent(s), DES",
author = "Paolo Zocca and Kok, {Marlies M.} and Kenneth Tandjung and Danse, {Peter W.} and Jessurun, {Gillian A.J.} and Hautvast, {Raymond W.M.} and {van Houwelingen}, {Gert K.} and Stoel, {Martin G.} and Schramm, {Alexander R.} and {Tjon Joe Gin}, {R. Melvyn} and {de Man}, {Frits H.A.F.} and Marc Hartmann and Louwerenburg, {J. (Hans) W.} and Linssen, {Gerard C.M.} and L{\"o}wik, {Marije M.} and Doggen, {Carine J.M.} and {von Birgelen}, Clemens",
year = "2018",
month = "3",
day = "12",
doi = "10.1016/j.jcin.2017.11.031",
language = "English",
volume = "11",
pages = "462--469",
journal = "JACC : cardiovascular interventions",
issn = "1936-8798",
publisher = "Elsevier",
number = "5",

}

Zocca, P, Kok, MM, Tandjung, K, Danse, PW, Jessurun, GAJ, Hautvast, RWM, van Houwelingen, GK, Stoel, MG, Schramm, AR, Tjon Joe Gin, RM, de Man, FHAF, Hartmann, M, Louwerenburg, JHW, Linssen, GCM, Löwik, MM, Doggen, CJM & von Birgelen, C 2018, '5-Year Outcome Following Randomized Treatment of All-Comers With Zotarolimus-Eluting Resolute Integrity and Everolimus-Eluting PROMUS Element Coronary Stents: Final Report of the DUTCH PEERS (TWENTE II) Trial' JACC : cardiovascular interventions, vol. 11, no. 5, pp. 462-469. https://doi.org/10.1016/j.jcin.2017.11.031

5-Year Outcome Following Randomized Treatment of All-Comers With Zotarolimus-Eluting Resolute Integrity and Everolimus-Eluting PROMUS Element Coronary Stents : Final Report of the DUTCH PEERS (TWENTE II) Trial. / Zocca, Paolo; Kok, Marlies M.; Tandjung, Kenneth; Danse, Peter W.; Jessurun, Gillian A.J.; Hautvast, Raymond W.M.; van Houwelingen, Gert K.; Stoel, Martin G.; Schramm, Alexander R.; Tjon Joe Gin, R. Melvyn; de Man, Frits H.A.F.; Hartmann, Marc; Louwerenburg, J. (Hans) W.; Linssen, Gerard C.M.; Löwik, Marije M.; Doggen, Carine J.M.; von Birgelen, Clemens (Corresponding Author).

In: JACC : cardiovascular interventions, Vol. 11, No. 5, 12.03.2018, p. 462-469.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - 5-Year Outcome Following Randomized Treatment of All-Comers With Zotarolimus-Eluting Resolute Integrity and Everolimus-Eluting PROMUS Element Coronary Stents

T2 - Final Report of the DUTCH PEERS (TWENTE II) Trial

AU - Zocca, Paolo

AU - Kok, Marlies M.

AU - Tandjung, Kenneth

AU - Danse, Peter W.

AU - Jessurun, Gillian A.J.

AU - Hautvast, Raymond W.M.

AU - van Houwelingen, Gert K.

AU - Stoel, Martin G.

AU - Schramm, Alexander R.

AU - Tjon Joe Gin, R. Melvyn

AU - de Man, Frits H.A.F.

AU - Hartmann, Marc

AU - Louwerenburg, J. (Hans) W.

AU - Linssen, Gerard C.M.

AU - Löwik, Marije M.

AU - Doggen, Carine J.M.

AU - von Birgelen, Clemens

PY - 2018/3/12

Y1 - 2018/3/12

N2 - Objectives: The study sought to evaluate for the first time the 5-year outcomes after treating an all-comers population with newer-generation cobalt chromium-based Resolute Integrity zotarolimus-eluting stents (ZES) (Medtronic, Santa Rosa, California) versus platinum chromium-based PROMUS Element everolimus eluting stents (EES) (Boston Scientific, Natick, Massachusetts).Background: The DUTCH PEERS (TWENTE II) (DUrable polymer-based sTent CHallenge of Promus ElemEnt versus ReSolute integrity: TWENTE II) trial is a randomized, multicenter, single-blinded, investigator-initiated all-comers trial that found at its main analysis similar 1-year safety and efficacy for both drug-eluting stents. It is the first randomized trial ever to investigate the Resolute Integrity ZES and the first trial to compare both devices.Methods: In total, 1,811 patients were 1:1 randomized to ZES versus EES. We performed a pre-specified assessment of the 5-year clinical outcomes in terms of safety and efficacy. The main endpoint target vessel failure (TVF) is a composite of cardiac death, target vessel–related myocardial infarction, or target vessel revascularization. Secondary endpoints included the individual components of TVF, and stent thrombosis. The study was independently monitored, and adverse clinical events were independently adjudicated.Results: Five-year clinical follow-up data was available in 1,798 (99.3%) patients. The ZES and EES groups showed favorable outcomes, with similar 5-year incidence of TVF (13.2% vs. 14.2%; plog-rank = 0.62) and its individual components: cardiac death (4.5% vs. 4.9%; plog-rank = 0.69), target vessel–related myocardial infarction (3.1% vs. 2.6%; plog-rank = 0.47), and target vessel revascularization (7.6% vs. 8.6%; plog-rank = 0.46). The 5-year incidence of definite or probable stent thrombosis was similar (1.5% vs. 1.3%; plog-rank = 0.83).Conclusions: At 5-year follow-up, the Resolute Integrity ZES and PROMUS Element EES showed similar and sustained results in terms of safety and efficacy for treating a broad population of all-comers.

AB - Objectives: The study sought to evaluate for the first time the 5-year outcomes after treating an all-comers population with newer-generation cobalt chromium-based Resolute Integrity zotarolimus-eluting stents (ZES) (Medtronic, Santa Rosa, California) versus platinum chromium-based PROMUS Element everolimus eluting stents (EES) (Boston Scientific, Natick, Massachusetts).Background: The DUTCH PEERS (TWENTE II) (DUrable polymer-based sTent CHallenge of Promus ElemEnt versus ReSolute integrity: TWENTE II) trial is a randomized, multicenter, single-blinded, investigator-initiated all-comers trial that found at its main analysis similar 1-year safety and efficacy for both drug-eluting stents. It is the first randomized trial ever to investigate the Resolute Integrity ZES and the first trial to compare both devices.Methods: In total, 1,811 patients were 1:1 randomized to ZES versus EES. We performed a pre-specified assessment of the 5-year clinical outcomes in terms of safety and efficacy. The main endpoint target vessel failure (TVF) is a composite of cardiac death, target vessel–related myocardial infarction, or target vessel revascularization. Secondary endpoints included the individual components of TVF, and stent thrombosis. The study was independently monitored, and adverse clinical events were independently adjudicated.Results: Five-year clinical follow-up data was available in 1,798 (99.3%) patients. The ZES and EES groups showed favorable outcomes, with similar 5-year incidence of TVF (13.2% vs. 14.2%; plog-rank = 0.62) and its individual components: cardiac death (4.5% vs. 4.9%; plog-rank = 0.69), target vessel–related myocardial infarction (3.1% vs. 2.6%; plog-rank = 0.47), and target vessel revascularization (7.6% vs. 8.6%; plog-rank = 0.46). The 5-year incidence of definite or probable stent thrombosis was similar (1.5% vs. 1.3%; plog-rank = 0.83).Conclusions: At 5-year follow-up, the Resolute Integrity ZES and PROMUS Element EES showed similar and sustained results in terms of safety and efficacy for treating a broad population of all-comers.

KW - Long-term outcome

KW - Newer-generation drug-eluting stent(s)

KW - PCI

KW - Percutaneous coronary intervention

KW - PROMUS Element everolimus-eluting stent(s)

KW - Resolute Integrity zotarolimus-eluting stent(s)

KW - DES

UR - http://www.scopus.com/inward/record.url?scp=85041405975&partnerID=8YFLogxK

U2 - 10.1016/j.jcin.2017.11.031

DO - 10.1016/j.jcin.2017.11.031

M3 - Article

VL - 11

SP - 462

EP - 469

JO - JACC : cardiovascular interventions

JF - JACC : cardiovascular interventions

SN - 1936-8798

IS - 5

ER -