DUrable polymer-based sTent CHallenge of Promus ElemEnt versus ReSolute integrity (DUTCH PEERS): Rationale and study design of a randomized multicenter trial in a Dutch all-comers population

Kenneth Tandjung, Mounir W.Z. Basalus, Hanim Sen, Gillian A.J. Jessurun, Peter W. Danse, Martin Stoel, Gerard C.M. Linssen, Anita Derks, Ton T. van Loenhout, Mark B. Nienhuis, Raymond W.M. Hautvast, Clemens von Birgelen

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Abstract

Background: Drug-eluting stents (DES) are increasingly used for the treatment of coronary artery disease. An optimized DES performance is desirable to successfully treat various challenging coronary lesions in a broad population of patients. In response to this demand, third-generation DES with an improved deliverability were developed. Promus Element (Boston Scientific, Natick, MA) and Resolute Integrity (Medtronic Vascular, Santa Rosa, CA) are 2 novel third-generation DES for which limited clinical data are available. Accordingly, we designed the current multicenter study to investigate in an all-comers population whether the clinical outcome is similar after stenting with Promus Element versus Resolute Integrity.

Methods: DUTCH PEERS is a multicenter, prospective, single-blinded, randomized trial in a Dutch all-comers population. Patients with all clinical syndromes who require percutaneous coronary interventions with DES implantation are eligible. In these patients, the type of DES implanted will be randomized in a 1:1 ratio between Resolute Integrity versus Promus Element. The trial is powered based on a noninferiority hypothesis. For each stent arm, 894 patients will be enrolled, resulting in a total study population of 1,788 patients. The primary end point is the incidence of target vessel failure at 1-year follow-up.

Summary: DUTCH PEERS is the first randomized multicenter trial with a head-to-head comparison of Promus Element and Resolute Integrity to investigate the safety and efficacy of these third-generation DES.
Original languageEnglish
Pages (from-to)557-562
JournalAmerican heart journal
Volume163
Issue number4
DOIs
Publication statusPublished - 2012

Fingerprint

Drug-Eluting Stents
Multicenter Studies
Stents
Polymers
Population
Percutaneous Coronary Intervention
Blood Vessels
Coronary Artery Disease
Safety
Incidence

Keywords

  • METIS-290188
  • IR-82395

Cite this

Tandjung, Kenneth ; Basalus, Mounir W.Z. ; Sen, Hanim ; Jessurun, Gillian A.J. ; Danse, Peter W. ; Stoel, Martin ; Linssen, Gerard C.M. ; Derks, Anita ; van Loenhout, Ton T. ; Nienhuis, Mark B. ; Hautvast, Raymond W.M. ; von Birgelen, Clemens. / DUrable polymer-based sTent CHallenge of Promus ElemEnt versus ReSolute integrity (DUTCH PEERS) : Rationale and study design of a randomized multicenter trial in a Dutch all-comers population. In: American heart journal. 2012 ; Vol. 163, No. 4. pp. 557-562.
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abstract = "Background: Drug-eluting stents (DES) are increasingly used for the treatment of coronary artery disease. An optimized DES performance is desirable to successfully treat various challenging coronary lesions in a broad population of patients. In response to this demand, third-generation DES with an improved deliverability were developed. Promus Element (Boston Scientific, Natick, MA) and Resolute Integrity (Medtronic Vascular, Santa Rosa, CA) are 2 novel third-generation DES for which limited clinical data are available. Accordingly, we designed the current multicenter study to investigate in an all-comers population whether the clinical outcome is similar after stenting with Promus Element versus Resolute Integrity.Methods: DUTCH PEERS is a multicenter, prospective, single-blinded, randomized trial in a Dutch all-comers population. Patients with all clinical syndromes who require percutaneous coronary interventions with DES implantation are eligible. In these patients, the type of DES implanted will be randomized in a 1:1 ratio between Resolute Integrity versus Promus Element. The trial is powered based on a noninferiority hypothesis. For each stent arm, 894 patients will be enrolled, resulting in a total study population of 1,788 patients. The primary end point is the incidence of target vessel failure at 1-year follow-up.Summary: DUTCH PEERS is the first randomized multicenter trial with a head-to-head comparison of Promus Element and Resolute Integrity to investigate the safety and efficacy of these third-generation DES.",
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author = "Kenneth Tandjung and Basalus, {Mounir W.Z.} and Hanim Sen and Jessurun, {Gillian A.J.} and Danse, {Peter W.} and Martin Stoel and Linssen, {Gerard C.M.} and Anita Derks and {van Loenhout}, {Ton T.} and Nienhuis, {Mark B.} and Hautvast, {Raymond W.M.} and {von Birgelen}, Clemens",
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Tandjung, K, Basalus, MWZ, Sen, H, Jessurun, GAJ, Danse, PW, Stoel, M, Linssen, GCM, Derks, A, van Loenhout, TT, Nienhuis, MB, Hautvast, RWM & von Birgelen, C 2012, 'DUrable polymer-based sTent CHallenge of Promus ElemEnt versus ReSolute integrity (DUTCH PEERS): Rationale and study design of a randomized multicenter trial in a Dutch all-comers population' American heart journal, vol. 163, no. 4, pp. 557-562. https://doi.org/10.1016/j.ahj.2012.02.001

DUrable polymer-based sTent CHallenge of Promus ElemEnt versus ReSolute integrity (DUTCH PEERS) : Rationale and study design of a randomized multicenter trial in a Dutch all-comers population. / Tandjung, Kenneth; Basalus, Mounir W.Z.; Sen, Hanim; Jessurun, Gillian A.J.; Danse, Peter W.; Stoel, Martin; Linssen, Gerard C.M.; Derks, Anita; van Loenhout, Ton T.; Nienhuis, Mark B.; Hautvast, Raymond W.M.; von Birgelen, Clemens.

In: American heart journal, Vol. 163, No. 4, 2012, p. 557-562.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - DUrable polymer-based sTent CHallenge of Promus ElemEnt versus ReSolute integrity (DUTCH PEERS)

T2 - Rationale and study design of a randomized multicenter trial in a Dutch all-comers population

AU - Tandjung, Kenneth

AU - Basalus, Mounir W.Z.

AU - Sen, Hanim

AU - Jessurun, Gillian A.J.

AU - Danse, Peter W.

AU - Stoel, Martin

AU - Linssen, Gerard C.M.

AU - Derks, Anita

AU - van Loenhout, Ton T.

AU - Nienhuis, Mark B.

AU - Hautvast, Raymond W.M.

AU - von Birgelen, Clemens

PY - 2012

Y1 - 2012

N2 - Background: Drug-eluting stents (DES) are increasingly used for the treatment of coronary artery disease. An optimized DES performance is desirable to successfully treat various challenging coronary lesions in a broad population of patients. In response to this demand, third-generation DES with an improved deliverability were developed. Promus Element (Boston Scientific, Natick, MA) and Resolute Integrity (Medtronic Vascular, Santa Rosa, CA) are 2 novel third-generation DES for which limited clinical data are available. Accordingly, we designed the current multicenter study to investigate in an all-comers population whether the clinical outcome is similar after stenting with Promus Element versus Resolute Integrity.Methods: DUTCH PEERS is a multicenter, prospective, single-blinded, randomized trial in a Dutch all-comers population. Patients with all clinical syndromes who require percutaneous coronary interventions with DES implantation are eligible. In these patients, the type of DES implanted will be randomized in a 1:1 ratio between Resolute Integrity versus Promus Element. The trial is powered based on a noninferiority hypothesis. For each stent arm, 894 patients will be enrolled, resulting in a total study population of 1,788 patients. The primary end point is the incidence of target vessel failure at 1-year follow-up.Summary: DUTCH PEERS is the first randomized multicenter trial with a head-to-head comparison of Promus Element and Resolute Integrity to investigate the safety and efficacy of these third-generation DES.

AB - Background: Drug-eluting stents (DES) are increasingly used for the treatment of coronary artery disease. An optimized DES performance is desirable to successfully treat various challenging coronary lesions in a broad population of patients. In response to this demand, third-generation DES with an improved deliverability were developed. Promus Element (Boston Scientific, Natick, MA) and Resolute Integrity (Medtronic Vascular, Santa Rosa, CA) are 2 novel third-generation DES for which limited clinical data are available. Accordingly, we designed the current multicenter study to investigate in an all-comers population whether the clinical outcome is similar after stenting with Promus Element versus Resolute Integrity.Methods: DUTCH PEERS is a multicenter, prospective, single-blinded, randomized trial in a Dutch all-comers population. Patients with all clinical syndromes who require percutaneous coronary interventions with DES implantation are eligible. In these patients, the type of DES implanted will be randomized in a 1:1 ratio between Resolute Integrity versus Promus Element. The trial is powered based on a noninferiority hypothesis. For each stent arm, 894 patients will be enrolled, resulting in a total study population of 1,788 patients. The primary end point is the incidence of target vessel failure at 1-year follow-up.Summary: DUTCH PEERS is the first randomized multicenter trial with a head-to-head comparison of Promus Element and Resolute Integrity to investigate the safety and efficacy of these third-generation DES.

KW - METIS-290188

KW - IR-82395

U2 - 10.1016/j.ahj.2012.02.001

DO - 10.1016/j.ahj.2012.02.001

M3 - Article

VL - 163

SP - 557

EP - 562

JO - American heart journal

JF - American heart journal

SN - 0002-8703

IS - 4

ER -