DUrable Polymer-based STent CHallenge of Promus Element Versus ReSolute Integrity in an All Comers Population
DUTCH PEERS
2 other identifiers
interventional
1,811
1 country
4
Brief Summary
The introduction of drug-eluting stents (DES) in the treatment of coronary artery disease has led to a significant reduction in morbidity but there are further demands on DES performance. Such demands are an optimized performance in very challenging coronary lesions; third generation DES were developed in an effort to further improve DES performance in such challenging lesions. Two CE-certified third generation DES (Resolute Integrity and Promus Element stents) are currently available; there are no data that indicate an advantage of one of these DES over the other.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2010
Typical duration for phase_4
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 30, 2011
CompletedFirst Posted
Study publicly available on registry
April 8, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedJuly 28, 2015
July 1, 2015
2.1 years
March 30, 2011
July 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Target vessel failure (TVF): a composite of Cardiac death, Target vessel related Myocardial Infarction and Clinically driven repeated target vessel revascularization
1 year
Study Arms (2)
Promus Element
ACTIVE COMPARATORResolute Integrity
ACTIVE COMPARATORInterventions
Third generation drug-eluting stent
Eligibility Criteria
You may qualify if:
- Minimum age of 18 years;
- Coronary artery disease and lesion(s) eligible for treatment with drug eluting stents according to clinical guidelines and/or the operators' judgement;
- Patient is willing and able to cooperate with study procedures and required follow-up visits; and patient has been informed and agrees on the participation by signing an EC approved written informed consent.
You may not qualify if:
- Participation in another randomized drug or device study before reaching primary endpoint;
- Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period;
- Intolerance to a P2Y12 receptor antagonist that results in the patient's inability to adhere to dual-antiplatelet therapy, or intolerance to aspirin, heparin, or components of the two DES examined;
- Known pregnancy;
- Life expectancy of less than 1 year.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Medisch Centrum Alkmaar
Alkmaar, Netherlands
Hospital Rijnstate
Arnhem, Netherlands
Scheper Hospital
Emmen, Netherlands
Thoraxcentrum Twente
Enschede, Netherlands
Related Publications (10)
Pinxterhuis TH, Ploumen EH, Doggen CJM, van Vliet D, Kok MM, Zocca P, Hartmann M, van Houwelingen KG, Stoel MG, de Man FHAF, Linssen GCM, von Birgelen C. Sex and age-specific 10-year mortality after coronary stenting: an analysis of two randomized trials. Eur Heart J Open. 2025 Jan 29;5(1):oeaf006. doi: 10.1093/ehjopen/oeaf006. eCollection 2025 Jan.
PMID: 39959922DERIVEDPinxterhuis TH, Ploumen EH, van Vliet D, Gert van Houwelingen K, Stoel MG, de Man FH, Hartmann M, Zocca P, Linssen GC, Geelkerken RH, Doggen CJ, von Birgelen C. Ten-year mortality after treating obstructive coronary atherosclerosis with contemporary stents in patients with or without concomitant peripheral arterial disease. Atherosclerosis. 2024 May;392:117488. doi: 10.1016/j.atherosclerosis.2024.117488. Epub 2024 Mar 26.
PMID: 38598970DERIVEDPinxterhuis TH, Ploumen EH, Zocca P, Doggen CJM, Schotborgh CE, Anthonio RL, Roguin A, Danse PW, Benit E, Aminian A, Hartmann M, Linssen GCM, von Birgelen C. Impact of premature coronary artery disease on adverse event risk following first percutaneous coronary intervention. Front Cardiovasc Med. 2023 Sep 7;10:1160201. doi: 10.3389/fcvm.2023.1160201. eCollection 2023.
PMID: 37745109DERIVEDPinxterhuis TH, Ploumen EH, Doggen CJM, Hartmann M, Schotborgh CE, Anthonio RL, Roguin A, Danse PW, Benit E, Aminian A, Linssen GCM, von Birgelen C. First myocardial infarction in patients with premature coronary artery disease: insights into patient characteristics and outcome after treatment with contemporary stents. Eur Heart J Acute Cardiovasc Care. 2023 Nov 16;12(11):774-781. doi: 10.1093/ehjacc/zuad098.
PMID: 37619976DERIVEDPinxterhuis TH, Ploumen EH, Zocca P, Doggen CJM, Schotborgh CE, Anthonio RL, Roguin A, Danse PW, Benit E, Aminian A, Stoel MG, Linssen GCM, Geelkerken RH, von Birgelen C. Outcome after percutaneous coronary intervention with contemporary stents in patients with concomitant peripheral arterial disease: A patient-level pooled analysis of four randomized trials. Atherosclerosis. 2022 Aug;355:52-59. doi: 10.1016/j.atherosclerosis.2022.05.002. Epub 2022 May 20.
PMID: 35641327DERIVEDZocca P, Kok MM, Tandjung K, Danse PW, Jessurun GAJ, Hautvast RWM, van Houwelingen KG, Stoel MG, Schramm AR, Tjon Joe Gin RM, de Man FHAF, Hartmann M, Louwerenburg JHW, Linssen GCM, Lowik MM, Doggen CJM, von Birgelen C. 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 Cardiovasc Interv. 2018 Mar 12;11(5):462-469. doi: 10.1016/j.jcin.2017.11.031.
PMID: 29519378DERIVEDvan der Heijden LC, Kok MM, Lowik MM, Danse PW, Jessurun GAJ, Hartmann M, Stoel MG, van Houwelingen KG, Hautvast RWM, Linssen GC, Doggen CJM, von Birgelen C. Three-Year Clinical Outcome of Patients with Coronary Disease and Increased Event Risk Treated with Newer-Generation Drug-Eluting Stents: From the Randomized DUTCH PEERS Trial. Cardiology. 2017;137(4):207-217. doi: 10.1159/000464320. Epub 2017 Apr 27.
PMID: 28445871DERIVEDvan der Heijden LC, Kok MM, Danse PW, Schramm AR, Hartmann M, Lowik MM, Linssen GC, Stoel MG, Doggen CJ, von Birgelen C. Small-vessel treatment with contemporary newer-generation drug-eluting coronary stents in all-comers: Insights from 2-year DUTCH PEERS (TWENTE II) randomized trial. Am Heart J. 2016 Jun;176:28-35. doi: 10.1016/j.ahj.2016.02.020. Epub 2016 Mar 17.
PMID: 27264217DERIVEDvon Birgelen C, Sen H, Lam MK, Danse PW, Jessurun GA, Hautvast RW, van Houwelingen GK, Schramm AR, Gin RM, Louwerenburg JW, de Man FH, Stoel MG, Lowik MM, Linssen GC, Said SA, Nienhuis MB, Verhorst PM, Basalus MW, Doggen CJ, Tandjung K. Third-generation zotarolimus-eluting and everolimus-eluting stents in all-comer patients requiring a percutaneous coronary intervention (DUTCH PEERS): a randomised, single-blind, multicentre, non-inferiority trial. Lancet. 2014 Feb 1;383(9915):413-23. doi: 10.1016/S0140-6736(13)62037-1. Epub 2013 Oct 31.
PMID: 24183564DERIVEDTandjung K, Basalus MW, Sen H, Jessurun GA, Danse PW, Stoel M, Linssen GC, Derks A, van Loenhout TT, Nienhuis MB, Hautvast RW, von Birgelen C. 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. Am Heart J. 2012 Apr;163(4):557-62. doi: 10.1016/j.ahj.2012.02.001.
PMID: 22520520DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor C. von Birgelen
Study Record Dates
First Submitted
March 30, 2011
First Posted
April 8, 2011
Study Start
November 1, 2010
Primary Completion
December 1, 2012
Study Completion
December 1, 2013
Last Updated
July 28, 2015
Record last verified: 2015-07