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DUrable Polymer-based STent CHallenge of Promus Element Versus ReSolute Integrity in an All Comers Population (DUTCH PEERS)

Primary Purpose

Acute Coronary Syndrome, Angina Pectoris, Angina, Unstable

Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Resolute Integrity (Zotarolimus-eluting stent)
Promus Element (Everolimus-eluting stent)
Sponsored by
Foundation of Cardiovascular Research and Education Enschede
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring drug-eluting stent, Zotarolimus, Everolimus, all comers population, target vessel failure, coronary artery disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Medisch Centrum Alkmaar
  • Hospital Rijnstate
  • Scheper Hospital
  • Thoraxcentrum Twente

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Promus Element

Resolute Integrity

Arm Description

Outcomes

Primary Outcome Measures

Target vessel failure (TVF): a composite of Cardiac death, Target vessel related Myocardial Infarction and Clinically driven repeated target vessel revascularization

Secondary Outcome Measures

Full Information

First Posted
March 30, 2011
Last Updated
July 27, 2015
Sponsor
Foundation of Cardiovascular Research and Education Enschede
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1. Study Identification

Unique Protocol Identification Number
NCT01331707
Brief Title
DUrable Polymer-based STent CHallenge of Promus Element Versus ReSolute Integrity in an All Comers Population
Acronym
DUTCH PEERS
Official Title
DUrable Polymer-based STent CHallenge of Promus Element Versus ReSolute Integrity (DUTCH PEERS): Randomized Multicenter Trial in All Comers Population Treated Within Eastern NeThErlands-2 (TWENTE-2)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Foundation of Cardiovascular Research and Education Enschede

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, Angina Pectoris, Angina, Unstable, Myocardial Infarction, Coronary Artery Disease, Coronary Stenosis, Coronary Restenosis
Keywords
drug-eluting stent, Zotarolimus, Everolimus, all comers population, target vessel failure, coronary artery disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1811 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Promus Element
Arm Type
Active Comparator
Arm Title
Resolute Integrity
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Resolute Integrity (Zotarolimus-eluting stent)
Intervention Description
Third generation drug-eluting stent
Intervention Type
Device
Intervention Name(s)
Promus Element (Everolimus-eluting stent)
Intervention Description
Third generation drug-eluting stent
Primary Outcome Measure Information:
Title
Target vessel failure (TVF): a composite of Cardiac death, Target vessel related Myocardial Infarction and Clinically driven repeated target vessel revascularization
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
Medisch Centrum Alkmaar
City
Alkmaar
Country
Netherlands
Facility Name
Hospital Rijnstate
City
Arnhem
Country
Netherlands
Facility Name
Scheper Hospital
City
Emmen
Country
Netherlands
Facility Name
Thoraxcentrum Twente
City
Enschede
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
35641327
Citation
Pinxterhuis 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.
Results Reference
derived
PubMed Identifier
29519378
Citation
Zocca 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.
Results Reference
derived
PubMed Identifier
28445871
Citation
van 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.
Results Reference
derived
PubMed Identifier
27264217
Citation
van 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.
Results Reference
derived
PubMed Identifier
24183564
Citation
von 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. Erratum In: Lancet. 2014 Feb 1;383(9915):412.
Results Reference
derived
PubMed Identifier
22520520
Citation
Tandjung 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.
Results Reference
derived

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DUrable Polymer-based STent CHallenge of Promus Element Versus ReSolute Integrity in an All Comers Population

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