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Acute Coronary SyndromePhase 4DUTCH PEERSNCT01331707

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

A Phase 4 study testing Resolute Integrity (Zotarolimus-eluting stent) and Promus Element (Everolimus-eluting stent) in people with Acute Coronary Syndrome and Angina Pectoris, run by Foundation of Cardiovascular Research and Education Enschede at 4 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Resolute Integrity (Zotarolimus-eluting stent) and Promus Element (Everolimus-eluting stent)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,811 participants
Where
4 sitesNetherlands
Study dates
Nov 2010to Dec 2013
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

4 sites in 1 country.

Netherlands4 sites

  • Medisch Centrum Alkmaar

    Alkmaar

  • Hospital Rijnstate

    Arnhem

  • Scheper Hospital

    Emmen

  • Thoraxcentrum Twente

    Enschede

Other trials in Netherlands

About this study

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)

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.

Being tested
Resolute Integrity (Zotarolimus-eluting stent), Promus Element (Everolimus-eluting stent)
Keywords
drug-eluting stent, Zotarolimus, Everolimus, all comers population, target vessel failure, coronary artery disease
Medical subject headings
Acute Coronary Syndrome, Angina Pectoris, Angina, Unstable, Myocardial Infarction, Coronary Artery Disease, Coronary Stenosis, Coronary Restenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Resolute Integrity (Zotarolimus-eluting stent)Device

    Third generation drug-eluting stent

  • Promus Element (Everolimus-eluting stent)Device

    Third generation drug-eluting stent

Study groups in NCT01331707
Study groupRoleWhat they receive
Promus ElementActive comparatorNot described
Receives: Device: Promus Element (Everolimus-eluting stent)
Resolute IntegrityActive comparatorNot described
Receives: Device: Resolute Integrity (Zotarolimus-eluting stent)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2011 (estimated)
  2. Study startNov 2010
  3. Primary completionDec 2012
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
1,811 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01331707
Sponsor's protocol ID
DUTCH PEERS
Other IDs
NTR2413
Acronym
DUTCH PEERS
Status last verified
Jul 2015
First submitted
30 Mar 2011
Last updated
28 Jul 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 39959922

  • Pinxterhuis 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.

    PubMed 38598970

  • Pinxterhuis 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.

    PubMed 37745109

  • Pinxterhuis 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.

    PubMed 37619976

  • 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.

    PubMed 35641327

  • 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.

    PubMed 29519378

  • 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.

    PubMed 28445871

  • 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.

    PubMed 27264217

  • 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.

    PubMed 24183564

  • 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.

    PubMed 22520520

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Resolute Integrity (Zotarolimus-eluting stent) and Promus Element (Everolimus-eluting stent) in people with Acute Coronary Syndrome and Angina Pectoris, run by Foundation of Cardiovascular Research and Education Enschede at 4 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01331707, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2015.

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