Bioresorbable Polymer ORSIRO Versus Durable Polymer RESOLUTE ONYX Stents

NCT02508714 | Unknown DMC

• 1 other identifier: P15-19
• Study Type: interventional
• Target: 2,470
• Locations: 3 countries
• Sites: 7

Brief Summary

The introduction of drug-eluting stents (DES) in the treatment of coronary artery disease has led to a significant reduction in morbidity. However, the first generation of these devices had no positive impact on the mortality after PCI (compared to bare metal stents), which was greatly attributed to a somewhat increased incidence of late and very late stent thrombosis. Concerns about the role of durable polymers as a potential trigger of inflammation and finally adverse events also led to the development of DES with bioresorbable coatings, which leave after degradation of the coating only a bare metal stent in the vessel wall that does not induce an inflammatory response. While such bioresorbable polymer DES are increasingly used in clinical practice, data from head-to-head comparisons between bioresorbable polymer DES with a contemporary highly flexible new generation permanent polymer coated DES.

Conditions

Coronary Artery Disease; Angina Pectoris; Unstable Angina Pectoris; Acute Coronary Syndrome; Coronary Stenosis; Coronary Restenosis

Outcome Measures

Primary Outcomes (1)

• Target vessel failure (TVF)

  Composite endpoint consisting of: Cardiac death (All deaths are considered cardiac, unless an unequivocal non-cardiac cause can be established); Target vessel related MI (Q-wave or non-Q-wave myocardial infarction that can be related to the target vessel or cannot be related to another vessel); Clinically driven repeated target vessel revascularization by means of CABG or PCI.

  1 year

Secondary Outcomes (8)

• Death at 1 and 2 year follow-up

  1 and 2 year

• Myocardial infarction at 1 and 2 year follow-up

  1 and 2 year

• Revascularization at 1 and 2 year follow-up

  1 and 2 year

• Stent thrombosis at 1 and 2 year follow-up

  1 and 2 year

• Target lesion failure (TLF) at 1 and 2 year follow-up

  1 and 2 year

Other Outcomes (1)

• Longitudinal stent deformation (LSD) and deliverability

  1 year

Study Arms (2)

Orsiro DES (Biotronik)

ACTIVE COMPARATOR

The ORSIRO hybrid coating DES (Biotronik, Switzerland) is a device which includes a modern, highly flexible, thin-strut stent platform, eluting sirolimus from a thin biodegradable BIO-lute coating grom PLLA (poly(L-lactic acid)) which is located mainly on the abluminal side.

Device: Orsiro

RESOLUTE ONYX DES (Medtronic)

ACTIVE COMPARATOR

The RESOLUTE ONYX is a permanent polymer DES that uses a novel highly flexible metallic stent backbone with increased radiographic visibility eluting the drug zotarolimus from the BioLinx durable polymer coating. The stent platform uses corewire technology that allows the stent to have a denser core metal surrounded by outer layer of cobalt-chromium.

Device: Resolute Onyx

Interventions

Orsiro DEVICE

stents will be implanted in case of significant coronary artery disease

Also known as: Orsiro drug eluting stent

Orsiro DES (Biotronik)

Resolute Onyx DEVICE

stents will be implanted in case of significant coronary artery disease based on coronary angiography

Also known as: Resolute Onyx drug eluting stent

RESOLUTE ONYX DES (Medtronic)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of 18 years and older, requiring PCI for the treatment of significant coronary artery or bypass graft lesions, being eligible for treatment with drug eluting stents according to clinical guidelines and/or the operators' judgement, and capable of providing informed consent.

You may not qualify if:

• Known intolerance to components of one of the study DES, or known intolerance to antithrombotic and/or anticoagulant therapy that prevents adherence to any dual anti-platelet therapy (DAPT).
• Planned elective surgical procedure necessitating interruption of DAPT during the first 3 months after randomization.
• Participation in another randomized cardiovascular device trial or randomized pharmacological study related to antithrombotic and/or anticoagulant therapy before reaching the primary endpoint.
• Known pregnancy, adherence to scheduled follow-up is unlikely, or life expectancy is assumed to be less than 1 year

Sponsors & Collaborators

• Thorax Centrum Twente: lead

Study Sites (7)

CHU Charleroi

Charleroi, Belgium

Location

Jessa Ziekenhuis

Hasselt, Belgium

Location

Rambam

Haifa, Israel

Location

Haga Ziekenhuis

The Hague, South Holland, 2504 LN, Netherlands

Location

Rijnstate Hospital

Arnhem, Netherlands

Location

Treant Zorggroep

Emmen, Netherlands

Location

Medisch Spectrum Twente

Enschede, Netherlands

Location

Related Publications (13)

• 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.

  PMID: 24183564 BACKGROUND

• Sen H, Lam MK, Lowik MM, Danse PW, Jessurun GA, van Houwelingen KG, Anthonio RL, Tjon Joe Gin RM, Hautvast RW, Louwerenburg JH, de Man FH, Stoel MG, van der Heijden LC, Linssen GC, IJzerman MJ, Tandjung K, Doggen CJ, von Birgelen C. Clinical Events and Patient-Reported Chest Pain in All-Comers Treated With Resolute Integrity and Promus Element Stents: 2-Year Follow-Up of the DUTCH PEERS (DUrable Polymer-Based STent CHallenge of Promus ElemEnt Versus ReSolute Integrity) Randomized Trial (TWENTE II). JACC Cardiovasc Interv. 2015 Jun;8(7):889-99. doi: 10.1016/j.jcin.2015.01.033. Epub 2015 May 20.

  PMID: 26003019 BACKGROUND

• van Vliet D, Pinxterhuis TH, Ploumen EH, Kok MM, Buiten RA, Zocca P, Roguin A, Schotborgh CE, Anthonio RL, Danse PW, Benit E, Aminian A, Doggen CJM, von Birgelen C. Impact of diabetes on three-year outcome after coronary stenting in patients with polyvascular atherosclerotic disease - a secondary analysis of the randomized TWENTE trials. Int J Cardiol Heart Vasc. 2025 Jul 6;59:101741. doi: 10.1016/j.ijcha.2025.101741. eCollection 2025 Aug.

  PMID: 40687396 DERIVED

• van Vliet D, Ploumen EH, Pinxterhuis TH, Doggen CJM, Aminian A, Schotborgh CE, Danse PW, Roguin A, Anthonio RL, Benit E, Kok MM, Linssen GCM, von Birgelen C. Elderly patients treated with Onyx versus Orsiro drug-eluting coronary stents in a randomized clinical trial with long-term follow-up. Clin Res Cardiol. 2025 Dec;114(12):1681-1691. doi: 10.1007/s00392-025-02622-7. Epub 2025 Mar 4.

  PMID: 40035811 DERIVED

• van Vliet D, Ploumen EH, Pinxterhuis TH, Buiten RA, Aminian A, Schotborgh CE, Danse PW, Roguin A, Anthonio RL, Benit E, Zocca P, Doggen CJM, von Birgelen C. Final 5-year report of BIONYX comparing the thin-composite wire-strut zotarolimus-eluting stent versus ultrathin-strut sirolimus-eluting stent. Catheter Cardiovasc Interv. 2024 Jul;104(1):1-9. doi: 10.1002/ccd.31067. Epub 2024 May 7.

  PMID: 38713843 DERIVED

• 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.

  PMID: 37745109 DERIVED

• Pinxterhuis TH, Ploumen EH, Zocca P, Doggen CJM, Schotborgh CE, Anthonio RL, Roguin A, Danse PW, Benit E, Aminian A, van Houwelingen KG, Linssen GCM, Geelkerken RH, von Birgelen C. Outcome of percutaneous coronary intervention using ultrathin-strut biodegradable polymer sirolimus-eluting versus thin-strut durable polymer zotarolimus-eluting stents in patients with comorbid peripheral arterial disease: a post-hoc analysis from two randomized trials. Cardiovasc Diagn Ther. 2023 Aug 31;13(4):673-685. doi: 10.21037/cdt-22-584. Epub 2023 Jul 24.

  PMID: 37675090 DERIVED

• 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.

  PMID: 37619976 DERIVED

• 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.

  PMID: 35641327 DERIVED

• Ploumen EH, Pinxterhuis TH, Zocca P, Roguin A, Anthonio RL, Schotborgh CE, Benit E, Aminian A, Danse PW, Doggen CJM, von Birgelen C, Kok MM. Impact of prediabetes and diabetes on 3-year outcome of patients treated with new-generation drug-eluting stents in two large-scale randomized clinical trials. Cardiovasc Diabetol. 2021 Oct 30;20(1):217. doi: 10.1186/s12933-021-01405-4.

  PMID: 34717627 DERIVED

• Ploumen EH, Buiten RA, Zocca P, Doggen CJ, Aminian A, Schotborgh CE, Jessurun GA, Roguin A, Danse PW, Benit E, von Birgelen C. First Report of 3-Year Clinical Outcome After Treatment With Novel Resolute Onyx Stents in the Randomized BIONYX Trial. Circ J. 2021 Oct 25;85(11):1983-1990. doi: 10.1253/circj.CJ-21-0292. Epub 2021 Jul 13.

  PMID: 34261828 DERIVED

• von Birgelen C, Zocca P, Buiten RA, Jessurun GAJ, Schotborgh CE, Roguin A, Danse PW, Benit E, Aminian A, van Houwelingen KG, Anthonio RL, Stoel MG, Somi S, Hartmann M, Linssen GCM, Doggen CJM, Kok MM. Thin composite wire strut, durable polymer-coated (Resolute Onyx) versus ultrathin cobalt-chromium strut, bioresorbable polymer-coated (Orsiro) drug-eluting stents in allcomers with coronary artery disease (BIONYX): an international, single-blind, randomised non-inferiority trial. Lancet. 2018 Oct 6;392(10154):1235-1245. doi: 10.1016/S0140-6736(18)32001-4. Epub 2018 Sep 22.

  PMID: 30253879 DERIVED

• van der Heijden LC, Kok MM, Zocca P, Jessurun GAJ, Schotborgh CE, Roguin A, Benit E, Aminian A, Danse PW, Lowik MM, Linssen GCM, van der Palen J, Doggen CJM, von Birgelen C. Bioresorbable Polymer-Coated Orsiro Versus Durable Polymer-Coated Resolute Onyx Stents (BIONYX): Rationale and design of the randomized TWENTE IV multicenter trial. Am Heart J. 2018 Apr;198:25-32. doi: 10.1016/j.ahj.2017.12.011. Epub 2017 Dec 21.

  PMID: 29653644 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Angina Pectoris; Angina, Unstable; Acute Coronary Syndrome; Coronary Stenosis; Coronary Restenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clemens von Birgelen, MD, PhD

  Thorax Centrum Twente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: July 23, 2015
• First Posted: July 27, 2015
• Study Start: October 7, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2019
• Last Updated: February 3, 2017

Record last verified: 2017-02

Locations

IL (1); NL (4); BE (2)