Comparison of BIOdegradable Polymer and DuRablE Polymer Drug-eluting Stents in an All COmeRs PopulaTion (BIO-RESORT)

NCT01674803 | Completed DMC

• 1 other identifier: BIO-RESORT
• Study Type: interventional
• Target: 3,514
• Locations: 1 country
• Sites: 1

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 biodegradable 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 biodegradable polymer DES are increasingly used in clinical practice, there is no data available from head-to-head comparisons between biodegradable and contemporary third generation durable polymer DES.

Conditions

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

Keywords

drug-eluting stent; zotarolimus; everolimus; sirolimus; all comers population; target vessel failure; coronary artery disease; durable polymer; biodegradable polymer

Outcome Measures

Primary Outcomes (1)

• Target vessel failure (TVF)

  Target vessel failure is a combined endpoint of cardiac death, target vessel related myocardial infarction and clinically driven target vessel revascularization.

  1 year

Secondary Outcomes (1)

• Target lesion failure (TLF)

  1 year

Study Arms (3)

Orsiro

ACTIVE COMPARATOR

Device: Orsiro

Synergy

ACTIVE COMPARATOR

Device: Synergy

Resolute Integrity

ACTIVE COMPARATOR

Device: Resolute Integrity

Interventions

Orsiro DEVICE

biodegradable polymer sirolimus eluting stent

Orsiro

Synergy DEVICE

biodegradable polymer everolimus eluting stent

Synergy

Resolute Integrity DEVICE

durable polymer zotarolimus-eluting stent

Resolute Integrity

Eligibility Criteria

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

You may qualify if:

• Minimum age of 18 years.
• Significant coronary artery disease and lesion(s) eligible for treatment with drug eluting stents according to clinical guidelines and/or the operators' judgement.
• Capable of providing informed consent.

You may not qualify if:

• Known intolerance to components of one of the stents that will be investigated or known intolerance to antithrombotic and/or anticoagulant therapy that prevents adherence to dual antiplatelet therapy.
• Planned elective surgical procedure necessitating interruption of dual antiplatelet therapy during the first 6 months after randomization.
• Participation in another randomized drug or device trial before reaching primary endpoint.
• Adherence to scheduled follow-up is unlikely or life expectancy assumed to be less than 1 year.
• Known pregnancy

Sponsors & Collaborators

• Foundation of Cardiovascular Research and Education Enschede: lead

Study Sites (1)

Albert Schweitzer Ziekenhuis

Dordrecht, Netherlands

Location

Related Publications (11)

• 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

• Ploumen EH, Pinxterhuis TH, Buiten RA, Zocca P, Danse PW, Schotborgh CE, Scholte M, Gin RMTJ, Somi S, van Houwelingen KG, Stoel MG, de Man HAF, Hartmann M, Linssen GCM, van der Heijden LC, Kok MM, Doggen CJM, von Birgelen C. Final 5-Year Report of the Randomized BIO-RESORT Trial Comparing 3 Contemporary Drug-Eluting Stents in All-Comers. J Am Heart Assoc. 2022 Nov 15;11(22):e026041. doi: 10.1161/JAHA.122.026041. Epub 2022 Nov 8.

  PMID: 36346050 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

• Buiten RA, Ploumen EH, Zocca P, Doggen CJM, van Houwelingen KG, Danse PW, Schotborgh CE, Stoel MG, Scholte M, Linssen GCM, de Man FHAF, von Birgelen C. Three contemporary thin-strut drug-eluting stents implanted in severely calcified coronary lesions of participants in a randomized all-comers trial. Catheter Cardiovasc Interv. 2020 Nov;96(5):E508-E515. doi: 10.1002/ccd.28886. Epub 2020 Apr 1.

  PMID: 32237060 DERIVED

• Buiten RA, Ploumen EH, Zocca P, Doggen CJM, Danse PW, Schotborgh CE, Scholte M, van Houwelingen KG, Stoel MG, Hartmann M, Tjon Joe Gin RM, Somi S, Linssen GCM, Kok MM, von Birgelen C. Thin, Very Thin, or Ultrathin Strut Biodegradable or Durable Polymer-Coated Drug-Eluting Stents: 3-Year Outcomes of BIO-RESORT. JACC Cardiovasc Interv. 2019 Sep 9;12(17):1650-1660. doi: 10.1016/j.jcin.2019.04.054. Epub 2019 Aug 14.

  PMID: 31422087 DERIVED

• Buiten RA, Ploumen EH, Zocca P, Doggen CJM, van der Heijden LC, Kok MM, Danse PW, Schotborgh CE, Scholte M, de Man FHAF, Linssen GCM, von Birgelen C. Outcomes in Patients Treated With Thin-Strut, Very Thin-Strut, or Ultrathin-Strut Drug-Eluting Stents in Small Coronary Vessels: A Prespecified Analysis of the Randomized BIO-RESORT Trial. JAMA Cardiol. 2019 Jul 1;4(7):659-669. doi: 10.1001/jamacardio.2019.1776.

  PMID: 31111862 DERIVED

• von Birgelen C, Kok MM, van der Heijden LC, Danse PW, Schotborgh CE, Scholte M, Gin RMTJ, Somi S, van Houwelingen KG, Stoel MG, de Man FHAF, Louwerenburg JHW, Hartmann M, Zocca P, Linssen GCM, van der Palen J, Doggen CJM, Lowik MM. Very thin strut biodegradable polymer everolimus-eluting and sirolimus-eluting stents versus durable polymer zotarolimus-eluting stents in allcomers with coronary artery disease (BIO-RESORT): a three-arm, randomised, non-inferiority trial. Lancet. 2016 Nov 26;388(10060):2607-2617. doi: 10.1016/S0140-6736(16)31920-1. Epub 2016 Oct 30.

  PMID: 27806902 DERIVED

• Lam MK, Sen H, Tandjung K, van Houwelingen KG, de Vries AG, Danse PW, Schotborgh CE, Scholte M, Lowik MM, Linssen GC, Ijzerman MJ, van der Palen J, Doggen CJ, von Birgelen C. Comparison of 3 biodegradable polymer and durable polymer-based drug-eluting stents in all-comers (BIO-RESORT): rationale and study design of the randomized TWENTE III multicenter trial. Am Heart J. 2014 Apr;167(4):445-51. doi: 10.1016/j.ahj.2013.11.014. Epub 2014 Jan 6.

  PMID: 24655691 DERIVED

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• 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: August 21, 2012
• First Posted: August 29, 2012
• Study Start: December 21, 2012
• Primary Completion: August 24, 2016
• Study Completion: August 25, 2020
• Last Updated: July 20, 2022

Record last verified: 2022-07

Locations

NL (1)