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

Primary Purpose

Acute Coronary Syndrome, Angina Pectoris, Angina, Unstable

Status

Completed

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Orsiro

Synergy

Resolute Integrity

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring drug-eluting stent, zotarolimus, everolimus, sirolimus, all comers population, target vessel failure, coronary artery disease, durable polymer, biodegradable polymer

Eligibility Criteria

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

Inclusion Criteria:

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.
Patients with all clinical syndromes will be enrolled without any exclusion based on number, type, location, or length of lesions to be treated.

Exclusion Criteria:

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

Sites / Locations

Albert Schweitzer Ziekenhuis

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Orsiro

Synergy

Resolute Integrity

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Target lesion failure (TLF)

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

Full Information

NCT ID

NCT01674803

First Posted

August 21, 2012

Last Updated

July 19, 2022

Sponsor

Foundation of Cardiovascular Research and Education Enschede

1. Study Identification

Unique Protocol Identification Number

NCT01674803

Brief Title

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

Acronym

BIO-RESORT

Official Title

Comparison of BIOdegradable Polymer and DuRablE Polymer Drug-eluting Stents in an All COmeRs PopulaTion: Randomized Multicenter Trial in an All Comers Population Treated Within thE NeThErlands 3 (TWENTE 3)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

December 21, 2012 (Actual)

Primary Completion Date

August 24, 2016 (Actual)

Study Completion Date

August 25, 2020 (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. 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.

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, sirolimus, all comers population, target vessel failure, coronary artery disease, durable polymer, biodegradable polymer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

3514 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Orsiro

Arm Type

Active Comparator

Arm Title

Synergy

Arm Type

Active Comparator

Arm Title

Resolute Integrity

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

Orsiro

Intervention Description

biodegradable polymer sirolimus eluting stent

Intervention Type

Device

Intervention Name(s)

Synergy

Intervention Description

biodegradable polymer everolimus eluting stent

Intervention Type

Device

Intervention Name(s)

Resolute Integrity

Intervention Description

durable polymer zotarolimus-eluting stent

Primary Outcome Measure Information:

Title

Target vessel failure (TVF)

Description

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

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Target lesion failure (TLF)

Description

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

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Patients with all clinical syndromes will be enrolled without any exclusion based on number, type, location, or length of lesions to be treated. Exclusion Criteria: 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

Facility Information:

Facility Name

Albert Schweitzer Ziekenhuis

City

Dordrecht

Country

Netherlands

12. IPD Sharing Statement

Citations:

PubMed Identifier

36346050

Citation

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.

Results Reference

derived

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

34717627

Citation

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.

Results Reference

derived

PubMed Identifier

32237060

Citation

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.

Results Reference

derived

PubMed Identifier

31422087

Citation

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.

Results Reference

derived

PubMed Identifier

31111862

Citation

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.

Results Reference

derived

PubMed Identifier

27806902

Citation

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.

Results Reference

derived

PubMed Identifier

24655691

Citation

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.

Results Reference

derived

Learn more about this trial

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

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