Bioresorbable Polymer ORSIRO Versus Durable Polymer RESOLUTE ONYX Stents

Coronary Artery Disease Clinical Trial

— BIONYX  

Official title:

Bioresorbable Polymer ORSIRO Versus Durable Polymer RESOLUTE ONYX Stents (BIONYX): A Randomized Trial With Stent Evaluation in All-comers IV (TWENTE IV)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02508714
• Other study ID #: P15-19
• Status: Active, not recruiting
• Phase: N/A
• First received: July 23, 2015
• Last updated: February 2, 2017
• Start date: October 7, 2016
• Est. completion date: March 2019

Study information

• Verified date: February 2017
• Source: Thorax Centrum Twente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

rationale: 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.

Aim:

The aim of the study is to compare the outcome of the bioresorbable polymer coated stent (ORSIRO) and a new generation permanent polymer coated stent (RESOLUTE ONYX) in an all-comers patient population and non-inferiority setting.

Study design:

The study is a prospective, randomized, single-blinded, multicentre trial with 1:1 randomization for drug-eluting stent type, stratified for gender and the presence of diabetes mellitus.

Study population:

Patients who require percutaneous coronary intervention (PCI) for the treatment of coronary stenoses with an indication for DES use, according to current guidelines and/or the operators clinical judgement. All clinical syndromes will be included. A total of 2,470 patients will be included.

Intervention:

One group will receive the ORSIRO stent, the other group will receive the RESOLUTE ONYX stent. All other intervention and procedural characteristics are similar.

Primary study outcome:

Incidence of target vessel failure (TVF) at 1 year follow-up (according to ARC definitions). Components of the primary endpoint in hierarchical order: - Cardiac death: all deaths are considered cardiac, unless an unequivocal non-cardiac cause can be established. - Target vessel related myocardial infarction (MI) that is Q-wave or non-Q-wave, that can be related to the target vessel or cannot be related to another vessel. - Clinically driven repeated target vessel revascularization by means of PCI or coronary artery bypass grafting (CABG).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2470
• Est. completion date: March 2019
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

• 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 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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Angina Pectoris
• Angina, Unstable
• Coronary Artery Disease
• Coronary Disease
• Coronary Restenosis
• Coronary Stenosis
• Myocardial Ischemia
• Unstable Angina Pectoris

Intervention

Device:
• Orsiro
stents will be implanted in case of significant coronary artery disease
• Resolute Onyx
stents will be implanted in case of significant coronary artery disease based on coronary angiography

Locations

Country	Name	City	State
Belgium	CHU Charleroi	Charleroi
Belgium	Jessa Ziekenhuis	Hasselt
Israel	Rambam	Haifa
Netherlands	Rijnstate Hospital	Arnhem
Netherlands	Haga Ziekenhuis	Den Haag	Zuid Holland
Netherlands	Treant Zorggroep	Emmen
Netherlands	Medisch Spectrum Twente	Enschede

Sponsors (1)

Lead Sponsor	Collaborator
Thorax Centrum Twente

Countries where clinical trial is conducted

Belgium,  Israel,  Netherlands, 

References & Publications (2)

Sen H, Lam MK, Löwik 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. — View 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, Löwik MM, Linssen GC, Saïd 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. Erratum in: Lancet. 2014 Feb 1;383(9915):412. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Longitudinal stent deformation (LSD) and deliverability	Identification of deformation of a stent in the longitudinal axis during coronary angiographic assessment.	1 year
Primary	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	Death at 1 and 2 year follow-up	Death distinguished into: cardiac, vascular, other causes, all-cause mortality	1 and 2 year
Secondary	Myocardial infarction at 1 and 2 year follow-up	Myocardial infarction distinguished into Q-wave and non-Q-wave myocardial infarction	1 and 2 year
Secondary	Revascularization at 1 and 2 year follow-up	Target-vessel revascularization distinguished into PCI or CABG	1 and 2 year
Secondary	Stent thrombosis at 1 and 2 year follow-up	Stent thrombosis was distinguished into definite, probable and possible according to the Academic Research Consortium (ARC) definition.	1 and 2 year
Secondary	Target lesion failure (TLF) at 1 and 2 year follow-up	Composite endpoint consisting of : cardiac death; target vessel-related MI; clinically driven target lesion revascularization (TLR)	1 and 2 year
Secondary	Major adverse cardiac events (MACE) at 1 and 2 year follow-up	Composite endpoint consisting of: any death; any myocardial infarction; emergent CABG; clinically indicated TLR	1 and 2 year follow-up
Secondary	Patient oriented composite endpoint (POCE) at 1 and 2 year follow-up	Composite endpoint consisting of: any death; any myocardial infarction; any revascularization.	1 and 2 year follow-up
Secondary	Major Bleeding at 1 and 2 year follow-up	Major bleeding that require surgery or blood transfusions or cerebral hemorrhages	1 and 2 year follow-up