BIONYX: Bioresorbable Polymer ORSIRO Versus Durable Polymer RESOLUTE ONYX Stents
Study Details
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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed 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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Orsiro DES (Biotronik) 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
stents will be implanted in case of significant coronary artery disease
Other Names:
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| Active Comparator: RESOLUTE ONYX DES (Medtronic) 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
stents will be implanted in case of significant coronary artery disease based on coronary angiography
Other Names:
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Outcome Measures
Primary Outcome Measures
- Target vessel failure (TVF) [1 year]
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.
Secondary Outcome Measures
- Death at 1 and 2 year follow-up [1 and 2 year]
Death distinguished into: cardiac, vascular, other causes, all-cause mortality
- Myocardial infarction at 1 and 2 year follow-up [1 and 2 year]
Myocardial infarction distinguished into Q-wave and non-Q-wave myocardial infarction
- Revascularization at 1 and 2 year follow-up [1 and 2 year]
Target-vessel revascularization distinguished into PCI or CABG
- Stent thrombosis at 1 and 2 year follow-up [1 and 2 year]
Stent thrombosis was distinguished into definite, probable and possible according to the Academic Research Consortium (ARC) definition.
- Target lesion failure (TLF) at 1 and 2 year follow-up [1 and 2 year]
Composite endpoint consisting of : cardiac death; target vessel-related MI; clinically driven target lesion revascularization (TLR)
- Major adverse cardiac events (MACE) at 1 and 2 year follow-up [1 and 2 year follow-up]
Composite endpoint consisting of: any death; any myocardial infarction emergent CABG; clinically indicated TLR
- Patient oriented composite endpoint (POCE) at 1 and 2 year follow-up [1 and 2 year follow-up]
Composite endpoint consisting of: any death; any myocardial infarction; any revascularization.
- Major Bleeding at 1 and 2 year follow-up [1 and 2 year follow-up]
Major bleeding that require surgery or blood transfusions or cerebral hemorrhages
Other Outcome Measures
- Longitudinal stent deformation (LSD) and deliverability [1 year]
Identification of deformation of a stent in the longitudinal axis during coronary angiographic assessment.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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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:
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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).
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Planned elective surgical procedure necessitating interruption of DAPT during the first 3 months after randomization.
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Participation in another randomized cardiovascular device trial or randomized pharmacological study related to antithrombotic and/or anticoagulant therapy before reaching the primary endpoint.
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Known pregnancy, adherence to scheduled follow-up is unlikely, or life expectancy is assumed to be less than 1 year
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU Charleroi | Charleroi | Belgium | ||
| 2 | Jessa Ziekenhuis | Hasselt | Belgium | ||
| 3 | Rambam | Haifa | Israel | ||
| 4 | Haga Ziekenhuis | Den Haag | Zuid Holland | Netherlands | 2504 LN |
| 5 | Rijnstate Hospital | Arnhem | Netherlands | ||
| 6 | Treant Zorggroep | Emmen | Netherlands | ||
| 7 | Medisch Spectrum Twente | Enschede | Netherlands |
Sponsors and Collaborators
- Thorax Centrum Twente
Investigators
- Principal Investigator: Clemens von Birgelen, MD, PhD, Thorax Centrum Twente
Study Documents (Full-Text)
None provided.More Information
Publications
- 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. Epub 2015 May 20.
- 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. Epub 2013 Oct 31. Erratum in: Lancet. 2014 Feb 1;383(9915):412.
- P15-19