Bioresorbable Polymer ORSIRO Versus Durable Polymer RESOLUTE ONYX Stents

NCT ID: NCT02508714

Last Updated: 2017-02-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 2470 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-07
• Study Completion Date: 2019-03-31

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.

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).

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Orsiro

Intervention Type: DEVICE

stents will be implanted in case of significant coronary artery disease

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.

Group Type: ACTIVE_COMPARATOR

Resolute Onyx

Intervention Type: DEVICE

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

Interventions

Orsiro

stents will be implanted in case of significant coronary artery disease

Intervention Type: DEVICE

Resolute Onyx

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

Intervention Type: DEVICE

Other Intervention Names

Orsiro drug eluting stent; Resolute Onyx drug eluting stent

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thorax Centrum Twente

OTHER

Sponsor Role: lead

Responsible Party

Clemens von Birgelen

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Clemens von Birgelen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Thorax Centrum Twente

Locations

CHU Charleroi

Charleroi, , Belgium

Jessa Ziekenhuis

Hasselt, , Belgium

Rambam

Haifa, , Israel

Haga Ziekenhuis

The Hague, South Holland, Netherlands

Rijnstate Hospital

Arnhem, , Netherlands

Treant Zorggroep

Emmen, , Netherlands

Medisch Spectrum Twente

Enschede, , Netherlands

Countries

Belgium; Israel; Netherlands

References

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Other Identifiers

P15-19

Identifier Type: -

Identifier Source: org_study_id