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

Study Overview
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Brief Summary
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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.

Official Title
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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)

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

Intervention / Treatment
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* Device: Orsiro
* Device: Synergy
* Device: Resolute Integrity


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Orsiro<br> | Device: Orsiro<br>* biodegradable polymer sirolimus eluting stent<br>|
| Active Comparator: Synergy<br> | Device: Synergy<br>* biodegradable polymer everolimus eluting stent<br>|
| Active Comparator: Resolute Integrity<br> | Device: Resolute Integrity<br>* durable polymer zotarolimus-eluting stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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drug-eluting stent, zotarolimus, everolimus, sirolimus, all comers population, target vessel failure, coronary artery disease, durable polymer, biodegradable polymer