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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3514 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-21

Study Completion Date

2020-08-25

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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Orsiro

Group Type ACTIVE_COMPARATOR

Orsiro

Intervention Type DEVICE

biodegradable polymer sirolimus eluting stent

Synergy

Group Type ACTIVE_COMPARATOR

Synergy

Intervention Type DEVICE

biodegradable polymer everolimus eluting stent

Resolute Integrity

Group Type ACTIVE_COMPARATOR

Resolute Integrity

Intervention Type DEVICE

durable polymer zotarolimus-eluting stent

Interventions

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Orsiro

biodegradable polymer sirolimus eluting stent

Intervention Type DEVICE

Synergy

biodegradable polymer everolimus eluting stent

Intervention Type DEVICE

Resolute Integrity

durable polymer zotarolimus-eluting stent

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No