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

Not Applicable

Completed

• Conditions: Angina, Unstable; Coronary Stenosis; Acute Coronary Syndrome; Coronary Artery Disease; Myocardial Infarction; Angina Pectoris; Coronary Restenosis
• Interventions: Device: Orsiro; Device: Synergy; Device: Resolute Integrity

• Registration Number: NCT01674803
• Lead Sponsor: Foundation of Cardiovascular Research and Education Enschede

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-21
• Study First Submitted QC: 2012-08-27
• Study First Posted: 2012-08-29
• Study Start: 2012-12-21
• Primary Completion: 2016-08-24
• Study Completion: 2020-08-25
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3514

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Orsiro	Orsiro	-
Synergy	Synergy	-
Resolute Integrity	Resolute Integrity	-

Primary Outcome Measures

Name	Time	Method
Target vessel failure (TVF)	1 year	Target vessel failure is a combined endpoint of cardiac death, target vessel related myocardial infarction and clinically driven target vessel revascularization.

Secondary Outcome Measures

Name	Time	Method
Target lesion failure (TLF)	1 year	Target lesion failure is a combined endpoint of cardiac death, target vessel related myocardial infarction, and clinically driven target lesion revascularization

Trial Locations

Locations (1)

Albert Schweitzer Ziekenhuis; 🇳🇱 Dordrecht, Netherlands