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)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Coronary Syndrome
- Sponsor
- Foundation of Cardiovascular Research and Education Enschede
- Enrollment
- 3514
- Locations
- 1
- Primary Endpoint
- Target vessel failure (TVF)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
prof. C. von Birgelen
Professor C. von Birgelen
Thorax Centrum Twente
Eligibility Criteria
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
Outcomes
Primary Outcomes
Target vessel failure (TVF)
Time Frame: 1 year
Target vessel failure is a combined endpoint of cardiac death, target vessel related myocardial infarction and clinically driven target vessel revascularization.
Secondary Outcomes
- Target lesion failure (TLF)(1 year)