Acute Coronary Syndrome, Angina Pectoris, Angina, Unstable, Myocardial Infarction, Coronary Artery Disease, Coronary Stenosis, Coronary Restenosis
Conditions
Keywords
drug-eluting stent, zotarolimus, everolimus, sirolimus, all comers population, target vessel failure, coronary artery disease, durable polymer, biodegradable polymer
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.
Interventions
DEVICEOrsiro
biodegradable polymer sirolimus eluting stent
DEVICESynergy
biodegradable polymer everolimus eluting stent
DEVICEResolute Integrity
durable polymer zotarolimus-eluting stent
Sponsors
Foundation of Cardiovascular Research and Education Enschede
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Netherlands
Outcome results
None listed