Multivessel Coronary Artery Disease
Conditions
Keywords
multivessel stenting
Brief summary
The risk of restenosis in the treatment of coronary artery disease has significantly lessened thanks to the introduction of Drug eluting stent. Yet, debates on the efficacy and safety of stents in complex lesions or patients have been circulated. Recently, PCI in multiple lesions is universally performed with the development of effective stents in various kinds in the clinics. However, a randomized study is rare for multi-vessel coronary artery disease in real procedural environments. The primary purpose of this study is to evaluate the clinical progress of biolimus A9-eluting stent and zotarolimus-eluting stent in multi-vessel coronary artery disease.
Detailed description
The patients who need multi-vessel stenting with multi-vessel coronary artery disease will be enrolled.Each randomization of the enrolled subjects will be done 1:1 (biolimus A9-eluting stent : zotarolimus-eluting stent). Randomization will be stratified by two factors: Diabetes mellitus and Acute coronary syndrome.Clinical follow-up will occur at the following time points; 1 month, 1 year and 2 years.
Interventions
PROCEDUREPercutaneous Coronary Intervention
Percutaneous Transluminal coronary angioplasty and Intervention will be performed in both of randomized groups of biolimus A9 eluting stent and zotarolimus eluting stent
Sponsors
Keimyung University Dongsan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients who need multi-vessel stenting with multi-vessel disease * patients with signed informed consent
Exclusion criteria
* known contraindication to any of the following medications: Aspirin,clopidogrel, heparin, contrast agent, Biolimus or Zotarolimus group * Cardiogenic shock * Pregnant women or women with potential childbearing * End-stage diseases with life expectancy shorter than 2 years * patients with other Drug eluting stents implanted * Patients requiring modification of antiplatelet agents for planned major surgery within the first 12 months after the enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2-year composite end points | up to 2 years | All cause death, non fatal myocardial infarction, any revascularization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| non-cardiac death | up to 2 years | non-cardiac death |
| cardiac death | up to 2 years | cardiac death |
| non fatal myocardial infarction | up to 2 years | non fatal myocardial infarction |
| All cause death | up to 2 years | All cause death |
| Target lesion revascularization | up to 2 years | Target lesion revascularization |
| Target vessel revascularization | up to 2 years | Target vessel revascularization |
| stent thrombosis | up to 2 years | stent thrombosis |
| Any revascularization | up to 2 years | Any revascularization |
Countries
South Korea
Outcome results
None listed