Coronary Artery Disease
Conditions
Keywords
Left Main
Brief summary
The purpose of this study is to observe clinical courses for long-term in patients with unprotected LMCA disease and to evaluate comparative results of medical treatment, coronary stenting with drug-eluting stents, and CABG for the treatment of an unprotected LMCA stenosis in the "real world" daily practice.
Detailed description
This study is a multicenter, large clinical registry to evaluate comparative outcomes of medical therapy, PCI with DES, or CABG for patients with unprotected LMCA stenosis in the Asia-Pacific, as recorded in the MAIN-IRIS Registry. Data will be prospectively collected on approximately 5000 subjects who diagnosed LM disease (\>50% by visual estimation) at approximately 65 centers in Korea and Asia-Pacific region. Brief study design is as depicted in the following figure
Interventions
None listed
Sponsors
Study design
Eligibility
Inclusion criteria
* Significant unprotected left main stenosis (\>50% by visual estimation) * The LMCA is considered unprotected if there are no patent coronary artery bypass grafts to the left anterior descending artery or the left circumflex artery. * No limitation of clinical or lesion characteristics * Age \>18 years * The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.
Exclusion criteria
* Protected left main stenosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite event rate of death, myocardial infarction, Target Vessel Revascularization or cerebrovascular event | 2-year | A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event that is considered to have occurred if any one of several different events is observed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Death | 10-year | — |
| Cardiac death | 10-year | — |
| Myocardial infarction | 10-year | — |
| Cerebrovascular event | 10-year | — |
| Target vessel revascularization | 10-year | — |
| Target lesion revascularization | 10-year | — |
| Stent thrombosis | 10-year | According to Academic Research Consortium (ARC) criteria |
| Binary restenosis and late luminal loss in both in-stent and in-segment | 9-month | Angiographic follow-up in the PCI group (as form of PCI substudy) |
| Rehospitalization | 10-year | — |
Countries
China, Malaysia, South Korea, Taiwan, Thailand
Contacts
CVRF