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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biolimus A9 eluting stent | Experimental | biolimus A9 stent( Biomatrix or Biomatrix Flex) will be placed in under Percutaneous Coronary Intervention. |
|
| Zotarolimus-eluting stent | Active Comparator | zotarolimus eluting stent (Resolute Integrity) will be placed in under Percutaneous Coronary Intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous Coronary Intervention | Procedure | Percutaneous Transluminal coronary angioplasty and Intervention will be performed in both of randomized groups of biolimus A9 eluting stent and zotarolimus eluting stent |
| Measure | Description | Time Frame |
|---|---|---|
| 2-year composite end points | All cause death, non fatal myocardial infarction, any revascularization | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| All cause death | All cause death | up to 2 years |
| non-cardiac death | non-cardiac death | up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chang-Wook Nam, Postdoctoral | Keimyung University Dongsan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonnam National University Hospital | Kwangju | Chonnam | South Korea | |||
| Ulsan University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40097279 | Derived | Lee CH, Lee HJ, Chung TW, Lee S, Hwang J, Kim IC, Cho YK, Yoon HJ, Hur SH, Kim JY, Kim YS, Jang WS, Lee JH, Kim W, Lee JB, Hong YJ, Heo JH, Lee BR, Doh JH, Shin ES, Koo BK, Nam CW. Comparison of Thick Biolimus A9-Eluting Stent and Thin Zotarolimus-Eluting Stent in Multi-Vessel Percutaneous Coronary Intervention. Korean Circ J. 2025 May;55(5):396-407. doi: 10.4070/kcj.2024.0101. Epub 2025 Feb 17. |
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|
| cardiac death | cardiac death | up to 2 years |
| non fatal myocardial infarction | non fatal myocardial infarction | up to 2 years |
| Any revascularization | Any revascularization | up to 2 years |
| Target lesion revascularization | Target lesion revascularization | up to 2 years |
| Target vessel revascularization | Target vessel revascularization | up to 2 years |
| stent thrombosis | stent thrombosis | up to 2 years |
| Ulsan |
| Gyeongsangbuk-do |
| South Korea |
| Inje University Ilsan Paik Hospital | Ilsan | Kyeongki | South Korea |
| Kosin University Hospital | Busan | South Korea |
| Daegu Catholic University Medical Center | Daegu | South Korea |
| Daegu Fatima Hospital | Daegu | South Korea |
| KyungPook National University Hospital | Daegu | South Korea |
| Yeungnam University Hospital | Daegu | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| C107909 | Biomatrix preparation |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
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