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DES are preferred over BMS for most patients, however prolonged dual antiplatelet therapy is required for patients treated with DES for prevention of late or very late stent thrombosis. which increases a risk of major bleeding. BioFreedom is a Biolimus A9-coated stent that consists of a stainless steel stent platform with a textured abluminal surface without use of any polymer in the coating. Biolimus A9 rapid release and polymer-free property may give BioFreedom the advantages of both DES and BMS that may require less duration of DAPT. BioMatrix Flex, Biolimus-eluting stent with biodegradable polymer, also demonstrated safety and efficacy. We will compare these two difference types of Biolimus A9-eluting stents with different duration of DAPT. With proven adequate and safe duration, we will compare between one versus more than six months of dual antiplatelet therapy after Biolimus A9-eluting stents implantation using different properties of BioFreedom and BioMatrix Flex.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short-term DAPT after Biofreedom | Experimental |
| |
| Long-term DAPT after BioMatrix or Ultimaster | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BioFreedom with 1 month DAPT | Device | The cath lab will follow site standard operating procedures for PTCA and stenting. Information will be collected and recorded on the treated study vessel including angiographic parameters. Dual antiplatelet therapy after PCI will be continued for 1 month. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of major adverse cardiovascular events | events including cardiac death, nonfatal myocardial infarction, target vessel revascularization, major bleeding and cerebrovascular accident | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine | Seoul | 120-752 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41044734 | Derived | Jin IT, Kim Y, Heo SJ, Lee YJ, Lee SJ, Hong SJ, Ahn CM, Kim JS, Cho DK, Ko YG, Choi D, Hong MK, Kim BK. Comparison of Short-term and Standard Duration Dual Antiplatelet Therapy in Elderly Patients: A Pooled Analysis of Five Korean Randomized Clinical Trials. Korean Circ J. 2025 Dec;55(12):1125-1137. doi: 10.4070/kcj.2025.0093. Epub 2025 Jul 14. | |
| 35470799 |
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| BioMatrix or Ultimaster with 6 to 12 months DAPT | Device | The cath lab will follow site standard operating procedures for PTCA and stenting. Information will be collected and recorded on the treated study vessel including angiographic parameters. Dual antiplatelet therapy after PCI will be the duration of dual antiplatelet therapy will be 6 to 12 months at the discretion of the interventionist. |
|
| Lee YJ, Cho JY, Yun KH, Lee SJ, Hong SJ, Ahn CM, Kim BK, Ko YG, Choi D, Hong MK, Jang Y, Kim JS. Impact of one-month DAPT followed by aspirin monotherapy in patients undergoing percutaneous coronary intervention according to clinical presentation: a post hoc analysis of the randomised One-Month DAPT trial. EuroIntervention. 2022 Aug 19;18(6):471-481. doi: 10.4244/EIJ-D-22-00135. |
| 34332946 | Derived | Hong SJ, Kim JS, Hong SJ, Lim DS, Lee SY, Yun KH, Park JK, Kang WC, Kim YH, Yoon HJ, Won H, Nam CM, Ahn CM, Kim BK, Ko YG, Choi D, Jang Y, Hong MK; One-Month DAPT Investigators. 1-Month Dual-Antiplatelet Therapy Followed by Aspirin Monotherapy After Polymer-Free Drug-Coated Stent Implantation: One-Month DAPT Trial. JACC Cardiovasc Interv. 2021 Aug 23;14(16):1801-1811. doi: 10.1016/j.jcin.2021.06.003. Epub 2021 Jul 28. |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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