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Studies exploring the feasibility of drug-eluting balloon (DCB) in de-novo coronary lesions are limited. There are scarce data comparing DCB with drug-eluting stent (DES) in patients with high bleeding risk (HBR), a situation in which long-term maintenance of dual antiplatelet therapy (DAPT) is a clinical dilemma. This target trial emulation aims to compare clinical outcomes between DCB angioplasty and conventional DES implantation in de-novo coronary lesions in patients with coronary artery disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug coated balloon | Patients receiving drug coated balloon angioplasty |
| |
| Drug-eluting stent | Patients receiving drug-eluting stent implantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug coated balloon | Device | Patients receiving drug coated balloon angioplasty for de novo coronary artery disease |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rates of MACCE (major adverse cardiac and cerebrovascular events) | all-cause death, myocardial infarction, revascularization, and stroke | 3 years after index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of Major bleeding | major bleeding requiring transfusion | 3 years after index procedure |
| Rates of NACE (net adverse clinical events) | MACCE and any major bleeding requiring transfusion |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with de novo coronary artery disease for relatively simple lesions undergoing percutaneous coronary intervention
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| Name | Affiliation | Role |
|---|---|---|
| Ki Hong Choi, MD, PhD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | 06351 | South Korea |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D054855 | Drug-Eluting Stents |
| ID | Term |
|---|---|
| D015607 | Stents |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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| Drug-eluting stent | Device | Patients receiving drug-eluting stent implantationfor de novo coronary artery disease |
|
| 3 years after index procedure |
| Rates of all-cause death | death from any causes | 3 years after index procedure |
| Rates of myocardial infarction | 3 years after index procedure |
| Rates of revascularization | repeat revascularization | 3 years after index procedure |
| Rates of stroke | 3 years after index procedure |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |