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To test whether the polymer-free drug-coated stent (DCS) BioFreedom is noninferior to the biodegradable polymer drug-eluting stent (DES) Ultimaster in terms of 1-year patient-oriented composite endpoint (POCE, composite of all-cause mortality, any MI, or any revascularization) in a setting of 1-month dual-antiplatelet therapy (DAPT) strategy (1-month DAPT followed ticagrelor monotherapy) after acute coronary syndrome.
This trial is an open-label, randomized, multi-center study. Patients with ACS requiring percutaneous coronary intervention will be randomized with a 1:1 ratio either of DCS group or DES group. After the index procedure, DAPT (100 mg aspirin qd and 90 mg ticagrelor bid) will be given for 1 month. After this, ticagrelor monotherapy will be maintained for 11 months. Clinical events will be evaluated within 12 months after randomization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DCS group | Experimental | Drug-coated stent group |
|
| DES group | Active Comparator | Drug-eluting stent group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug-coated stent | Device | The polymer-free drug-coated stent (BioFreedom Ultra stent) will be implanted for the DCS group. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient-Oriented Composite Endpoint (POCE) | The composite of all-cause death, MI, or any revascularization | At 1 year after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Device-Oriented Composite Endpoint (DOCE) | The composite of cardiovascular death, MI (not clearly attributable to a non-target vessel), or clinically-driven target-lesion revascularization (TLR) | At 1 year after randomization |
| All-cause death |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chul-Min Ahn | Contact | +82-2-2228-8532 | drcello@yuhs.ac | |
| Sung-Jin Hong, MD, PhD | Contact | +82-2-2228-8452 | hongs@yuhs.ac |
| Name | Affiliation | Role |
|---|---|---|
| Chul-Min Ahn | Yonsei University Health System, Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei Cardiovascular Hospital, Yonsei University College of Medicine | Recruiting | Seoul | South Korea |
The data will be available from the principal investigator on reasonable request.
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular 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 | The Biodegradable polymer drug-eluting stent (Ultimaster stent) will be implanted for the DES group. |
|
|
All death including cardiovascular death
| At 1 year after randomization |
| Cardiovascular death | Death resulting from cardiovascular causes or undetermined cause of death not attributable to any other category because of the absence of any relevant source documents | At 1 year after randomization |
| Myocardial infarction | A spontaneous event according to the fourth universal definition of myocardial infarction and the Academic Research Consortium-2 Consensus Document | At 1 year after randomization |
| Stroke | Loss of neurologic function caused by an ischemic or hemorrhagic event | At 1 year after randomization |
| Stent thrombosis (definite or probable) | By the Academic Research Consortium-2 Consensus Document | At 1 year after randomization |
| Any revascularization | All revascularizations including target-vessel revascularization and and non-target-vessel revascularization | At 1 year after randomization |
| Target-vessel revascularization | Clinically indicated or ischemia driven any repeat percutaneous intervention or surgical bypass of any segment of the target vessel including the target lesion | At 1 year after randomization |
| Non-target vessel revascularization | Clinically indicated or ischemia driven any repeat percutaneous intervention or surgical bypass of any segment of the non-target vessel | At 1 year after randomization |
| Target-lesion revascularization | Clinically indicated or ischemia driven repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion | At 1 year after randomization |
| BARC type 2-5 bleeding | According to a consensus report from the Bleeding Academic Research Consortium | At 1 year after randomization |
| BARC type 3-5 bleeding | According to a consensus report from the Bleeding Academic Research Consortium | At 1 year after randomization |