DCS Versus DES for One-month DAPT in Patients With ACS: ONE-PASS Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Drug-Coated Stent Versus Drug-Eluting Stent for One-month Dual-antiplatelet Therapy in Patients With Acute Coronary Syndrome: ONE-PASS Trial

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Device: Drug-coated stent
* Device: Drug-eluting stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥19 years All subjects who are acceptable candidates for treatment with a drug-coated stent or drug-eluting stent because of acute coronary syndrome Provision of informed consent Exclusion Criteria: Current or potential pregnancy Need of oral anticoagulation therapy Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DCS group<br>Drug-coated stent group | Device: Drug-coated stent<br>* The polymer-free drug-coated stent (BioFreedom Ultra stent) will be implanted for the DCS group.<br>* Other names: BioFreedom Ultra stent;|
| Active Comparator: DES group<br>Drug-eluting stent group | Device: Drug-eluting stent<br>* The Biodegradable polymer drug-eluting stent (Ultimaster stent) will be implanted for the DES group.<br>* Other names: Ultimaster stent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-Oriented Composite Endpoint (POCE) | The composite of all-cause death, MI, or any revascularization | At 1 year after randomization | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ticagrelor, Acute coronary syndrome, Drug-eluting stent, Dual-antiplatelet therapy