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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Device: Drug-coated stent; Device: Drug-eluting stent

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 3520
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sung-Jin Hong, MD, PhD; Phone Number: +82-2-2228-8452; Email: hongs@yuhs.ac
• Study Contact Backup: Name: Chul-Min Ahn; Phone Number: +82-2-2228-8532; Email: drcello@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
    • Contact: Chul-Min Ahn; Phone Number: 82-2-2228-8532; Email: drcello@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥19 years
2. All subjects who are acceptable candidates for treatment with a drug-coated stent or drug-eluting stent because of acute coronary syndrome
3. Provision of informed consent

Exclusion Criteria:

1. Current or potential pregnancy
2. Need of oral anticoagulation therapy
3. Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: Chul-Min Ahn, Yonsei University Health System, Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2022
• Primary Completion (Estimated): February 14, 2030
• Study Completion (Estimated): February 14, 2030

Study Registration Dates

• First Submitted: March 22, 2022
• First Submitted That Met QC Criteria: March 22, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Actual): May 21, 2025
• Last Update Submitted That Met QC Criteria: May 18, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Ticagrelor; Acute coronary syndrome; Drug-eluting stent; Dual-antiplatelet therapy
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Disease; Myocardial Ischemia; Syndrome; Acute Coronary Syndrome
• Other Study ID Numbers: 1-2021-0089

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data will be available from the principal investigator on reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No