Drug-Coated Balloon Versus Drug-Eluting Stent for Treatment of De-Novo Coronary Lesions in Patients With High Bleeding Risk-2 (DCB-HBR-2)

November 21, 2025 updated by: Joo Myung Lee, Samsung Medical Center

Discontinuation of Antiplatelet Agent After Drug-Coated Balloon Angioplasty in Stabilized Patients With High Bleeding Risk and Coronary Artery Disease

A prospective, multi-center, open-label, randomized controlled, and superiority trial. The trial will compare clinical outcomes between discontinuation of antiplatelet agent and continuation of antiplatelet agent in HBR patients with chronic coronary syndrome treated by DCB angioplasty and standard duration of DAPT, followed by maintenance of single antiplatelet agent without clinical event for at least 1 year from the index procedure.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In patients with chronic coronary syndrome, the benefit of percutaneous coronary intervention (PCI) has been controversial for a survival benefit while reducing the risk of spontaneous myocardial infarction (MI) or anginal symptoms. Therefore, unlike patients with acute coronary syndrome, routine PCI with drug-eluting stents (DES) for patients with chronic coronary syndrome should be individualized, considering the risk of long term possibility of stent failure and the need for maintaining dual antiplatelet therapy (DAPT) for certain period due to permanent vascular implant and increased risk of bleeding, especially in patients with high bleeding risk (HBR). Drug-coated balloon (DCB), a novel treatment strategy, which has benefit of having shorter antiplatelet therapy duration due to the absence of metallic scaffolds and polymers, could be an alternative treatment for patients with chronic coronary syndrome, especially in patients with HBR. Given the expanding indications for DCB including de novo coronary artery lesions, shorter duration of DAPT, and potentially reduced risk of bleeding might be a reasonable treatment strategy in patients with HBR.

In current guidelines, standard duration of DAPT after PCI is recommended for 1 to 3 months in patients with HBR. Then, it is recommended as Class IA recommendation for maintaining single antiplatelet agent for lifelong as a secondary prevention, regardless of the devices used during PCI and the risk of patients' bleeding risk. However, it should be noted that the supporting evidence for lifelong maintenance of single antiplatelet agent were derived from previous randomized controlled trials conducted in patients with acute myocardial infarction or stroke. In addition, the supporting evidence for lifelong maintenance of single antiplatelet agent after PCI was derived from the recent randomized controlled trials using metallic stents including bare metal stent, 1st generation DES, or 2nd generation DES. The gap in the evidence is that no previous trial evaluated the need of lifelong maintenance of single antiplatelet agent in HBR patients with chronic coronary syndrome treated by DCB angioplasty after standard duration of DAPT. Furthermore, although recent trial have shown that long-term antiplatelet monotherapy with clopidogrel demonstrated better clinical outcomes than antiplatelet monotherapy with aspirin in patients with chronic coronary syndrome undergoing PCI with DES, there has been scarce data regarding long-term antiplatelet therapy for HBR patients with chronic coronary syndrome treated by DCB angioplasty after standard duration of DAPT.

On this background, the current trial aims to compare clinical outcomes between discontinuation of antiplatelet agent and continuation of antiplatelet agent in HBR patients with chronic coronary syndrome treated by DCB angioplasty and standard duration of DAPT, followed by maintenance of single antiplatelet agent without clinical event for at least 1 year from the index procedure. Having this evidence will be able to more establish the evidence for the post-adjunctive medical treatment in patients with HBR after DCB angioplasty.

Study Type

Interventional

Enrollment (Estimated)

1200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Seung Hun Lee, MD, PhD
  • Phone Number: 82-10-6413-7449
  • Email: lsh8602@naver.com

Study Locations

  • South Korea
      • Ansan, South Korea
        • Recruiting
        • Korea University Ansan Hospital
        • Contact:
        • Principal Investigator:
          • Sunwon Kim, MD, PhD
      • Daegu, South Korea
        • Recruiting
        • Keimyung University Dongsan Medical Center
        • Contact:
        • Principal Investigator:
          • Hyuck-Jun Yoon, MD, PhD
      • Gangneung, South Korea
        • Recruiting
        • Gangneung Asan Hospital, University of Ulsan College of Medicine
        • Contact:
        • Principal Investigator:
          • Hanbit Park, MD, PhD
      • Goyang, South Korea
        • Recruiting
        • Ilsan Paik Hospital
        • Contact:
        • Principal Investigator:
          • Joon-Hyung Doh, MD,PhD
        • Sub-Investigator:
          • Sung Woo Cho, MD,PhD
        • Sub-Investigator:
          • Sung-Eun Kim, MD,PhD
        • Sub-Investigator:
          • Hyun Cho, MD,PhD
      • Gwangju, South Korea
        • Recruiting
        • Chonnam National University Hospital, Chonnam National University Medical School
        • Contact:
        • Sub-Investigator:
          • Seung Hun Lee, MD, PhD
        • Contact:
        • Principal Investigator:
          • Young Joon Hong, MD, PhD
        • Sub-Investigator:
          • Joon Ho Ahn, MD, PhD
      • Gwangmyeong, South Korea
        • Recruiting
        • Chung-Ang University Gwangmyeong Hospital
        • Contact:
        • Principal Investigator:
          • Sang Yeub Lee, MD, PhD
        • Sub-Investigator:
          • Jun Hwan Cho, MD, PhD
        • Sub-Investigator:
          • Jinhwan Jo, MD, PhD
      • Incheon, South Korea
        • Recruiting
        • Inha University Hospital
        • Contact:
        • Principal Investigator:
          • Sang Don Park, MD, PhD
        • Sub-Investigator:
          • Sung-Hwan Choi, MD, PhD
      • Incheon, South Korea
        • Recruiting
        • Catholic Kwandong University International St. Mary's Hospital
        • Contact:
        • Principal Investigator:
          • Hyung-Bok Park, MD, PhD
      • Incheon, South Korea
        • Recruiting
        • Gachon Cardiovascular Research Institute, Gachon University
        • Contact:
        • Principal Investigator:
          • Albert Youngwoo Jang, MD, PhD
      • Jeonju, South Korea
        • Recruiting
        • Chonbuk National University Hospital and Chonbuk National University Medical School
        • Contact:
        • Principal Investigator:
          • Yisik Kim, MD, PhD
        • Sub-Investigator:
          • Chang Hoon Kim, MD, PhD
      • Jinju, South Korea
        • Recruiting
        • Gyeongsang National University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hangyul Kim, MD, PhD
        • Sub-Investigator:
          • Jin-Sin Koh, MD, PhD
        • Sub-Investigator:
          • Min Gyu Kang, MD, PhD
      • Seoul, South Korea
        • Recruiting
        • Chung-Ang University Hospital
        • Contact:
        • Principal Investigator:
          • Ho Youn Won, MD, PhD
      • Seoul, South Korea
        • Recruiting
        • Samsung Medical Center
        • Principal Investigator:
          • Joo Myung Lee, MD, MPH, PhD
        • Contact:
        • Sub-Investigator:
          • Ki Hong Choi, MD, PhD
        • Contact:
        • Sub-Investigator:
          • Taek Kyu Park, MD, PhD
        • Sub-Investigator:
          • Jeong Hoon Yang, MD, PhD
        • Sub-Investigator:
          • Young Bin Song, MD, PhD
        • Sub-Investigator:
          • Joo-Yong Hahn, MD, PhD
      • Seoul, South Korea
        • Recruiting
        • Korea University Guro Hospital
        • Contact:
        • Principal Investigator:
          • Dong-Oh Kang, MD, PhD
      • Seoul, South Korea
        • Recruiting
        • Kangbuk Samsung Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Seung-Jae Lee, MD, PhD
        • Sub-Investigator:
          • Jong-Young Lee, MD, PhD
        • Principal Investigator:
          • Woochan Kwon, MD, PhD
      • Seoul, South Korea
        • Recruiting
        • SMG-SNU Boramae Medical Center
        • Contact:
        • Principal Investigator:
          • Hyun Sung Joh, MD, PhD
      • Suwon, South Korea
        • Recruiting
        • Ajou University School of Medicine
        • Contact:
        • Principal Investigator:
          • Hong-Seok Lim, MD, PhD
      • Uijeongbu-si, South Korea
        • Recruiting
        • Uijeongbu St. Mary Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Seonghyeon Bu, MD, PhD
        • Sub-Investigator:
          • Chan Joon Kim, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subject must be at least 19 years of age
  2. Subject who is able to understand risks, benefits and treatment alternatives and sign informed consent voluntarily.
  3. Patients with chronic coronary syndrome and at least one de novo lesion of reference vessel size ≥2.25 mm, treated with DCB angioplasty
  4. Patients with high bleeding risk: one or more of the criteria listed A. Age ≥ 75 years old B. Baseline Hemoglobin <11 g/dl (or anemia requiring transfusion during the 4 weeks prior to randomization) C. Any prior intra-cerebral bleed D. Hospital admission for bleeding during the prior 12 months E. Non skin cancer diagnosed or treated < 3 years F. Planned daily NSAID (other than aspirin) or steroids for >30 days after PCI G. Planned surgery that would require interruption of DAPT (within next 12 months) H. Renal failure defined as calculated creatinine clearance <40 ml/min or on dialysis I. Hematological disorders (platelet count <100,000/mm3 or any coagulation disorder) J. Severe chronic liver disease defined as patients who have developed any of the following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice K. Expected non-compliance to secondary prevention medications after PCI for other medical reasons
  5. Patients who completed standard duration of DAPT (1-3months) and followed by maintenance of single antiplatelet agent (aspirin or P2Y12 inhibitor) for at least 1 year from index procedure.
  6. No bleeding (BARC 2, 3, or 5 bleeding) or ischemic events (cardiovascular death, non-fatal MI, or clinically-indicated repeat revascularization) for at least 1 year from index procedure.

Exclusion Criteria:

  1. Patients unable to provide consent
  2. Patients with acute myocardial infarction or unstable angina
  3. Patients with known intolerance to aspirin, P2Y12 inhibitors, or components of DCB
  4. Patients with indication of oral anticoagulant
  5. Patients with concomitant drug-eluting stent implantation during index PCI
  6. Patients with history of ischemic stroke or previous myocardial infarction
  7. Patients with peripheral arterial occlusive disease
  8. Patients with angiographic findings of A. Left main coronary artery disease B. In-stent restenosis is the cause of target lesion C. Target lesion in bypass graft D. True bifurcation lesion that requires upfront 2-stenting E. Patients with residual stenosis on non-target vessels after PCI (>70% diameter stenosis or FFR≤0.80)
  9. Patients who have non-cardiac co-morbid conditions with life expectancy <1 year
  10. Patients who may result in protocol non-compliance (site investigator's medical judgment)
  11. Patients with cardiogenic shock or cardiac arrest
  12. Patients with severe left ventricular systolic dysfunction (ejection fraction <30%)
  13. Patients with severe valvular heart disease requiring open heart surgery
  14. Pregnant or lactating women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Discontinuation of antiplatelet agent group
In this group, antiplatelet monotherapy will be discontinued at the time of randomization. Randomization will be performed at 1 year from the index procedure using DCB angioplasty, standard duration of DAPT (1-3 months), and maintenance of antiplatelet monotherapy at least 1 year from the index procedure in patients with HBR and chronic coronary syndrome. In patients who are still under DAPT at 1 year from index DCB angioplasty, all antiplatelet agents will be discontinued after randomization.
Other: Discontinuation of antiplatelet agent group
In this group, antiplatelet monotherapy will be discontinued at the time of randomization. Randomization will be performed at 1 year from the index procedure using DCB angioplasty, standard duration of DAPT (1-3 months), and maintenance of antiplatelet monotherapy at least 1 year from the index procedure in patients with HBR and chronic coronary syndrome. In patients who are still under DAPT at 1 year from index DCB angioplasty, all antiplatelet agents will be discontinued after randomization.
Active Comparator: Continuation of antiplatelet agent group
In this group, lifelong antiplatelet monotherapy will be continued after the time of randomization. Randomization will be performed at 1 year from the index procedure using DCB angioplasty, standard duration of DAPT (1-3 months), and maintenance of antiplatelet monotherapy at least 1 year from the index procedure in patients with HBR and chronic coronary syndrome. In patients who are still under DAPT at 1 year from index DCB angioplasty, DAPT will be changed to single antiplatelet therapy (aspirin or clopidogrel). The choice between aspirin or clopidogrel will be determined by the physician's discretion.
Other: Continuation of antiplatelet agent group
In this group, lifelong antiplatelet monotherapy will be continued after the time of randomization. Randomization will be performed at 1 year from the index procedure using DCB angioplasty, standard duration of DAPT (1-3 months), and maintenance of antiplatelet monotherapy at least 1 year from the index procedure in patients with HBR and chronic coronary syndrome. In patients who are still under DAPT at 1 year from index DCB angioplasty, DAPT will be changed to single antiplatelet therapy (aspirin or clopidogrel). The choice between aspirin or clopidogrel will be determined by the physician's discretion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major bleeding (BARC 2, 3, or 5 bleeding)
Time Frame: 1 year after last patient enrollment
BARC 2, 3, or 5 bleeding
1 year after last patient enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause death
Time Frame: 1 year after last patient enrollment
All-cause death
1 year after last patient enrollment
Cardiovascular death
Time Frame: 1 year after last patient enrollment
Cardiovascular death
1 year after last patient enrollment
Patient-oriented composite outcome
Time Frame: 1 year after last patient enrollment
a composite of all-cause death, non-fatal myocardial infarction, and any revascularization
1 year after last patient enrollment
Target-vessel myocardial infarction
Time Frame: 1 year after last patient enrollment
Target-vessel myocardial infarction
1 year after last patient enrollment
Non-fatal MI
Time Frame: 1 year after last patient enrollment
Non-fatal MI
1 year after last patient enrollment
Clinically indicated target-lesion revascularization (TLR)
Time Frame: 1 year after last patient enrollment
Clinically indicated target-lesion revascularization (TLR)
1 year after last patient enrollment
Clinically indicated target-vessel revascularization (TVR)
Time Frame: 1 year after last patient enrollment
Clinically indicated target-vessel revascularization (TVR)
1 year after last patient enrollment
Any revascularization
Time Frame: 1 year after last patient enrollment
Any revascularization
1 year after last patient enrollment
Cardiovascular death or target-vessel MI
Time Frame: 1 year after last patient enrollment
Cardiovascular death or target-vessel MI
1 year after last patient enrollment
All-cause death or non-fatal MI
Time Frame: 1 year after last patient enrollment
All-cause death or non-fatal MI
1 year after last patient enrollment
Target vessel failure
Time Frame: 1 year after last patient enrollment
a composite of cardiovascular death, target-vessel MI, and clinically indicated target-vessel revascularization
1 year after last patient enrollment
Severe major bleeding (BARC 3 or 5 bleeding)
Time Frame: 1 year after last patient enrollment
BARC 3 or 5 bleeding
1 year after last patient enrollment
Major bleeding (TIMI major bleeding)
Time Frame: 1 year after last patient enrollment
TIMI major bleeding
1 year after last patient enrollment
Cerebrovascular accident (CVA)
Time Frame: 1 year after last patient enrollment
Cerebrovascular accident (CVA) including Ischemic stroke, Hemorrhagic stroke, or Transient ischemic attack (TIA)
1 year after last patient enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Collaborators

Chonnam National University Hospital

Investigators

  • Study Chair: Young Bin Song, MD, PhD, Samsung Medical Center
  • Principal Investigator: Joo Myung Lee, MD, MPH, PhD, Samsung Medical Center
  • Study Chair: Joo-Yong Hahn, MD, PhD, Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2025

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2031

Study Registration Dates

First Submitted

December 15, 2024

First Submitted That Met QC Criteria

December 15, 2024

First Posted (Actual)

December 19, 2024

Study Record Updates

Last Update Posted (Actual)

November 28, 2025

Last Update Submitted That Met QC Criteria

November 21, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCT314316452025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After completion of primary trial report, executive committee members will have discussion about sharing the individual participant data (IPD) upon reasonable requests,

IPD Sharing Time Frame

After completion of primary trial report

IPD Sharing Access Criteria

Upon reasonable requests, executive committee members will have discussion about sharing the individual participant data (IPD).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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