Comparing drug-coated balloons and drug-eluting stents for patients with high bleeding risk and chronic coronary syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a prospective, multi-center, open-label, randomized controlled trial that aims to compare the clinical outcomes of patients with chronic coronary syndrome who are treated with drug-coated balloon (DCB) angioplasty versus those treated with drug-eluting stents (DES). The study focuses on patients at high bleeding risk (HBR) and evaluates the effects of continuing or discontinuing antiplatelet therapy after the procedure. By assessing the need for dual antiplatelet therapy (DAPT) in these patients, the trial seeks to determine if DCB can provide a safer alternative with shorter therapy duration. The primary goal is to analyze the incidence of clinical events over a year following the intervention.

Why it matters

Who can join: the full rules

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

Where it's running

• Korea University Ansan Hospital
  Ansan, South Korea Recruiting
• Keimyung University Dongsan Medical Center
  Daegu, South Korea Recruiting
• Gangneung Asan Hospital, University of Ulsan College of Medicine
  Gangneung, South Korea Recruiting
• Ilsan Paik hospital
  Goyang, South Korea Recruiting
• Chonnam National University Hospital, Chonnam National University Medical School
  Gwangju, South Korea Recruiting
• Chung-Ang University Gwangmyeong Hospital
  Gwangmyeong, South Korea Recruiting

Study contacts

• Principal investigator: Joo Myung Lee, MD, MPH, PhD — Samsung Medical Center
• Study coordinator: Joo Myung Lee, MD, MPH, PhD
• Email: drone80@hanmail.net
• Phone: 82-2-3410-2575

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.