Comparing drug-coated balloons and drug-eluting stents for patients with high bleeding risk and chronic coronary syndrome
Discontinuation of Antiplatelet Agent After Drug-Coated Balloon Angioplasty in Stabilized Patients With High Bleeding Risk and Coronary Artery Disease
This study is testing whether using drug-coated balloons instead of drug-eluting stents can help patients with chronic coronary syndrome who are at high risk for bleeding, while also looking at how long they need to take blood-thinning medicine after the procedure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1200 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Samsung Medical Center Academic / other |
| Locations | 18 sites (Ansan and 17 other locations) |
| Trial ID | NCT06742931 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 19 and older with chronic coronary syndrome and at least one de novo coronary lesion, who also meet the criteria for high bleeding risk.
Not a fit: Patients who do not have chronic coronary syndrome or those who do not meet the high bleeding risk criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer treatment option for patients with chronic coronary syndrome who are at high risk of bleeding.
How similar studies have performed: Other studies have shown promising results with drug-coated balloons in similar patient populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Ansan and 17 other locations
- 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)
- Catholic Kwandong University International St. Mary's Hospital — Incheon, South Korea (Recruiting)
- Gachon Cardiovascular Research Institute, Gachon University — Incheon, South Korea (Recruiting)
- Inha University Hospital — Incheon, South Korea (Recruiting)
- Chonbuk National University Hospital and Chonbuk National University Medical School — Jeonju, South Korea (Recruiting)
- Gyeongsang National University Hospital — Jinju, South Korea (Recruiting)
- Chung-Ang University Hospital — Seoul, South Korea (Recruiting)
- Kangbuk Samsung Hospital — Seoul, South Korea (Recruiting)
- Korea University Guro Hospital — Seoul, South Korea (Recruiting)
- Samsung Medical Center — Seoul, South Korea (Recruiting)
- SMG-SNU Boramae Medical Center — Seoul, South Korea (Recruiting)
- Ajou University School of Medicine — Suwon, South Korea (Recruiting)
- Uijeongbu St. Mary Hospital — Uijeongbu-si, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.