Comparing drug-coated balloons to drug-eluting stents for heart patients at high bleeding risk

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

This study is testing whether drug-coated balloons can be a safer and effective treatment for heart patients at high risk of bleeding compared to drug-eluting stents.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1350 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: Samsung Medical Center (Academic / other)
• Locations: 17 sites (Ansan and 16 other locations)
• Trial ID: NCT05221931 on ClinicalTrials.gov

What this trial studies

The DCB-HBR trial is a prospective, multi-center, open-label, randomized controlled trial aimed at evaluating the clinical outcomes of drug-coated balloons (DCB) versus drug-eluting stents (DES) in patients with high bleeding risk who require treatment for de-novo coronary lesions. This study addresses the challenges associated with long-term dual antiplatelet therapy required for DES, which can lead to increased bleeding events. By utilizing DCB, which does not involve permanent vascular implants, the trial seeks to determine if this alternative can provide similar efficacy with reduced risks. The study will include patients with significant coronary artery disease and high bleeding risk factors, comparing the two treatment modalities over time.

Who should consider this trial

Good fit: Ideal candidates for this study are patients aged 19 and older with de-novo coronary artery lesions and high bleeding risk factors.

Not a fit: Patients who do not meet the high bleeding risk criteria or have other contraindications for percutaneous coronary intervention may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer treatment option for patients with coronary artery disease who are at high risk for bleeding.

How similar studies have performed: Previous studies have shown that drug-coated balloons can be noninferior to drug-eluting stents in certain populations, but this specific comparison in high bleeding risk patients is less explored.

Eligibility 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 at least one lesion with greater than 50% diameter stenosis or fractional flow reserve ≤0.80 requiring revascularization in de-novo coronary artery of reference vessel size ≥2.25 mm
4. Patients with high bleeding risk: one or more of the criteria listed (1) Adjunctive oral anticoagulation treatment planned to continue after PCI (2) Age ≥ 75 years old (3) Baseline Hemoglobin \<11 g/dl (or anemia requiring transfusion during the 4 weeks prior to randomization) (4) Any prior intra-cerebral bleeding (5) Stroke at any time or transient ischemic attack in the previous 6 months. (6) Hospital admission for bleeding during the prior 12 months (7) Non skin cancer diagnosed or treated \< 3 years (8) Planned daily NSAID (other than aspirin) or steroids for \>30 days after PCI (9) Planned surgery that would require interruption of DAPT (within next 12 months) (10) Renal failure defined as calculated creatinine clearance \<40 ml/min or on dialysis (11) Hematological disorders (platelet count \<100,000/mm3 or any coagulation disorder) (12) Severe chronic liver disease defined as patients who have developed any of the following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice (13) Expected non-compliance to prolonged DAPT for other medical reasons

Exclusion Criteria:

1. Patients unable to provide consent
2. Patients with known intolerance to aspirin, P2Y12 inhibitors, or components of drug-eluting stents
3. Patients with angiographic findings of (1) Left main coronary artery disease (2) In-stent restenosis is the cause of target lesion (3) Target lesion in bypass graft (4) True bifurcation lesion that requires upfront 2-stenting
4. Patients who have non-cardiac co-morbid conditions with life expectancy \<2 year
5. Patients who may result in protocol non-compliance (site investigator's medical judgment)
6. Patients with cardiogenic shock or cardiac arrest
7. Patients with severe left ventricular systolic dysfunction (ejection fraction \<30%)
8. Patients with severe valvular heart disease requiring open heart surgery
9. Pregnant or lactating women

Where this trial is running

Ansan and 16 other locations

• Korea University Ansan Hospital — Ansan, Korea, Republic of (Recruiting)
• Chungbuk National University — Cheongju, Korea, Republic of (Recruiting)
• Keimyung University Dongsan Hospital — Daegu, Korea, Republic of (Recruiting)
• Gangneung Asan Hospital, University of Ulsan College of Medicine — Gangneung, Korea, Republic of (Recruiting)
• Chonnam National University Hospital — Gwangju, Korea, Republic of (Recruiting)
• Chung-Ang University Gwangmyeong Hospital — Gwangmyeong, Korea, Republic of (Recruiting)
• Inha University Hospital — Incheon, Korea, Republic of (Recruiting)
• Gyeongsang National University Hospital — Jinju, Korea, Republic of (Recruiting)
• Seoul National University Bundang Hospital — Seongnam-si, Korea, Republic of (Recruiting)
• Ewha Womans University College of Medicine — Seoul, Korea, Republic of (Recruiting)
• Kangbuk Samsung Hospital — Seoul, Korea, Republic of (Recruiting)
• Korea University Kuro Hospital — Seoul, Korea, Republic of (Recruiting)
• Samsung Medical Center — Seoul, Korea, Republic of (Recruiting)
• Seoul National University Boramae Medical Center — Seoul, Korea, Republic of (Recruiting)
• Seoul St. Mary's Hospital, The Catholic University of Korea — Seoul, Korea, Republic of (Recruiting)
• The Catholic University of Korea, Uijeongbu St. Mary's Hospital — Uijeongbu, Korea, Republic of (Recruiting)
• Wonju Severance Christian Hospital — Wonju, Korea, Republic of (Recruiting)

Study contacts

• Principal investigator: Joo Myung Lee, MD, PhD — Samsung Medical Center
• Study coordinator: Joo Myung Lee, MD, PhD

Conditions Coronary Artery Disease; Percutaneous Coronary Intervention; De-Novo Coronary Lesion; Drug-Coated Balloon; High Bleeding Risk; Prognosis