Drug-Coated Balloon in Patients With High Bleeding Risk

Not Applicable

Recruiting

• Conditions: Coronary Artery Disease

• Registration Number: NCT05221931
• Lead Sponsor: Samsung Medical Center

Brief Summary

DCB-HBR trial is prospective, multi-center, open-label, randomized controlled, noninferiority trial.

The aim of the study is to compare clinical outcomes of drug-coated balloon (DCB) with drug-eluting stent (DES) for treatment of de-novo coronary lesion under intravascular imaging-guided optimization in patients with high bleeding risk (HBR).

Detailed Description

Second-generation drug-eluting stent (DES) is the standard of care for patients with coronary artery disease who are deemed eligible for percutaneous coronary intervention (PCI). Despite many advantages, DES inevitably accompanies disadvantages such as the occurrence of late stent thrombosis and the need for maintaining dual antiplatelet (DAPT) for certain period due to permanent vascular implant, which leads to both increased ischemic and bleeding events.

As an alternative to DES, drug-coated balloon (DCB), a novel treatment strategy, which has benefit of having shorter DAPT maintenance duration due to the absence of scaffolds and polymers, has been introduced. Based on meta-analysis based on many randomized clinical trials (RCT), its use has been established in in-stent restenosis of bare-metal stents (BMS) and DES. Furthermore, recently published RCTs demonstrated efficacy and safety of DCB in de-novo coronary lesions in small vessels. However, studies exploring the feasibility of DCB in de-novo coronary lesions are limited. In particular, there are scarce data comparing DCB with DES in patients with high bleeding risk (HBR), a situation in which long-term maintenance of DAPT is a clinical dilemma. In the previous two RCTs, DCB showed noninferiority to DES in lesions in large vessels. Nevertheless, these studies were conducted in non-HBR patients and the number of participated patients was insufficient. In another RCT, only patients with HBR were included, but the efficacy of DCB was compared with BMS not DES.

Recently, studies have proved short term (1-3 months) DAPT has comparable efficacy to longer DAPT in HBR patients using latest second-generation DES. On this background, this trial aims to compare clinical outcomes between DCB and DES in de-novo coronary lesions in large vessels in patients with HBR receiving short term DAPT.

Study Timeline

• Study First Submitted: 2022-01-23
• Study First Submitted QC: 2022-01-23
• Study First Posted: 2022-02-03
• Study Start: 2022-07-29
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-08
• Last Update Posted: 2025-09-10
• Primary Completion: 2027-11
• Study Completion: 2028-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1350

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 bleed (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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Target vessel failure (TVF)	2 years from last patient enrollment	a composite of cardiovascular death, target-vessel myocardial infarction (MI), and clinically indicated target-vessel revascularization (TVR)

Secondary Outcome Measures

Name	Time	Method
Cardiovascular death	2 years from last patient enrollment	Cardiovascular death
All-cause death	2 years from last patient enrollment	All-cause death
Target-vessel MI	2 years from last patient enrollment	Target-vessel MI
Non-fatal MI	2 years from last patient enrollment	Non-fatal MI
Clinically indicated target-lesion revascularization (TLR)	2 years from last patient enrollment	Clinically indicated target-lesion revascularization (TLR)
Clinically indicated TVR	2 years from last patient enrollment	Clinically indicated TVR
Any revascularization	2 years from last patient enrollment	Any revascularization
Vessel or stent thrombosis	2 years from last patient enrollment	definite by Academic Research Consortium (ARC) definition
Cardiovascular death or target-vessel MI	2 years from last patient enrollment	Cardiovascular death or target-vessel MI
All-cause death or non-fatal MI	2 years from last patient enrollment	All-cause death or non-fatal MI
Target lesion failure (TLF)	2 years from last patient enrollment	a composite of cardiovascular death, target-vessel MI, and clinically indicated TLR
Cardiovascular death, target-vessel MI, or vessel or stent thrombosis	2 years from last patient enrollment	Cardiovascular death, target-vessel MI, or vessel or stent thrombosis
All-cause death, non-fatal MI, or TVR	2 years from last patient enrollment	All-cause death, non-fatal MI, or TVR
Bleeding (Major secondary endpoint)	2 years from last patient enrollment	BARC type 2, 3 or 5 bleeding
Major bleeding	2 years from last patient enrollment	The Thrombolysis in Myocardial Infarction (TIMI) major bleeding
Cerebrovascular accident (CVA)	2 years from last patient enrollment	Ischemic stroke, Hemorrhagic stroke, Transient ischemic attack (TIA)
Target vessel failure (TVF) at Extended Follow-up	4 years from last patient enrollment	a composite of cardiovascular death, target-vessel myocardial infarction (MI), and clinically indicated target-vessel revascularization (TVR) at Extended Follow-up
Cardiovascular death at Extended Follow-up	4 years from last patient enrollment	Cardiovascular death at Extended Follow-up
All-cause death at Extended Follow-up	4 years from last patient enrollment	All-cause death at Extended Follow-up
Target-vessel MI at Extended Follow-up	4 years from last patient enrollment	Target-vessel MI at Extended Follow-up
Non-fatal MI at Extended Follow-up	4 years from last patient enrollment	Non-fatal MI at Extended Follow-up
Clinically indicated target-lesion revascularization (TLR) at Extended Follow-up	4 years from last patient enrollment	Clinically indicated target-lesion revascularization (TLR) at Extended Follow-up
Clinically indicated TVR at Extended Follow-up	4 years from last patient enrollment	Clinically indicated TVR at Extended Follow-up
Any revascularization at Extended Follow-up	4 years from last patient enrollment	Any revascularization at Extended Follow-up
Vessel or stent thrombosis at Extended Follow-up	4 years from last patient enrollment	definite ㅍessel or stent thrombosis at Extended Follow-up by Academic Research Consortium (ARC) definition
Cardiovascular death or target-vessel MI at Extended Follow-up	4 years from last patient enrollment	Cardiovascular death or target-vessel MI at Extended Follow-up
All-cause death or non-fatal MI at Extended Follow-up	4 years from last patient enrollment	All-cause death or non-fatal MI at Extended Follow-up
Target lesion failure (TLF) at Extended Follow-up	4 years from last patient enrollment	Target lesion failure (TLF) at Extended Follow-up
Cardiovascular death, target-vessel MI, or vessel or stent thrombosis at Extended Follow-up	4 years from last patient enrollment	Cardiovascular death, target-vessel MI, or vessel or stent thrombosis at Extended Follow-up
All-cause death, non-fatal MI, or TVR at Extended Follow-up	4 years from last patient enrollment	All-cause death, non-fatal MI, or TVR at Extended Follow-up
Bleeding (Major secondary endpoint) at Extended Follow-up	4 years from last patient enrollment	BARC type 2, 3 or 5 bleeding at Extended Follow-up
Major bleeding at Extended Follow-up	4 years from last patient enrollment	The Thrombolysis in Myocardial Infarction (TIMI) major bleeding at Extended Follow-up
Cerebrovascular accident (CVA) at Extended Follow-up	4 years from last patient enrollment	Ischemic stroke, Hemorrhagic stroke, Transient ischemic attack (TIA)

Trial Locations

Locations (17)

Korea University Ansan Hospital; 🇰🇷 Ansan, South Korea

Chungbuk National University; 🇰🇷 Cheongju-si, South Korea

Keimyung University Dongsan Hospital; 🇰🇷 Daegu, South Korea

Gangneung Asan Hospital, University of Ulsan College of Medicine; 🇰🇷 Gangneung, South Korea

Chonnam National University Hospital; 🇰🇷 Gwangju, South Korea

Chung-Ang University Gwangmyeong Hospital; 🇰🇷 Gwangmyeong, South Korea

Inha University Hospital; 🇰🇷 Incheon, South Korea

Gyeongsang National University Hospital; 🇰🇷 Jinju, South Korea

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, South Korea

Ewha Womans University College of Medicine; 🇰🇷 Seoul, South Korea

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