Drug-Coated Balloon in Patients With High Bleeding Risk

N/AActive Not RecruitingNCT05221931

Samsung Medical Center1,359 enrolled

Overview

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 in patients with high bleeding risk (HBR).

Second-generation 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 accompany 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 lead 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 metallic 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 RCT demonstrated efficacy and safety of DCB in de-novo coronary lesions in small vessels with reference vessel size\<3.0mm. However, studies exploring the feasibility of DCB in de-novo coronary artery stenosis beyond small vessels are limited. Furthermore, there is scarce data comparing DCB with DES in patients with de-novo coronary artery stenosis and high bleeding risk (HBR), a situation in which long-term maintenance of DAPT is a clinical dilemma. In previous BASKET-SMALL 2 trial, DCB showed noninferiority to DES in patients with de-novo coronary artery stenosis and small vessel disease. However, this trial was conducted in non-HBR patients, and the number of participated patients was insufficient. In another RCT, DEBUT trial exclusively enrolled patients with HBR and de-novo coronary artery stenosis. Although the DEBUT trial showed superiority of DCB angioplasty over implantation of BMS to treat de-novo coronary artery stenosis in patients with HBR, the results could not be applicable in contemporary practice because BMS has been no longer in clinical use. Recently, multiple RCTs have proved short-term DAPT (1-3 months) has comparable efficacy to longer term DAPT in HBR patients using latest second-generation DES. On this background, the current trial aims to compare clinical outcomes between DCB and DES to treat de-novo coronary artery stenosis in patients with HBR receiving guideline-directed short-term DAPT.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

1,359

Conditions

Coronary Artery Disease

Interventions

Percutaneous coronary interventionPROCEDURE

1:1 randomization to DES (Ultimaster Tansei) or DCB (Agent \[Boston Scientific, USA\], Prevail \[Medtronic, USA\], or SeQuent Please, SeQuent Please NEO \[B-Braun, Germany\])

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (17)

Korea University Ansan Hospital

Ansan, South Korea

Chungbuk National University

Cheongju-si, South Korea

Outcomes

Primary Outcomes

Target vessel failure (TVF)

a composite of cardiovascular death, target-vessel myocardial infarction (MI), and clinically indicated target-vessel revascularization (TVR)

Time frame: 2 years from last patient enrollment

Secondary Outcomes

BARC type 2, 3 or 5 bleeding (Major secondary endpoint)

BARC type 2, 3 or 5 bleeding

Time frame: 2 years from last patient enrollment

Cardiovascular death

Time frame: 2 years from last patient enrollment

All-cause death

Time frame: 2 years from last patient enrollment

Target-vessel MI

Time frame: 2 years from last patient enrollment

Non-target vessel related MI

Time frame: 2 years from last patient enrollment

Non-fatal MI

Time frame: 2 years from last patient enrollment

Clinically indicated target-lesion revascularization (TLR)

Time frame: 2 years from last patient enrollment

Clinically indicated TVR

Data from ClinicalTrials.gov

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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

...and 7 more locations

Clinically indicated TVR

Time frame: 2 years from last patient enrollment

Non-target vessel revascularization

Time frame: 2 years from last patient enrollment

Any revascularization

Time frame: 2 years from last patient enrollment

Vessel or stent thrombosis

definite by Academic Research Consortium (ARC) definition

Time frame: 2 years from last patient enrollment

Cardiovascular death or target-vessel MI

Time frame: 2 years from last patient enrollment

Target vessel failure without procedure-related MI

a composite of cardiovascular death, target-vessel myocardial infarction (MI) without procedure-related MI, and clinically indicated target-vessel revascularization (TVR)

Time frame: 2 years from last patient enrollment

Target lesion failure (TLF)

a composite of cardiovascular death, target-vessel MI, and clinically indicated TLR

Time frame: 2 years from last patient enrollment

Cardiovascular death, target-vessel MI, or vessel or stent thrombosis

Time frame: 2 years from last patient enrollment

All-cause death, non-fatal MI, or any revascularization

Time frame: 2 years from last patient enrollment

Bleeding according to BARC definition

Time frame: 2 years from last patient enrollment

Bleeding according to TIMI definition

Time frame: 2 years from last patient enrollment

Cerebrovascular accident (CVA)

Ischemic stroke, Hemorrhagic stroke, Transient ischemic attack (TIA)

Time frame: 2 years from last patient enrollment

Target vessel failure (TVF) at Extended Follow-up

a composite of cardiovascular death, target-vessel myocardial infarction (MI), and clinically indicated target-vessel revascularization (TVR) at Extended Follow-up

Time frame: 4 years from last patient enrollment

BARC type 2, 3 or 5 bleeding (Major secondary endpoint) at Extended Follow-up

BARC type 2, 3 or 5 bleeding at Extended Follow-up

Time frame: 4 years from last patient enrollment

Cardiovascular death at Extended Follow-up

Time frame: 4 years from last patient enrollment

All-cause death at Extended Follow-up

Time frame: 4 years from last patient enrollment

Target-vessel MI at Extended Follow-up

Time frame: 4 years from last patient enrollment

Non-target vessel related MI at Extended Follow-up

Time frame: 4 years from last patient enrollment

Non-fatal MI at Extended Follow-up

Time frame: 4 years from last patient enrollment

Clinically indicated target-lesion revascularization (TLR) at Extended Follow-up

Time frame: 4 years from last patient enrollment

Clinically indicated TVR at Extended Follow-up

Time frame: 4 years from last patient enrollment

Non-target vessel revascularization at Extended Follow-up

Time frame: 4 years from last patient enrollment

Any revascularization at Extended Follow-up

Time frame: 4 years from last patient enrollment

Vessel or stent thrombosis at Extended Follow-up

definite ㅍessel or stent thrombosis at Extended Follow-up by Academic Research Consortium (ARC) definition

Time frame: 4 years from last patient enrollment

Target vessel failure without procedure-related MI at Extended Follow-up

a composite of cardiovascular death, target-vessel myocardial infarction (MI) without procedure-related MI, and clinically indicated target-vessel revascularization (TVR)

Time frame: 4 years from last patient enrollment

Cardiovascular death or target-vessel MI at Extended Follow-up

Time frame: 4 years from last patient enrollment

Target lesion failure (TLF) at Extended Follow-up

Time frame: 4 years from last patient enrollment

Cardiovascular death, target-vessel MI, or vessel or stent thrombosis at Extended Follow-up