Drug-Coated Balloon in Patients With High Bleeding Risk

Last updated: March 12, 2025
Sponsor: Samsung Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Disease

Cardiac Disease

Chest Pain

Treatment

Percutaneous coronary intervention

Clinical Study ID

NCT05221931
DCBHBR2021-12-111-001
  • Ages > 19
  • All Genders

Study 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 in patients with high bleeding risk (HBR).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subject must be at least 19 years of age

  2. Subject who is able to understand risks, benefits and treatment alternatives andsign informed consent voluntarily.

  3. Patients with at least one lesion with greater than 50% diameter stenosis orfractional flow reserve ≤0.80 requiring revascularization in de-novo coronary arteryof reference vessel size ≥2.25 mm

  4. Patients with high bleeding risk: one or more of the criteria listed (1) Adjunctiveoral 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 weeksprior to randomization) (4) Any prior intra-cerebral bleeding (5) Stroke at any timeor transient ischemic attack in the previous 6 months. (6) Hospital admission forbleeding during the prior 12 months (7) Non skin cancer diagnosed or treated < 3years (8) Planned daily NSAID (other than aspirin) or steroids for >30 days afterPCI (9) Planned surgery that would require interruption of DAPT (within next 12months) (10) Renal failure defined as calculated creatinine clearance <40 ml/min oron dialysis (11) Hematological disorders (platelet count <100,000/mm3 or anycoagulation disorder) (12) Severe chronic liver disease defined as patients who havedeveloped any of the following: variceal hemorrhage, ascites, hepatic encephalopathyor jaundice (13) Expected non-compliance to prolonged DAPT for other medical reasons

Exclusion

Exclusion Criteria:

  1. Patients unable to provide consent

  2. Patients with known intolerance to aspirin, P2Y12 inhibitors, or components ofdrug-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 medicaljudgment)

  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

Total Participants: 1350
Treatment Group(s): 1
Primary Treatment: Percutaneous coronary intervention
Phase:
Study Start date:
July 29, 2022
Estimated Completion Date:
December 31, 2028

Study Description

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.

Connect with a study center

  • Korea University Ansan Hospital

    Ansan,
    Korea, Republic of

    Active - Recruiting

  • Chungbuk National University

    Cheongju,
    Korea, Republic of

    Active - Recruiting

  • Keimyung University Dongsan Hospital

    Daegu,
    Korea, Republic of

    Active - Recruiting

  • Gangneung Asan Hospital, University of Ulsan College of Medicine

    Gangneung,
    Korea, Republic of

    Active - Recruiting

  • Chonnam National University Hospital

    Gwangju,
    Korea, Republic of

    Active - Recruiting

  • Chung-Ang University Gwangmyeong Hospital

    Gwangmyeong,
    Korea, Republic of

    Active - Recruiting

  • Inha University Hospital

    Incheon,
    Korea, Republic of

    Active - Recruiting

  • Gyeongsang National University Hospital

    Jinju,
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si,
    Korea, Republic of

    Active - Recruiting

  • Ewha Womans University College of Medicine

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Kangbuk Samsung Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Korea University Kuro Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Boramae Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Seoul St. Mary's Hospital, The Catholic University of Korea

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • The Catholic University of Korea, Uijeongbu St. Mary's Hospital

    Uijeongbu,
    Korea, Republic of

    Active - Recruiting

  • Wonju Severance Christian Hospital

    Wonju,
    Korea, Republic of

    Active - Recruiting

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