Drug-Coated Balloon in Patients With High Bleeding Risk (DCB-HBR)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Procedure: Percutaneous coronary intervention

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 Type: Interventional
• Enrollment (Estimated): 1350
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joo Myung Lee, MD, PhD; Phone Number: 82-2-3410-3391; Email: drone80@hanmail.net
• Study Contact Backup: Name: Min-Jeong Seok; Phone Number: 82-2-3410-3391; Email: smg0492@naver.com

Study Locations

• Korea, Republic of
  • Ansan, Korea, Republic of
    • Recruiting
    • Korea University Ansan Hospital
    • Contact: Sunwon Kim, MD, PhD; Email: sunwon11@hanmail.net
    • Principal Investigator: Sunwon Kim, MD, PhD
  • Cheongju, Korea, Republic of
    • Recruiting
    • Chungbuk National University
    • Contact: Jang-Whan Bae, MD, PhD; Email: drcorazon@hanmail.net
    • Principal Investigator: Jang-Whan Bae, MD, PhD
  • Daegu, Korea, Republic of
    • Recruiting
    • Keimyung University Dongsan Hospital
    • Contact: Hyuck-Jun Yoon, MD, PhD; Email: hippsons@gmail.com
    • Principal Investigator: Hyuck-Jun Yoon, MD, PhD
  • Gangneung, Korea, Republic of
    • Recruiting
    • Gangneung Asan Hospital, University of Ulsan College of Medicine
    • Contact: Hanbit Park, MD, PhD; Email: phb8012@gmail.com
    • Principal Investigator: Hanbit Park, MD, PhD
  • Gwangju, Korea, Republic of
    • Recruiting
    • Chonnam National University Hospital
    • Contact: Seung Hun Lee, MD, PhD; Email: lsh8602@naver.com
    • Principal Investigator: Seung Hun Lee, MD, PhD
    • Contact: Young Joon Hong, MD, PhD; Email: hyj200@hanmail.net
    • Principal Investigator: Young Joon Hong, MD, PhD
  • Gwangmyeong, Korea, Republic of
    • Recruiting
    • Chung-Ang University Gwangmyeong Hospital
    • Contact: Sang Yeub Lee, MD, PhD; Email: louisahj@gmail.com
    • Principal Investigator: Sang Yeub Lee, MD, PhD
  • Incheon, Korea, Republic of
    • Recruiting
    • Inha University Hospital
    • Contact: Sang Don Park, MD, PhD; Email: denki1@inha.ac.kr
    • Principal Investigator: Sang Don Park, MD, PhD
  • Jinju, Korea, Republic of
    • Recruiting
    • Gyeongsang National University Hospital
    • Contact: Jin-Sin Koh, MD, PhD; Email: kjs0175@gmail.com
    • Contact: Hangyul Kim, MD, PhD; Email: 13medicine@naver.com
    • Principal Investigator: Hangyul Kim, MD, PhD
    • Principal Investigator: Jin-Sin Koh, MD, PhD
  • Seongnam-si, Korea, Republic of
    • Recruiting
    • Seoul National University Bundang Hospital
    • Contact: Ki-Hyun Jeon, MD, PhD; Email: imcardio@gmail.com
    • Principal Investigator: Ki-Hyun Jeon, MD, PhD
  • Seoul, Korea, Republic of
    • Recruiting
    • Samsung Medical Center
    • Principal Investigator: Joo Myung Lee, MD, MPH, PhD
    • Contact: David Hong, MD; Phone Number: 82-2-3410-2575; Email: hongdawi@naver.com
    • Sub-Investigator: Ki Hong Choi, MD, PhD
    • Contact: Joo Myung Lee, MD, MPH, PhD; Phone Number: 82-2-3410-2575; Email: drone80@hanmal.net
    • Sub-Investigator: Taek Kyu Park, MD, PhD
    • Sub-Investigator: Jeong Hoon Yang, MD, PhD
    • Sub-Investigator: Young Bin Song, MD, PhD
    • Sub-Investigator: Joo-Yong Hahn, MD, PhD
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul St. Mary's Hospital, The Catholic University of Korea
    • Contact: Eun Ho Choo, MD, PhD; Email: cmcchu@catholic.ac.kr
    • Contact: Kwan Yong Lee, MD, PhD; Email: kyle210@naver.com
    • Principal Investigator: Eun Ho Choo, MD, PhD
    • Sub-Investigator: Kwan Yong Lee, MD, PhD
  • Uijeongbu, Korea, Republic of
    • Recruiting
    • The Catholic University of Korea, Uijeongbu St. Mary's Hospital
    • Contact: Seonghyeon Bu, MD, PhD; Email: buseonghyeon@gmail.com
    • Contact: Chan Joon Kim, MD, PhD; Email: godandsci@naver.com
    • Principal Investigator: Seonghyeon Bu, MD, PhD
    • Principal Investigator: Chan Joon Kim, MD, PhD
  • Wonju, Korea, Republic of
    • Recruiting
    • Wonju Severance Christian Hospital
    • Contact: Sung Gyun Ahn, MD, PhD; Email: sgahn@yonsei.ac.kr
    • Principal Investigator: Sung Gyun Ahn, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: DES group; Patients will be randomized to either the DCB group or the DES group with 1:1 ratio during the index procedure after diagnostic angiography. In DES group, latest second-generation DES will be used (Ultimaster Tansei) during the index procedure	Procedure: Percutaneous coronary intervention; 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])
Experimental: DCB group; Patients will be randomized to either the DCB group or the DES group with 1:1 ratio during the index procedure after diagnostic angiography. In DCB group, Agent (Boston Scientific, USA), Prevail (Medtronic, USA), or SeQuent Please, SeQuent Please NEO (B-Braun, Germany) will be used during the index procedure.	Procedure: Percutaneous coronary intervention; 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])

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular death	Cardiovascular death	2 years from last patient enrollment
All-cause death	All-cause death	2 years from last patient enrollment
Target-vessel MI	Target-vessel MI	2 years from last patient enrollment
Non-fatal MI	Non-fatal MI	2 years from last patient enrollment
Clinically indicated target-lesion revascularization (TLR)	Clinically indicated target-lesion revascularization (TLR)	2 years from last patient enrollment
Clinically indicated TVR	Clinically indicated TVR	2 years from last patient enrollment
Any revascularization	Any revascularization	2 years from last patient enrollment
Vessel or stent thrombosis	definite or probable by Academic Research Consortium (ARC) definition	2 years from last patient enrollment
Cardiovascular death or target-vessel MI	Cardiovascular death or target-vessel MI	2 years from last patient enrollment
All-cause death or non-fatal MI	All-cause death or non-fatal MI	2 years from last patient enrollment
Target lesion failure (TLF)	a composite of cardiovascular death, target-vessel MI, and clinically indicated TLR	2 years from last patient enrollment
Cardiovascular death, target-vessel MI, or vessel or stent thrombosis	Cardiovascular death, target-vessel MI, or vessel or stent thrombosis	2 years from last patient enrollment
All-cause death, non-fatal MI, or TVR	All-cause death, non-fatal MI, or TVR	2 years from last patient enrollment
Major bleeding (Major secondary endpoint)	BARC type 2, 3 or 5 bleeding	2 years from last patient enrollment
Major bleeding	The Thrombolysis in Myocardial Infarction (TIMI) major bleeding	2 years from last patient enrollment

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Collaborators: Seoul St. Mary's Hospital; Chonnam National University Hospital; Seoul National University Bundang Hospital; Gyeongsang National University Hospital; Keimyung University Dongsan Medical Center; Chungbuk National University; Wonju Severance Christian Hospital; Inha University Hospital; Uijeongbu St. Mary Hospital; Korea University Ansan Hospital; Chung-Ang University Gwangmyeong Hospital; Gangneung Asan Hospital, University of Ulsan College of Medicine
• Investigators: Principal Investigator: Joo Myung Lee, MD, PhD, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2022
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: January 23, 2022
• First Submitted That Met QC Criteria: January 23, 2022
• First Posted (Actual): February 3, 2022

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Prognosis; Percutaneous Coronary Intervention; Drug-Coated Balloon; High Bleeding Risk; De-Novo Coronary Lesion
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Hemorrhage
• Other Study ID Numbers: DCBHBR2021-12-111-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked
• IPD Sharing Time Frame: After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked
• IPD Sharing Access Criteria: After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No