Drug-Coated Balloon in Patients With High Bleeding Risk

Coronary Artery Disease Clinical Trial

— DCB-HBR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05221931
• Other study ID #: DCBHBR2021-12-111-001
• Status: Recruiting
• Phase: N/A
• Start date: July 29, 2022
• Est. completion date: December 2028

Study information

• Verified date: February 2024
• Source: Samsung Medical Center
• Contact: Joo Myung Lee, MD, PhD
• Phone: 82-2-3410-3391
• Email: drone80[@]hanmail.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1350
• Est. completion date: December 2028
• Est. primary completion date: July 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Hemorrhage

Intervention

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])

Locations

Country	Name	City	State
Korea, Republic of	Korea University Ansan Hospital	Ansan
Korea, Republic of	Chungbuk National University	Cheongju
Korea, Republic of	Keimyung University Dongsan Hospital	Daegu
Korea, Republic of	Gangneung Asan Hospital, University of Ulsan College of Medicine	Gangneung
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Chung-Ang University Gwangmyeong Hospital	Gwangmyeong
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	Gyeongsang National University Hospital	Jinju
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul St. Mary's Hospital, The Catholic University of Korea	Seoul
Korea, Republic of	The Catholic University of Korea, Uijeongbu St. Mary's Hospital	Uijeongbu
Korea, Republic of	Wonju Severance Christian Hospital	Wonju

Sponsors (13)

Lead Sponsor

Collaborator

Samsung Medical Center

Chonnam National University Hospital, Chung-Ang University Gwangmyeong Hospital, Chungbuk National University, Gangneung Asan Hospital, University of Ulsan College of Medicine, Gyeongsang National University Hospital, Inha University Hospital, Keimyung University Dongsan Medical Center, Korea University Ansan Hospital, Seoul National University Bundang Hospital, Seoul St. Mary's Hospital, Uijeongbu St. Mary Hospital, Wonju Severance Christian Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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