Clinical trial NCT05221931: Drug-Coated Balloon in Patients With High Bleeding Risk
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Percutaneous Coronary Intervention
De-Novo Coronary Lesion
Drug-Coated Balloon
High Bleeding Risk
Prognosis
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Seoul St. Mary's Hospital
name: Seoul National University Bundang Hospital
name: Korea University Ansan Hospital
name: Chonnam National University Hospital
name: Chung-Ang University Gwangmyeong Hospital
name: Gangneung Asan Hospital, University of Ulsan College of Medicine
name: Gyeongsang National University Hospital
name: Uijeongbu St. Mary Hospital
name: Keimyung University Dongsan Medical Center
name: Inha University Hospital
name: Chungbuk National University
name: Wonju Severance Christian Hospital
name: SMG-SNU Boramae Medical Center
name: Kangbuk Samsung Hospital, Sungkyunkwan University
name: Ewha Womans University
name: Korea University Guro Hospital
First posted: 2022-02-03
Enrollment: 1350
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, multi-center, open-label, randomized controlled, noninferiority trial
Primary purpose: TREATMENT

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 in patients with high bleeding risk (HBR).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Target vessel failure (TVF)
timeFrame: 2 years from last patient enrollment
Secondary outcomes:
measure: Cardiovascular death
timeFrame: 2 years from last patient enrollment
measure: All-cause death
timeFrame: 2 years from last patient enrollment
measure: Target-vessel MI
timeFrame: 2 years from last patient enrollment
measure: Non-fatal MI
timeFrame: 2 years from last patient enrollment
measure: Clinically indicated target-lesion revascularization (TLR)
timeFrame: 2 years from last patient enrollment
measure: Clinically indicated TVR
timeFrame: 2 years from last patient enrollment
measure: Any revascularization
timeFrame: 2 years from last patient enrollment
measure: Vessel or stent thrombosis
timeFrame: 2 years from last patient enrollment
measure: Cardiovascular death or target-vessel MI
timeFrame: 2 years from last patient enrollment
measure: All-cause death or non-fatal MI
timeFrame: 2 years from last patient enrollment
measure: Target lesion failure (TLF)
timeFrame: 2 years from last patient enrollment
measure: Cardiovascular death, target-vessel MI, or vessel or stent thrombosis
timeFrame: 2 years from last patient enrollment
measure: All-cause death, non-fatal MI, or TVR
timeFrame: 2 years from last patient enrollment
measure: Major bleeding (Major secondary endpoint)
timeFrame: 2 years from last patient enrollment
measure: Major bleeding
timeFrame: 2 years from last patient enrollment
measure: Cerebrovascular accident (CVA)
timeFrame: 2 years from last patient enrollment
Other outcomes:
Locations:
city: Ansan
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Cheongju
country: Korea, Republic of
facility: Chungbuk National University
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
city: Gangneung
country: Korea, Republic of
facility: Gangneung Asan Hospital, University of Ulsan College of Medicine
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Gwangmyeong
country: Korea, Republic of
facility: Chung-Ang University Gwangmyeong Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Jinju
country: Korea, Republic of
facility: Gyeongsang National University Hospital
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University College of Medicine
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Kuro Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital, The Catholic University of Korea
city: Uijeongbu
country: Korea, Republic of
facility: The Catholic University of Korea, Uijeongbu St. Mary's Hospital
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
Study officials:
affiliation: Samsung Medical Center
name: Joo Myung Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: