Drug-Coated Balloon in Patients With High Bleeding Risk (DCB-HBR)
Coronary Artery Disease
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Percutaneous Coronary Intervention, De-Novo Coronary Lesion, Drug-Coated Balloon, High Bleeding Risk, Prognosis
Eligibility Criteria
Inclusion Criteria:
- Subject must be at least 19 years of age
- Subject who is able to understand risks, benefits and treatment alternatives and sign informed consent voluntarily.
- 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
- 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:
- Patients unable to provide consent
- Patients with known intolerance to aspirin, P2Y12 inhibitors, or components of drug-eluting stents
- 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
- Patients who have non-cardiac co-morbid conditions with life expectancy <1 year
- Patients who may result in protocol non-compliance (site investigator's medical judgment)
- Patients with cardiogenic shock or cardiac arrest
- Patients with severe left ventricular systolic dysfunction (ejection fraction <30%)
- Patients with severe valvular heart disease requiring open heart surgery
- Pregnant or lactating women
Sites / Locations
- Korea University Ansan HospitalRecruiting
- Chungbuk National UniversityRecruiting
- Keimyung University Dongsan HospitalRecruiting
- Gangneung Asan Hospital, University of Ulsan College of MedicineRecruiting
- Chonnam National University HospitalRecruiting
- Chung-Ang University Gwangmyeong HospitalRecruiting
- Inha University HospitalRecruiting
- Gyeongsang National University HospitalRecruiting
- Seoul National University Bundang HospitalRecruiting
- Samsung Medical CenterRecruiting
- Seoul St. Mary's Hospital, The Catholic University of KoreaRecruiting
- The Catholic University of Korea, Uijeongbu St. Mary's HospitalRecruiting
- Wonju Severance Christian HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
DES group
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 DES group, latest second-generation DES will be used (Ultimaster Tansei) during the index procedure
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.