Drug-Coated Balloon Versus Drug-Eluting Stent for Treatment of De-Novo Coronary Lesions in Patients With High Bleeding Risk-2

Prior treatment

• Patients with known intolerance to aspirin, P2Y12 inhibitors, or components of DCB
• Patients with concomitant drug-eluting stent implantation during index PCI
• Patients with history of ischemic stroke or previous myocardial infarction

Other illness

• Patients with acute myocardial infarction or unstable angina
• Patients with peripheral arterial occlusive disease
• Patients with angiographic findings of A. Left main coronary artery disease B. In-stent restenosis is the cause of target lesion C. Target lesion in bypass graft D. True bifurcation lesion that requires upfront 2-stenting E. Patients with residual stenosis on non-target vessels after PCI (\>70% diameter stenosis or FFR≤0.80)
• Patients who have non-cardiac co-morbid conditions with life expectancy \<1 year
• Patients with cardiogenic shock or cardiac arrest
• Patients with severe valvular heart disease requiring open heart surgery

Lab values

• Patients with severe left ventricular systolic dysfunction (ejection fraction \<30%)

Other

• Patients unable to provide consent
• Patients with indication of oral anticoagulant
• Patients who may result in protocol non-compliance (site investigator's medical judgment)
• Pregnant or lactating women

• 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 chronic coronary syndrome and at least one de novo lesion of reference vessel size ≥2.25 mm, treated with DCB angioplasty
• Patients with high bleeding risk: one or more of the criteria listed A. Age ≥ 75 years old B. Baseline Hemoglobin \<11 g/dl (or anemia requiring transfusion during the 4 weeks prior to randomization) C. Any prior intra-cerebral bleed D. Hospital admission for bleeding during the prior 12 months E. Non skin cancer diagnosed or treated \< 3 years F. Planned daily NSAID (other than aspirin) or steroids for \>30 days after PCI G. Planned surgery that would require interruption of DAPT (within next 12 months) H. Renal failure defined as calculated creatinine clearance \<40 ml/min or on dialysis I. Hematological disorders (platelet count \<100,000/mm3 or any coagulation disorder) J. Severe chronic liver disease defined as patients who have developed any of the following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice K. Expected non-compliance to secondary prevention medications after PCI for other medical reasons
• Patients who completed standard duration of DAPT (1-3months) and followed by maintenance of single antiplatelet agent (aspirin or P2Y12 inhibitor) for at least 1 year from index procedure.
• No bleeding (BARC 2, 3, or 5 bleeding) or ischemic events (cardiovascular death, non-fatal MI, or clinically-indicated repeat revascularization) for at least 1 year from index procedure.