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

Samsung Medical Center0 个研究点目标入组 1,350 人开始时间: 待定最近更新: 2024年3月4日

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•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

•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 <1 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

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