None listed
Conditions
Interventions
Others : Patients will be randomized to either the discontinuation of antiplatelet agent group or the continuation of antiplatelet agent group with 1:1 ratio after 1 year from the index procedure afte
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion 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 de novo lesion of reference vessel size =2.25 mm, treated with DCB angioplasty 4) Patients with high bleeding risk: one or more of the criteria listed A. Age = 75 years old B. Baseline Hemoglobin 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 prolonged DAPT for other medical reasons 5) 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. 6) 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.
Exclusion criteria
Exclusion criteria: Patients unable to provide consent Patients with acute myocardial infarction or unstable angina Patients with known intolerance to aspirin, P2Y12 inhibitors, or components of DCB Patients with indication of oral anticoagulant Patients with concomitant drug-eluting stent implantation during index PCI Patients with history of ischemic stroke Patients with peripheral arterial occlusive disease Patients with angiographic findings of Left main coronary artery disease In-stent restenosis is the cause of target lesion Target lesion in bypass graft True bifurcation lesion that requires upfront 2-stenting 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major bleeding (BARC 2, 3, or 5 bleeding) after randomization;Patient-oriented composite outcome (all-cause death, non-fatal myocardial infarction, and any revascularization) after randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Cardiovascular death;All-cause death;Target-vessel MI;Non-fatal MI;Clinically indicated target-lesion revascularization, TLR;Clinically indicated target-vessel revascularization, TVR;Any revascularization;Cardiovascular death or target-vessel MI;All-cause death or non-fatal MI;Target vessel failure, TVF, a composite of cardiovascular death, target-vessel MI, and clinically indicated TVR;Bleeding Academic Research Consortium, BARC 3, 5 ;TIMI bleeding events ;Cerebrovascular accident, CVA | — |
Countries
Korea, Republic of
Contacts
Public ContactMin Jeong Seok
Samsung Medical Center
Outcome results
None listed