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

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 1350

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 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

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

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Target vessel failure (a composite of cardiovascular death, target-vessel myocardial infarction [MI], and clinically indicated target-vessel revascularization [TVR])

Secondary Outcome Measures

Name	Time	Method
Cardiovascular death ;All-cause death;Target-vessel MI ;Non-fatal MI ;Clinically indicated target-lesion revascularization;Clinically indicated target-vessel revascularization;Any revascularization;Vessel or stent thrombosis, definite or probable by Academic Research Consortium [ARC] definition;Cardiovascular death or target-vessel MI ;All-cause death or non-fatal MI ;Target lesion failure (TLF, a composite of cardiovascular death, target-vessel MI, and clinically indicated TLR) ;Cardiovascular death, target-vessel MI, or vessel or stent thrombosis ;All-cause death, non-fatal MI, or TVR ;Major bleeding (BARC type 2, 3 or 5 bleeding) ;Major bleeding (TIMI bleeding classification)