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

ConditionChronic Coronary Syndrome

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age19+

SponsorSamsung Medical Center

About this trial

A prospective, multi-center, open-label, randomized controlled, and superiority trial. The trial will compare clinical outcomes between discontinuation of antiplatelet agent and continuation of antiplatelet agent in HBR patients with chronic coronary syndrome treated by DCB angioplasty and standard duration of DAPT, followed by maintenance of single antiplatelet agent without clinical event for at least 1 year from the index procedure.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Discontinuation of antiplatelet agent group
Other intervention
In this group, antiplatelet monotherapy will be discontinued at the time of randomization. Randomization will be performed at 1 year from the index procedure using DCB angioplasty, standard duration of DAPT (1-3 months), and maintenance of antiplatelet monotherapy at least 1 year from the index procedure in patients with HBR and chronic coronary syndrome. In patients who are still under DAPT at 1 year from index DCB angioplasty, all antiplatelet agents will be discontinued after randomization.
Continuation of antiplatelet agent group
Other intervention
In this group, lifelong antiplatelet monotherapy will be continued after the time of randomization. Randomization will be performed at 1 year from the index procedure using DCB angioplasty, standard duration of DAPT (1-3 months), and maintenance of antiplatelet monotherapy at least 1 year from the index procedure in patients with HBR and chronic coronary syndrome. In patients who are still under DAPT at 1 year from index DCB angioplasty, DAPT will be changed to single antiplatelet therapy (aspirin or clopidogrel). The choice between aspirin or clopidogrel will be determined by the physician's discretion.

Treatment groups

1,200 Participants

are divided into 2 treatment groups

Group A: Discontinuation of antiplatelet agent groupExperimental treatment 1 intervention

Group B: Continuation of antiplatelet agent groupActive comparator 1 intervention

Trial outcomes