Bioflow-DAPT Study

Inclusion Criteria

• •1. Subject is acceptable candidate for treatment with a DES
• •2. Subject is considered at high bleeding risk (HBR), defined as meeting one or more of the following criteria at the time of enrollment:
• •1. ≥ 75 years of age
• •2. Moderate (estimated GFR 30-59 ml/min) or severe (estimated GFR \< 30 ml/min) chronic kidney disease or failure (dialysis dependent)
• •3. Advanced liver disease, defined as having cirrhosis with or without portal hypertension and with or without gastroesophageal varices.
• •4. Cancer (excluding non-melanoma skin cancer) diagnosed or treated within the previous 12 months or actively treated
• •5. Anemia with hemoglobin \< 11.0 g/dL or requiring transfusion within 4 weeks prior to randomization
• •6. Baseline thrombocytopenia defined as a platelet count \<100,000/mm3
• •7. History of stroke (ischemic or hemorrhagic), previous intracerebral hemorrhage (ICH) (spontaneous at any time or traumatic within the past 12 months) or presence of a brain arteriovenous malformation
• •8. History of hospitalization for bleeding within the previous 12 months
• •9. Chronic clinically significant bleeding diathesis
• •10. Clinical indication for chronic or lifelong oral anticoagulation (OAC) (with a vitamin K antagonist or non-vitamin K OAC)
• •11. Clinical indication for chronic or lifelong steroid or oral nonsteroidal anti-inflammatory drug(s) (NSAIDs), other than aspirin
• •12. Nondeferrable major surgery on DAPT
• •13. Recent major surgery or major trauma within 30 days before PCI
• •14. Precise DAPT score ≥ 25
• •3. Subject is ≥ 18 years or the minimum age required for legal adult consent in the country of enrollment
• •4. Subject is capable (no legally authorized representative allowed) to provide written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site prior to any study related procedure
• •5. Subject is willing to comply with all protocol and follow-up requirements, including agreement to discontinue DAPT at 1 month
• •6. Subject is eligible for dual antiplatelet therapy treatment with aspirin plus a P2Y12 inhibitor agent for 1-month post index procedure