Bioflow-DAPT Study

A Prospective, Randomized, Multi-center Study to Assess the Safety of the Orsiro Mission Stent Compared to the Resolute Onyx Stent in Subjects at High Risk for Bleeding in Combination With 1-month Dual Antiplatelet Therapy (DAPT)

BIOFLOW-DAPT is a prospective, multi-center, international, two-arm randomized controlled clinical study. A total of 1'948 subjects will be randomized 1:1 to receive either Orsiro Mission or Resolute Onyx. After index procedure, all patients will receive DAPT (ASA + P2Y12 inhibitor) for 30 days, followed by monotherapy with either P2Y12 inhibitor or ASA only until the end of the study. Clinical follow-up visits will be scheduled at 1, 6 and 12 months post-procedure.

DAPT, Dual antiplatelet therapy, high bleeding risk, HBR, Coronary artery disease, Percutaneous coronary intervention, PCI

It's a non-surgical procedure that uses a catheter to place a stent into a coronary blood vessel in order to open up the vessel.

Composite of cardiac death, myocardial infarction (MI) and definite or probable stent thrombosis at 12 months

Attainment of less than 30% residual stenosis of the target lesion using assigned stent only without occurrence of in-hospital major adverse cardiac events

Inclusion Criteria: Subject is acceptable candidate for treatment with a DES Subject is considered at high bleeding risk (HBR), defined as meeting one or more of the following criteria at the time of enrollment: ≥ 75 years of age Moderate (estimated GFR 30-59 ml/min) or severe (estimated GFR < 30 ml/min) chronic kidney disease or failure (dialysis dependent) Advanced liver disease, defined as having cirrhosis with or without portal hypertension and with or without gastroesophageal varices. Cancer (excluding non-melanoma skin cancer) diagnosed or treated within the previous 12 months or actively treated Anemia with hemoglobin < 11.0 g/dL or requiring transfusion within 4 weeks prior to randomization Baseline thrombocytopenia defined as a platelet count <100,000/mm3 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 History of hospitalization for bleeding within the previous 12 months Chronic clinically significant bleeding diathesis Clinical indication for chronic or lifelong oral anticoagulation (OAC) (with a vitamin K antagonist or non-vitamin K OAC) Clinical indication for chronic or lifelong steroid or oral nonsteroidal anti-inflammatory drug(s) (NSAIDs), other than aspirin Nondeferrable major surgery on DAPT Recent major surgery or major trauma within 30 days before PCI Precise DAPT score ≥ 25 Subject is ≥ 18 years or the minimum age required for legal adult consent in the country of enrollment 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 Subject is willing to comply with all protocol and follow-up requirements, including agreement to discontinue DAPT at 1 month Subject is eligible for dual antiplatelet therapy treatment with aspirin plus a P2Y12 inhibitor agent for 1-month post index procedure Exclusion Criteria: Subject who previously experienced a stent or scaffold thrombosis in any coronary vessel Subject has a known allergy to all types of P2Y12 inhibitor (Clopidogrel, Ticagrelor, Prasugrel, Ticlopidine and Cangrelor; thus preventing the use of the appropriate P2Y12 inhibitor), aspirin, both heparin and bivalirudin, L-605 cobalt-chromium (Co-Cr) alloy or one of its major elements (cobalt, chromium, tungsten, nickel), molybdenum, platinum and irridium, silicon carbide, PLLA,polymers, mTOR inhibiting drugs such as zotarolimus or sirolimus, or contrast media Revascularization of any target vessel within 9 months prior to the index procedure or previous PCI of any non-target vessel within 72 hours prior to or during the index procedure 4. Subject with documented left ventricular ejection fraction (LVEF) <30% as evaluated by the most recent imaging exam (i.e. echocardiogram, ventriculogram, MUGA, etc.), but within 90 days pre/procedure or during the index procedure Subject judged by physician as inappropriate for discontinuation from DAPT at 1 month following index procedure, due to another condition requiring chronic DAPT Subject with planned surgery or procedure necessitating discontinuation of P2Y12 inhibitor and/or aspirin within the first month post-index procedure Note - planned staged procedure at the time of index procedure is not allowed Active bleeding at the time of inclusion Subject with a current medical condition with a life expectancy of less than 12 months Subject is currently participating or intends to participate in another investigational drug or device trial within 12 months following the index procedure or any other clinical trial that may interfere with the treatment or protocol of this study Subject is pregnant and/or breastfeeding or intends to become pregnant during the duration of the study In the investigator's opinion, subject will not be able to comply with the follow-up requirements Subjects who need an impartial witness to give an informed consent

Capodanno D. Another Coronary Stent for Patients at High Bleeding Risk. JACC Cardiovasc Interv. 2021 Sep 13;14(17):1884-1887. doi: 10.1016/j.jcin.2021.07.028. No abstract available.