DIrect Oral Anticoagulation and Bioprothesis Aortic Valve

Ki vehet részt

• Male or female ≥18 years of age
• Prior implantation of a surgical bioprosthesis in the aortic position at least 7 days and before hospital discharge (excluding TAVI)
• Participants currently not requiring chronic anticoagulation for another reason (atrial fibrillation, pulmonary embolism or any other condition)
• Patients affiliated to social security
• Patient able to give free, informed and written consent

Ki nem vehet részt

• Any cardiac surgery less than 7 days prior to enrollment or more than 1 month
• Mechanical valve in any position or combined valve surgery (mitral or tricuspid)
• Any major bleeding in the three months (90 days) prior to enrollment
• Need to be on dual antiplatelet therapy (aspirin >100 mg daily and a P2Y12 inhibitor, i.e. clopidogrel, ticagrelor, prasugrel) or requiring chronic anticoagulation whatever the treatment (oral or injection)
• Concomitant combined strong P-gp and CYP3A4 inducers or inhibitors
• Active bleeding or high risk of bleeding after cardiac surgery (i.e. hemopericardium) or lesion or condition considered as a significant risk factor for major bleeding according to investigator
• Known hypersensitivity or other contraindications to apixaban (hepatic disease associated with coagulopathy and clinically relevant bleeding risk)
• Known hypersensitivity or other contraindications to aspirin (Hypersensitivity to aspirin or any of the excipients, history of asthma induced by the administration of salicylates, ongoing peptic ulcer, constitutional or acquired hemorrhagic disease including gastrointestinal bleeding, history of hemorrhagic stroke and thrombocytopenia, pregnancy after 24 weeks of gestation, risk of bleeding, severe renal failure, severe hepatic impairment, uncontrolled severe heart failure
• Known hypersensitivity or other contraindications to heparin or low molecular weight heparin (history of heparin-induced thrombocytopenia, hypersensitivity to any of the excipients…)
• Ischemic stroke within 1 month or intracranial hemorrhage
• History of non-compliance
• Active cancer or life expectancy less than 1 year
• Creatinine clearance <40 mL/min (Cockcroft) or patients requiring apixaban dose reduction
• Atrial fibrillation requiring chronic anticoagulation
• Active endocarditis at the time of screening for enrollment
• Women of childbearing potential without efficient contraception, pregnant or breastfeeding women
• Participation in another interventional study
• Persons deprived of their liberty by judicial or administrative decision