SAFE-HEART is a single-centre, randomized controlled trial comparing the safety and efficiency of Apixaban versus Warfarin in the early period (3 months) after repair or bioprosthetics of the mitral and aortic valve cardiac surgery in patients with atrial fibrillation requiring oral anticoagulation.
Age ≥18 years at the time of enrolment
Open heart aortic or mitral valve repair or biological valve replacement in the last 10 days
Atrial fibrillation requiring anticoagulation (including pre-existing or post-operative atrial fibrillation),
Informed consent from either the patient or a substitute decision-maker.
Mechanical valve replacement
Antiphospholipid syndrome (triple positive)
Severe renal failure (Cockcroft-Gault equation; creatinine clearance <15 ml/min)
Known significant liver disease (Child-Pugh classification B and C)
Parallel
Apixaban
DrugPatients in the intervention group will receive Apixaban at doses recommended for the indication, adjusted for their renal function is required.
Warfarin
DrugPatients in the control group will receive VKA once daily; the individual dose will be titrated to achieve a guideline-recommended INR range.
Major Bleeding
Major bleeding defined as bleeding that results in death and/or symptomatic bleeding in a critical area or organ, bleeding into a surgical site requiring reoperation, bleeding leading to hospitalization (including presentation to an acute care facility without overnight stay) and/or bleeding that causes a drop in the hemoglobin level of 20g/L or more or that which requires the transfusion of ≥2 units of packed red blood cells or whole blood (as defined by the International Society of Thrombosis and Hemostasis)
Death and/or thromboembolic complications
Stroke Myocardial infarction Intracardiac thrombosis Systemic embolism Deep vein thrombosis Pulmonary embolism
Minor Bleeding
Quality of Life - EQ-5D-5L
EQ-5D is a standardised instrument developed by the EuroQol Group to provide a simple, generic measure of HRQoL for clinical and economic appraisal The descriptive system measures five dimensions of health: MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT and ANXIETY / DEPRESSION. Each dimension has five response levels: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems. The respondent is asked to indicate his/her health state by checking the box next to the most appropriate response level for them in each of the five dimensions. Responses are coded as single-digit numbers expressing the severity level selected in each dimention. The EQ VAS records the respondent's overall current health on a vertical visual analogue scale (0-100), where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The EQ VAS provides a quantitative measure of the patient's perception of their overall health.
Patient Satisfaction with Anticoagulant treatment
This indicator will be assessed using a questionnaire (Perception of Anticoagulant Treatment Questionnaire (PACT-Q)). The Perception of Anticoagulant Treatment Questionnaire (PACT-Q) is a validated, two-part, 20-item patient-reported tool that measures expectations (PACT-Q1) before treatment and convenience/satisfaction (PACT-Q2) during treatment. All theitems of PACT-Q1 and PACT-Q2 parts are to be answeredon a 5-point Likert scale.
Pleural or pericardial effusion requiring drainage
Incidence of pericarditis/pleuritis requiring drainage in both groups
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