Aortic Valve Surgery, Atrial Fibrillation (AF), Mitral Valve Annuloplasty, Mitral Valve Repair, Mitral Valve Surgery, Valve Disease, Heart, Valve Replacement Surgery
Conditions
Keywords
anticoagulation, bioprosthetics, atrial fibrillation, mitral valve repair, aortic valve repair, Apixaban, Warfarin
Brief summary
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.
Detailed description
Oral anticoagulation with vitamin K antagonists (VKAs) is currently recommended for 3 months following surgical reconstruction or bioprosthetic replacement of the mitral and aortic valves, regardless of rhythm status. Despite their effectiveness, the use of warfarin is limited by its narrow therapeutic index, which requires frequent international normalized ratio (INR) measurements to ensure adequate anticoagulation levels. This key limitation leads to failure to maintain target INR levels and treatment discontinuation. Additionally, in the first 3 months after heart surgery, the duration of the therapeutic period is short, even with careful monitoring by experienced physicians. Over the past decade, direct oral anticoagulants (DOACs)-factor Xa or thrombin inhibitors-have gained widespread use in anticoagulant therapy. It has been demonstrated that DOAC treatment in patients with atrial fibrillation reduces the risk of stroke or systemic embolism and carries a similar risk of major bleeding compared to VKAs during long-term follow-up in patients with atrial fibrillation. Moreover, they offer rapid onset of action, fixed dosing, no need for laboratory monitoring, and minimal interactions with food and other medications. In the postoperative period, DOAC use may also shorten hospital stays and reduce costs. However, the safety of DOACs in the first months after surgical valve correction (reconstruction/bioprosthetic replacement of the mitral and aortic valves) remains uncertain, which is reflected in the recommendation classes for anticoagulant therapy following these procedures. The purpose of this study is to establish whether Apixaban is as safe and effective as Warfarin in the first 3 months after reconstruction or bioprosthetics of the mitral and aortic valvescardiac surgery in patients with atrial fibrillation requiring oral anticoagulation.
Interventions
DRUGApixaban
Patients in the intervention group will receive Apixaban at doses recommended for the indication, adjusted for their renal function is required.
DRUGWarfarin
Patients in the control group will receive VKA once daily; the individual dose will be titrated to achieve a guideline-recommended INR range.
Sponsors
Meshalkin Research Institute of Pathology of Circulation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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) * Left ventricular thrombus * Ongoing bleeding, hemorrhagic disorders, or bleeding diathesis * Known contraindication for any DOAC or VKA * Women who are pregnant, breastfeeding, or of childbearing potential * Follow-up not possible
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Bleeding | 3 months | 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 | 3 months | Stroke Myocardial infarction Intracardiac thrombosis Systemic embolism Deep vein thrombosis Pulmonary embolism |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Minor Bleeding | 3 months | — |
| Quality of Life - EQ-5D-5L | 3 months | 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 | 3 months | 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 | 3 months | Incidence of pericarditis/pleuritis requiring drainage in both groups |
Countries
Russia
Contacts
CONTACTAlexander Afanasyev
CONTACTMaria Agarkova
Outcome results
None listed