Anticoagulation for Aortic Bioprosthesis (ANTIPRO)
- Conditions
- Aortic Valve StenosisAortic Valve DiseaseAortic Valve InsufficiencyAortic Valve Regurgitation
- Interventions
- Registration Number
- NCT03807921
- Lead Sponsor
- Instituto Nacional de Cirugia Cardiaca, Uruguay
- Brief Summary
This study evaluates the clinical and hemodynamic outcome in patients after aortic valve replacement. Half of the patients will receive warfarin + aspirin and the other half will receive only aspirin. The investigators will focus mainly on early bioprosthesis degeneration.
- Detailed Description
Aortic bioprosthesis have the advantage that they do not require life-long anticoagulation. Current guidelines support the use of aspirin (AAS) 100 mg as a class I indication.
Current evidence, mainly derived from transaortic valve implantation (TAVI) patients, have shown that aortic bioprosthesis suffer subclinical thrombosis which may explain the increase in gradient and bioprosthetic degeneration. Anticoagulation in this cases improve leaflet mobility and decrease in gradient. Evidence supporting early anticoagulation in patients with aortic bioprosthesis is not as strong as in the case of mitral bioprosthesis. Nonetheless, current American Heart Association/American College of Cardiology (AHA/ACC) guidelines recommend (IIa) the use of warfarin for at least 3 months after aortic valve replacement.
The aim is to conduct a single blinded (echocardiographist) randomized control study in patients who receive an aortic bioprosthesis. Comparison will be performed between the use of warfarin + aspirin vs aspirin alone. Duration of anticoagulation will be for 3 months and patients follow-up for 1 year. Clinical and echocardiographic evaluation will be performed in every patients. Some patients will undergo Positron Emission Tomography (PET-Scan).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 140
- Patients with indication of aortic valve replacement with porcine bioprosthesis
- Concomitant mitral valve replacement
- Previous atrial fibrillation
- Previous use oral anticoagulation
- Contraindication for the use of oral anticoagulation (high risk of bleeding, intolerance, allergy)
- Jehovah witness
- Platelet count below 90,000.
- Liver disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Warfarin Warfarin Warfarin will be started 48-72h after aortic valve replacement. Dose will be 5 mg daily in order to obtain an Internation normal ratio (INR) of 2-3. Warfarin treatment will continue for 3 months. Aspirin will be administered 100 mg daily. Warfarin Aspirin Warfarin will be started 48-72h after aortic valve replacement. Dose will be 5 mg daily in order to obtain an Internation normal ratio (INR) of 2-3. Warfarin treatment will continue for 3 months. Aspirin will be administered 100 mg daily. Aspirin only Aspirin Aspirin will be started 48-72h after aortic valve replacement. Dose will be 100 mg daily. Patients who undergo coronary artery revascularization will receive 325 mg daily.
- Primary Outcome Measures
Name Time Method Transprosthetic aortic gradient 3 months and 1 year Change in Transprosthetic mean gradient
Change in New York Heart Association (NYHA) class 1 year NYHA class
- Secondary Outcome Measures
Name Time Method Embolic events 3 months and 1 year Number of patients with cerebral and peripheral ischemic events
Prosthetic leak 3 months and 1 year Change in severity of prosthetic and paraprosthetic leakage
Major bleeding 3 months and 1 year number of patients admitted due to Genitourinary (GU) or Gastrointestinal (GI) bleeding, pericardial tamponade, pleural effusion
Trial Locations
- Locations (2)
Instituto Nacional de Cirugia Cardiaca
🇺🇾Montevideo, Uruguay
Centro Cardiovascular Universitario
🇺🇾Montevideo, Uruguay