Anticoagulation for Aortic Bioprosthesis (ANTIPRO)

Instituto Nacional de Cirugia Cardiaca, Uruguay

Status and phase: Completed; Phase 4

Conditions: Aortic Valve Stenosis; Aortic Valve Regurgitation; Aortic Valve Disease; Aortic Valve Insufficiency

Treatments: Drug: Aspirin; Drug: Warfarin

Study type: Interventional

Funder types: Other

Identifiers

NCT03807921

ANTIPRO

Details and patient eligibility

About

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.

Full 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).

Enrollment: 140 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with indication of aortic valve replacement with porcine bioprosthesis

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 2 patient groups

Warfarin

Experimental group

Description:

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.

Treatment:

Drug: Warfarin

Drug: Aspirin

Aspirin only

Active Comparator group

Description:

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.

Treatment:

Drug: Aspirin