Clinical trial NCT03807921: Anticoagulation for Aortic Bioprosthesis (ANTIPRO)
Official title: Randomized Control Study of Anticoagulation With Warfarin Por Patients With Aortic Bioprosthesis vs Aspirin Only
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Aortic Valve Stenosis
Aortic Valve Disease
Aortic Valve Insufficiency
Aortic Valve Regurgitation
Keywords: aortic valve replacement
bioprosthesis
anticoagulation
Lead sponsor: Instituto Nacional de Cirugia Cardiaca, Uruguay
Sponsor class: OTHER
Collaborators: name: Universidad de la Republica
First posted: 2019-01-17
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Transprosthetic aortic gradient
timeFrame: 3 months and 1 year
measure: Change in New York Heart Association (NYHA) class
timeFrame: 1 year
Secondary outcomes:
measure: Major bleeding
timeFrame: 3 months and 1 year
measure: Embolic events
timeFrame: 3 months and 1 year
measure: Prosthetic leak
timeFrame: 3 months and 1 year
Other outcomes:
Locations:
city: Montevideo
country: Uruguay
facility: Centro Cardiovascular Universitario
city: Montevideo
country: Uruguay
facility: Instituto Nacional de Cirugia Cardiaca
Study officials:
affiliation: Instituto Nacional de Cirugia Cardiaca
name: Victor Dayan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro Cardiovascular Universitario
name: Diego Freire, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fernandez A, Loza G, Parma G, Florio L, Estigarribia J, Soca G, Robaina R, Duran A, Brusich D, Dayan V. Early anticoagulation after aortic valve replacement with porcine bioprosthesis randomized control trial (ANTIPRO). Eur J Cardiothorac Surg. 2022 Dec 2;63(1):ezac507. doi: 10.1093/ejcts/ezac507.