What is the clinical evidence from this study?

Study design: Cohort. Population: Aortic bioprosthesis implantation (n=57). Intervention: No early oral anticoagulation. Primary outcome: Thromboembolic complications.

August 1, 1995

Aortic Bioprosthesis Without Early Anticoagulation-Risk of Thromboembolism

JBJörg Babin–EbellRhön-Klinikum WSWolfgang SchmidSt. Josef-Hospital PEP. EigelKlinikum Passau

Key Result

Omission of early oral anticoagulation after aortic bioprosthesis implantation was associated with a 1.75% risk of thromboembolic complications in the first six months following surgery.

Study Design

Type

Cohort (n=57)

Structured PICO

Does omitting early oral anticoagulation increase the risk of thromboembolism in patients with an aortic bioprosthesis?

Population

57 patients who underwent implantation of an aortic bioprosthesis and did not receive early oral anticoagulation, investigated retrospectively.

Exposure

No oral anticoagulation after implantation

Outcome

Thromboembolic complications during the first six months following surgeryhard clinical

Omitting early oral anticoagulation after aortic bioprosthesis implantation is associated with a low risk of thromboembolism (1.75% at 6 months), suggesting standard anticoagulation may not be necessary given its bleeding risks.

Abstract

Anticoagulation after implantation of a bioprosthetic heart valve has been suggested during a high-risk period of 3 months following surgery. There is little information available concerning the risk of thromboembolism during this period if anticoagulation is not carried out. However, this is of interest since 60-80% of all bleeding complications due to anticoagulation occur during the first year of treatment. Between 1983 and 1993, 57 of our patients did not receive oral anticoagulation after implantation of a bioprothesis in the aortic position (49 Hancock, 7 Mitroflow and one Edwards stentless). All patients were investigated retrospectively. A risk for thromboembolic complications of 1.75% is calculated for the first six months following surgery, being 3.5 per 100 patients/year. There seems to be no advantage in standard anticoagulation (INR 2.5-4) with its risk of serious bleeding complications of about 4% during this period of treatment. Low-dose anticoagulation (INR 2.0-2.3), however, preferably in combination with prothrombin estimation by the patients, seems to offer a relatively safe treatment for these patients.

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