Affiliation:
1. Instituto Nacional de Cirugia Cardiaca , Montevideo, Uruguay
2. Centro Cardiovascular Universitario, Universidad de la Republica del Uruguay , Montevideo, Uruguay
Abstract
Abstract
OBJECTIVES
Most evidence for anticoagulation (AC) in aortic bioprosthesis is centred on embolic events, bleeding and reintervention risk. The effect of AC on haemodynamics has not been previously assessed. Our hypothesis was that patients with early AC after aortic valve replacement (AVR) with porcine bioprosthesis have better haemodynamics at 1 year of follow-up.
METHODS
Prospective, randomized, open-label trial conducted at 2 cardiac surgery centres. All patients undergoing AVR with porcine bioprosthesis were consecutively recruited. The anticoagulated group received warfarin + aspirin and the non-anticoagulated (control) only aspirin. The primary outcome was mean gradient after 1 year of AVR and change in New York Heart Association class. Secondary outcomes were major and minor bleeding, embolic events and prosthetic leak.
RESULTS
Of 140 participants in the study, 71 were assigned to the anticoagulated group and 69 to the control group. The mean age of the overall population was 72.4 (SD: 7.1) years. Global EuroSCORE was 7.65 (SD: 5.73). At 1 year, the mean gradient was similar between both groups [18.6 (SD: 1.1 mmHg) and 18.1 (SD: 1.0 mmHg) in the control and anticoagulated groups, respectively, P = 0.701]. No differences in functional class at 3 months or 1 year were found among groups. No differences were found among groups in the secondary outcomes.
CONCLUSIONS
The addition of 3 months of oral AC to anti-aggregation treatment was not detected to affect bioprosthetic haemodynamics nor functional class at 1 year after AVR. Likewise, AC does not lead to the higher incidence of complications.
Funder
Fondo Sectorial de Salud of the Agencia Nacional de Investigacion e Innovacion
Publisher
Oxford University Press (OUP)
Subject
Cardiology and Cardiovascular Medicine,Pulmonary and Respiratory Medicine,General Medicine,Surgery
Cited by
3 articles.
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