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Efficacy and Safety of Direct Oral Anticoagulants in Patients of Southern Italy with Atrial Fibrillation: Real-world Data from the EGINA Registry

1A.P.T.E.A., Bari, Italy, 2Hemostasis and Thrombosis Center, Avellino, Italy, 3Thrombosis and Blood Transfusion Center, Taranto, Italy, 4Thrombosis and Blood Transfusion, "Di Venere" Hospital, Bari, Italy, 5Thrombosis Center, Department of Clinical Pathology, Altamura, Italy, 6Thrombosis and Blood Transfusion Center, Molfetta, Italy, 7Department of Hematology, Acquaviva delle Fonti, Italy, 8Hemostasis and Thrombosis Center, Nocera Inferiore-Pagani-Scafati, Italy, 9Department of Internal Medicine, Gallipoli, Italy, 10Hemostasis and Blood Transfusion Center, "San Paolo" Hospital, Bari, Italy, 11Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, A. Bianchi Bonomi Hemophilia and Thrombosis Center, Milan, Italy, 12Department of Interdisciplinary Medicine, University of Bari, Bari, Italy

Abstract Number: PB1074

Meeting: ISTH 2021 Congress

Theme: Venous Thromboembolism » Atrial Fibrillation

Background: Oral anticoagulant therapy has been historically managed in Italy in patients with atrial fibrillation (AF) by a network of Anticoagulation Centers (ACs). Patients taking direct oral anticoagulants (DOACs) no longer required periodical blood withdrawal for the modification of the drug dosage and therefore their follow-up might be less strict than before. From 2018 onwards, 19 ACs of southern Italy have been using a clinical model, named EGINA (Excellence model for the Integrated Management of New Anticoagulants), designed to improve the management of such patients.

Aims: To evaluate the incidence of ischemic and hemorrhagic events in patients taking DOACs, followed according to the EGINA model.

Methods: This multi-center study included patients with AF who started a DOAC from Jan 2018 to Feb 2020. Data were collected retrospectively by 9 ACs of southern Italy. The observational period lasted a maximum of 12 months from the date of initiation of therapy with a DOAC. Diagnosis of major and minor bleeding was made according to the International Society on Thrombosis and Haemostasis (ISTH).

Results: Overall 395 patients with AF has been assessed. Mean age was 75.76 years (SD= 9.48, ranging from 31 to 100 years old) and 170 patients were female (43%). On average, at baseline assessment CHA2DS2-VASc score was 3.49 (SD= 1.3) and HAS-BLED 1.79 (SD= 0.95). The 33.2% of patients were naïve for anticoagulation. Apixaban was the most prescribed DOACs (35.4%), followed by edoxaban (32.4%), rivaroxaban (17.0%) and dabigatran (15.2%). Dose reduction was recommended in 30.9% of patients. Collectively, we observed a low incidence of major (0.8%) and minor bleedings (1.3%), with no significant difference according the DOACs dosage (standard or reduced). Only one ischemic event was observed.

Conclusions: Our real-world data show a low incidence of bleeding events, demonstrating that the accurate follow-up of patients anticoagulated with DOACs may guarantee good clinical outcomes.  

To cite this abstract in AMA style:

Ciavarella N, Ciampa A, Bradamante S, Colucci A, Dirienzo G, Iannone AM, Polimeno G, Rescigno G, Ria L, Scarafile R, Ciavarella A, Custodero C, Sabbà C. Efficacy and Safety of Direct Oral Anticoagulants in Patients of Southern Italy with Atrial Fibrillation: Real-world Data from the EGINA Registry [abstract]. Res Pract Thromb Haemost. 2021; 5 (Suppl 2). https://abstracts.isth.org/abstract/efficacy-and-safety-of-direct-oral-anticoagulants-in-patients-of-southern-italy-with-atrial-fibrillation-real-world-data-from-the-egina-registry/. Accessed June 25, 2022.

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