• Intern Emerg Med · Nov 2019

    The effect of management models on thromboembolic and bleeding rates in anticoagulated patients: an ecological study.

    • Alberto Tosetto, Sophie Testa, Gualtiero Palareti, Oriana Paoletti, Ilaria Nichele, Francesca Catalano, Rossella Morandini, Maria Di Paolo, Maurizio Tala, Pilar Esteban, Francesco Cora', Salvatore Mannino, Anna Maroni, Maria Sessa, and Giancarlo Castaman.
    • Haemostasis and Thrombosis Unit, Haematology Department, San Bortolo Hospital, Via Rodolfi 37, 36100, Vicenza, Italy. alberto.tosetto@aulss8.veneto.it.
    • Intern Emerg Med. 2019 Nov 1; 14 (8): 1307-1315.

    AbstractThe primary study objective is to compare the outcomes of patients taking oral anticoagulant medications in two distinct populations treated according to different management models (comprehensive vs. usual care). (Design: regional prospective cohort study; setting: hospital admission data from two regions). Eligible partecipants were patients taking oral anticoagulant drugs (vitamin K antagonist or direct oral anticoagulants), residents in the Vicenza and Cremona districts from February 1st, 2016 to June 30th, 2017. Patients were identified by accessing the administrative databases of patient drug prescriptions. The primary study outcome was admission to the Emergency Department for stroke, systemic arterial embolism, recurrence of venous thromboembolism or major bleeding. The study evaluated outcomes in 14,226 patients taking oral anticoagulants, of whom 6725 being followed in Cremona with a comprehensive management model. There were 19 and 45 thromboembolic events over 6205 and 6530 patient-years in the Cremona and Vicenza cohort, respectively (IRR 0.44, 95% CI 0.24-0.77). The reduction of events in the Cremona cohort was almost entirely explained by a decrease of events in patients taking VKA (IRR 0.41, 95% CI 0.20-0.78) but not DOACs (IRR 1.08, 95% CI 0.25-5.24). The rate of major bleeding was non-significantly higher in Cremona than in Vicenza (IRI 1.32; 95% CI 0.74-2.40). Across the two cohorts, the risk of bleeding was lower in patients being treated with DOACs rather than warfarin (10/4574 vs. 42/8161 event/person-years, respectively, IRR 0.42 95% CI 0.19-0.86). We conclude that a comprehensive management model providing centralized dose prescription and follow-up may significantly reduce the rate of thromboembolic complications, without substantially increasing the number of bleeding complications. Patients treated with direct oral anticoagulants appear to have a rate of thromboembolic complications comparable to VKA patients under the best management model, with a reduction of major bleeding.

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