Thromb Haemost 2014; 112(03): 511-521
DOI: 10.1160/TH14-01-0081
Blood Coagulation, Fibrinolysis and Cellular Haemostasis
Schattauer GmbH

Poor predictive value of contemporary bleeding risk scores during long-term treatment of venous thromboembolism

A multicentre retrospective cohort study

Authors

  • Nicoletta Riva

    1   Department of Clinical and Experimental Medicine, University of Insubria, Varese, Italy
  • Marta Bellesini

    1   Department of Clinical and Experimental Medicine, University of Insubria, Varese, Italy
  • Matteo Nicola Dario Di Minno

    2   Department of Clinical Medicine and Surgery, Federico II University, Naples, Italy
  • Nicola Mumoli

    3   Department of Internal Medicine, Ospedale Civile Livorno, Livorno, Italy
  • Fulvio Pomero

    4   Department of Internal Medicine, ‘S. Croce e Carle’ Hospital, Cuneo, Italy
  • Massimo Franchini

    5   Department of Transfusion Medicine and Haematology, Carlo Poma Hospital, Mantua, Italy
  • Chiara Fantoni

    1   Department of Clinical and Experimental Medicine, University of Insubria, Varese, Italy
  • Roberta Lupoli

    2   Department of Clinical Medicine and Surgery, Federico II University, Naples, Italy
  • Barbara Brondi

    3   Department of Internal Medicine, Ospedale Civile Livorno, Livorno, Italy
  • Valentina Borretta

    4   Department of Internal Medicine, ‘S. Croce e Carle’ Hospital, Cuneo, Italy
  • Carlo Bonfanti

    5   Department of Transfusion Medicine and Haematology, Carlo Poma Hospital, Mantua, Italy
  • Walter Ageno

    1   Department of Clinical and Experimental Medicine, University of Insubria, Varese, Italy
  • Francesco Dentali

    1   Department of Clinical and Experimental Medicine, University of Insubria, Varese, Italy
Further Information

Publication History

Received: 25 January 2014

Accepted after major revision: 11 April 2014

Publication Date:
20 November 2017 (online)

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Summary

Bleeding is a common and feared complication of oral anticoagulant therapy. Several prediction models have been recently developed, but there is a lack of evidence in patients with venous thromboembolism (VTE). The aim of this study was to validate currently available bleeding risk scores during long-term oral anticoagulation for VTE. We retrospectively included adult patients on vitamin K antagonists for VTE secondary prevention, followed by five Italian Anticoagulation Clinics (Cuneo, Livorno, Mantova, Napoli, Varese), between January 2010 and August 2012. All bleeding events were classified as major bleeding (MB) or clinically-relevant-non-major-bleeding (CRNMB). A total of 681 patients were included (median age 63 years; 52.0% female). During a mean follow-up of 8.82 (± 3.59) months, 50 bleeding events occurred (13 MB and 37 CRNMB), for an overall bleeding incidence of 9.99/100 patient-years. The rate of bleeding was higher in the first three months of treatment (15.86/100 patient-years) than afterwards (7.13/100 patient-years). The HAS-BLED showed the best predictive value for bleeding complications during the first three months of treatment (area under the curve [AUC] 0.68, 95% confidence interval [CI] 0.59–0.78), while only the ACCP score showed a modest predictive value after the initial three months (AUC 0.61, 95%CI 0.51–0.72). These two scores had also the highest sensitivity and the highest negative predictive value. None of the scores predicted MB better than chance. Currently available bleeding risk scores had only a modest predictive value for patients with VTE. Future studies should aim at the creation of a new prediction rule, in order to better define the risk of bleeding of VTE patients.