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    Poster Networking

    Venous Thromboembolism

    Poster Networking Session

    PB0463 - Safety and Efficacy of Rivaroxaban for Extended-Phase Anticoagulation of Patients with Unprovoked or Recurrent Venous Thromboembolism: Real-Life Data from the MAC Project

    Sunday, June 25, 2023
    18:30 – 19:30 ET
    Room: Exhibition

      Presenting Author(s)

    • Giuseppe Camporese, MD

      Vascular Physician
      Department of Internal Medicine, Padua University Hospital
      Padua, Veneto, Italy

      • Co-Author(s)

    • CB

      Cristiano Bortoluzzi

      Internist
      Hospital of Venice
      Venice, Veneto, Italy

    • EB

      Enrico Bernardi

      Emergency Physician
      Emergency and Accident Medicine, Hospital of Treviso
      Treviso, Veneto, Italy

    • FN

      Franco Noventa

      Internist
      QUOVADIS no-profit Associaton
      Padua, Veneto, Italy

    • Paolo Simioni, MD, PhD (he/him/his)

      Full Professor
      Department of Medicine, Thrombotic and Haemorrhagic Diseases Unit, University of Padua Medical School, Padua (Italy)
      Padua, Veneto, Italy

    Background: Optimal duration of anticoagulation in patients with venous thromboembolism (VTE) still is matter of debate. Latest guidelines suggest long-term anticoagulation in patients with cancer-associated thrombosis or in those with unprovoked VTE and a low bleeding risk.

    Aims: To evaluate efficacy and safety of rivaroxaban for extended-phase anticoagulation in patients with unprovoked and recurrent VTE included in the real-life MAC (Monitoring Anticoagulant Therapy) Project over a 5-year follow-up period

    Methods: MAC Project is a prospective-cohort, multi-center, observational study investigating VTE patients treated with DOACs, currently ongoing in Italy. Exclusion criteria are life expectancy < 6 months and refusal to sign the informed consent or to attend the planned follow-up visit at 3, 6, and 12 months after the index event, and then annually for up to 5 years. The primary efficacy and safety end-points are symptomatic recurrent VTE and major bleeding.

    Results: We analyzed 450 consecutive VTE patients treated with rivaroxaban. Of them, 267 (55%) had unprovoked VTE, and 377 (87%) were symptomatic. During a mean 22-months follow-up recurrent VTE occurred in 12 patients while on treatment (IR 1.7 per 100 person-years) and was more frequent in men than in women. Overall, bleeding events occurred in 33 (7.3%) patients: 13 (2.9%) major bleeding, 12 (2.7%) clinically relevant non-major bleeding, 8 minor bleeding, none fatal bleeding, mostly occurring within the first 2 years of treatment. In addition, bleedings were significantly higher in patients with a baseline HAS-BLED score of 3-4 versus those with a score of 0-2, mainly during the first 3 months of treatment (RR 5.9).

    Conclusion(s): Rivaroxaban appears to be safe and effective for the long-term treatment of patients with recurrent or unprovoked VTE. Our results match previously published data, and we are confident that the continuation of the follow-up for up to 5 years will confirm these data.