Skip to main content
ISTH 2024 Main banner
Back
CME Evaluation

Oral Communication Session

Venous Thromboembolism

Session: Improving outcomes in VTE

OC 52.1 - Reduced-Dose Direct Oral Anticoagulants for the Extended Treatment of Venous Thromboembolism: Results from the GARFIELD-VTE Registry

Tuesday, June 25, 2024
09:30 – 09:45 ICT
Room: Ballroom B2

    Presenting Author(s)

  • Nicola Potere, MD

    Medical Resident
    G. d'Annunzio University, Chieti, Italy
    Chieti, Abruzzi, Italy

    • Co-Author(s)

  • MF

    Meg Fluharty

    Statistician
    Thrombosis Research Institute, London, UK
    London, England, United Kingdom

  • SH

    Sylvia Haas

    Professor
    Technical University of Munich, Munich, Germany
    Munich, Bayern, Germany

  • Ajay Kakkar

    Professor
    Thrombosis Research Institute, London, UK
    London, England, United Kingdom

  • PJ

    Petr Jansky

    Professor
    Department of Cardiovascular Surgery, Motol University Hospital, Prague, Czech Republic
    Prague, Hlavni mesto Praha, Czech Republic

  • SS

    Sebastian Schellong

    Professor
    Municipal Hospital Dresden, Dresden, Germany
    Dreden, Sachsen, Germany

  • CS

    Clifford Smith

    Medical Doctor
    Morningside MediClinic, Sandton, Johannesburg, South Africa
    Johannesburg, Gauteng, South Africa

  • JW

    Jeffrey I. Weitz

    Professor
    McMaster Univeristy
    Hamilton, Ontario, Canada

  • Peter MacCallum

    Professor
    Thrombosis Research Institute, London, UK
    London, England, United Kingdom

  • PP

    Paolo Prandoni

    MD, PhD
    Fondazione Arianna
    Padova, Veneto, Italy

  • AT

    Alexander GG Turpie, MD

    Department of Medicine and Thromboembolism Unit
    McMaster University, Hamilton, Ontario, Canada
    Hamilton, Ontario, Canada

  • MM

    Manuel Monreal

    Professor
    Chair for the Study of Thromboembolic Disease, Faculty of Health Sciences, UCAM - Universidad Católica San Antonio de Murcia, Spain
    Murcia, Murcia, Spain

  • Pantep Angchaisuksiri

    Professor of Medicine and Chief of the Haemostasis and Thrombosis Unit
    Department of Medicine, Ramathibodi Hospital, Mahidol University
    Bangkok, Krung Thep, Thailand

  • OO

    Oztekin Oto

    Professor
    Department of Cardiovascular Surgery, Faculty of Medicine, Dokuz Eylul University, Izmir, Turkey
    Izmir, Izmir, Turkey

  • GK

    Gloria Kayani

    Statistician
    Thrombosis Research Institute, London, UK
    London, England, United Kingdom

  • Walter Ageno, MD

    Professor
    University of Varese
    Bellinzona, Ticino, Switzerland

  • KP

    Karen Pieper

    Director of Statistics
    Thrombosis Research Institute, London, UK
    London, England, United Kingdom

Background: The direct oral anticoagulants (DOACs) apixaban and rivaroxaban can be administered at either full- or reduced-dose for the extended treatment of venous thromboembolism (VTE). Limited information is available on factors associated with dose reduction and the associated clinical outcomes in real-life.

Aims: To evaluate the clinical characteristics and the long-term outcomes of patients receiving reduced- vs full-dose DOACs after completing 3 months of therapy in the Global Anticoagulant Registry in the FIELD (GARFIELD)-VTE.

Methods: GARFIELD-VTE (NCT02155491) was a global, prospective, non-interventional study enrolling, between May 2014 and January 2017, 10679 subjects with objectively-confirmed VTE managed in real-life settings.

Results: Reduced- and full-dose DOACs were used by 326 (8.6%) and 3454 (91.4%) patients, respectively. In the reduced-dose group, 151 (46.3%) used apixaban and 175 (53.7%) rivaroxaban. Overall, subjects receiving reduced doses were older (p= < 0.001), and had lower median body mass index and platelet count (p=0.002 for both). Factors associated with greater chance of dose reduction were thrombocytopenia, renal insufficiency, prior VTE and known thrombophilia; with full-dose, factors included VTE secondary to surgery or hospitalization (Table 1). Over a mean follow-up of 964±305 days, recurrent VTE occurred in 7.4% and 9.3% of subjects receiving reduced- and full-dose DOACs (p=0.244), respectively, and major bleeding in 4.3% and 2.6% (p=0.077), respectively. When examining dose change as a time-dependent variable, bleeding and MI/ACS events were significantly higher among patients receiving reduced doses (Table 2).

Conclusion(s): Older age, low body mass index and impaired renal function were associated with the decision to reduce DOAC dose at 3 months for extended VTE treatment in real-life. The recurrence rate of reduced-dose DOACs was similar to that of full-dose, but bleeding and arterial events were increased, possibly due to the higher risk profile of reduced-dose users.