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Hokusai Post-DVT Study: A Follow-up Study on Long-term Outcomes of Deep Vein Thrombosis in Patients Treated with Edoxaban vs Warfarin

1Amsterdam UMC, University of Amsterdam, Amsterdam Cardiovascular Sciences, Vascular Medicine, Amsterdam Zuid-oost, the Netherlands, 2Flevoziekenhuis, Internal Medicine, Almere, the Netherlands, 3Amsterdam UMC, University of Amsterdam, Amsterdam Cardiovascular Sciences, Internal Medicine, Amsterdam, the Netherlands, 4Noordwest Ziekenhuisgroep, Pulmonology, Alkmaar, the Netherlands, 5University Medical Center Groningen, Hematology, Groningen, the Netherlands, 6University Hospital Leuven, Vascular Medicine and Hemostasis, Leuven, the Netherlands, 7Maastricht University Medical Center (MUMC+), Thrombosis Expertise Centre, Heart+Vascular Center, Maastricht, the Netherlands, 8University Hospital Carl Gustav Carus Dresden, Center for Vascular Medicine, Dresden, Germany, 9Städtisches Klinikum Dresden, Medizinische Klinik, Dresden, Germany, 10Amsterdam UMC, University of Amsterdam, Amsterdam Cardiovascular Sciences, Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam, the Netherlands, 11McGill University, Medicine, Montreal, Canada, 12San Paolo Hospital, Hematology and Thrombosis, Milan, Italy, 13Østfold Hospital and Institute of Clinical Medicine, University of Oslo, Research, Oslo, Norway, 14St George Hospital, Hematology, Sydney, Australia, 15Amsterdam UMC, University of Amsterdam, Amsterdam Cardiovascular Sciences, Vascular Medicine, Amsterdam, the Netherlands, 16Strasbourg Regional University Hospital, Hypertension, Vascular Disease and Clinical Pharmacology, Strasbourg, France, 17Hôpital du Bocage, Service de Médecine Interne, Dijon, France, 18Clinique du Parc, Vascular Medicine Unit, Castelnau Le Lez, France, 19Montpellier University Hospital and University of Montpellier, Vascular Medicine, Montpellier, France, 20Amsterdam UMC, University of Amsterdam, Amsterdam Cardiovascular Sciences, Vascular Medicine, Amsterdam, France

Abstract Number: PB2207

Meeting: ISTH 2020 Congress

Theme: Venous Thromboembolism and Cardioembolism » Post-thrombotic Syndrome

Background: Post-thrombotic syndrome (PTS) is a long-term complication of deep vein thrombosis (DVT) and it is associated with a decreased quality of life (QoL). Unfortunately, therapeutic options are limited and therefore, prevention of PTS is very important. Few studies have indicated that treatment of DVT with direct oral anticoagulant (DOAC) may be associated with a lower risk for PTS development compared to vitamin K antagonist (VKA) treatment. To our knowledge, no studies have been conducted in which edoxaban was compared to VKA. We hypothesize that edoxaban treatment compared to VKA treatment (both preceded by heparin) for DVT leads to a lower incidence of PTS along with an improved QoL.

Aims: To assess the cumulative incidence of PTS after acute DVT and the long-term quality of life following DVT in patients treated with edoxaban in comparison to patients treated with warfarin.

Methods: The present study is a follow up of the original HOKUSAI VTE trial (NCT00986154). We are collecting data from previously enrolled patients at least 5 years after the index DVT. Primary outcome is the incidence of PTS, defined by the Villalta score. The secondary outcome is QoL, assessed by the validated generic (SF-36) and DVT-specific (VEINES-QoL) questionnaires. We will compare these outcomes in both treatment arms. Ethical approval was granted in all participating centers and patients signed informed consent.

Results: Up to now, 22 of the 76 (29%) of the centers that were invited managed to participate and we have currently included 277 patients. The analyses will be performed after completion of data collection (May 2020).

Conclusions: So far, we have included 277 patients. Inclusions will continue until May 2020 and at the ISTH 2020 be able to present our results on PTS incidence and QoL after DVT in patients treated with edoxaban compared to patients treated with warfarin.

To cite this abstract in AMA style:

Bistervels I, Bavalia R, Boersma W, Meijer K, Verhamme P, ten Cate-Hoek AJ, Beyer-Westendorf J, Schellong S, Hutten B, Kahn S, Cattaneo M, Ghanima W, Hugman A, Coppens M, ten Wolde M, Stephan D, Falvo N, Brisot D, Quere I, Middeldorp S, Hokusai PTS investigators . Hokusai Post-DVT Study: A Follow-up Study on Long-term Outcomes of Deep Vein Thrombosis in Patients Treated with Edoxaban vs Warfarin [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/hokusai-post-dvt-study-a-follow-up-study-on-long-term-outcomes-of-deep-vein-thrombosis-in-patients-treated-with-edoxaban-vs-warfarin/. Accessed November 30, 2021.

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