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Semin Thromb Hemost 2020; 46(08): 977-985
DOI: 10.1055/s-0040-1718891
Review Article

Rivaroxaban Compared to Placebo for the Treatment of Leg Superficial Vein Thrombosis: A Randomized Trial

Authors

  • Clive Kearon

    1   Department of Medicine, McMaster University, Hamilton, Ontario, Canada

  • Marc Carrier

    2   Department of Medicine, Ottawa Hospital Research Institute at the University of Ottawa, Ottawa, Ontario, Canada

  • Chu-Shu Gu

    3   Department of Oncology, McMaster University, Hamilton, Ontario, Canada

  • Sam Schulman

    1   Department of Medicine, McMaster University, Hamilton, Ontario, Canada
    4   Department of Obstetrics and Gynecology, I.M. Sechenov First Moscow State Medical University, Moscow, Russia

  • Shannon M. Bates

    1   Department of Medicine, McMaster University, Hamilton, Ontario, Canada

  • Susan R. Kahn

    5   Department of Medicine, McGill University, Montreal, Quebec, Canada

  • Isabelle Chagnon

    6   Department of Medicine, University of Montreal, Montreal, Quebec, Canada

  • Doan Trang Nguyen

    6   Department of Medicine, University of Montreal, Montreal, Quebec, Canada

  • Cynthia Wu

    7   Department of Medicine, University of Alberta, Edmonton, Alberta, Canada

  • Lisa Rudd-Scott

    3   Department of Oncology, McMaster University, Hamilton, Ontario, Canada

  • Jim A. Julian

    3   Department of Oncology, McMaster University, Hamilton, Ontario, Canada

Funding The study was funded by an investigator-initiated grant from Bayer Inc.
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Abstract

The role of rivaroxaban in the treatment of leg superficial venous thrombosis (SVT) is uncertain. This article aims to determine if rivaroxaban is an effective and safe treatment for leg SVT. Patients with symptomatic leg SVT of at least 5 cm length were randomized to 45 days of rivaroxaban 10 mg daily or to placebo, and followed for a total of 90 days. Treatment failure (required a nonstudy anticoagulant; had proximal deep vein thrombosis or pulmonary embolism; or had surgery for SVT) at 90 days was the primary efficacy outcome. Secondary efficacy outcomes included leg pain severity, and venous disease-specific and general health-related quality of life over 90 days. Major bleeding at 90 days was the primary safety outcome. Poor enrollment led to the trial being stopped after 85 of the planned 600 patients were randomized to rivaroxaban (n = 43) or placebo (n = 42). One rivaroxaban and five placebo patients had a treatment failure by 90 days (absolute risk reduction = 9.0%, 95% confidence interval: −22 to 5.9%). Leg pain improvement did not differ at 7 (p = 0.16) or 45 days (p = 0.89), but was greater with rivaroxaban at 90 days (p = 0.011). There was no difference in venous disease-specific (p = 0.99) or general health-related (p = 0.37) quality of life over 45 days. There were no major bleeds or deaths in either group. There were no identifiable differences in efficacy or safety between rivaroxaban and placebo in patients with symptomatic SVT but comparisons were undermined by a much smaller than planned sample size (NCT1499953).

Keywords

superficial vein - clinical trial - treatment - leg - venous thrombosis

Trial Investigators Additional to the Authors

Clinical centers (patients enrolled), collaborators: The Ottawa Hospital—General Campus, Ottawa, Ontario (ON), Canada (25 patients): W. Aikens, L. Castellucci, C. Code, L. Duffett, A. Dugal, M. Forgie, C. Gonsalves, A. Haspect, A. Karovitch, G. Le Gal, S. Reddie, M. Rodger, D. Scarvelis, P. Wells, A. Clement, H. Carr, and A. Pecarski; Hamilton Health Sciences—General Hospital, Hamilton, ON, Canada (16 patients): N. Bedek, J. Douketis, M. Zondag, and J. Eikelboom; Hamilton Health Sciences—Juravinski Hospital, Hamilton, ON, Canada (14 patients): K. de Witt, S. Dodds, P. Gross, A. Iorio, L-A. Linkins, P. Stevens, C. Webb, and J. Weitz; The Jewish General Hospital, Montreal, Quebec (QC), Canada (8 patients): M. Blostein, C. Strulovitch, and V. Tagalakis; Hôpital du Sacré-Cœur, Montreal, QC, Canada (8 patients): M. Goulet, N. Routhier, and G. Marcotte; Hôpital Maisonneuve—Rosemount, Montreal, QC, Canada (6 patients): E. Foldes, J. Kassis, M. Sergerie, M. Quach, J. Trinh Lu, and D. Sylvestre; Hamilton Health Sciences—McMaster University Medical Centre, Hamilton, ON, Canada (5 patients): S. Bates and M. Pai; University of Alberta Hospital, Edmonton, Alberta, Canada (3 patients): L. Bolster, J. Brandwein, L. Larratt, J. Patterson, A. Peters, B. Ritchie, L. Saini, I. Sandhu, M. Tapara, N. Zhu, C. Crittenden, P. Bellot, A. Shirokova, A. Strilchuk, R. Cairns, and S. Cleary.


Independent Adjudication Committee: Drs. S. Schulman, J. Weitz. and L-A. Linkins.


Data Management and Study Coordination: L. Rudd-Scott, E. McGean, and D. McCarty (Ontario Clinical Oncology Group, McMaster University, Hamilton, ON, Canada).


Data Safety Monitoring Committee: Drs. J. Singer, F. Rickles, J. Sussman, and P. Ellis.




Publication History

Article published online:
23 December 2020

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