Advertisement

The Efficacy and Safety of Rivaroxaban and Dalteparin in the Treatment of Cancer Associated Venous Thrombosis

  • Ateefa Chaudhury
  • Asha Balakrishnan
  • Christy Thai
  • Bjorn Holmstrom
  • Sowmya Nanjappa
  • Zhenjun Ma
  • Michael V. Jaglal
Original Article
  • 256 Downloads

Abstract

Venous thromboembolism (VTE) is a complication of malignancy that is associated with significant mortality. The CLOT trial showed superiority of dalteparin in comparison to warfarin in preventing VTE recurrence. Rivaroxaban has been approved for treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE). In the absence of large randomized trials in the oncology population, the efficacy and safety of rivaroxaban for the treatment of VTE in cancer patients needs to be assessed. A single-center retrospective chart review was conducted to assess the efficacy and safety of rivaroxaban compared with dalteparin in cancer-associated thrombosis. Out of 671 patients identified, 286 patients (107 in the rivaroxaban group and 179 in the dalteparin group) were eligible for analysis. The rivaroxaban group had a rate of VTE recurrence at 6 months of 4.9 versus 11.1% with dalteparin (p = 0.252). The incidence of recurrent DVT at 6 months was lower in patients treated with rivaroxaban (0%) compared with dalteparin (8.2%) at 6 months (p = 0.025). Incidence of recurrent PE in the rivaroxaban group (5%) versus dalteparin group (3.1%) at 6 months was not statistically significant (p = 0.675). No significant difference was identified between the rivaroxaban group and dalteparin group in the rate of major bleeding (2.8 vs. 1.1%, respectively). Rivaroxaban was comparable to dalteparin in prevention of VTE recurrence while having no significant differences with major or minor bleeding.

Keywords

Venous thrombosis Cancer associated thrombosis Venous thromboembolism Thrombosis Novel anticoagulants 

Notes

Acknowledgements

We thank Rasa Hamilton (H. Lee Moffitt Cancer Center & Research Institute) for editorial assistance.

Author’s Contributions

Ateefa Chaudhury, Asha Balakrishnan, Christy Thai, Bjorn Holmstrom, Sowmya Nanjappa, Zhenjun Ma, Michael V. Jaglal: Study conception and design, Acquisition of data, Analysis and interpretation of data, Drafting the manuscript.

Compliance with Ethical Standards

Conflict of interest

The authors declares that they have no conflicts of interest to disclose.

Human and Animal Rights Statement

All human and animal studies have been approved by the appropriate ethics committee and have therefore been performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments. For studies with human subjects include the following: All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2008 (5).

Informed Consent

All persons gave their informed consent prior to their inclusion in the study. Informed consent was obtained from all patients for being included in the study.

References

  1. 1.
    White RH (2003) The epidemiology of venous thromboembolism. Circulation 107:I-4–I-8CrossRefGoogle Scholar
  2. 2.
    Lyman GH, Bohlke K, Khorana AA et al (2015) Venous thromboembolism prophylaxis and treatment in patients with cancer: American Society of Clinical Oncology clinical practice guideline update 2014. J Clin Oncol 33:654–656CrossRefPubMedPubMedCentralGoogle Scholar
  3. 3.
    Lee AY, Levine MN (2003) Venous thromboembolism and cancer: risks and outcomes. Circulation 107:I-17–I-21Google Scholar
  4. 4.
    (NCCN) NCCN (2015) Venous thromboembolic diseaseGoogle Scholar
  5. 5.
    Di Nisio M, Ferrante N, De Tursi M et al (2010) Incidental venous thromboembolism in ambulatory cancer patients receiving chemotherapy. Thromb Haemost 104:1049CrossRefPubMedGoogle Scholar
  6. 6.
    Stein PD, Beemath A, Meyers FA, Skaf E, Sanchez J, Olson RE (2006) Incidence of venous thromboembolism in patients hospitalized with cancer. Am J Med 119:60–68CrossRefPubMedGoogle Scholar
  7. 7.
    Hull RD, Pineo GF, Brant RF et al (2006) Long-term low-molecular-weight heparin versus usual care in proximal-vein thrombosis patients with cancer. Am J Med 119:1062–1072CrossRefPubMedGoogle Scholar
  8. 8.
    Lee AY, Levine MN, Baker RI et al (2003) Low-molecular-weight heparin versus a coumarin for the prevention of recurrent venous thromboembolism in patients with cancer. N Engl J Med 349:146–153CrossRefPubMedGoogle Scholar
  9. 9.
    Investigators EP (2012) Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med 2012:1287–1297CrossRefGoogle Scholar
  10. 10.
    Investigators E (2010) Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med 2010:2499–2510Google Scholar
  11. 11.
    Schulman S, Kearon C (2005) Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost 3:692–694CrossRefPubMedGoogle Scholar
  12. 12.
    Seaman S, Nelson A, Noble S (2014) Cancer-associated thrombosis, low-molecular-weight heparin, and the patient experience: a qualitative study. Patient Prefer Adherence 8:453PubMedPubMedCentralGoogle Scholar
  13. 13.
    Prins MH, Lensing AW, Brighton TA et al (2014) Oral rivaroxaban versus enoxaparin with vitamin K antagonist for the treatment of symptomatic venous thromboembolism in patients with cancer (EINSTEIN-DVT and EINSTEIN-PE): a pooled subgroup analysis of two randomised controlled trials. Lancet Haematol 1:e37–e46CrossRefPubMedGoogle Scholar
  14. 14.
    Akl EA, Labedi N, Barba M, et al (2011) Anticoagulation for the long‐term treatment of venous thromboembolism in patients with cancer. The Cochrane LibraryGoogle Scholar
  15. 15.
    Lee AY, Kamphuisen PW, Meyer G et al (2015) Tinzaparin vs warfarin for treatment of acute venous thromboembolism in patients with active cancer: a randomized clinical trial. JAMA 314:677–686CrossRefPubMedGoogle Scholar
  16. 16.
    van Es N, Di Nisio M, Bleker SM et al (2015) Edoxaban for treatment of venous thromboembolism in patients with cancer. Thromb Haemost 114:1268–1276CrossRefPubMedGoogle Scholar

Copyright information

© Indian Society of Hematology and Blood Transfusion 2017

Authors and Affiliations

  • Ateefa Chaudhury
    • 1
    • 2
  • Asha Balakrishnan
    • 3
  • Christy Thai
    • 4
  • Bjorn Holmstrom
    • 5
  • Sowmya Nanjappa
    • 5
  • Zhenjun Ma
    • 6
  • Michael V. Jaglal
    • 1
    • 2
    • 3
  1. 1.Department of Malignant HematologyH. Lee Moffitt Cancer Center & Research InstituteTampaUSA
  2. 2.Department of Internal Medicine, Division of Hematology and Medical OncologyUniversity of South FloridaTampaUSA
  3. 3.Department of Internal MedicineUniversity of South FloridaTampaUSA
  4. 4.Department of PharmacyH. Lee Moffitt Cancer Center & Research InstituteTampaUSA
  5. 5.Department of Internal Hospital MedicineH. Lee Moffitt Cancer Center & Research InstituteTampaUSA
  6. 6.Department of Biostatistics and BioinformaticsH. Lee Moffitt Cancer Center & Research InstituteTampaUSA

Personalised recommendations