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Thromb Haemost 2018; 118(05): 914-921
DOI: 10.1055/s-0038-1641150
Stroke, Systemic or Venous Thromboembolism
Schattauer GmbH Stuttgart

Renal Impairment, Recurrent Venous Thromboembolism and Bleeding in Cancer Patients with Acute Venous Thromboembolism—Analysis of the CATCH Study

Authors

  • Rupert Bauersachs

    1   Department of Vascular Medicine, Klinikum Darmstadt GmbH, Darmstadt, Germany
    2   Center for Thrombosis and Hemostasis, University Medical Center Mainz, Mainz, Germany

  • Agnes Y. Y. Lee

    3   Division of Hematology, University of British Columbia and British Columbia Cancer Agency, Vancouver, Canada

  • Pieter W. Kamphuisen

    4   Department of Internal Medicine, Tergooi, Hilversum, and Vascular Medicine, University Medical Center Groningen, Groningen, The Netherlands

  • Guy Meyer

    5   Respiratory Unit, Hospital European Georges Pompidou, Assistance Publique-Hopitaux de Paris, and Université Paris Descartes, Sorbonne Paris Cité, Paris, France

  • Mette S. Janas

    6   LEO Pharma, Ballerup, Denmark

  • Mikala F. Jarner

    6   LEO Pharma, Ballerup, Denmark

  • Alok A. Khorana

    7   Taussig Cancer Institute, Cleveland Clinic Foundation, Cleveland, Ohio, United States
    • on behalf of the CATCH Investigators

Funding The study was sponsored and funded by LEO Pharma. LEO Pharma had a role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review or approval of the manuscript; and decision to submit the manuscript for publication. Medical writing support was provided by Matthew Burns VetMB, from Mudskipper Business Ltd, funded by LEO Pharma.
Further Information

Publication History

21 July 2017

09 February 2018

Publication Date:
04 April 2018 (online)

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Abstract

Objective This article assesses the impact of renal impairment (RI) on the efficacy and safety of anticoagulation in patients with cancer-associated thrombosis from the Comparison of Acute Treatments in Cancer Hemostasis (CATCH) study (NCT01130025).

Materials and Methods Renal function was assessed using the Modification of Diet in Renal Disease equation in patients with cancer-associated thrombosis who received either tinzaparin (175 IU/kg) once daily or warfarin for 6 months, in an open-label, randomized, multi-centre trial with blinded adjudication of outcomes. Associations between baseline RI (glomerular filtration rate [GFR] <60 mL/min/1.73m2) and recurrent symptomatic or incidental venous thromboembolism (VTE), clinically relevant bleeding (CRB), major bleeding and death were assessed using Fisher's exact test.

Results Baseline-centralized GFR data were available for 864 patients (96% of study population). RI was found in 131 patients (15%; n = 69 tinzaparin). Recurrent VTE occurred in 14% of patients with and 8% of patients without RI (relative risk [RR] 1.74; 95% confidence interval [CI] 1.06, 2.85), CRB in 19% and 14%, respectively (RR 1.33; 95% CI 0.90, 1.98), major bleeding in 6.1% and 2.0%, respectively (RR 2.98; 95% CI 1.29, 6.90) and mortality rate was 40% and 34%, respectively (RR 1.20; 95% CI 0.94, 1.53). Patients with RI on tinzaparin showed no difference in recurrent VTE, CRB, major bleeding or mortality rates versus those on warfarin.

Conclusion RI in patients with cancer-associated thrombosis on anticoagulation was associated with a statistically significant increase in recurrent VTE and major bleeding, but no significant increase in CRB or mortality. No differences were observed between long-term tinzaparin therapy and warfarin.

Keywords

cancer-associated thrombosis - recurrent venous thromboembolism - renal impairment - anticoagulation - tinzaparin

Authors' Contributions

All authors had full access to all of the data in the study, take responsibility for the integrity of the data and the accuracy of the data analysis, and contributed to drafting of the article. All the authors were involved in data analysis and interpretation, manuscript writing, final approval of manuscript and were accountable for all aspects of the work. Conception and design: P.W.K., A.Y.Y.L., G.M., R.B., M.S.J., A.A.K. Administrative support: M.S.J. Collection and assembly of data: M.S.J., M.F.J.


Note

The CATCH Investigators are listed in the [Supplementary Material] (available in the online version).


Supplementary Material