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CC BY-NC-ND 4.0 · TH Open 2017; 01(01): e33-e42
DOI: 10.1055/s-0037-1603924
Original Article
Georg Thieme Verlag KG Stuttgart · New York

Subgroup Analysis of Patients with Cancer in XALIA: A Noninterventional Study of Rivaroxaban versus Standard Anticoagulation for VTE

Walter Ageno
1   Department of Clinical and Experimental Medicine, University of Insubria, Varese, Italy
,
Lorenzo G. Mantovani
2   CESP-Center for Public Health Research, University of Milan Bicocca, Monza, Italy
,
Sylvia Haas
3   Technical University of Munich, Munich, Germany
,
Reinhold Kreutz
4   Institute of Clinical Pharmacology and Toxicology, Charité Universitätsmedizin, Berlin, Germany
,
Danja Monje
5   Bayer AG, Leverkusen, Germany
,
Jonas Schneider
6   Bayer AG, Berlin, Germany
,
Martin van Eickels
6   Bayer AG, Berlin, Germany
,
Martin Gebel
7   Bayer AG, Wuppertal, Germany
,
Alexander G. G. Turpie
8   Department of Medicine, Hamilton Health Sciences, Hamilton, Ontario, Canada
› Author Affiliations
Further Information

Publication History

Publication Date:
28 June 2017 (online)

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Abstract

Background The noninterventional XALIA study compared rivaroxaban with standard anticoagulation for deep vein thrombosis treatment. This substudy describes the demographics, clinical characteristics, and outcomes of the patients with cancer.

Methods Therapy type, dose, and duration were at the physician's discretion. The cohorts identified were rivaroxaban (rivaroxaban alone or after heparin or fondaparinux for ≤48 hours); early switchers (rivaroxaban after heparin or fondaparinux for >48 hours to 14 days and/or a vitamin K antagonist [VKA] for 1–14 days); standard anticoagulation (heparin or fondaparinux and a VKA); low-molecular-weight heparin (LMWH) alone; and miscellaneous (other heparins, fondaparinux alone, VKA alone). Primary outcomes were major bleeding, recurrent venous thromboembolism, and all-cause mortality.

Results In XALIA, 587 patients (11.4% of the XALIA cohort) were with cancer: 146 (24.9%) rivaroxaban, 30 (5.1%) early switchers, 141 (24.0%) standard anticoagulation, 223 (38.0%) LMWH, and 47 (8.0%) miscellaneous. Patients with gastrointestinal or lung cancer more commonly received LMWH than rivaroxaban; the opposite occurred in patients with breast or genitourinary cancer. Rates of primary outcome in the rivaroxaban group were as follows: major bleeding, 1.4% (n = 2); recurrent venous thromboembolism, 3.4% (n = 5); and all-cause mortality, 4.8% (n = 7).

Conclusion In XALIA, physicians treated cancer-associated thrombosis with various anticoagulant regimens, most commonly LMWH. In addition, the choice of anticoagulant varied with cancer type. In rivaroxaban-treated patients, rates for the primary outcomes were low, suggesting that patients administered rivaroxaban were a good prognosis group.

Keywords

cancer-associated thrombosis - low-molecular-weight heparin - rivaroxaban - routine clinical practice - venous thromboembolism

Contributions of Authors

W.A. created the initial draft of this report. W.A., L.G.M., S.H., R.K., and A.G.G.T. were members of the Adjudication Committee. M.G. performed the statistical analysis. All authors participated in writing and review of the report and accept full responsibility for its overall content.


Funding

Funding for this study was provided by Bayer AG and Janssen Scientific Affairs, LLC.


Trial Registration Number

NCT01619007.


 

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