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CC BY 4.0 · TH Open 2019; 03(01): e85-e93
DOI: 10.1055/s-0039-1683968
Original Article
Georg Thieme Verlag KG Stuttgart · New York

Patient Management Strategies and Long-Term Outcomes in Isolated Distal Deep-Vein Thrombosis versus Proximal Deep-Vein Thrombosis: Findings from XALIA

Walter Ageno
1   Department of Medicine and Surgery, University of Insubria, Varese, Italy
,
Lorenzo G. Mantovani
2   CESP-Center for Public Health Research, University of Milano-Bicocca, Monza, Italy
,
Sylvia Haas
3   Formerly Institute for Experimental Oncology and Therapy Research, Technical University of Munich, Munich, Germany
,
Reinhold Kreutz
4   Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Clinical Pharmacology and Toxicology, Berlin, Germany
,
Danja Monje
5   Bayer AG, Berlin, Germany
,
Jonas Schneider
5   Bayer AG, Berlin, Germany
,
Jörg-Peter Bugge
5   Bayer AG, Berlin, Germany
,
Martin Gebel
6   Bayer AG, Wuppertal, Germany
,
Alexander G. G. Turpie
7   Department of Medicine, Hamilton Health Sciences, Hamilton, Ontario, Canada
› Author Affiliations
Further Information

Publication History

13 June 2018

06 February 2019

Publication Date:
26 March 2019 (online)

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Abstract

Background Overall, 30 to 50% of lower-limb deep-vein thrombosis (DVT) cases are isolated distal DVT (IDDVT). The recurrent venous thromboembolism (VTE) risk is unclear, leaving uncertainty over optimal IDDVT treatment. We present data on patients with IDDVT and proximal DVT (PDVT) from the prospective, noninterventional XALIA study of rivaroxaban for acute and extended VTE treatment.

Methods Patients aged ≥18 years scheduled to receive ≥3 months' anticoagulation with rivaroxaban or standard anticoagulation were eligible, with follow-up for ≥12 months. We describe baseline characteristics, management strategies, and incidence proportions of VTE recurrence, major bleeding, and all-cause mortality in patients with IDDVT or PDVT, with or without distal vein involvement.

Findings Overall, 1,004 patients with IDDVT and 3,098 with PDVT were enrolled; 641 (63.8%) and 1,683 (54.3%) received rivaroxaban, respectively. Patients with IDDVT were younger and had lower incidences of renal impairment, cancer, and unprovoked VTE than those with PDVT. On-treatment recurrence incidences for IDDVT versus PDVT were 1.0 versus 2.4% (adjusted hazard ratio [HR]: 0.56; 95% confidence interval [CI]: 0.29–1.08), and incidences posttreatment cessation were 1.1 versus 2.1% (adjusted HR: 0.65; 95% CI: 0.32–1.35), respectively. On-treatment major bleeding incidences were 0.9 versus 1.4% and mortality was 0.8 versus 2.2%, respectively. Median treatment duration in patients with IDDVT was shorter than in those with PDVT (102 vs. 192 days, respectively).

Interpretation Patients with IDDVT had fewer comorbidities and were more frequently treated with rivaroxaban than those with PDVT. On-treatment and posttreatment recurrences were less frequent in patients with IDDVT.

Trial registration number: NCT01619007.

Keywords

deep-vein thrombosis - rivaroxaban - routine clinical practice - venous thromboembolism

Financial Support

Financial support for the study was provided by Bayer AG and Janssen Research & Development, LLC.


 

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