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

Walter Ageno; Lorenzo G. Mantovani; Sylvia Haas; Reinhold Kreutz; Danja Monje; Jonas Schneider; Jörg-Peter Bugge; Martin Gebel; Alexander G. G. Turpie

doi:10.1055/s-0039-1683968

TH Open, Inhaltsverzeichnis

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

Authors

Walter Ageno

¹Department of Medicine and Surgery, University of Insubria, Varese, Italy
Lorenzo G. Mantovani

²CESP-Center for Public Health Research, University of Milano-Bicocca, Monza, Italy
Sylvia Haas

³Formerly Institute for Experimental Oncology and Therapy Research, Technical University of Munich, Munich, Germany
Reinhold Kreutz

⁴Charité-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

⁵Bayer AG, Berlin, Germany
Jonas Schneider

⁵Bayer AG, Berlin, Germany
Jörg-Peter Bugge

⁵Bayer AG, Berlin, Germany
Martin Gebel

⁶Bayer AG, Wuppertal, Germany
Alexander G. G. Turpie

⁷Department of Medicine, Hamilton Health Sciences, Hamilton, Ontario, Canada

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

Volltext

Referenzen

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