title: XALIA: rationale and design of a non-interventional study of rivaroxaban compared with standard therapy for initial and long-term anticoagulation in deep vein thrombosis.
abstract: Venous thromboembolism (VTE), comprising deep vein thrombosis (DVT) and pulmonary embolism, poses a substantial clinical risk, and the incidence of these thrombotic-related diseases remains high. Anticoagulation aims to prevent thrombus extension and reduce the risk of recurrent events, particularly fatal pulmonary embolism. In EINSTEIN DVT, rivaroxaban was non-inferior to enoxaparin/vitamin K antagonists for the reduction of recurrent VTE, with a similar safety profile and a net clinical benefit. EINSTEIN EXT investigated patients receiving long-term treatment in whom there was no clear decision about continuing or stopping anticoagulation; rivaroxaban was superior to placebo in the reduction of recurrent VTE, showing an acceptable benefit-risk balance. Rivaroxaban has the potential to replace standard therapy, usually parenteral low molecular weight heparin overlapping with and followed by a vitamin K antagonist, for the treatment of acute symptomatic DVT and the secondary prevention of VTE. As the use of rivaroxaban for DVT treatment increases in clinical practice, a fundamental understanding of its clinical benefits in everyday patient care is essential. XALIA (XArelto for Long-term and Initial Anticoagulation in venous thromboembolism) is a multicentre, prospective, non-interventional, observational study investigating the effectiveness and safety of a single-drug approach with rivaroxaban compared with standard therapy in patients with DVT. The study cohort will include approximately 4800 patients (≥18 years old) with objectively confirmed acute DVT who will be treated for a period of ≥3 months. The primary outcomes will be the incidence of treatment-emergent adverse events (primarily major bleeding), symptomatic recurrent venous thromboembolic events and all-cause mortality. Secondary outcomes include: major cardiovascular events; patient-reported treatment satisfaction and adherence; healthcare resource utilization; reasons for drug switching or interruption of treatment; and adverse events. XALIA will follow an international cohort of patients in more than 20 European countries, and others including Israel and Canada. The first patient was enrolled in June 2012, with results expected in 2015. It is anticipated that XALIA will provide important information on the treatment of DVT in a heterogeneous, unselected patient population in a real-world setting and provide important supplementary information to that obtained from the EINSTEIN DVT phase III study.
authors.affiliation: Department of Clinical and Experimental Medicine, University of Insubria, Via Guicciardini 9, Varese 21100, Italy.
authors.forename: Walter
authors.initials: W
authors.lastname: Ageno
authors.affiliation: Department of Clinical Medicine and Surgery, Università degli Studi di Napoli Federico II, Naples, Italy.
authors.forename: Lorenzo G
authors.initials: LG
authors.lastname: Mantovani
authors.affiliation: Vascular Centre, Normannenstr. 34a, Munich 81925, Germany.
authors.forename: Sylvia
authors.initials: S
authors.lastname: Haas
authors.affiliation: Institute of Clinical Pharmacology and Toxicology, Charité-Universitätsmedizin, Berlin, Germany.
authors.forename: Reinhold
authors.initials: R
authors.lastname: Kreutz
authors.affiliation: Bayer Vital GmbH, Leverkusen, K56, 51368, Germany.
authors.forename: Verena
authors.initials: V
authors.lastname: Haupt
authors.affiliation: Bayer Pharma AG, Muellerstr. 178 S101, Berlin 13353, Germany.
authors.forename: Jonas
authors.initials: J
authors.lastname: Schneider
authors.affiliation: Department of Medicine, Hamilton Health Sciences, General Division, 237 Barton Street East, Hamilton, Ontario L8L 2X2, Canada.
authors.forename: Alexander Gg
authors.initials: AG
authors.lastname: Turpie
keywords: Deep vein thrombosis; Outcomes; Real-world experience; Rivaroxaban
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