- •‘Early switchers’ received rivaroxaban after prolonged parenteral/VKA therapy.
- •They had more VTE recurrence risk factors than the rivaroxaban cohort.
- •The crude incidence rates for the primary outcomes reflected this difference.
- •Hospital stay duration was also longer for early switchers.
XALIA assessed the safety and effectiveness of rivaroxaban for deep vein thrombosis (DVT) treatment in routine clinical practice. This substudy describes the clinical characteristics and outcomes of ‘early switchers’ – patients who received heparin or fondaparinux for >2–14 days and/or a vitamin K antagonist (VKA) for 1–14 days before switching to rivaroxaban.
Materials and methods
Patients with DVT (latterly with concomitant pulmonary embolism) received rivaroxaban or standard anticoagulation (initial treatment with heparin or fondaparinux, usually overlapping with and followed by a VKA). Patients administered rivaroxaban alone, or heparin or fondaparinux for ≤48 h pre-enrollment were included in the rivaroxaban cohort. Therapy type, dose, and duration were at the physician's discretion. Primary outcomes were major bleeding, recurrent venous thromboembolism (VTE), and all-cause mortality.
In 368 early switchers, recurrence or bleeding risk factors were more prevalent versus the rivaroxaban cohort, including creatinine clearance < 50 mL/min (6.5% vs. 3.9%), previous major bleeding (4.6% vs. 1.4%), active cancer (8.2% vs. 5.6%), and concomitant pulmonary embolism (20.9% vs. 8.4%). Crude incidence rates were numerically higher versus the rivaroxaban cohort for major bleeding (1.4% vs. 0.7%), recurrent VTE (2.2% vs. 1.4%), and all-cause mortality (0.8% vs. 0.5%).
Patients who switched to rivaroxaban early in the treatment process had a higher frequency of risk factors for bleeding and recurrent VTE than patients treated with rivaroxaban; reflected by the higher risk of adverse events in that group during follow-up.
Abbreviations:CNS (central nervous system), DVT (deep vein thrombosis), IQR (interquartile range), PE (pulmonary embolism), Q (quartile), VKA (vitamin K antagonist), VTE (venous thromboembolism)
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Published online: April 14, 2017
Accepted: April 2, 2017
Received in revised form: March 29, 2017
Received: November 16, 2016
© 2017 Published by Elsevier Ltd.