Reinhold Kreutz1, Lorenzo G Mantovani2, Sylvia Haas3, Danja Monje4, Jonas Schneider5, Jörg-Peter Bugge6, Martin Gebel7, Miriam Tamm8, Walter Ageno9, Alexander G G Turpie10. 1. Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Clinical Pharmacology and Toxicology, Germany. Electronic address: reinhold.kreutz@charite.de. 2. CESP-Center for Public Health Research, University of Milan Bicocca, Monza, Italy. Electronic address: lorenzo.mantovani@unimib.it. 3. Formerly Technical University Munich, Munich, Germany. Electronic address: sylvia.haas@thromboscientific.com. 4. Bayer AG, Berlin, Germany. Electronic address: danja.monje@bayer.com. 5. Bayer AG, Berlin, Germany. Electronic address: jonas.schneider@bayer.com. 6. Bayer AG, Wuppertal, Germany. Electronic address: joerg-peter.bugge@bayer.com. 7. Bayer AG, Wuppertal, Germany. Electronic address: martin.gebel@bayer.com. 8. Bayer AG, Wuppertal, Germany. Electronic address: miriam.tamm@bayer.com. 9. Department of Clinical and Experimental Medicine, University of Insubria, Varese, Italy. Electronic address: walter.ageno@uninsubria.it. 10. Department of Medicine, Hamilton Health Sciences, Hamilton, Ontario, Canada. Electronic address: turpiea@mcmaster.ca.
Abstract
INTRODUCTION: The prospective, non-interventional XALIA study investigated the safety and effectiveness of rivaroxaban and standard anticoagulation for the treatment of deep vein thrombosis (DVT). XALIA-LEA was conducted in regions not included in XALIA (Latin America, Eastern Europe, the Middle East, Africa, and the Asia-Pacific), and enrolled patients with isolated pulmonary embolism (PE). MATERIALS AND METHODS: Adult patients with acute venous thromboembolism (VTE) indicated for ≥3 months' anticoagulant treatment were eligible; treatment strategies were at the physician's discretion. Patients receiving rivaroxaban or standard anticoagulation (unfractionated or low-molecular weight heparin/fondaparinux alone or overlapping with and followed by a vitamin K antagonist [VKA]) were included in the safety analysis. "Early switchers" to rivaroxaban (i.e. after receiving heparin/fondaparinux for >2-14 days and/or a VKA for 1-14 days) were not included in the safety analysis set. RESULTS: Of the 1972 eligible patients, 1285 received rivaroxaban, 402 received standard anticoagulation, and 285 were early switchers. Most patients who received rivaroxaban were appropriately selected, received the correct dosing schedule, reported few adverse effects. Outcomes were similar to previously published results, with rivaroxaban associated with a low rate of major bleeding (1.6%), recurrent VTE (1.4%) and all-cause mortality (2.3%). Including early switchers, relatively fewer patients with index isolated PE received rivaroxaban (14.4%) versus standard anticoagulation therapy (20.9%). Some regional variations and differences in outcomes by VTE subtype were apparent with standard anticoagulation treatment. CONCLUSION: XALIA-LEA reaffirms the safety and effectiveness of rivaroxaban for VTE treatment for countries not included in XALIA.
INTRODUCTION: The prospective, non-interventional XALIA study investigated the safety and effectiveness of rivaroxaban and standard anticoagulation for the treatment of deep vein thrombosis (DVT). XALIA-LEA was conducted in regions not included in XALIA (Latin America, Eastern Europe, the Middle East, Africa, and the Asia-Pacific), and enrolled patients with isolated pulmonary embolism (PE). MATERIALS AND METHODS: Adult patients with acute venous thromboembolism (VTE) indicated for ≥3 months' anticoagulant treatment were eligible; treatment strategies were at the physician's discretion. Patients receiving rivaroxaban or standard anticoagulation (unfractionated or low-molecular weight heparin/fondaparinux alone or overlapping with and followed by a vitamin K antagonist [VKA]) were included in the safety analysis. "Early switchers" to rivaroxaban (i.e. after receiving heparin/fondaparinux for >2-14 days and/or a VKA for 1-14 days) were not included in the safety analysis set. RESULTS: Of the 1972 eligible patients, 1285 received rivaroxaban, 402 received standard anticoagulation, and 285 were early switchers. Most patients who received rivaroxaban were appropriately selected, received the correct dosing schedule, reported few adverse effects. Outcomes were similar to previously published results, with rivaroxaban associated with a low rate of major bleeding (1.6%), recurrent VTE (1.4%) and all-cause mortality (2.3%). Including early switchers, relatively fewer patients with index isolated PE received rivaroxaban (14.4%) versus standard anticoagulation therapy (20.9%). Some regional variations and differences in outcomes by VTE subtype were apparent with standard anticoagulation treatment. CONCLUSION:XALIA-LEA reaffirms the safety and effectiveness of rivaroxaban for VTE treatment for countries not included in XALIA.
Authors: Sylvia Haas; Lorenzo G Mantovani; Reinhold Kreutz; Danja Monje; Jonas Schneider; Elizabeth R Zell; Miriam Tamm; Martin Gebel; Jörg-Peter Bugge; Walter Ageno; Alexander G G Turpie Journal: Res Pract Thromb Haemost Date: 2021-03-20