Giancarlo Agnelli1, Ulrich Hoffmann2, Philippe Hainaut3, Sean Gaine4, Cihan Ay5, Michiel Coppens6, Marc Schindewolf7, David Jimenez8, Bernd Brüggenjürgen9, Pierre Levy10, Petra Laeis11, Eva-Maria Fronk12, Wolfgang Zierhut13, Thomas Malzer14, Marius Constantin Manu15, Paul-Egbert Reimitz16, Peter Bramlage17, Alexander T Cohen18. 1. Internal and Cardiovascular Medicine-Stroke Unit, University of Perugia, Perugia, Italy. Electronic address: giancarlo.agnelli@unipg.it. 2. Division of Angiology, Medical Clinic IV, University Hospital, Ludwig-Maximilians-University, Munich, Germany. Electronic address: ulrich.hoffmann@med.uni-muenchen.de. 3. Department of General Internal Medicine, Cliniques Universitaires Saint Luc, UCL, Bruxelles, Belgium. Electronic address: philippe.hainaut@uclouvain.be. 4. National Pulmonary Hypertension Unit, Mater Misericordiae University Hospital, Dublin, Ireland. Electronic address: sgaine@mater.ie. 5. Clinical Division of Haematology and Haemostaseology, Department of Medicine I, Medical University of Vienna, Vienna, Austria. Electronic address: cihan.ay@meduniwien.ac.at. 6. Department of Vascular Medicine, Academic Medical Center, Amsterdam, the Netherlands. Electronic address: m.coppens@amc.nl. 7. Division of Angiology, Swiss Cardiovascular Center, Inselspital, Bern University Hospital, University of Bern, Switzerland. Electronic address: marc.schindewolf@insel.ch. 8. Respiratory Department, Ramón y Cajal Hospital, Madrid, Spain. 9. Institute for Health Economics, Steinbeis-University, Berlin, Germany. Electronic address: bernd.brueggenjuergen@charite.de. 10. LEDa-LEGOS, Université Paris-Dauphine, PSL University, Paris, France. Electronic address: pierre.levy@dauphine.fr. 11. Daiichi Sankyo Europe GmbH, Munich, Germany. Electronic address: petra.laeis@daiichi-sankyo.eu. 12. Daiichi Sankyo Europe GmbH, Munich, Germany. Electronic address: eva-maria.fronk@daiichi-sankyo.eu. 13. Daiichi Sankyo Europe GmbH, Munich, Germany. Electronic address: wolfgang.zierhut@daiichi-sankyo.eu. 14. Daiichi Sankyo Europe GmbH, Munich, Germany. Electronic address: thomas.malzer@daiichi-sankyo.eu. 15. Daiichi Sankyo Europe GmbH, Munich, Germany. Electronic address: marius.manu@daiichi-sankyo.eu. 16. Daiichi Sankyo Europe GmbH, Munich, Germany. Electronic address: paul-egbert.reimitz@daiichi-sankyo.eu. 17. Institute for Pharmacology and Preventive Medicine, Berlin, Germany. Electronic address: peter.bramlage@ippmed.de. 18. Guy's and St Thomas' NHS Foundation Trust, King's College London, United Kingdom. Electronic address: alexander.cohen@kcl.ac.uk.
Abstract
INTRODUCTION: Edoxaban had a positive risk-benefit ratio for the treatment of venous thromboembolism (VTE) compared to conventional therapy with warfarin. The objective of this analysis of the ongoing ETNA-VTE Europe study was to assess the real-world benefits and risks of edoxaban during the first 3 months of treatment, the highest risk period for further VTE events. METHODS: ETNA-VTE Europe is a prospective, non-interventional, post-authorization study, conducted in eight European countries. Participants had initial or recurrent acute VTE (deep vein thrombosis [DVT] and/or pulmonary embolism [PE]) that occurred ≤2 weeks prior to enrolment and received edoxaban therapy. RESULTS: The analysis set included 2672 patients (PE ± DVT, n = 1117; DVT only, n = 1555); mean age 62.9 ± 16.0 years, bodyweight 81.9 ± 17.4 kg, estimated glomerular filtration rate 95.4 ± 42.8 mL/min; 46.4% were female. Overall, 66.4% of patients (PE ± DVT, 68.5%; DVT-only, 64.8%) received heparin lead-in treatment for at least 5 days. Most patients (87.7%) received edoxaban at a dose of 60 mg once daily. Event rates at 3 months were: recurrent VTE 0.34% (n = 9), major bleeding 0.97% (n = 26), all-cause mortality 0.79% (n = 21). Rates were numerically higher in the PE ± DVT group compared with the DVT-only group (recurrent VTE, 0.45% (n = 5) versus 0.26% (n = 4); major bleeding, 1.34% (n = 15) versus 0.71% (n = 11); and all-cause mortality 1.16% (n = 13) versus 0.51% (n = 8)). CONCLUSIONS: The results support the safety and effectiveness of edoxaban in a general VTE population during the most critical time period, the first 3 months. The outcomes of this study extend the principal efficacy and safety data on edoxaban into the routine clinical practice setting.
INTRODUCTION:Edoxaban had a positive risk-benefit ratio for the treatment of venous thromboembolism (VTE) compared to conventional therapy with warfarin. The objective of this analysis of the ongoing ETNA-VTE Europe study was to assess the real-world benefits and risks of edoxaban during the first 3 months of treatment, the highest risk period for further VTE events. METHODS: ETNA-VTE Europe is a prospective, non-interventional, post-authorization study, conducted in eight European countries. Participants had initial or recurrent acute VTE (deep vein thrombosis [DVT] and/or pulmonary embolism [PE]) that occurred ≤2 weeks prior to enrolment and received edoxaban therapy. RESULTS: The analysis set included 2672 patients (PE ± DVT, n = 1117; DVT only, n = 1555); mean age 62.9 ± 16.0 years, bodyweight 81.9 ± 17.4 kg, estimated glomerular filtration rate 95.4 ± 42.8 mL/min; 46.4% were female. Overall, 66.4% of patients (PE ± DVT, 68.5%; DVT-only, 64.8%) received heparin lead-in treatment for at least 5 days. Most patients (87.7%) received edoxaban at a dose of 60 mg once daily. Event rates at 3 months were: recurrent VTE 0.34% (n = 9), major bleeding 0.97% (n = 26), all-cause mortality 0.79% (n = 21). Rates were numerically higher in the PE ± DVT group compared with the DVT-only group (recurrent VTE, 0.45% (n = 5) versus 0.26% (n = 4); major bleeding, 1.34% (n = 15) versus 0.71% (n = 11); and all-cause mortality 1.16% (n = 13) versus 0.51% (n = 8)). CONCLUSIONS: The results support the safety and effectiveness of edoxaban in a general VTE population during the most critical time period, the first 3 months. The outcomes of this study extend the principal efficacy and safety data on edoxaban into the routine clinical practice setting.