Journal article
ETNA-VTE Europe: Benefits and risks of venous thromboembolism treatment using edoxaban in the first 3 months.
- Agnelli G Internal and Cardiovascular Medicine-Stroke Unit, University of Perugia, Perugia, Italy. Electronic address: giancarlo.agnelli@unipg.it.
- Hoffmann U Division of Angiology, Medical Clinic IV, University Hospital, Ludwig-Maximilians-University, Munich, Germany. Electronic address: ulrich.hoffmann@med.uni-muenchen.de.
- Hainaut P Department of General Internal Medicine, Cliniques Universitaires Saint Luc, UCL, Bruxelles, Belgium. Electronic address: philippe.hainaut@uclouvain.be.
- Gaine S National Pulmonary Hypertension Unit, Mater Misericordiae University Hospital, Dublin, Ireland. Electronic address: sgaine@mater.ie.
- Ay C Clinical Division of Haematology and Haemostaseology, Department of Medicine I, Medical University of Vienna, Vienna, Austria. Electronic address: cihan.ay@meduniwien.ac.at.
- Coppens M Department of Vascular Medicine, Academic Medical Center, Amsterdam, the Netherlands. Electronic address: m.coppens@amc.nl.
- Schindewolf M Division of Angiology, Swiss Cardiovascular Center, Inselspital, Bern University Hospital, University of Bern, Switzerland. Electronic address: marc.schindewolf@insel.ch.
- Jimenez D Respiratory Department, Ramón y Cajal Hospital, Madrid, Spain.
- Brüggenjürgen B Institute for Health Economics, Steinbeis-University, Berlin, Germany. Electronic address: bernd.brueggenjuergen@charite.de.
- Levy P LEDa-LEGOS, Université Paris-Dauphine, PSL University, Paris, France. Electronic address: pierre.levy@dauphine.fr.
- Laeis P Daiichi Sankyo Europe GmbH, Munich, Germany. Electronic address: petra.laeis@daiichi-sankyo.eu.
- Fronk EM Daiichi Sankyo Europe GmbH, Munich, Germany. Electronic address: eva-maria.fronk@daiichi-sankyo.eu.
- Zierhut W Daiichi Sankyo Europe GmbH, Munich, Germany. Electronic address: wolfgang.zierhut@daiichi-sankyo.eu.
- Malzer T Daiichi Sankyo Europe GmbH, Munich, Germany. Electronic address: thomas.malzer@daiichi-sankyo.eu.
- Manu MC Daiichi Sankyo Europe GmbH, Munich, Germany. Electronic address: marius.manu@daiichi-sankyo.eu.
- Reimitz PE Daiichi Sankyo Europe GmbH, Munich, Germany. Electronic address: paul-egbert.reimitz@daiichi-sankyo.eu.
- Bramlage P Institute for Pharmacology and Preventive Medicine, Berlin, Germany. Electronic address: peter.bramlage@ippmed.de.
- Cohen AT Guy's and St Thomas' NHS Foundation Trust, King's College London, United Kingdom. Electronic address: alexander.cohen@kcl.ac.uk.
- 2020-09-20
Published in:
- Thrombosis research. - 2020
Clinical outcomes
Deep vein thrombosis
Edoxaban
Pulmonary embolism
Registry
Routine clinical practice
Venous thromboembolism
English
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.
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.
- Language
-
- English
- Open access status
- closed
- Identifiers
-
- DOI 10.1016/j.thromres.2020.09.001
- PMID 32950897
- Persistent URL
- https://sonar.ch/global/documents/122477
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