@article{1aa4b0c5ddbc4b78b1612916d5cfdeb6,
title = "Quality of life in patients with pulmonary embolism treated with edoxaban versus warfarin",
abstract = "Background: Long-term sequelae of acute pulmonary embolism (PE) include decreased quality of life (QoL). Evidence suggests that adequacy of initial anticoagulant treatment in the acute phase of venous thrombosis has a key impact on late postthrombotic complications. We hypothesize that patients with acute PE treated with edoxaban for acute PE experience have improved QoL compared to those treated with warfarin. Methods: Patients with PE who participated in the Hokusai-VTE trial were contacted between June 2017 and September 2020 for a single long-term follow-up visit. Main outcomes were the generic and disease-specific QoL measured by the 36-Item Short Form Health Survey (SF-36) and Pulmonary Embolism Quality of Life questionnaire. Results: We included 251 patients from 26 centers in eight countries, of which 129 (51%) had been assigned to edoxaban and 122 (49%) to warfarin. Patient- and thrombus-specific characteristics were similar in both groups. Mean time since randomization in the Hokusai-VTE trial was 7.0 years (standard deviation, 1.0). No relevant or statistical differences were observed in the QoL for patients treated with edoxaban compared to patients treated with warfarin. The mean difference between patients treated with edoxaban and patients with PE treated with warfarin was 0.8 (95% confidence interval [CI]. −1.6 to 3.2) for the SF-36 summary mental score and 1.6 (95% CI, −0.9 to 4.1) for summary physical score. Conclusion: Our findings indicate that patients with an index PE treated with edoxaban or warfarin have a similar long-term QoL. Since our study was a follow-up study from a well-controlled clinical trial setting, future studies should be designed in a daily clinical practice setting. We suggest a longitudinal design for investigation of changes in QoL over time.",
keywords = "edoxaban, pulmonary embolism, quality of life, warfarin",
author = "Roisin Bavalia and Bistervels, {Ingrid M.} and Boersma, {Wim G.} and Isabelle Quere and Dominique Brisot and Nicolas Falvo and Dominique Stephan and Francis Couturaud and Sebastian Schellong and Jan Beyer-Westendorf and Karine Montaclair and Waleed Ghanima and {ten Wolde}, Marije and Michiel Coppens and Emile Ferrari and Olivier Sanchez and Patrick Carroll and Pierre-Marie Roy and Kahn, {Susan R.} and Karina Meijer and Simone Birocchi and Kovacs, {Michael J.} and Amanda Hugman and {ten Cate}, Hugo and Hilde Wik and Gilles Pernod and Marie-Antoinette Sevestre-Pietri and Grosso, {Michael A.} and Minggao Shi and Yong Lin and Hutten, {Barbara A.} and Peter Verhamme and {the Hokusai post-PE study investigators} and Saskia Middeldorp",
note = "Funding Information: This study was an investigator-initiated study with Amsterdam UMC, location AMC as its sponsor. Daiichi-Sankyo provided financial support for conducting the study. Daiichi-Sankyo had no influence on the study design or conduct, the collection and analyses of data, and the final manuscript writing and approval. We thank all participating patients and study staff and nurses who contributed to this study. A special thanks to Marjolein Brekelmans and Pythia Nieuwkerk (Amsterdam UMC, University of Amsterdam, the Netherlands) for their help in protocol preparation and analyses. Funding Information: HtC received funding from Bayer and Pfizer and consulting fees from Portola and Alveron; he is a stockholder in Coagulation Profile. JBW reports personal fees and other from Bayer HealthCare, Boehringer Ingelheim, BMS/Pfizer, CSL Behring, Daiichi Sankyo, and LEO Pharma, outside the submitted work. FC reports grants from BMS/Pfizer; personal fees and other from Bayer, AstraZeneka, MSD, GSK, and Novartis; and other from Janssen, outside the submitted work. K Meijer received other from Bayer, Uniqure, and Alexion, outside the submitted work. M Coppens reports personal fees from Bayer, Boehringer Ingelheim, Bristol‐Myers Squib, CSL Behring, Daiichi Sankyo, Pfizer, Portola, and Sanquin Blood Supply, outside the submitted work. MASP reports honoraria from Bayer, Pfizer, and Leo Pharma. PV reports grants, personal fees, and other from Bayer HealthCare; grants, personal fees, and other from Boehringer Ingelheim; personal fees and other from BMS/Pfizer; grants from Sanofi‐Aventis; other from Daiichi Sankyo; grants and other from LEO Pharma; and personal fees from Thrombogenics, from null, outside the submitted work. SM reports grants and fees paid to her institution from GSK, BMS/Pfizer, Aspen, Daiichi Sankyo, Bayer, Boehringer Ingelheim, Sanofi, and Portola. SMS reports receiving consulting fees from Bayer and Boehringer Ingelheim, and lecture fees from Bayer, Boehringer Ingelheim, and Bristol‐Myers Squibb–Pfizer. WG reports grants and other from Bayer and Pfizer; and other from Novartis, Amgen, Principia, Sanofi, MSD, and Sobi, outside the submitted work. No other potential conflicts of interest were reported. Publisher Copyright: {\textcopyright} 2021 The Authors. Research and Practice in Thrombosis and Haemostasis published by Wiley Periodicals LLC on behalf of International Society on Thrombosis and Haemostasis (ISTH).",
year = "2021",
month = jul,
day = "1",
doi = "https://doi.org/10.1002/rth2.12566",
language = "English",
volume = "5",
journal = "Research and practice in thrombosis and haemostasis",
issn = "2475-0379",
publisher = "Wiley-Blackwell Publishing Ltd",
number = "5",
}