TY - JOUR T1 - Survival and Quality of Life after Early Discharge in Low-Risk Pulmonary Embolism JF - European Respiratory Journal JO - Eur Respir J DO - 10.1183/13993003.02368-2020 SP - 2002368 AU - Stefano Barco AU - Irene Schmidtmann AU - Walter Ageno AU - Toni Anušić AU - Rupert M. Bauersachs AU - Cecilia Becattini AU - Enrico Bernardi AU - Jan Beyer-Westendorf AU - Luca Bonacchini AU - Johannes Brachmann AU - Michael Christ AU - Michael Czihal AU - Daniel Duerschmied AU - Klaus Empen AU - Christine Espinola-Klein AU - Joachim H. Ficker AU - Cândida Fonseca AU - Sabine Genth-Zotz AU - David Jiménez AU - Veli-Pekka Harjola AU - Matthias Held AU - Lorenzo Iogna Prat AU - Tobias J. Lange AU - Mareike Lankeit AU - Athanasios Manolis AU - Andreas Meyer AU - Thomas Münzel AU - Pirjo Mustonen AU - Ursula Rauch-Kroehnert AU - Pedro Ruiz-Artacho AU - Sebastian Schellong AU - Martin Schwaiblmair AU - Raoul Stahrenberg AU - Luca Valerio AU - Peter E. Westerweel AU - Philipp S. Wild AU - Stavros V. Konstantinides A2 - , Y1 - 2020/01/01 UR - http://erj.ersjournals.com/content/early/2020/08/18/13993003.02368-2020.abstract N2 - Background Early discharge of patients with acute low-risk pulmonary embolism (PE) requires validation by prospective trials with clinical and quality of life outcomes.Methods The multinational Home Treatment of Pulmonary Embolism (HoT-PE) single-arm management trial investigated early discharge followed by ambulatory treatment with rivaroxaban. The study was stopped for efficacy after the positive results of the predefined interim analysis at 50% of the planned population. The present analysis includes the entire trial population (576 patients). In addition to three-month recurrence (primary outcome) and one-year overall mortality, we analysed self-reported disease-specific (Pulmonary Embolism Quality of Life [PEmb-QoL] questionnaire) and generic (five-level five-dimension EuroQoL [EQ-5D-5L] scale) quality of life as well as treatment satisfaction (Anti-Clot Treatment Scale [ACTS]) after PE.Results The primary efficacy outcome occurred in three (0.5%; upper 95.0% CI 1.3%) patients. One-year mortality was 2.4%. The mean PEmb-QoL decreased from 28.9±20.6% at 3 weeks to 19.9±15.4% at 3 months, a mean change (improvement) of −9.1% (p<0.0001). Improvement was consistent across all PEmb-QoL dimensions. EQ-5D-5L was 0.89±0.12 3 weeks after enrolment and improved to 0.91±0.12 at 3 months (p<0.0001). Female sex and cardiopulmonary disease were associated with poorer disease-specific and generic quality of life; older age, with faster worsening of generic quality of life. The ACTS burden score improved from 40.5±6.6 points at 3 weeks to 42.5±5.9 at 3 months (p<0.0001).Conclusions Our results further support early discharge and ambulatory oral anticoagulation for selected patients with low-risk PE. Targeted strategies may be necessary to further improve quality of life in specific patient subgroups.FootnotesThis manuscript has recently been accepted for publication in the European Respiratory Journal. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJ online. Please open or download the PDF to view this article.Conflict of interest: Dr. Barco reports personal fees from Biocompatibles Group UK, LeoPharma, Bayer, non-financial support from Bayer HealthCare, non-financial support from Daiichi Sankyo, grants from Sanofi, outside the submitted work.Conflict of interest: Dr. Schmidtmann reports grants from Merck Serono, outside the submitted work.Conflict of interest: Dr. Ageno reports grants from Bayer, personal fees from Boehringer Ingelheim, personal fees from Daiichi Sankyo, personal fees from BMS/Pfizer, outside the submitted work.Conflict of interest: Dr. Anusic has nothing to disclose.Conflict of interest: Dr. Bauersachs reports personal fees from Bayer Health Care, personal fees from BMS/Pfizer, personal fees from Daiichi-Sankyo, during the conduct of the study.Conflict of interest: Dr. Becattini reports personal fees from Bayer Health Care, personal fees from Daiichi Sankyo, personal fees from Bristol Meyer Squibb, outside the submitted work.Conflict of interest: Dr. BERNARDI has nothing to disclose.Conflict of interest: Dr. Beyer-Westendorf reports other from CTH Mainz (Sponsor), during the conduct of the study; grants and personal fees from Bayer, outside the submitted work.Conflict of interest: Dr. Bonacchini has nothing to disclose.Conflict of interest: Dr. Brachmann reports grants and personal fees from Medtronic, during the conduct of the study; grants from Medtronic, grants from St. Jude, grants from Biotronik, outside the submitted work.Conflict of interest: Dr. Christ reports grants from University of Mainz, during the conduct of the study.Conflict of interest: Dr. Czihal reports personal fees from Bayer Health Care, personal fees from Roche, personal fees from Astra-Zeneca, personal fees from MSD Sharp & Dohme, personal fees from Leo Pharma, outside the submitted work.Conflict of interest: Dr. Duerschmied reports personal fees and non-financial support from Bayer, personal fees and non-financial support from Pfizer, personal fees and non-financial support from Daiichi Sankyo, personal fees and non-financial support from CytoSorbents, outside the submitted work.Conflict of interest: Dr. Empen reports non-financial support from Bayer HeathCare, personal fees from Bayer HeathCare, outside the submitted work.Conflict of interest: Dr. Espinola-Klein reports other from Bayer Health Care, outside the submitted work.Conflict of interest: Dr. Ficker reports personal fees from Daiichi Sankyo, outside the submitted work.Conflict of interest: Dr. Fonseca reports personal fees from Bayer, outside the submitted workConflict of interest: Dr. Genth-Zotz has nothing to disclose.Conflict of interest: Dr. Jimenez has nothing to disclose.Conflict of interest: Dr. Harjola reports personal fees from Bayer, personal fees from Boehringer-Ingelheim, personal fees from MSD, personal fees from Pfizer, outside the submitted work.Conflict of interest: Dr. Held reports other from Actelion, Bayer, Boehringer, MSD, Daiichii Sankyo, Roche, other from Actelion, Bayer, Berlin Chemie, BMS, MSD, Daichii Sankyo, Pfizer, OMT, grants from Actelion, outside the submitted work.Conflict of interest: Dr. Iogna Prat has nothing to disclose.Conflict of interest: Dr. Lange reports non-financial support from Center for Thrombosis and Hemostasis, University Medical Center Mainz, during the conduct of the study; personal fees from Bayer, personal fees from Pfizer, outside the submitted work.Conflict of interest: Dr. Lankeit reports personal fees and non-financial support from Actelion, personal fees and non-financial support from Bayer, personal fees and non-financial support from Daiichi-Sankyo, personal fees from MSD, personal fees from Pfizer - Bristol-Myers Squibb, grants from BRAHMS – Thermo Fisher scientific, outside the submitted work.Conflict of interest: Dr. Manolis has nothing to disclose.Conflict of interest: Dr. Meyer has nothing to disclose.Conflict of interest: Dr. Muenzel has nothing to disclose.Conflict of interest: Dr. Mustonen reports personal fees from Boehringer-Ingelheim, personal fees from BAYER, personal fees from Sanofi-Anetis, personal fees from LeoPhrama, personal fees from BMS-Pfizer, personal fees from MSD, outside the submitted work.Conflict of interest: Dr. Rauch-Kroehnert reports grants from UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz, Interdisziplinäres Zentrum Klinische Studien (IZKS) during the conduct of the study; personal fees from Bayer Vital GmbH, outside the submitted work.Conflict of interest: Dr. Ruiz-Artacho reports personal fees from Bayer, Daiichi Sankyo, Sanofi, Pfizer, Leo-Pharma and Rovi, outside the submitted work.Conflict of interest: Dr. Schellong reports personal fees from Bayer, personal fees from Boehringer Ingelheim, grants and personal fees from BMS, personal fees from Daiichi Sankyo, personal fees from Aspen, outside the submitted work.Conflict of interest: Dr. Schwaiblmair has nothing to disclose.Conflict of interest: Dr. Stahrenberg has nothing to disclose.Conflict of interest: Dr. Valerio has nothing to disclose.Conflict of interest: Dr. Westerweel has nothing to disclose.Conflict of interest: Dr. Wild reports grants and personal fees from Boehringer Ingelheim, grants from Philips Medical Systems, grants and personal fees from Sanofi-Aventis, grants and personal fees from Bayer Vital, grants from Daiichi Sankyo Europe, personal fees from Bayer Health Care, personal fees from Astra Zeneca, personal fees and non-financial support from DiaSorin, non-financial support from I.E.M., outside the submitted work.Conflict of interest: Dr. Konstantinides reports grants and non-financial support from Bayer AG, during the conduct of the study; grants and personal fees from Boehringer Ingelheim, personal fees from Bayer AG, grants and personal fees from Actelion, grants and personal fees from Daiichi-Sankyo, grants and personal fees from Biocompatibles Group UK, personal fees from Pfizer - Bristol-Myers Squibb, grants and personal fees from MSD, outside the submitted work. 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