TY - JOUR
T1 - Survival and quality of life after early discharge in low-risk pulmonary embolism
AU - Barco, Stefano
AU - Schmidtmann, Irene
AU - Ageno, Walter
AU - Anušic, Toni
AU - Bauersachs, Rupert M.
AU - Becattini, Cecilia
AU - Bernardi, Enrico
AU - Beyer-Westendorf, Jan
AU - Bonacchini, Luca
AU - Brachmann, Johannes
AU - Christ, Michael
AU - Czihal, Michael
AU - Duerschmied, Daniel
AU - Empen, Klaus
AU - Espinola-Klein, Christine
AU - Ficker, Joachim H.
AU - Fonseca, Cândida
AU - Genth-Zotz, Sabine
AU - Jiménez, David
AU - Harjola, Veli Pekka
AU - Held, Matthias
AU - Prat, Lorenzo Iogna
AU - Lange, Tobias J.
AU - Lankeit, Mareike
AU - Manolis, Athanasios
AU - Meyer, Andreas
AU - Mönzel, Thomas
AU - Mustonen, Pirjo
AU - Rauch-Kroehnert, Ursula
AU - Ruiz-Artacho, Pedro
AU - Schellong, Sebastian
AU - Schwaiblmair, Martin
AU - Stahrenberg, Raoul
AU - Valerio, Luca
AU - Westerweel, Peter E.
AU - Wild, Philipp S.
AU - Konstantinides, Stavros V.
N1 - Funding Information:
M. Held reports honoraria for advisory board work from Actelion, Bayer, Boehringer, MSD, Daiichi Sankyo and Roche, honoraria for lectures from Actelion, Bayer, Berlin-Chemie, Bristol Myers Squibb, MSD, Daichi Sankyo, Pfizer and OMT, grants from Actelion, outside the submitted work. L. Iogna Prat has nothing to disclose. T.J. Lange reports nonfinancial support for meeting attendance from the Center for Thrombosis and Hemostasis (CTH), University Medical Center Mainz, during the conduct of the study; personal fees from Bayer and Pfizer, outside the submitted work. M. Lankeit reports personal fees for lectures and nonfinancial support (travel costs) from Actelion, Bayer and Daiichi Sankyo, personal fees for lectures from MSD and Bristol Myers Squibb/Pfizer, grants from BRAHMS – Thermo Fisher Scientific, outside the submitted work. A. Manolis has nothing to disclose. A. Meyer has nothing to disclose. T. Münzel has nothing to disclose. P. Mustonen reports personal fees for lectures and advisory board work from Boehringer Ingelheim, Bayer, Sanofi-Anetis, LEO Pharma, Bristol Myers Squibb/Pfizer and MSD, outside the submitted work. U. 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, outside the submitted work. P. Ruiz-Artacho reports personal fees from Bayer, Daiichi Sankyo, Sanofi, Pfizer, LEO Pharma and Rovi, outside the submitted work. S. Schellong reports personal fees for lectures and consultancy from Bayer, Boehringer Ingelheim, Daiichi Sankyo and Aspen, grants and personal fees for lectures and consultancy from Bristol Myers Squibb, outside the submitted work. M. Schwaiblmair has nothing to disclose. R. Stahrenberg has nothing to disclose. L. Valerio has nothing to disclose. P.E. Westerweel has nothing to disclose. P.S. Wild reports grants and personal fees from Boehringer Ingelheim, Sanofi-Aventis, Bayer Vital and Bayer HealthCare, grants from Philips Medical Systems and Daiichi Sankyo Europe, personal fees from AstraZeneca, personal fees and equipment provision from DiaSorin, equipment provision from IEM, outside the submitted work. S.V. Konstantinides reports grants and provision of study drug from Bayer, during the conduct of the study; grants and personal fees for consultancy and lectures from Boehringer Ingelheim, Daiichi Sankyo, Biocompatibles Group UK and MSD, personal fees for consultancy and lectures from Bayer and Bristol Myers Squibb/Pfizer, grants and personal fees for lectures from Actelion, grants from Servier, outside the submitted work.
Funding Information:
Conflict of interest: S. Barco reports personal fees from Biocompatibles Group UK, LEO Pharma, Bayer, nonfinancial support from Bayer HealthCare and Daiichi Sankyo, grants from Sanofi, outside the submitted work. I. Schmidtmann reports grants from Merck Serono, outside the submitted work. W. Ageno reports grants from Bayer, personal fees from Boehringer Ingelheim, Daiichi Sankyo and Bristol Myers Squibb/Pfizer, outside the submitted work. T. Anušić has nothing to disclose. R.M. Bauersachs reports personal fees for lectures and advisory board work from Bayer HealthCare, Bristol Myers Squibb/Pfizer and Daiichi Sankyo, during the conduct of the study. C. Becattini reports personal fees for consultancy and lectures from Bayer HealthCare, Daiichi Sankyo and Bristol Myers Squibb, outside the submitted work. E. Bernardi has nothing to disclose. J. Beyer-Westendorf reports patient fees from the Center for Thrombosis and Hemostasis (CTH), University Medical Center Mainz, during the conduct of the study; grants and personal fees for advisory board work, lectures and travel support from Bayer, outside the submitted work. L. Bonacchini has nothing to disclose. J. Brachmann reports grants and personal fees from Medtronic, during the conduct of the study; grants from Medtronic, St Jude and Biotronik, outside the submitted work. M. Christ reports grants from the University of Mainz, during the conduct of the study. M. Czihal reports personal fees from Bayer HealthCare, Roche, AstraZeneca, MSD Sharp & Dohme and LEO Pharma, outside the submitted work. D. Duerschmied reports personal fees for lectures and nonfinancial support (travel costs) from Bayer, Pfizer, Daiichi Sankyo and CytoSorbents, outside the submitted work. K. Empen reports travel costs and personal fees for lectures from Bayer HealthCare, outside the submitted work. C. Espinola-Klein reports lecture fees from Bayer HealthCare, outside the submitted work. J.H. Ficker reports personal fees for lectures from Daiichi Sankyo, outside the submitted work. C. Fonseca reports personal fees for consultancy and lectures from Bayer, outside the submitted work S. Genth-Zotz has nothing to disclose. D. Jiménez has nothing to disclose. V-P. Harjola reports personal fees for lectures from Bayer, personal fees for lectures and advisory board work from Boehringer Ingelheim and Pfizer, personal fees for advisory board work from MSD, outside the submitted work.
Funding Information:
Support statement: HoT-PE is an independent, investigator-initiated trial with an academic sponsor (Center for Thrombosis and Hemostasis (CTH), University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany). The work of S. Barco, M. Lankeit, L. Valerio, P.S. Wild and S.V. Konstantinides was supported by the German Federal Ministry of Education and Research (BMBF 01EO1003 and 01EO1503). In addition, the sponsor has obtained the study drug (rivaroxaban) and a grant from the market authorisation holder of rivaroxaban, Bayer AG. The funding bodies had no influence on the design or conduct of the study; collection, management, analysis or interpretation of the data; preparation, review or approval of the manuscript; or the decision to submit the manuscript for publication. Funding information for this article has been deposited with the Crossref Funder Registry.
Publisher Copyright:
© 2021 European Respiratory Society. All rights reserved.
PY - 2021/2/1
Y1 - 2021/2/1
N2 - Introduction: Early discharge of patients with acute low-risk pulmonary embolism requires validation by prospective trials with clinical and quality-of-life outcomes. Methods: The multinational Home Treatment of Patients with Low-Risk Pulmonary Embolism with the Oral Factor Xa Inhibitor Rivaroxaban (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 3-month recurrence (primary outcome) and 1- 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 pulmonary embolism. Results: The primary efficacy outcome occurred in three (0.5%, one-sided upper 95% CI 1.3%) patients. The 1-year mortality was 2.4%. The mean±SD 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. The EQ-5D-5L was 0.89±0.12 at 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 was associated 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 points at 3 months (p<0.0001). Conclusions: Our results further support early discharge and ambulatory oral anticoagulation for selected patients with low-risk pulmonary embolism. Targeted strategies may be necessary to further improve quality of life in specific patient subgroups.
AB - Introduction: Early discharge of patients with acute low-risk pulmonary embolism requires validation by prospective trials with clinical and quality-of-life outcomes. Methods: The multinational Home Treatment of Patients with Low-Risk Pulmonary Embolism with the Oral Factor Xa Inhibitor Rivaroxaban (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 3-month recurrence (primary outcome) and 1- 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 pulmonary embolism. Results: The primary efficacy outcome occurred in three (0.5%, one-sided upper 95% CI 1.3%) patients. The 1-year mortality was 2.4%. The mean±SD 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. The EQ-5D-5L was 0.89±0.12 at 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 was associated 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 points at 3 months (p<0.0001). Conclusions: Our results further support early discharge and ambulatory oral anticoagulation for selected patients with low-risk pulmonary embolism. Targeted strategies may be necessary to further improve quality of life in specific patient subgroups.
UR - http://www.scopus.com/inward/record.url?scp=85100974115&partnerID=8YFLogxK
U2 - 10.1183/13993003.02368-2020
DO - 10.1183/13993003.02368-2020
M3 - Article
C2 - 32859673
AN - SCOPUS:85100974115
SN - 0903-1936
VL - 57
JO - European Respiratory Journal
JF - European Respiratory Journal
IS - 2
M1 - 2002368
ER -