Abstract
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.
Abstract
The results of the complete primary outcome analysis of the HoT-PE study, as well as long-term mortality and quality-of-life data, support early discharge and ambulatory oral anticoagulation with rivaroxaban for selected patients with acute low-risk PE https://bit.ly/32qX0mu
Footnotes
This article has an editorial commentary: https://doi.org/10.1183/13993003.03811-2020
This article has supplementary material available from erj.ersjournals.com
The HoT-PE Trial Investigators are: Stavros V. Konstantinides, Rupert Martin Bauersachs, Christoph Bode, Michael Christ, Christine Espinola-Klein, Annette Geibel, Mareike Lankeit, Michael Pfeifer, Sebastian Schellong, Philipp S. Wild, Harald Binder, Luca Valerio, Kurt Quitzau, Nadine Martin, Dorothea Becker, Stefano Barco, Irene Schmidtmann, Toni Anusic, Martin Schwaiblmair, Ursula Rauch-Kröhnert, Martin Möckel, Johannes Brachmann, Jan Beyer-Westendorf, Daniel Duerschmied, Sabine Blaschke, Marius M. Hoeper, Evangelos Giannitis, Klaus Empen, Rainer Schmiedel, Ulrich Hoffman, Ibrahim Akin, Andreas Meyer, Sabine Genth-Zotz, Joachim Ficker, Tobias Geisler, Matthias Held, Cecilia Becattini, Ludovica Cimini, Walter Ageno, Rodolfo Sbrojavacca, Enrico Bernardi, Giuseppe Bettoni, Roberto Cosentini, Paolo Moscatelli, Cinzia Nitti, Maria Pazzaglia, Raffaele Pesavento, Alessandra Ascani, Francesca Cortellaro, Nicola Montano, Peter E. Westerweel, Pedro Ruiz-Artacho, David Jiménez, Aitor Ballaz-Quincoces, Raquel Lopez Reyes, Remedios Otero, Candida Fonseca, Tiago Judas, Inês Araujo, Sergio Batista, Fabienne Goncalves, Veli-Pekka Harjola, Pirjo Mustonen, Georgios Hahalis, Athanassios Manginas, Konstantinos Gougoulianis, Athanasios Manolis, Michael Czihal, Tobias J. Lange, Raoul Stahrenberg, Thomas Meinertz, Menno V. Huisman, Paolo Prandoni and Walter Lehmacher.
This study is registered at EudraCT with identifier number 2013-001657-28. Individual participant data can be made available upon request for individual participant data meta-analysis. For information, please contact the corresponding author.
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.
Conflict of interest: I. Schmidtmann reports grants from Merck Serono, outside the submitted work.
Conflict of interest: W. Ageno reports grants from Bayer, personal fees from Boehringer Ingelheim, Daiichi Sankyo and Bristol Myers Squibb/Pfizer, outside the submitted work.
Conflict of interest: T. Anušić has nothing to disclose.
Conflict of interest: 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.
Conflict of interest: C. Becattini reports personal fees for consultancy and lectures from Bayer HealthCare, Daiichi Sankyo and Bristol Myers Squibb, outside the submitted work.
Conflict of interest: E. Bernardi has nothing to disclose.
Conflict of interest: 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.
Conflict of interest: L. Bonacchini has nothing to disclose.
Conflict of interest: 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.
Conflict of interest: M. Christ reports grants from the University of Mainz, during the conduct of the study.
Conflict of interest: M. Czihal reports personal fees from Bayer HealthCare, Roche, AstraZeneca, MSD Sharp & Dohme and LEO Pharma, outside the submitted work.
Conflict of interest: D. Duerschmied reports personal fees for lectures and nonfinancial support (travel costs) from Bayer, Pfizer, Daiichi Sankyo and CytoSorbents, outside the submitted work.
Conflict of interest: K. Empen reports travel costs and personal fees for lectures from Bayer HealthCare, outside the submitted work.
Conflict of interest: C. Espinola-Klein reports lecture fees from Bayer HealthCare, outside the submitted work.
Conflict of interest: J.H. Ficker reports personal fees for lectures from Daiichi Sankyo, outside the submitted work.
Conflict of interest: C. Fonseca reports personal fees for consultancy and lectures from Bayer, outside the submitted work
Conflict of interest: S. Genth-Zotz has nothing to disclose.
Conflict of interest: D. Jiménez has nothing to disclose.
Conflict of interest: 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.
Conflict of interest: 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.
Conflict of interest: L. Iogna Prat has nothing to disclose.
Conflict of interest: 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.
Conflict of interest: 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.
Conflict of interest: A. Manolis has nothing to disclose.
Conflict of interest: A. Meyer has nothing to disclose.
Conflict of interest: T. Münzel has nothing to disclose.
Conflict of interest: 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.
Conflict of interest: 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.
Conflict of interest: P. Ruiz-Artacho reports personal fees from Bayer, Daiichi Sankyo, Sanofi, Pfizer, LEO Pharma and Rovi, outside the submitted work.
Conflict of interest: 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.
Conflict of interest: M. Schwaiblmair has nothing to disclose.
Conflict of interest: R. Stahrenberg has nothing to disclose.
Conflict of interest: L. Valerio has nothing to disclose.
Conflict of interest: P.E. Westerweel has nothing to disclose.
Conflict of interest: 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.
Conflict of interest: 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.
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.
- Received June 17, 2020.
- Accepted August 21, 2020.
- Copyright ©ERS 2021
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