Early discharge and home treatment of patients with low-risk pulmonary embolism with the oral factor Xa inhibitor rivaroxaban
| Autor(a) principal: | |
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| Data de Publicação: | 2020 |
| Outros Autores: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
| Tipo de documento: | Artigo |
| Idioma: | eng |
| Título da fonte: | Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
| Texto Completo: | http://hdl.handle.net/10362/147800 |
Resumo: | Funding: HoT-PE is an independent, investigator-initiated trial with an academic sponsor (Centre for Thrombosis and Haemostasis, University Medical Centre Mainz, Germany). The work of Stefano Barco, Philipp S. Wild, Stavros V. Konstantinides, and Mareike Lankeit 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 authorization holder of rivaroxaban, Bayer AG. |
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Early discharge and home treatment of patients with low-risk pulmonary embolism with the oral factor Xa inhibitor rivaroxabanan international multicentre single-arm clinical trialHome treatmentManagement trialPulmonary embolismRight ventricular dysfunctionRisk stratificationRivaroxabanCardiology and Cardiovascular MedicineSDG 3 - Good Health and Well-beingFunding: HoT-PE is an independent, investigator-initiated trial with an academic sponsor (Centre for Thrombosis and Haemostasis, University Medical Centre Mainz, Germany). The work of Stefano Barco, Philipp S. Wild, Stavros V. Konstantinides, and Mareike Lankeit 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 authorization holder of rivaroxaban, Bayer AG.AIMS: To investigate the efficacy and safety of early transition from hospital to ambulatory treatment in low-risk acute PE, using the oral factor Xa inhibitor rivaroxaban. METHODS AND RESULTS: We conducted a prospective multicentre single-arm investigator initiated and academically sponsored management trial in patients with acute low-risk PE (EudraCT Identifier 2013-001657-28). Eligibility criteria included absence of (i) haemodynamic instability, (ii) right ventricular dysfunction or intracardiac thrombi, and (iii) serious comorbidities. Up to two nights of hospital stay were permitted. Rivaroxaban was given at the approved dose for PE for ≥3 months. The primary outcome was symptomatic recurrent venous thromboembolism (VTE) or PE-related death within 3 months of enrolment. An interim analysis was planned after the first 525 patients, with prespecified early termination of the study if the null hypothesis could be rejected at the level of α = 0.004 (<6 primary outcome events). From May 2014 through June 2018, consecutive patients were enrolled in seven countries. Of the 525 patients included in the interim analysis, three (0.6%; one-sided upper 99.6% confidence interval 2.1%) suffered symptomatic non-fatal VTE recurrence, a number sufficiently low to fulfil the condition for early termination of the trial. Major bleeding occurred in 6 (1.2%) of the 519 patients comprising the safety population. There were two cancer-related deaths (0.4%). CONCLUSION: Early discharge and home treatment with rivaroxaban is effective and safe in carefully selected patients with acute low-risk PE. The results of the present trial support the selection of appropriate patients for ambulatory treatment of PE.NOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM)RUNBarco, StefanoSchmidtmann, IreneAgeno, WalterBauersachs, Rupert M.Becattini, CeciliaBernardi, EnricoBeyer-Westendorf, JanBonacchini, LucaBrachmann, JohannesChrist, MichaelCzihal, MichaelDuerschmied, DanielEmpen, KlausEspinola-Klein, ChristineFicker, Joachim H.Fonseca, CândidaGenth-Zotz, SabineJiménez, DavidHarjola, Veli PekkaHeld, MatthiasIogna Prat, LorenzoLange, Tobias J.Manolis, AthanasiosMeyer, AndreasMustonen, PirjoRauch-Kroehnert, UrsulaRuiz-Artacho, PedroSchellong, SebastianSchwaiblmair, MartinStahrenberg, RaoulWesterweel, Peter E.Wild, Philipp S.Konstantinides, Stavros V.Lankeit, Mareike2023-01-18T22:14:00Z2020-01-212020-01-21T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/article10application/pdfhttp://hdl.handle.net/10362/147800eng0195-668XPURE: 16777203https://doi.org/10.1093/eurheartj/ehz367info:eu-repo/semantics/openAccessreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAP2024-03-11T05:29:01Zoai:run.unl.pt:10362/147800Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-20T03:53:04.908956Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse |
| dc.title.none.fl_str_mv |
Early discharge and home treatment of patients with low-risk pulmonary embolism with the oral factor Xa inhibitor rivaroxaban an international multicentre single-arm clinical trial |
| title |
Early discharge and home treatment of patients with low-risk pulmonary embolism with the oral factor Xa inhibitor rivaroxaban |
| spellingShingle |
Early discharge and home treatment of patients with low-risk pulmonary embolism with the oral factor Xa inhibitor rivaroxaban Barco, Stefano Home treatment Management trial Pulmonary embolism Right ventricular dysfunction Risk stratification Rivaroxaban Cardiology and Cardiovascular Medicine SDG 3 - Good Health and Well-being |
| title_short |
Early discharge and home treatment of patients with low-risk pulmonary embolism with the oral factor Xa inhibitor rivaroxaban |
| title_full |
Early discharge and home treatment of patients with low-risk pulmonary embolism with the oral factor Xa inhibitor rivaroxaban |
| title_fullStr |
Early discharge and home treatment of patients with low-risk pulmonary embolism with the oral factor Xa inhibitor rivaroxaban |
| title_full_unstemmed |
Early discharge and home treatment of patients with low-risk pulmonary embolism with the oral factor Xa inhibitor rivaroxaban |
| title_sort |
Early discharge and home treatment of patients with low-risk pulmonary embolism with the oral factor Xa inhibitor rivaroxaban |
| author |
Barco, Stefano |
| author_facet |
Barco, Stefano Schmidtmann, Irene Ageno, Walter Bauersachs, Rupert M. Becattini, Cecilia Bernardi, Enrico Beyer-Westendorf, Jan Bonacchini, Luca Brachmann, Johannes Christ, Michael Czihal, Michael Duerschmied, Daniel Empen, Klaus Espinola-Klein, Christine Ficker, Joachim H. Fonseca, Cândida Genth-Zotz, Sabine Jiménez, David Harjola, Veli Pekka Held, Matthias Iogna Prat, Lorenzo Lange, Tobias J. Manolis, Athanasios Meyer, Andreas Mustonen, Pirjo Rauch-Kroehnert, Ursula Ruiz-Artacho, Pedro Schellong, Sebastian Schwaiblmair, Martin Stahrenberg, Raoul Westerweel, Peter E. Wild, Philipp S. Konstantinides, Stavros V. Lankeit, Mareike |
| author_role |
author |
| author2 |
Schmidtmann, Irene Ageno, Walter Bauersachs, Rupert M. Becattini, Cecilia Bernardi, Enrico Beyer-Westendorf, Jan Bonacchini, Luca Brachmann, Johannes Christ, Michael Czihal, Michael Duerschmied, Daniel Empen, Klaus Espinola-Klein, Christine Ficker, Joachim H. Fonseca, Cândida Genth-Zotz, Sabine Jiménez, David Harjola, Veli Pekka Held, Matthias Iogna Prat, Lorenzo Lange, Tobias J. Manolis, Athanasios Meyer, Andreas Mustonen, Pirjo Rauch-Kroehnert, Ursula Ruiz-Artacho, Pedro Schellong, Sebastian Schwaiblmair, Martin Stahrenberg, Raoul Westerweel, Peter E. Wild, Philipp S. Konstantinides, Stavros V. Lankeit, Mareike |
| author2_role |
author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author |
| dc.contributor.none.fl_str_mv |
NOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM) RUN |
| dc.contributor.author.fl_str_mv |
Barco, Stefano Schmidtmann, Irene Ageno, Walter Bauersachs, Rupert M. Becattini, Cecilia Bernardi, Enrico Beyer-Westendorf, Jan Bonacchini, Luca Brachmann, Johannes Christ, Michael Czihal, Michael Duerschmied, Daniel Empen, Klaus Espinola-Klein, Christine Ficker, Joachim H. Fonseca, Cândida Genth-Zotz, Sabine Jiménez, David Harjola, Veli Pekka Held, Matthias Iogna Prat, Lorenzo Lange, Tobias J. Manolis, Athanasios Meyer, Andreas Mustonen, Pirjo Rauch-Kroehnert, Ursula Ruiz-Artacho, Pedro Schellong, Sebastian Schwaiblmair, Martin Stahrenberg, Raoul Westerweel, Peter E. Wild, Philipp S. Konstantinides, Stavros V. Lankeit, Mareike |
| dc.subject.por.fl_str_mv |
Home treatment Management trial Pulmonary embolism Right ventricular dysfunction Risk stratification Rivaroxaban Cardiology and Cardiovascular Medicine SDG 3 - Good Health and Well-being |
| topic |
Home treatment Management trial Pulmonary embolism Right ventricular dysfunction Risk stratification Rivaroxaban Cardiology and Cardiovascular Medicine SDG 3 - Good Health and Well-being |
| description |
Funding: HoT-PE is an independent, investigator-initiated trial with an academic sponsor (Centre for Thrombosis and Haemostasis, University Medical Centre Mainz, Germany). The work of Stefano Barco, Philipp S. Wild, Stavros V. Konstantinides, and Mareike Lankeit 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 authorization holder of rivaroxaban, Bayer AG. |
| publishDate |
2020 |
| dc.date.none.fl_str_mv |
2020-01-21 2020-01-21T00:00:00Z 2023-01-18T22:14:00Z |
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info:eu-repo/semantics/publishedVersion |
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info:eu-repo/semantics/article |
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article |
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publishedVersion |
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http://hdl.handle.net/10362/147800 |
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http://hdl.handle.net/10362/147800 |
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eng |
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eng |
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0195-668X PURE: 16777203 https://doi.org/10.1093/eurheartj/ehz367 |
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info:eu-repo/semantics/openAccess |
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openAccess |
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10 application/pdf |
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