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dc.creatorSchmidtmann, I. (Irene)-
dc.creatorAgeno, W. (Walter)-
dc.creatorBauersachs, R.M. (Rupert M.)-
dc.creatorBecattini, C. (Cecilia)-
dc.creatorBernardi, E. (Enrico)-
dc.creatorBeyer-Westendorf, J. (Jan)-
dc.creatorBonacchini, L. (Luca)-
dc.creatorBrachmann, J. (Johannes)-
dc.creatorChrist, M. (Michael)-
dc.creatorCzihal, M. (Michael)-
dc.creatorDuerschmied, D. (Daniel)-
dc.creatorEmpen, K. (Klaus)-
dc.creatorEspinola-Klein, C. (Christine)-
dc.creatorFicker, J.H. (Joachim H.)-
dc.creatorFonseca, C. (Candida)-
dc.creatorGenth-Zotz, S. (Sabine)-
dc.creatorJiménez, D. (David)-
dc.creatorHarjola, V.P. (Veli-Pekka)-
dc.creatorHeld, M. (Matthias)-
dc.creatorIogna-Prat, L. (Lorenzo)-
dc.creatorLange, T.J. (Tobias J.)-
dc.creatorManolis, A. (Athanasios)-
dc.creatorMeyer, A. (Andreas)-
dc.creatorMustonen, P. (Pirjo)-
dc.creatorRauch-Kroehnert, U. (Ursula)-
dc.creatorRuiz-Artacho, P. (Pedro)-
dc.creatorSchellong, S. (Sebastian)-
dc.creatorSchwaiblmair, M. (Martin)-
dc.creatorStahrenberg, R. (Raoul)-
dc.creatorWesterweel, P.E. (Peter)-
dc.creatorWild, P.S. (Philipp S.)-
dc.creatorKonstantinides, S.V. (Stavros V.)-
dc.creatorLankeit, M. (Mareike)-
dc.identifier.citationBarco, S. (Stefano); Schmidtmann, I. (Irene); Ageno, W. (Walter); et al. "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". European Heart Journal. 41 (4), 2020, 509 - 518es_ES
dc.description.abstractAims 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 a = 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.es_ES
dc.description.sponsorshipHoT-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.es_ES
dc.subjectPulmonary embolismes_ES
dc.subjectHome treatmentes_ES
dc.subjectRight ventricular dysfunctiones_ES
dc.subjectManagement triales_ES
dc.subjectRisk stratificationes_ES
dc.titleEarly discharge and home treatment of patients with low-risk pulmonary embolism with the oral factor Xa inhibitor rivaroxaban: an international multicentre single-arm clinical triales_ES
dc.description.noteThis is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.comes_ES
dadun.citation.publicationNameEuropean Heart Journales_ES

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