{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,8]],"date-time":"2026-11-08T03:10:00Z","timestamp":1794107400502,"version":"4.8.0"},"reference-count":27,"publisher":"Oxford University Press (OUP)","issue":"4","license":[{"start":{"date-parts":[[2019,5,23]],"date-time":"2019-05-23T00:00:00Z","timestamp":1558569600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"German Federal Ministry of Education and Research","award":["BMBF 01EO1003"],"award-info":[{"award-number":["BMBF 01EO1003"]}]},{"name":"German Federal Ministry of Education and Research","award":["01EO1503"],"award-info":[{"award-number":["01EO1503"]}]},{"DOI":"10.13039\/100004326","name":"Bayer AG","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004326","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2020,1,21]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and results<\/jats:title>\n                    <jats:p>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 \u22653\u2009months. The primary outcome was symptomatic recurrent venous thromboembolism (VTE) or PE-related death within 3\u2009months 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 \u03b1\u2009=\u20090.004 (&amp;lt;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%).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/eurheartj\/ehz367","type":"journal-article","created":{"date-parts":[[2019,5,14]],"date-time":"2019-05-14T07:40:28Z","timestamp":1557819628000},"page":"509-518","source":"Crossref","is-referenced-by-count":136,"title":["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"],"prefix":"10.1093","volume":"41","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2618-347X","authenticated-orcid":false,"given":"Stefano","family":"Barco","sequence":"first","affiliation":[{"name":"Center for Thrombosis and Hemostasis (CTH), University Medical Center of the Johannes Gutenberg University , Langenbeckstrasse 1, Building 403, 55131 Mainz, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8743-6752","authenticated-orcid":false,"given":"Irene","family":"Schmidtmann","sequence":"additional","affiliation":[{"name":"Institute of Medical Biostatistics, Epidemiology and Informatics (IMBEI), University Medical Center Mainz , Obere Zahlbacher Strasse 69, 55131 Mainz, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Walter","family":"Ageno","sequence":"additional","affiliation":[{"name":"Department of Medicine and Surgery, Research Center on Thromboembolic Diseases and Antithrombotic Therapies , University of Insubria, Viale Luigi Borri 57, 21100 Varese, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rupert M","family":"Bauersachs","sequence":"additional","affiliation":[{"name":"Department of Vascular Medicine, Klinikum Darmstadt , Grafenstrasse 9, 64283 Darmstadt, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cecilia","family":"Becattini","sequence":"additional","affiliation":[{"name":"Internal and Cardiovascular Medicine - Stroke Unit, University of Perugia , Via G. 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