{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,24]],"date-time":"2026-08-24T23:22:15Z","timestamp":1787613735699,"version":"build-2736575974"},"reference-count":17,"publisher":"Georg Thieme Verlag KG","funder":[{"DOI":"10.13039\/100015731","name":"Bayer Yakuhin","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100015731","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Semin Thromb Hemost"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>The ONCO PE trial showed that 18-month rivaroxaban was superior to 6-month rivaroxaban for preventing recurrent venous thromboembolism (VTE) in patients with cancer-associated low-risk pulmonary embolism (PE). However, the influence of concomitant deep vein thrombosis (DVT) on this benefit was unclear. The current post-hoc subgroup analysis of the ONCO PE trial categorized patients into DVT subgroup (N\u2009=\u2009104) and no DVT subgroup (N\u2009=\u200974) based on the presence or absence of a concomitant DVT at PE diagnosis. We compared the primary endpoint of 18-month recurrent VTE and the major secondary endpoint of 18-month major bleeding between the 18- and 6-month rivaroxaban groups in the DVT and no DVT subgroups. The cumulative 18-month incidence of recurrent VTE in the 18-month rivaroxaban group was numerically lower compared with that in the 6-month rivaroxaban group in the DVT subgroup (11.5 vs. 20.9%, log-rank p\u2009=\u20090.25) and was significantly lower in the no DVT subgroup (0.0 vs. 24.2%, log-rank p\u2009=\u20090.006), without significant interaction between treatment durations and concomitant DVT (Pinteraction\u2009=\u20090.99). There were no significant differences in the cumulative 18-month incidence of major bleeding between the 18- and 6-month rivaroxaban groups in both the DVT (4.6 vs. 5.8%, log-rank p\u2009=\u20090.70) and no DVT (13.4 vs. 5.8%, log-rank p\u2009=\u20090.29) subgroups, without significant interaction (Pinteraction\u2009=\u20090.34). The current exploratory analysis showed that extended rivaroxaban treatment might have a potential benefit for patients with cancer-associated low-risk PE in preventing recurrent VTE, irrespective of concomitant DVT status, without a significantly increased risk of major bleeding.<\/jats:p>","DOI":"10.1055\/a-2938-3392","type":"journal-article","created":{"date-parts":[[2026,8,14]],"date-time":"2026-08-14T23:16:07Z","timestamp":1786749367000},"source":"Crossref","is-referenced-by-count":0,"title":["Extended Anticoagulation Therapy with Rivaroxaban for Cancer-Associated Low-Risk Pulmonary Embolism According to Status of Concomitant Deep Vein Thrombosis: Insights from the ONCO PE Randomized Trial"],"prefix":"10.1055","clinical-trial-number":[{"clinical-trial-number":"nct04724460","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2126-8535","authenticated-orcid":false,"given":"Wei","family":"Xiong","sequence":"additional","affiliation":[{"name":"Xinhua Hospital, Shanghai Jiaotong University School of Medicine, People's Republic of China","place":["Shanghai"],"department":["Department of Pulmonary and Critical Care Medicine"]},{"name":"Graduate School of Medicine, Kyoto University, Kyoto, Japan","place":["Sakyo-ku"],"department":["Department of Cardiovascular Medicine"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yugo","family":"Yamashita","sequence":"additional","affiliation":[{"name":"Graduate School of Medicine, Kyoto University, Kyoto, Japan","place":["Sakyo-ku"],"department":["Department of Cardiovascular Medicine"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takeshi","family":"Morimoto","sequence":"additional","affiliation":[{"name":"Hyogo Medical University, Hyogo Prefecture, Japan","place":["Nishinomiya"],"department":["Department of Data Science"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nao","family":"Muraoka","sequence":"additional","affiliation":[{"name":"Shizuoka Cancer Center, Shizuoka Prefecture, Japan","place":["Sunto District"],"department":["Division of Cardiology"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wataru","family":"Shioyama","sequence":"additional","affiliation":[{"name":"Shiga University of Medical Science, Shiga Prefecture, Japan","place":["Otsu"],"department":["Department of Cardiovascular Medicine"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshihisa","family":"Nakagawa","sequence":"additional","affiliation":[{"name":"Shiga University of Medical Science, Shiga Prefecture, Japan","place":["Otsu"],"department":["Department of Cardiovascular Medicine"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ryuki","family":"Chatani","sequence":"additional","affiliation":[{"name":"Kurashiki Central Hospital, Okayama Prefecture, Japan","place":["Kurashiki"],"department":["Department of Cardiovascular Medicine"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiromi","family":"Yamamoto","sequence":"additional","affiliation":[{"name":"Kurashiki Central Hospital, Okayama Prefecture, Japan","place":["Kurashiki"],"department":["Department of Cardiovascular Medicine"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tatsuhiro","family":"Shibata","sequence":"additional","affiliation":[{"name":"Kurume University School of Medicine, Fukuoka Prefecture, Japan","place":["Kurume"],"department":["Department of Internal Medicine, Division of Cardiovascular Medicine"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nagisa","family":"Morikawa","sequence":"additional","affiliation":[{"name":"Kurume University School of Medicine, Fukuoka Prefecture, Japan","place":["Kurume"],"department":["Department of Internal Medicine, Division of Cardiovascular Medicine"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshihiro","family":"Fukumoto","sequence":"additional","affiliation":[{"name":"Kurume University School of Medicine, Fukuoka Prefecture, Japan","place":["Kurume"],"department":["Department of Internal Medicine, Division of Cardiovascular Medicine"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuji","family":"Nishimoto","sequence":"additional","affiliation":[{"name":"Osaka General Medical Center, Osaka Prefecture, Japan","place":["Osaka"],"department":["Division of Cardiology"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Koh","family":"Ono","sequence":"additional","affiliation":[{"name":"Graduate School of Medicine, Kyoto University, Kyoto, Japan","place":["Sakyo-ku"],"department":["Department of Cardiovascular Medicine"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takeshi","family":"Kimura","sequence":"additional","affiliation":[{"name":"Hirakata Kosai Hospital, Osaka Prefecture, Japan","place":["Hirakata"],"department":["Department of Cardiology"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"194","published-online":{"date-parts":[[2026,8,24]]},"reference":[{"key":"ref1","doi-asserted-by":"crossref","first-page":"64","DOI":"10.1016\/S0140-6736(20)32658-1","article-title":"Venous thromboembolism","volume":"398","author":"F Khan","year":"2021","journal-title":"Lancet"},{"key":"ref2","doi-asserted-by":"crossref","first-page":"e072715","DOI":"10.1136\/bmj-2022-072715","article-title":"Prevention of venous thromboembolism in patients with cancer","volume":"381","author":"S R Guntupalli","year":"2023","journal-title":"BMJ"},{"issue":"04","key":"ref3","doi-asserted-by":"crossref","first-page":"543","DOI":"10.1093\/eurheartj\/ehz405","article-title":"2019 ESC guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS)","volume":"41","author":"S V Konstantinides","year":"2020","journal-title":"Eur Heart J"},{"issue":"06","key":"ref4","doi-asserted-by":"crossref","first-page":"e545","DOI":"10.1016\/j.chest.2021.07.055","article-title":"Antithrombotic therapy for VTE disease: second update of the CHEST guideline and expert panel report","volume":"160","author":"S M Stevens","year":"2021","journal-title":"Chest"},{"issue":"04","key":"ref5","doi-asserted-by":"crossref","first-page":"927","DOI":"10.1182\/bloodadvances.2020003442","article-title":"American Society of Hematology 2021 guidelines for management of venous thromboembolism: prevention and treatment in patients with cancer","volume":"5","author":"G H Lyman","year":"2021","journal-title":"Blood Adv"},{"issue":"07","key":"ref6","doi-asserted-by":"crossref","first-page":"483","DOI":"10.6004\/jnccn.2024.0046","article-title":"Cancer-Associated Venous Thromboembolic Disease, Version 2.2024, NCCN clinical practice guidelines in oncology","volume":"22","author":"M B Streiff","year":"2024","journal-title":"J Natl Compr Canc Netw"},{"issue":"07","key":"ref7","doi-asserted-by":"crossref","first-page":"e334","DOI":"10.1016\/S1470-2045(22)00160-7","article-title":"2022 international clinical practice guidelines for the treatment and prophylaxis of venous thromboembolism in patients with cancer, including patients with COVID-19","volume":"23","author":"D Farge","year":"2022","journal-title":"Lancet Oncol"},{"issue":"16","key":"ref8","doi-asserted-by":"crossref","first-page":"3063","DOI":"10.1200\/JCO.23.00294","article-title":"Venous thromboembolism prophylaxis and treatment in patients with cancer: ASCO guideline update","volume":"41","author":"N S Key","year":"2023","journal-title":"J Clin Oncol"},{"issue":"05","key":"ref9","doi-asserted-by":"crossref","first-page":"601","DOI":"10.1007\/s11239-025-03103-4","article-title":"The current status and future perspective of extended anticoagulation therapy for cancer-associated venous thromboembolism","volume":"58","author":"W Xiong","year":"2025","journal-title":"J Thromb Thrombolysis"},{"issue":"09","key":"ref10","doi-asserted-by":"crossref","first-page":"589","DOI":"10.1161\/CIRCULATIONAHA.124.072758","article-title":"Rivaroxaban for 18 months versus 6 months in patients with cancer and acute low-risk pulmonary embolism: an open-label, multicenter, randomized clinical trial (ONCO PE Trial)","volume":"151","author":"Y Yamashita","year":"2025","journal-title":"Circulation"},{"issue":"18","key":"ref11","doi-asserted-by":"crossref","first-page":"4510","DOI":"10.3390\/cancers14184510","article-title":"Concomitant deep vein thrombosis in cancer patients with unsuspected pulmonary embolism","volume":"14","author":"A Qdaisat","year":"2022","journal-title":"Cancers (Basel)"},{"issue":"08","key":"ref12","doi-asserted-by":"crossref","first-page":"2267","DOI":"10.3390\/cancers12082267","article-title":"Prognostic significance of incidental deep vein thrombosis in patients with cancer presenting with incidental pulmonary embolism","volume":"12","author":"M Barca-Hernando","year":"2020","journal-title":"Cancers (Basel)"},{"issue":"04","key":"ref13","doi-asserted-by":"crossref","first-page":"692","DOI":"10.1111\/j.1538-7836.2005.01204.x","article-title":"Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients","volume":"3","author":"S Schulman","year":"2005","journal-title":"J Thromb Haemost"},{"issue":"03","key":"ref14","doi-asserted-by":"crossref","first-page":"636","DOI":"10.1016\/j.chest.2019.08.2206","article-title":"Usefulness of simplified Pulmonary Embolism Severity Index score for identification of patients with low-risk pulmonary embolism and active cancer: from the COMMAND VTE Registry","volume":"157","author":"Y Yamashita","year":"2020","journal-title":"Chest"},{"issue":"05","key":"ref15","doi-asserted-by":"crossref","first-page":"529","DOI":"10.1200\/JCO.23.00429","article-title":"Clinical presentation and outcomes of patients with cancer-associated isolated distal deep vein thrombosis","volume":"42","author":"J P Galanaud","year":"2024","journal-title":"J Clin Oncol"},{"issue":"01","key":"ref16","doi-asserted-by":"crossref","first-page":"e58","DOI":"10.1055\/s-0039-1683374","article-title":"Recurrence risk after first symptomatic distal versus proximal deep vein thrombosis according to baseline risk factors","volume":"3","author":"L Valerio","year":"2019","journal-title":"TH Open"},{"issue":"08","key":"ref17","doi-asserted-by":"crossref","first-page":"e12604","DOI":"10.1002\/rth2.12604","article-title":"Cancer-associated thrOmboSIs - Patient-reported outcoMes with rivarOxaban (COSIMO)\u2014baseline characteristics and clinical outcomes","volume":"5","author":"A Maraveyas","year":"2021","journal-title":"Res Pract Thromb Haemost"}],"container-title":["Seminars in Thrombosis and Hemostasis"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/www.thieme-connect.de\/products\/ejournals\/pdf\/10.1055\/a-2938-3392.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,24]],"date-time":"2026-08-24T22:47:09Z","timestamp":1787611629000},"score":1,"resource":{"primary":{"URL":"http:\/\/www.thieme-connect.de\/DOI\/DOI?10.1055\/a-2938-3392"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,8,14]]},"references-count":17,"URL":"https:\/\/doi.org\/10.1055\/a-2938-3392","archive":["Portico","CLOCKSS"],"relation":{},"ISSN":["0094-6176","1098-9064"],"issn-type":[{"value":"0094-6176","type":"print"},{"value":"1098-9064","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2026,8,14]]},"published":{"date-parts":[[2026,8,14]]}}}