{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T18:53:01Z","timestamp":1791312781366,"version":"4.3.1"},"reference-count":27,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"9","license":[{"start":{"date-parts":[[2025,3,4]],"date-time":"2025-03-04T00:00:00Z","timestamp":1741046400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["Circulation"],"published-print":{"date-parts":[[2025,3,4]]},"abstract":"<jats:sec>\n                    <jats:title>BACKGROUND:<\/jats:title>\n                    <jats:p>The optimal duration of anticoagulation therapy for patients with cancer and acute low-risk pulmonary embolism (PE) is clinically relevant, but evidence is lacking. Prolonged anticoagulation therapy could have a potential benefit for prevention of thrombotic events; however, it could also increase the risk of bleeding.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS:<\/jats:title>\n                    <jats:p>In a multicenter, open-label, adjudicator-blinded, randomized clinical trial at 32 institutions in Japan, we randomly assigned patients with cancer and acute low-risk PE of the simplified version of the Pulmonary Embolism Severity Index score of 1, in a 1:1 ratio, to receive either an 18-month or a 6-month rivaroxaban treatment. The primary end point was recurrent venous thromboembolism (VTE) at 18 months. The major secondary end point was major bleeding at 18 months according to the criteria of the International Society on Thrombosis and Hemostasis. The primary hypothesis was that an 18-month treatment was superior to a 6-month treatment in terms of the primary end point.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS:<\/jats:title>\n                    <jats:p>\n                      From February 2021 to March 2023, 179 patients were randomized, and after the exclusion of one patient who withdrew consent, 178 were included in the intention-to-treat population: 89 patients in the 18-month rivaroxaban group and 89 in the 6-month rivaroxaban group. The mean age was 65.7 years; 47% of the patients were men, and 12% had symptoms of PE at baseline. The primary end point of recurrent VTE occurred in 5 of the 89 patients (5.6%) in the 18-month rivaroxaban group and in 17 of the 89 (19.1%) in the 6-month rivaroxaban group (odds ratio, 0.25 [95% CI, 0.09\u20130.72];\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      =0.01). Among 22 recurrent VTE, 5 patients presented with a symptomatic recurrent VTE; recurrent PE occurred in 11 patients, including 2 with main and 4 with lobar PEs; and recurrent deep vein thrombosis was seen in 11 patients, including 3 with proximal deep vein thromboses. The major secondary end point of major bleeding occurred in 7 of the 89 patients (7.8%) in the 18-month rivaroxaban group and in 5 of the 89 patients (5.6%) in the 6-month rivaroxaban group (odds ratio, 1.43 [95% CI, 0.44\u20134.70];\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      =0.55).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSIONS:<\/jats:title>\n                    <jats:p>In patients with cancer and acute low-risk PE of the simplified version of the Pulmonary Embolism Severity Index score of 1, the 18-month rivaroxaban treatment was superior to the 6-month rivaroxaban treatment with respect to recurrent VTE events.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>REGISTRATION:<\/jats:title>\n                    <jats:p>\n                      URL:\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.clinicaltrials.gov\">https:\/\/www.clinicaltrials.gov<\/jats:ext-link>\n                      ; Unique identifier: NCT04724460.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1161\/circulationaha.124.072758","type":"journal-article","created":{"date-parts":[[2024,11,18]],"date-time":"2024-11-18T09:48:09Z","timestamp":1731923289000},"page":"589-600","update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":27,"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)"],"prefix":"10.1161","volume":"151","clinical-trial-number":[{"clinical-trial-number":"nct04724460","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2583-1321","authenticated-orcid":true,"given":"Yugo","family":"Yamashita","sequence":"first","affiliation":[{"name":"Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Japan (Y.Y., K.O.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6844-739X","authenticated-orcid":true,"given":"Takeshi","family":"Morimoto","sequence":"additional","affiliation":[{"name":"Department of Clinical Epidemiology, Hyogo Medical University, Nishinomiya, Japan (T.M.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nao","family":"Muraoka","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Shizuoka Cancer Center, Japan (N.M.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4336-749X","authenticated-orcid":true,"given":"Wataru","family":"Shioyama","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Medicine, Shiga University of Medical Science, Japan (W.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-7622-8494","authenticated-orcid":true,"given":"Ryuki","family":"Chatani","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Medicine, Kurashiki Central Hospital, Japan (R.C.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0972-7604","authenticated-orcid":true,"given":"Tatsuhiro","family":"Shibata","sequence":"additional","affiliation":[{"name":"Division of Cardiovascular Medicine, Department of Internal Medicine, Kurume University School of Medicine, Japan (T. Shibata)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1996-8540","authenticated-orcid":true,"given":"Yuji","family":"Nishimoto","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Osaka General Medical Center, Japan (Y.N.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6659-4660","authenticated-orcid":true,"given":"Yoshito","family":"Ogihara","sequence":"additional","affiliation":[{"name":"Department of Cardiology and Nephrology, Mie University Graduate School of Medicine, Tsu, Japan (Y. Ogihara)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-6054-0076","authenticated-orcid":true,"given":"Kosuke","family":"Doi","sequence":"additional","affiliation":[{"name":"Department of Cardiology, National Hospital Organization Kyoto Medical Center, Japan (K.D.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4342-2118","authenticated-orcid":true,"given":"Maki","family":"Oi","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Japanese Red Cross Otsu Hospital, Japan (M.O.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Taro","family":"Shiga","sequence":"additional","affiliation":[{"name":"Department of Onco-Cardiology\/Cardiovascular Medicine, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo (T. Shiga)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0960-0339","authenticated-orcid":true,"given":"Daisuke","family":"Sueta","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Japan (D.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kitae","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Medicine, Kobe City Medical Center General Hospital, Japan (K. Kim)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8580-9404","authenticated-orcid":true,"given":"Yasuhiro","family":"Tanabe","sequence":"additional","affiliation":[{"name":"Department of Cardiology, St. Marianna University School of Medicine, Kawasaki, Japan (Y.T.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2113-3422","authenticated-orcid":true,"given":"Norimichi","family":"Koitabashi","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Medicine, Gunma University Graduate School of Medicine, Maebashi, Japan (N.K.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takuma","family":"Takada","sequence":"additional","affiliation":[{"name":"Institute of Advanced Biomedical Engineering and Science, and Department of Cardiology, Tokyo Women\u2019s Medical University, Japan (T.T.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8163-8038","authenticated-orcid":true,"given":"Satoshi","family":"Ikeda","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Medicine, Nagasaki University Graduate School of Biomedical Sciences, Japan (S.I.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1394-8509","authenticated-orcid":true,"given":"Hitoshi","family":"Nakagawa","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Medicine, Nara Medical University, Japan (H.N.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kengo","family":"Tsukahara","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Fujisawa City Hospital, Japan (K.T.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masaaki","family":"Shoji","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Medicine, National Cancer Center Hospital, Tokyo, Japan (M.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jiro","family":"Sakamoto","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Tenri Hospital, Japan (J.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shinji","family":"Hisatake","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Medicine, Toho University Faculty of Medicine, Tokyo, Japan (S. Hisatake)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yutaka","family":"Ogino","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Yokohama City University, Japan (Y. Ogino)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masashi","family":"Fujita","sequence":"additional","affiliation":[{"name":"Department of Onco-Cardiology, Osaka International Cancer Institute, Japan (M.F.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3845-3542","authenticated-orcid":true,"given":"Naohiko","family":"Nakanishi","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Medicine, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Japan (N.N.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomohiro","family":"Dohke","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Kohka Public Hospital, Koka, Japan (T.D.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Seiichi","family":"Hiramori","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Kokura Memorial Hospital, Kokura, Japan (S. Hiramori)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ryuzo","family":"Nawada","sequence":"additional","affiliation":[{"name":"Shizuoka City Shizuoka Hospital, Japan (R.N.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4329-5975","authenticated-orcid":true,"given":"Kazuhisa","family":"Kaneda","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Medicine, Mitsubishi Kyoto Hospital, Japan (K. 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