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.

Authors

Wei Xiong, Yugo Yamashita, Takeshi Morimoto, Nao Muraoka, Wataru Shioyama, Yoshihisa Nakagawa, Ryuki Chatani, Hiromi Yamamoto, Tatsuhiro Shibata, Nagisa Morikawa, Yoshihiro Fukumoto, Yuji Nishimoto, Koh Ono, Takeshi Kimura

Published in

Seminars in thrombosis and hemostasis. Aug 14, 2026. Epub Aug 14, 2026.

Abstract

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=104) and no DVT subgroup (N=74) 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-month 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=0.25) and was significantly lower in the no DVT subgroup (0.0% vs. 24.2%, log-rank P=0.006), without significant interaction between treatment durations and concomitant DVT (Pinteraction=0.99). There were no significant differences in the cumulative 18-month incidence of major bleeding between the 18-month and 6-month rivaroxaban groups in both the DVT (4.6% vs. 5.8%, log-rank P=0.70) and no DVT (13.4% vs. 5.8%, Log-rank P=0.29) subgroups, without significant interaction (Pinteraction=0.34). 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.

PMID:
42601051
Bibliographic data and abstract were imported from PubMed on 15 Aug 2026.

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