Trial reportCirculation2025
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).
Trial report in Circulation, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04724460 (Optimal Duration of Anticoagulation Therapy for Low-risk Pulmonary Embolism Patients With Cancer), which is not on this map. Cited by 8 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Optimal Duration of Anticoagulation Therapy for Low-risk Pulmonary Embolism Patients With Cancer
Who cites it
8 citing papers in PubMed.
- Extended Anticoagulation Therapy With Rivaroxaban for Cancer-Associated Low-Risk Pulmonary Embolism According to Different Performance Status Scores: Insights From the ONCO PE Randomized Trial.Journal of the American Heart Association · 2026Trial
- A Bleeding Risk Score for Cancer-Associated Venous Thromboembolism in Patients Receiving Direct Oral Anticoagulants.JACC. CardioOncology · 2026Article
- Comparison of aspirin and rivaroxaban for the prevention of pulmonary embolism and deep vein thrombosis in high thrombotic risk patients with systemic lupus erythematosus: study protocol for a multicentre, prospective, randomised controlled trial.Lupus science & medicine · 2026Article
- Antithrombotic therapy for cancer-associated venous thromboembolism.Clinical research in cardiology : official journal of the German Cardiac Society · 2026Review
- Venous Thromboembolism Management and Anticoagulation Opportunities in Cancer Patients.European cardiology · 2026Review
- [Lung Cancer with Pulmonary Embolism: Evidence-based Progress in Anticoagulation Assessment and Management].Zhongguo fei ai za zhi = Chinese journal of lung cancer · 2025Review
- Management of cancer-associated venous thromboembolism: Perspectives on optimizing current therapeutics with a focus on factor XI inhibition.Journal of thrombosis and thrombolysis · 2025Review
- Long-term bleeding events post-percutaneous coronary intervention in patients with malignancy with and without anticoagulant therapy.Cardiovascular intervention and therapeutics · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
32 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe 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.
methodsIn 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.
resultsFrom 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, 0.09-0.72];
conclusionsIn 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. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04724460.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.