Pulmonary vascular disease & thromboembolismRandomised controlled trial
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 Pulmonary Embolism (PE) Trial)
- Randomised controlled trial
- open-label
- adjudicator-blinded
- multicentre
- 32 institutions in Japan
Authors' conclusion
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.
Study context
- Population
- Patients with cancer and acute low-risk PE (simplified PESI score 1)178 ITT
- Participants
- 179 patients
- Comparison
- Rivaroxaban 18 months vs 6 months
- 18-month rivaroxabann = 89
- 6-month rivaroxabann = 89reference
- Primary endpoint
- Recurrent VTE
- Follow-up
- 18 months
Primary result
As reported in the abstract
Odds ratio
0.25
95% CI 0.09–0.72
P = 0.01
Events by treatment group
18-month rivaroxaban vs 6-month rivaroxaban
OR 0.25 (95% CI 0.09–0.72); P = 0.01
Secondary outcomes
Recurrent venous thromboembolism (VTE) types (all 22 events)
- Symptomatic recurrent VTE
- 5
- Recurrent PE (2 main, 4 lobar)
- 11
- Recurrent DVT (3 proximal)
- 11
Safety
| Outcome | 18-month rivaroxaban | 6-month rivaroxaban | OR (95% CI) | P value | |
|---|---|---|---|---|---|
| Major bleeding (ISTH), major secondary end point · 18 months | 7.8% | 5.6% | 1.43 (0.44–4.70) | P = 0.55 | |
| 0.20.5125Odds ratio (log scale) |
Original publication
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). Circulation. Published 18 November 2024. doi:10.1161/circulationaha.124.072758
Summarised from the published abstract; every number is checked against it