ONCO PE
Trial question
What is the role of 18-month rivaroxaban therapy in patients with cancer and acute low-risk PE?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
53.0% female
47.0% male
N = 178
178 patients (95 female, 83 male).
Inclusion criteria: patients with cancer and acute low-risk PE.
Key exclusion criteria: anticoagulation therapy; contraindication to rivaroxaban; life expectancy ≤ 6 months.
Interventions
N=89 18-month rivaroxaban (at a dose of 15 mg BID for the first 3 weeks followed by 15 mg once daily thereafter for a total of 18 months).
N=89 6-month rivaroxaban (at a dose of 15 mg BID for the first 3 weeks followed by 15 mg once daily thereafter for a total of 6 months).
Primary outcome
Recurrent venous thromboembolism at 18 months
5.6%
19.1%
19.1 %
14.3 %
9.6 %
4.8 %
0.0 %
18-month
rivaroxaban
6-month
rivaroxaban
Significant
decrease ▼
NNT = 7
Significant decrease in recurrent VTE at 18 months (5.6% vs. 19.1%; OR 0.25, 95% CI 0.09 to 0.72).
Secondary outcomes
No significant difference in major bleeding at 18 months (7.8% vs. 5.6%; OR 1.43, 95% CI 0.44 to 4.7).
No significant difference in all-cause mortality (32.6% vs. 25.8%; OR 1.39, 95% CI 0.72 to 2.66).
No significant difference in symptomatic recurrent VTE (1.1% vs. 4.5%; OR 0.24, 95% CI 0.03 to 2.2).
Conclusion
In patients with cancer and acute low-risk PE, 18-month rivaroxaban was superior to 6-month rivaroxaban with respect to recurrent VTE at 18 months.
Reference
Yugo Yamashita, Takeshi Morimoto, Nao Muraoka et al. 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. 2024 Nov 18. Online ahead of print.
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