Monday, March 30, 2026

Home treatment for low-risk cancer-associated PE shows 4.6% major bleeding rate in ONCO PE companion report

Key Takeaway
Consider home treatment as a potential option for active cancer patients with low-risk PE (sPESI score=1).

This predetermined companion report from the multicenter, randomized ONCO PE trial in Japan evaluated the 3-month clinical outcomes of home treatment versus in-hospital treatment for active cancer patients with low-risk pulmonary embolism (PE). The parent trial investigated the optimal duration of rivaroxaban treatment in cancer-associated PE patients with a simplified Pulmonary Embolism Severity Index (sPESI) score of 1. Among 178 study patients, 66 (37%) were assigned to home treatment and 112 (63%) to in-hospital treatment. The primary endpoint was a composite of PE-related death, recurrent venous thromboembolism (VTE), and major bleeding. At 3 months, this composite endpoint occurred in 3 patients (4.6% [95% CI: 0.0-9.6%]) in the home treatment group and in 2 patients (1.8% [95% CI: 0.0-4.3%]) in the in-hospital treatment group. A detailed analysis of the home treatment group revealed no cases of PE-related death or recurrent VTE. However, major bleeding occurred in 3 patients (4.6% [95% CI: 0.0-9.6%]), and 2 of these patients (3.0% [95% CI: 0.0-7.2%]) required hospitalization due to the bleeding events. The report concludes that active cancer patients with PE and an sPESI score of 1 could be potential candidates for home treatment.

View Original Abstract ↓
BACKGROUND: Patients with appropriately selected low-risk pulmonary embolism (PE) can be treated at home, although it has been controversial whether applies to patients with cancer, who are considered not to be at low risk.Methods and Results: The current predetermined companion report from the ONCO PE trial evaluated the 3-month clinical outcomes of patients with home treatment and those with in-hospital treatment. The ONCO PE trial was a multicenter, randomized clinical trial among 32 institutions in Japan investigating the optimal duration of rivaroxaban treatment in cancer-associated PE patients with a score of 1 using the simplified version of the Pulmonary Embolism Severity Index (sPESI). Among 178 study patients, there were 66 (37%) in the home treatment group and 112 (63%) in the in-hospital treatment group. The primary endpoint of a composite of PE-related death, recurrent venous thromboembolism (VTE) and major bleeding occurred in 3 patients (4.6% [0.0-9.6%]) in the home treatment group and in 2 patients (1.8% [0.0-4.3%]) in the in-hospital treatment group. In the home treatment group, there were no cases of PE-related death or recurrent VTE, but major bleeding occurred in 3 patients (4.6% [0.0-9.6%]), and 2 patients (3.0% [0.0-7.2%]) required hospitalization due to bleeding events. CONCLUSIONS: Active cancer patients with PE of sPESI score=1 could be potential candidates for home treatment.