Patients with provoked venous thromboembolism (VTE) usually discontinue anticoagulation after 3 to 6 months. However, in the presence of persistent factors such as obesity, immobility, heart failure, or chronic lung disease, the risk of recurrence may remain elevated.
The HI-PRO study evaluated whether a prolonged low-dose apixaban strategy could reduce this risk without significantly increasing major bleeding.
This was a randomized, double-blind trial that included 600 patients with DVT/PE previously treated with full anticoagulation for at least 3 months, without prior recurrences, but with ≥1 persistent risk factor. Patients with anemia, active cancer within the past 5 years, pregnancy, or breastfeeding, among others, were excluded.
Participants were randomized to apixaban 2.5 mg twice daily or placebo for 12 months. The primary endpoint was confirmed symptomatic recurrence of VTE.
Results showed that apixaban significantly reduced recurrence risk compared to placebo (HR 0.13; 95% CI 0.04–0.36; p=0.001). The benefit was achieved with a low rate of major bleeding, although with a numerical increase in clinically relevant non-major bleeding.
Read also: ESC 2025 | DIGIT-HF: Digitoxin in Heart Failure with Reduced Ejection Fraction.
The authors concluded that, in patients with provoked VTE but persistent risk factors, extended low-dose apixaban provides additional protection against recurrence, with a favorable safety profile.
Presented by Gregory Piazza in Major Late Breaking Trials, ESC 2025, Madrid, Spain.
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