Apixaban for Extended Treatment of Provoked Venous Thromboembolism
HI-PRO trial design and results
Design
Phase 4 randomised controlled trial
Treatment
Low-intensity apixaban for 12 months
Control
Placebo
Population
600 patients with provoked venous thromboembolism and enduring risk factors, mean age 59.5, 57.0% female
Follow-up
12 months
Primary endpoint
Symptomatic recurrent venous thromboembolism
Result
Symptomatic recurrent venous thromboembolism occurred in 4 of 300 (1.3%) on apixaban, substantially fewer than on placebo, with a low risk of major bleeding.
Secondary endpoints
Major bleeding, clinically relevant non-major bleeding, all-cause mortality
Among patients with provoked VTE and enduring risk factors, low-intensity therapy with apixaban for 12 months resulted in a lower risk of symptomatic recurrent VTE than placebo, with a low risk of major bleeding.
The trial authors, in the published abstract
How it has aged
Attacks the assumption that a provoked clot needs only a short course. Where the provoking factor has not gone away, extended low-intensity treatment prevents recurrence cheaply and safely. Complements RENOVE, which asked the dose question in patients already on indefinite treatment.
Publications
Apixaban for Extended Treatment of Provoked Venous Thromboembolism
Piazza G, Bikdeli B, Pandey AK, et al. Apixaban for Extended Treatment of Provoked Venous Thromboembolism. N Engl J Med 2025 Sep 25;393(12):1166-1176.
Symptomatic recurrent VTE in 1.3% on apixaban
Low rate of major bleeding
Population had provoked VTE with persisting risk factors