Respiratory Trials·org

Pulmonary embolism · Extended anticoagulation

HI-PRO randomised trial

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