Phase III clinical trial results demonstrate that rivaroxaban (Xarelto), a once-daily, oral investigational anticoagulant, showed superior efficacy in preventing venous blood clots in patients following total knee replacement (TKR) compared with injectable enoxaparin, whilst maintaining low major bleeding rates.
Data from the RECORD4 trial were presented today at the 9th Annual Meeting of the European Federation of National Associations of Orthopaedics & Traumatology (EFORT) in Nice, France.
The RECORD4 data show that rivaroxaban (10mg tablet once-daily) provided TKR surgery patients with a statistically significant reduction of total venous thromboembolism (VTE) event rates over twice daily injectable enoxaparin (6.9% and 10.1% respectively).
While the RECORD1, 2 and 3 studies compared rivaroxaban against enoxaparin 40mg injected once-daily to reduce blood clots after major orthopaedic surgery, RECORD4 is the first trial to evaluate rivaroxaban against enoxaparin 30mg injected subcutaneously twice-daily, which is the US Food and Drug Administration (FDA)-approved treatment regimen for enoxaparin.
“The superior efficacy and similar adverse event profile of rivaroxaban demonstrated in RECORD4 are in line with the outstanding results of the earlier RECORD studies,” said Dr A G G Turpie, Professor of Medicine, McMaster University, Canada and Principal Investigator for the RECORD programme.
“The success of this trial strengthens my belief that direct Factor Xa inhibition with rivaroxaban has the potential to revolutionise the way we prevent the formation of dangerous blood clots.”