Results from a pre-specified pooled analysis of three phase III studies, RECORD1, 2 and 3, were presented at the 20th International Congress on Thrombosis (ICT) in Athens.
The investigational anticoagulant rivaroxaban (Xarelto), taken as one tablet once daily, has shown to be significantly more effective than enoxaparin at reducing the composite of symptomatic venous thromboembolism (VTE) and all cause mortality at day 12 of treatment after major orthopedic surgery.
With these findings, rivaroxaban is the first novel oral anticoagulant to demonstrate a significant reduction of this clinical endpoint when compared to existing standard therapy. Adverse events that may affect surgical outcomes were not significantly increased including bleeding.
Rivaroxaban is being jointly developed by Bayer HealthCare AG and Johnson & Johnson Pharmaceutical Research & Development LLC.
“Results from this pooled analysis emphasise the potential of rivaroxaban to play a key role in reducing the risks for patients undergoing major orthopedic surgery,” said Dr Graham Turpie, Professor of Medicine, McMaster University, Canada and Principal Investigator for the RECORD programme.
“It is the first time since anticoagulants were introduced that a new oral compound has significantly reduced the number of symptomatic blood clots and deaths compared to current standards.
“Together with its improved convenience and the outstanding efficacy results from the individual RECORD studies, rivaroxaban has the promise to set a new clinical standard in the prevention of VTE.”