Data from three phase III clinical trials published recently suggests that rivaroxaban, an oral anticoagulant, substantially reduced the number of venous blood clots in patients undergoing total hip replacement surgery, compared to subcutaneous enoxaparin.
Two of the studies, RECORD1 (REgulation of Coagulation in major Orthopedic surgery reducing the Risk of DVT and PE) and RECORD3 are published today in the New England Journal of Medicine.
RECORD1 showed that rivaroxaban, a direct Factor Xa inhibitor, provided patients undergoing total hip replacement surgery with a 70% relative risk reduction (RRR) in total venous thromboembolism (VTE) from 3.7% in those administered enoxaparin to 1.1% for those on rivaroxaban, without an increase in bleeding rate.
The second study, RECORD3, showed that rivaroxaban provided patients undergoing total knee replacement surgery with a 49% RRR in total VTE from 18.9% in those administered enoxaparin to 9.6% for those on rivaroxaban – without increasing bleeding rates.
The RECORD2 data, published online in The Lancet journal yesterday, show that five weeks of treatment with rivaroxaban provided patients undergoing total hip replacement surgery with a statistically significant 79% RRR in total venous thromboembolic events (p<0.0001) compared to two weeks of subcutaneous enoxaparin followed by placebo. Major bleeding rates were identical and very low in both treatment groups (< 0.1% in both groups).
“Today’s publications on rivaroxaban have the potential to change clinical practice in this field,” said Bengt Eriksson, MD, PhD, Department of Orthopaedics, at the Sahlgrenska University Hospital, Sweden, and RECORD1 clinical trial leader.
“The results demonstrate that we now seem to have an effective and safe oral anticoagulant for convenient prophylaxis of venous thromboembolism. This is of great importance since patients undergoing major surgery of the hip and knee are at high risk of developing such potentially life threatening complications and the risk of VTE extends beyond hospitalisation.”
Top line results from all three studies had already been presented.
Rivaroxaban is being jointly developed by Bayer HealthCare AG and Johnson & Johnson Pharmaceutical Research & Development, LLC.