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RE-NOVATE II: Dabigatran superior to enoxaparin after total hip replacement
Dabigatran had a lower composite total of VTE and death from all causes.
Extended prophylaxis with the oral anticoagulant dabigatran was superior in efficacy to subcutaneous enoxaparin at preventing venous thromboembolism and death from any cause in patients undergoing total hip replacement, according to the results of the RE-NOVATE II trial.
“These positive findings, together with the results of the RE-NOVATE trial combining the results from more than 5,000 patients, confirm that dabigatran etexilate once daily is as effective as enoxaparin in patients following total hip replacement surgery for the prevention of VTE, with a similar safety profile,” said Michael Huo, MD, department of orthopedic surgery, University of Texas Southwestern Medical Center. “The additional and encouraging finding from this trial is that dabigatran etexilate was associated with significantly lower rates of major VTE and VTE-related death.”
The double blind, noninferiority trial examined 2,055 patients undergoing total hip replacement surgery. The trial was designed to compare efficacy and safety of oral dabigatran to subcutaneous enoxaparin. Patients were randomly assigned prophylactic treatment for 28 to 35 days with dabigatran 220 mg daily or enoxaparin 40 mg once daily.
The primary efficacy endpoint was a composite total of VTE and death from all causes; the primary safety endpoint was major bleeding. A secondary efficacy endpoint was major VTE and VTE-related death.
The median duration of patient treatment was 32 days. Of the total number of patients enrolled, 1,577 were included in the efficacy analysis.
Composite total of VTE and death from all causes occurred in 7.7% of patients in the dabigatran group vs. 8.8% of patients in the enoxaparin group (P<.0001). When examining the secondary efficacy endpoint, the researchers found that it occurred in 2.2% of the dabigatran group vs. 4.2% of the enoxaparin group (P=.03).
There was no significant difference found in the rates of major bleeding between the two treatments.
“As dabigatran etexilate is taken by mouth, it is more convenient than injectable anticoagulants such as enoxaparin. This advantage can also provide cost-saving benefits for national health care systems, as shown in the United Kingdom, where the extended use of dabigatran etexilate was shown to provide a significant reduction in costs due to its oral administration when compared with enoxaparin,” Huo said in a press release. “Dabigatran etexilate should therefore be considered as a treatment option in this clinical setting.”
For more information:
- Huo M. Oral dabigatran versus enoxaparin for thromboprophylaxis after primary total hip arthroplasty: the RE-NOVATE II randomized trial. Presented at: 15th Congress of the European Hematology Association; June 10-13; Barcelona.