New agent proves superior in VTE prophylaxis

Michael Huo, MD

Barcelona— A new trial supports previous research suggesting the novel agent dabigatran is superior to the gold standard in venous thromboembolism (VTE) prophylaxis.

The RE-NOVATE II study compared dabigatran and enoxaparin as VTE prophylaxis in patients who underwent hip replacement. The agents demonstrated comparable efficacy with regard to the total incidence of VTE and all-cause mortality, but dabigatran proved twice as effective as enoxaparin at decreasing the incidence of major VTE and VTE-related mortality.

“This is the fourth phase 3 clinical trial using [dabigatran] in comparison to the standard therapy,” said investigator Michael Huo, MD, of University of Texas Southwestern Medical Center. “The additional data that we have from this study further validate the clinical efficacy and safety of this particular agent.”

More than 2000 patients were enrolled in RE-NOVATE II. Roughly half (n=1010) were given oral dabigatran at a dose of 220mg. The other half (n=1003) received subcutaneous injections of enoxaparin at 40mg. The treatment period ranged from 28 to 35 days.

Patient demographics were similar in both treatment arms. Males and females were represented equally in the study, and the median age in both groups was about 62 years of age. Weight, body mass index, race, and creatinine clearance were similar in both treatment arms.

Dr Huo and his colleagues first found that dabigatran met non-inferiority criteria with regard to the total incidence of VTE and all-cause mortality. The incidence of VTE and mortality was 7.7% in patients who received dabigatran and 8.8% in those given enoxaparin.

“[However,] the most important finding in this study, in my opinion, is that the major VTE and VTE-related death… was significantly lower in the dabigatran group, at 2.2% versus 4.4%,” Dr Huo said. “That is the most important finding because [dabigatran has] reduced the most clinically significant event rates.”

Dr Huo went on to say that dabigatran proved safe in this patient population. There was no need for monitoring the therapy or adjusting the dose. And there was no significant difference in major bleeding events between patients who took dabigatran and those who received enoxaparin¾1.4% and 0.9%, respectively.

Dr Huo presented these data as part of the Presidential Symposium at the 15th Congress of the European Hematology Association, which took place June 10-13.