AAOS2017: Assessing major wound complication rate of rivaroxaban, LMWH or placebo in THA

Study Type: Randomized Trial
OE Level of Evidence: N/A
Journal Level of Evidence: N/A
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Synopsis
958 patients scheduled for total hip arthroplasty were randomized to different groups for thromboprophylaxis. In patients <60 years of age (n=600), randomization was to either rivaroxaban, enoxaparin, or placebo. In patients 60 Please login to view the rest of this report. Please login to view the rest of this report.
Why was this study needed now?
Over the past decade, the use of oral direct factor Xa inhibitors, such as rivaroxaban, for anticoagulation following total joint arthroplasty has increased, with a number of randomized controlled trials demonstrating efficacy in comparison to more standard drugs like low-molecular-weight heparin. Despite effectiveness, many have expressed concerns that previous studies have failed to thoroughly evaluate and compare the incidence of major wound surgical complications.
What was the principal research question?
In total hip arthroplasty, is there any significant difference in the incidence of surgical wound complications between oral factor Xa direct inhibitor (rivaroxaban) and either low molecular weight heparin (enoxaparin) or placebo?
Population: 958 patients scheduled for primary total hip arthroplasty. Randomization was stratified by age: patients under the age of 60 years were randomized to one of rivaroxaban, enoxaparin, or placebo; patients 60 years of age or older were randomized to either rivaroxaban or enoxaparin.
Intervention: Rivaroxaban: Beginning 12 hours after surgery, administration of rivaroxaban was started, and continued for two weeks postoperatively. (n=200 patients <60 years of age; n=179 patients >60 years of age)
Comparison: Enoxaparin: Beginning 12 hours after surgery, administration of enoxaparin was started, and continued for two weeks postoperatively. (n=200 patients <60 years of age; n=179 patients >60 years of age) Placebo: Beginning 12 hours after surgery, administration of placebo was started, and continued for two weeks postoperatively. (n=200 patients <60 years of age)
Outcomes: The primary outcome was the incidence of major surgical wound complications. The secondary outcome was the incidence of minor surgical wound complications.
Methods: RCT
Time: Follow-up was scheduled for 14 days.
What were the important findings?
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How will this affect the care of my patients?
The authors responsible for this critical appraisal and ACE Report indicate no potential conflicts of interest relating to the content in the original publication.