Related ACE Reports
- Published: Mar 2017
- ACE Report #9601
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
CONFERENCE ACE REPORTS
This ACE Report is a summary of a conference presentation or abstract. The information provided has limited the ability to provide an accurate assessment of the risk of bias or the overall quality. Please interpret the results with caution as trials may be in progress and select results may have been presented.
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.|
|Time:||Follow-up was scheduled for 14 days.|
What were the important findings?
What should I remember most?
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.