Arthroscopy: The Journal of Arthroscopic & Related Surgery
Original ArticleExtended-Duration Thromboprophylaxis With Enoxaparin After Arthroscopic Surgery of the Anterior Cruciate Ligament: A Prospective, Randomized, Placebo-Controlled Study
Section snippets
Methods
This was a randomized, double-blind, prospective trial performed in a university teaching hospital in patients undergoing arthroscopic ACL surgery. The study was approved by the local ethics committee, and all participating patients provided written informed consent before enrollment.
Patients aged 19 to 55 years, with a maximum weight of 100 kg, who were admitted to the hospital for arthroscopic ACL surgery were included in this study. Patients were excluded if they had participated in another
Results
A total of 175 patients were enrolled in the study, and all patients received enoxaparin during the inpatient phase (Fig 1). At hospital discharge, no patient had MRV-confirmed DVT. Postdischarge, 87 patients were randomized to the enoxaparin treatment group and 88 patients to the placebo group.
Thirty-five patients were not included in the ITT population (Fig 1) on either medical grounds (they underwent arthroscopy but not ACL surgery, n = 16), because of noncompliance with the study protocol
Discussion
Results from this study show that, in patients who have undergone arthroscopic ACL surgery, the incidence of DVT is significantly reduced (P < .001) with extended-duration postdischarge thromboprophylaxis with enoxaparin (40 mg SC OD) for an additional 20 days compared with enoxaparin limited to in-hospital thromboprophylaxis (3 to 8 days), without an associated increase in major or minor bleeding.
The rates of DVT found in this study (extended-duration thromboprophylaxis, 2.8%; in-hospital
Conclusions
Extending the duration of thromboprophylaxis with enoxaparin by an additional 20 days postoperatively resulted in a statistically significant reduction (P < .001) in venographically detected DVT without an associated increase in major or minor bleeding compared with enoxaparin limited to in-hospital thromboprophylaxis for 3 to 8 days.
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Supported by an unrestricted educational grant from Sanofi-Aventis, Paris, France.