Purpose: To compare the efficacy of extended-duration thromboprophylaxis with enoxaparin for
20 days in the outpatient setting with in-hospital thromboprophylaxis with enoxaparin
(3 to 8 days) only in patients who had undergone arthroscopic surgery of the anterior
cruciate ligament (ACL). Methods: This was a single-center, randomized, double-blind, prospective trial investigating
175 ACL surgery patients. All patients received subcutaneous enoxaparin 40 mg once
daily 12 to 18 hours presurgery and 3 to 8 days postsurgery during hospitalization.
After discharge, patients were randomized to 40 mg enoxaparin (n = 87) or placebo
(n = 88) self-administered once daily subcutaneously for 20 days. The primary efficacy
end-points were the incidences of symptomatic and asymptomatic deep vein thrombosis
(DVT) and pulmonary embolism (PE). Primary safety endpoints were the incidences of
major and minor bleeding. Results: Thirty-five patients were excluded because of noncompliance with the predefined protocol.
No patient had DVT confirmed by magnetic resonance venography (MRV) at discharge.
Of 140 patients in the intention-to-treat population, 2 (2.8%) who received postdischarge
enoxaparin (n = 72) and 28 (41.2%) who received placebo (n = 68) had DVT confirmed
by MRV (P < .001). No patients were diagnosed with PE. No major bleeds occurred. Minor bleeding
occurred in 13 (2.5%) out of 513 postdischarge enoxaparin injections and 10 (2.0%)
out of 492 placebo injections (P = .595). Risk factors for DVT during the 20 days postdischarge were age >30 years
(odds ratio [OR]: 3.241; 95% confidence interval [CI], 1.015 to 10.349) and immobilization
before surgery (OR 18.195; 95% CI, 2.046 to 161.837). Conclusions: Extended-duration postdischarge thromboprophylaxis for 20 days with enoxaparin in
the outpatient setting significantly reduced the incidence of DVT in ACL surgery patients
compared with enoxaparin limited to in-hospital thromboprophylaxis without increasing
major or minor bleeding. Level of Evidence: Level I, high-quality randomized controlled trial.
Key Words
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Article info
Footnotes
Supported by an unrestricted educational grant from Sanofi-Aventis, Paris, France.
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© 2007 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.
