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Apixaban in VTE prevention in knee surgery compared to enoxaparin – Conflicting Results from two studies using two doses of enoxaparin

Bethany Weinmeister, Pharm.D. Candidate
South Dakota State University- College of Pharmacy

Tadd Hellwig, Pharm.D., BCPS
Assistant Professor/Clinical Pharmacist
South Dakota State University-College of Pharmacy
Sanford USD Medical Center

Michael Gulseth, Pharm.D., BCPS
Director of Anticoagulation Services
Sanford USD Medical Center

Posted December, 2011

The ADVANCE 2 trial is a randomized, double-blind phase 3 study assessing apixaban’s efficacy and safety in preventing DVT in patients following knee replacement surgery1. This trial compared apixaban 2.5 mg orally twice daily (n=1528) starting 12-24 hours after wound closure to enoxaparin 40 mg subcutaneously once daily (n=1529) starting 12 hours before surgery for 10-14 days. The primary efficacy analysis, the composite occurrence of symptomatic and asymptomatic DVT, non-fatal PE, and all-cause death occurred in 147 (15%) patients taking apixaban and 243 (24%) patients receiving enoxaparin (p <0.0001). The primary safety outcome was bleeding that occurred during the trial. Major bleeding events occurred in 9 (0.6%) patients receiving apixaban compared to 14 (0.9%) patients receiving enoxaparin (p=0.30). Major or clinically relevant non-major bleeding, including wound hematoma, occurred in 53 (3.5%) of apixaban treated patients and 72 (4.8%) of enoxaparin treated patients (p=0.09).

In the ADVANCE-2 trial, apixaban displayed superiority compared to enoxaparin 40 mg daily for DVT prophylaxis following knee replacement surgery. However, results of the ADVANCE-1 trial, apixaban 2.5 mg daily compared to enoxaparin 30 mg twice daily, did not meet pre-specified non-inferiority criteria2. These conflicting outcomes question the overall efficacy of apixaban following knee replacement surgery and further study may be needed to know if these differences are clinically relevant. The ADVACE-2 trial did seem to demonstrate a favorable bleeding profile, when compared to enoxaparin, similar to what was seen in ADVANCE-1.

References:

  1. Lassen MR, Raskob GE, Gallus A, et al. Apixaban versus enoxaparin for thromboprophylaxis after knee replacement (ADVANCE – 2): a randomized double-blind trial. Lancet. 2010;375;807-15.

  2. Lassen MR, Raskob GE, Gallus A, et al. Apixaban or Enoxaparin for Thromboprophylaxis after Knee Replacement. N Engl J Med. 2009;361:594-604.
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