Venous Thromboembolism Chemoprophylaxis in Plastic Surgery: A Randomized Controlled Trial of Apixaban versus Enoxaparin.

BACKGROUND

Venous thromboembolism (VTE) remains an important safety issue in surgery. Although enoxaparin is the most common medication for VTE chemoprophylaxis in plastic surgery, several limitations have been discussed that may contribute to breakthrough VTE events. These include the following: (1) the need for weight-based dosing; (2) the need for factor Xa monitoring to ensure adequate therapeutic levels; and (3) the need for subcutaneous injection. Apixaban may represent a potential solution; however, experience with direct factor Xa inhibitors in the plastic surgery literature is limited. Thus, the authors present a first-of-its-kind randomized controlled trial of apixaban versus enoxaparin for VTE chemoprophylaxis among high-risk breast cancer patients undergoing autologous breast reconstruction.

METHODS

This was a single-center, blinded, randomized controlled trial comparing enoxaparin versus apixaban VTE chemoprophylaxis among women undergoing microsurgical breast reconstruction with free abdominal flaps.

RESULTS

Seventy-nine eligible patients were enrolled, of whom 40 (51%) were randomized to enoxaparin and 39 (49%) were randomized to apixaban. Treatment groups demonstrated similar demographics and comorbidities. Overall, of bleeding events that occurred after initiation of VTE chemoprophylaxis, 1 (3%) occurred in the apixaban arm and 1 (3%) occurred in the enoxaparin arm. On multivariable logistic regression adjusting for demographic/clinical characteristics, the adjusted odds of a bleeding event for apixaban versus enoxaparin was 1.0 (99% CI, 0.9 to 1.1). There were no symptomatic VTE events reported in either treatment arm.

CONCLUSIONS

Apixaban is a safe fixed-dose, oral VTE chemoprophylaxis agent for use after autologous breast reconstruction. It presents a novel paradigm shift in VTE prevention after reconstructive surgery.

CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.