Oral Apixaban May Be Safe Alternative to Subcutaneous Enoxaparin for Thromboprophylaxis

Research published in JAMA Network Open suggested that oral apixaban (Eliquis) is a safe potential alternative to subcutaneous enoxaparin (Lovenox) for thromboprophylaxis in women undergoing surgery for gynecologic cancer.¹

Moreover, satisfaction was markedly better in those treated with apixaban, and adherence rates within the trial appeared to be similar between both modalities.

“With enoxaparin use in outpatient prophylaxis demonstrating poor adherence, a more cost-effective and easier to use medication could affect VTE outcomes,” the authors wrote. “Oral anticoagulation therapy could obviate many of the negative effects associated with the subcutaneous route of administration.”

In this patient-based, multicenter, open-label, blinded, end point, randomized clinical trial conducted in outpatient and inpatient gynecologic oncology settings, women undergoing surgery for suspected or confirmed gynecologic cancer were randomized to either 28 days of apixaban at 2.5 mg taken orally twice daily or enoxaparin at 40 mg administered subcutaneously daily.

The primary outcome was major bleeding and clinically relevant nonmajor bleeding events. Key secondary outcomes included incidence of venous thromboembolic events, adverse events (AEs), medication adherence, participant quality of life (QOL), and medication satisfaction.

Of the total cohort of 400 women enrolled in the study, 204 received apixaban and 196 received enoxaparin. Importantly, the treatment groups did not differ with regard to race/ethnicity, cancer stage, or surgery modality.

Overall, no statistically significant differences were observed between the apixaban and enoxaparin groups in terms of rates of major bleeding events (0.5% vs 0.5%; OR, 1.04; 95% CI, 0.07-16.76; P > 0.99), clinically relevant nonmajor bleeding events (5.4% vs 9.7%; OR, 1.88; 95% CI, 0.87-4.1; P = 0.11), venous thromboembolic events (1.0% vs 1.5%; OR, 1.57; 95% CI, 0.26-9.50; P = 0.68), AEs, medication adherence, or QOL between the groups.

However, patient satisfaction was found to be significantly greater in the apixaban group in terms of the ease of taking the medication (98.9% vs 58.8%; OR, 0.06; 95% CI, 0.01-0.25; P < 0.001) and pain associated with taking the medication (2.1% vs 49.2%; OR, 9.20; 95% CI, 2.67-31.82; P < 0.001).

“Given the number of cancer operations that require large abdominal incisions in a variety of disease sites (e.g., pancreas or colon), these data could be considered in other disease sites that require extensive abdominal debulking,” the authors noted.

In an editorial written by Elisabeth Jenefer Diver, MD, a gynecologic oncologist and minimally invasive gynecologic surgeon at Stanford, it was suggested that efficacy is a critical outcome for this patient population and given that this study was not designed with a primary outcome of efficacy, larger randomized studies will be required to validate the current findings.²

“As more data are acquired through general use and repeated clinical trials, we are likely to see the emergence of a new standard of care for these women that improves patient satisfaction and may improve compliance,” Diver wrote. “In light of these data, a noninferiority trial designed to assess efficacy of VTE prevention will be required to change standard of care for all women in this patient population, and this study provides the scientific rationale to launch such an investigation.”

Moving forward, the study authors recommended that surgeons continue to use appropriate postoperative venous thromboembolism prophylaxis in high-risk surgical oncology patients and consider the safety of thromboprophylaxis options at their own discretion.

References:

1. Guntupalli SR, Brennecke A, Behbakht K, et al. Safety and Efficacy of Apixaban vs Enoxaparin for Preventing Postoperative Venous Thromboembolism inWomen Undergoing Surgery for Gynecologic Malignant Neoplasm. JAMA Network Open. doi: 10.1001/jamanetworkopen.2020.7410.

2. Diver E. Apixaban vs Enoxaparin for Postoperative Prophylaxis: Safety of an Oral Alternative for the Prevention of Venous Thromboembolism. JAMA Network Open. doi: 10.1001/jamanetworkopen.2020.8019.