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A new randomized trial suggests oral apixaban may be as effective as enoxaparin for thromboprophylaxis following surgery for gynecologic cancer.
Saketh Guntupalli, MD
Results of a new randomized clinical trial suggest oral apixaban is a potentially safe and less painful alternative to subcutaneous enoxaparin for thromboprophylaxis in patients undergoing surgery for gynecologic cancer.
Based on the results of the study, which compared the agents in 400 women, indicate apixaban could be as efficacious as enoxaparin for prevention venous thromboembolic events in women undergoing surgery for gynecologic cancer.
With adherence to subcutaneous enoxaparin a persistent issue among women following surgery for gynecologic cancer, a team of investigators led by Saketh Guntupalli, MD, sought to investigate the safety and efficacy of oral apixaban as an alternative for thromboprophylaxis. The current study was conducted from May 2015-March 2019 with a patient-based, multicenter, open-label, blinded, randomized design.
Patients included in the trial were randomized to receive 2.5 mg apixaban twice daily or subcutaneous 40 mg enoxaparin daily for 28 days. In total 500 women were recruited for the study. Of these, 400 were enrolled—204 were randomized to apixaban and 196 were randomized to enoxaparin. Of note, treatment groups did not differ based upon race/ethnicity, cancer stage, or surgery modality.
The goal of the study was to compare rates of major bleeding and clinically relevant nonmajor bleeding events during the first 90 days following surgery using a modified intent-to-treat analysis. Secondary endpoints for the study included the incidence of venous thromboembolism (VTE) outcomes during treatment and in the 60-day post-treatment period, adherence rates, quality of life, and medication satisfaction for apixaban versus subcutaneous enoxaparin.
Results of the analysis indicated there were no statistically significant differences between the 2 arms of the study in regard to major bleeding events (0.5% vs 0.5%; OR, 1.04; 95% CI, .07-16.76; P >.99), clinically relevant nonmajor bleeding (5.4% vs 9.7%; OR, 1.88; 95% CI, 0.87-4.1; P=.11), or VTE events (1.0% vs 1.5%; OR, 1.57; 95% CI, 0.26-9.50; P=.68). Additionally, no statically significant differences were observed between the 2 groups in regard to adverse events, medication adherence, or quality of life.
Investigators pointed out satisfaction among participants was significantly greater among those receiving apixaban when examining the ease of taking the medication (98.9% vs 58.8%; OR, 0.06; 95% CI, 0.01-0.25; P <.001) and pain associated with administration (2.1% vs 49.2%; OR, 9.20; 95% CI, 2.67-31.82; P <.001).
In a related editorial penned by Elisabeth Diver, MD, of the Department of Obstetrics and Gynecology at Stanford Cancer Institute at the Stanford University School of Medicine, noted the results of the current study support the use of oral apixaban as a safe alternative for women uninterested in continuing or using enoxaparin.
“For women who cannot or will not perform self-injection with enoxaparin, Guntupalli and his colleagues have demonstrated that an alternative, oral VTE prevention strategy with apixaban in the postoperative setting is feasible, and possibly as safe with similar VTE outcomes,” Diver wrote. “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.”
This study, “Safety and Efficacy of Apixaban vs Enoxaparin for Preventing Postoperative Venous Thromboembolism in Women Undergoing Surgery for Gynecologic Malignant Neoplasm,” was published in JAMA Network Open.