Author: By Lynda Williams, Senior medwireNews Reporter
medwireNews: Study findings suggest the oral factor Xa antagonist apixaban does not increase the risk of bleeding events after gynaecological cancer surgery compared with the low molecular weight heparin enoxaparin.
The open-label trial included patients who underwent laparotomy or laparoscopic surgery for a confirmed or suspected diagnosis of ovarian, uterine, cervical or vulvar cancer and did not have a known history of venous thromboembolism (VTE) or other risk factors, such as bleeding disorders.
The primary endpoint of major bleeding and clinically relevant non-major bleeding over 90 days of follow-up was comparable for the 204 patients randomly assigned to receive apixaban 2.5 mg twice daily for 28 days and the 196 patients who instead received subcutaneous enoxaparin 40 mg/day for the same duration.
Major bleeding occurred in one patient (0.5%) in both groups, while clinically relevant non-major bleeding events occurred in a statistically comparable 5.4% of apixaban-treated patients and 9.7% of those given enoxaparin, report Saketh Guntupalli, from the University of Colorado in Denver in the USA, and co-authors.
The secondary endpoint of VTE occurred in 1.0% and 1.5% of the apixaban and enoxaparin groups, respectively.
“Although this study was underpowered for the prevention of VTE, rates were slightly lower in the apixaban group, although the difference was not significant”, the investigators write in JAMA Network Open.
“This finding suggests that this modality is effective in preventing VTE [in] a greater sample size of high-risk women with gynecologic cancer”, they remark.
The apixaban and enoxaparin treatment groups had comparable experiences in terms of rates of adverse events, such as wound infection (3.4 vs 5.1%) and headache (3.4 vs 2.6%), as well as adherence to treatment (84.8 vs 83.7% missing fewer than 2 days of treatment) and physical and mental quality of life on ShortForm-8 measures.
But patients taking apixaban were significantly more likely to be satisfied than enoxaparin-treated participants with ease of use (98.9 vs 58.8%) and less likely to experience pain on use (2.1 vs 49.2%).
“These findings suggest that oral apixaban is a potentially safe, less painful, and easier-to-take alternative to subcutaneous enoxaparin for thromboprophylaxis after surgery for gynecologic cancer”, Saketh Guntupalli et al conclude.
“The efficacy of apixaban to prevent venous thromboembolic events is hypothesized as being equivalent.”
Elisabeth Diver, from Stanford University in California, USA, writes in a linked commentary that the study findings demonstrate that “[f]or women who cannot or will not perform self-injection with enoxaparin […] an alternative, oral VTE prevention strategy with apixaban in the postoperative setting is feasible, and possibly as safe with similar VTE outcomes.”
She concludes: “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.”
References
Guntupalli SR, Brennecke A, Behbakht K, et al. Safety and efficacy of apixaban vs enoxaparin for preventing postoperative venous thromboembolism in women undergoing surgery for gynecologic malignant neoplasm. JAMA Netw Open; 3:e207410. Published online 26 June 2020. doi:10.1001/jamanetworkopen.2020.7410
Diver E. Apixaban vs enoxaparin for postoperative prophylaxis: Safety of an oral alternative for the prevention of venous thromboembolism. JAMA Netw Open; 3:e208019. Published online 26 June 2020. doi:10.1001/jamanetworkopen.2020.8019
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