Apixaban is a potentially safe, less painful and easier to take alternative to subcutaneous enoxaparin, for thromboprophylaxis after surgery for gynaecologic cancer, according to a randomised clinical trial reported in JAMA Network Open.
Participants with gynaecologic cancer undergoing surgery (n=400), were randomised to receive oral apixaban (n=204)(2.5mg twice daily) for 28 days or subcutaneous enoxaparin (196) (40mg daily) for 28 days. Patients were evaluated on study day 1 (first dose), day 14, day 28 and day 90 (±14 days).
No statistically significant differences were seen between apixaban and enoxaparin groups in the primary endpoints of major bleeding (1 patient per group), clinically relevant non-major (CRNM) bleeding events (12 patients versus 19 patients, respectively), during the treatment phase and 30 days post-treatment.
No significant differences were seen in the secondary endpoints of venous thromboembolism (VTE) (2 patients versus 3 patients, respectively), adverse events, medication compliance, or quality of life.
Participant satisfaction was significantly greater in the apixaban group with regard to ease of taking the medication (186 patients versus 110, respectively) and pain associated with taking the medication (4 patients versus 92, respectively).
A noninferiority trial for apixaban is required to further confirm efficacy and safety.