XARELTO - Reversal agents in human studies - aPCC - Sheikh-Taha et al (2023)

Sheikh-Taha et al (2023) conducted a single-center, retrospective study that evaluated the efficacy and safety of aPCC in reversing the anticoagulant effect of XARELTO and apixaban in patients with major bleeding from August 2019 through July 2022.¹

• Of the 217 patients included in the study, 52 and 165 were on anticoagulation therapy with XARELTO and apixaban, respectively. The mean age was 76.2 years, and 113 patients were male.
• The most common indication for anticoagulation was atrial fibrillation (n=173), followed by DVT/PE (n=38) and the most common bleeding sites were ICH (n=100), followed by GI (n=87) and visceral (n=15).
• After administering aPCC, the XARELTO group had 39 (75%) patients who achieved clinical hemostasis and 13 (25%) who did not. In the apixaban group, 131 (79.4%) patients achieved clinical hemostasis, whereas 34 (20.6%) did not.
  • Based on the site of bleeding, the risk of not achieving clinical hemostasis was significantly higher for patients with ICH-related bleeding vs non-ICH-related bleeding (2.5; 95% CI, 1.44-4.34; P<0.001).
• One 67-year-old female patient developed a DVT on day 2 after receiving aPCC.
• Overall, 8 patients (all with ICH) who did not achieve clinical hemostasis died during hospitalization. Additionally, 1 patient (with ICH) who achieved clinical hemostasis died due to aspiration pneumonia complicated by septic shock.
  • Mortality was significantly lower with non-ICH-related bleeding vs ICH-related bleeding (0.91; 95% CI, 0.86-0.97; P<0.001).

aPCC, activated prothrombin complex concentrate; CI, confidence interval; DVT, deep vein thrombosis; GI, gastrointestinal; ICH, intracranial hemorrhage.