New data reinforces the value of recombinant factor Xa (Andexxa, Portola Pharmaceuticals, South San Francisco, CA). Use of recombinant factor Xa to reverse anticoagulation with rivaroxaban, apixaban, or warfarin was associated with a lower rate of in-hospital and 30-day mortality compared with 4-factor prothrombin complex concentrate (4F-PCC), which is approved only for reversal of warfarin. The lowered rates of mortality were seen with recombinant factor Xa in individuals with multiple bleed types including intracranial hemorrhage (ICH), gastrointestinal bleeding (GI), and bleeding due to trauma. Recombinant factor Xa is the first and only eversal agent approved by the Food and Drug Administration (FDA) for the Factor Xa inhibitors rivaroxaban or apixaban.
Case matched data showed 30-day mortality was 14.6% with recombinant factor Xa vs 34.1% with 4F-PCC across all bleed types, a relative risk reduction of 57.2%. Among the subgroup of individuals who experienced ICH, 30-day mortality was lower in those who received recombinant factor Xavs 4F-PCC (15.3% vs 48.9%), and the relative risk reduction was greater (68.7%).In a separate analysis, real-world data showed in-hospital mortality was 4% with recombinant factor Xa vs 10% with 4F-PCC across all bleed types. Among those who experienced ICH, the in-hospital mortality was 9% with recombinant factor Xa vs 25% with 4F-PCC.
These findings are based on the results of multiple data sets. An indirect comparison of recombinant factor Xa and 4F-PCC results was made with case-matched data from 2 large studies of people treated with factor Xa inhibitor. The 322 participant Annexa-4 study (NCT02329327) and the Orange, a 3-year prospective registry of participants with major bleeding who received 4F-PCC. The second was a real-world study of electronic medical records from 45 US hospitals used to identify individuals admitted for bleeding related to factor Xa inhibitors (1,075 bleeds).
"These findings contribute to the growing body of evidence supporting the potential life-saving benefits of Andexxa, the first and only FDA-approved reversal agent for the factor Xa inhibitors rivaroxaban or apixaban," said Rajiv Patni, MD, Portola's chief medical officer." We have a robust strategy to generate and present additional data over the next year, which we believe will enhance our ability to educate key hospital stakeholders that by choosing Andexxa, they can prioritize both the clinical value it provides and responsible budgeting in their patient care."
Duriel I. Hardy, MD, and Sona Narula, MD
Vishnu Anand Cuddapah, MD, PhD; Susan Matesanz, MD; Sabrina W. Yum, MD; Brenda L. Banwell, MD; and Donna Stephenson, MD