Adjunct Associate Professor of Pharmacy University of New Mexico Health Sciences Center Albuquerque, New Mexico, United States
Background: Increasing numbers of US patients are being prescribed Factor Xa inhibitors (FXaI); thus, more patients are presenting to hospitals for major bleeding. Recent studies show significant reductions for in-hospital and 30-day mortality with andexanet versus 4 Factor Prothrombin Complex Concentrate (4F-PCC) suggesting that deaths are preventable with the use of approved antidotes.
Aims: To estimate the number of patients presenting to US hospitals in 2024 prescribed Apixaban or Rivaroxaban requiring major bleeding treatment and the number of preventable deaths if andexanet was utilized versus non-specific factor replacement strategies.
Methods: 2020 data suggests that the number of ED Visits for DOACS was 189,325 with 93.716 patients requiring hospitalization for major bleeding with 93.4% (87, 531) on apixaban/rivaroxaban. FXaI prescriptions are rising approximately 25% per year suggesting a similar increases for major bleeding. Prescription data from 2020 was underestimated; thus with mathematical modeling, bleeding data will be inflated by year at current rates to estimate the total number of major bleeds per year and the number of preventable deaths if the antidote andexanet was optimized.
Results: Undercapture of FXaI prescription data was around 15%; thus, baseline bleeds were increased from 87,531 to 100,660 patients. Given a fixed annual increase of 25%, major bleeds from FXaI requiring hospitalization will rise to 125,826, 157,282, 196,603, and 245,753 in 2021 through 2024. Assuming 80% (196,602 patients) require bleed management and 75% of these will be given 4F-PCC yields 147,452 patients. With the 4.6% reduction of in-house and 12.4% reduction of 30-day mortality with andexanet , 6,783 to 18,284 deaths are preventable deaths if andexanet use was optimized.
Conclusion(s): 6,783 to 18,284 US deaths could be prevented in 2024 if andexanet was used vs 4F-PCC for FXaI major bleeds. This is likely underestimated given emerging data on improved hemostatic efficacy, hematoma volumes, and reductions in anti-Factor Xa levels with andexanet.
