Wesley Kafka, PharmD, BCCCP, MBA,
Critical Care Clinical Pharmacy Specialist
Charleston Area Medical Center
Charleston, West Virginia
Disclosure information not submitted.
Anthony Nowling, PharmD
Emergency Medicine Clinical Pharmacy Specialist
Charleston Area Medical Center
Charleston, West Virginia, United States
Disclosure information not submitted.
Apexa Patel, n/a
Research Associate
Charleston Area Medical Center, United States
Disclosure information not submitted.
Title: Four-factor PCC versus andexanet alfa for oral factor Xa inhibitor-associated major bleeds
Introduction: This study is to assess the rates of clinical hemostasis, in-hospital mortality, thromboembolism, and consumption of blood products to provide information to guide providers in choosing an agent for factor Xa inhibitor-associated major bleeding events.
Methods: The design was an observational cohort study that compared two cohorts (patients that received four-factor prothrombin complex (4F-PCC) vs. patients that received andexanet alfa for factor Xa associated major bleeds). It included a retrospective review of patients admitted to any Charleston Area Medical Center hospital from June 1, 2019 to December 1, 2020.
Results: A total of 201 patients were screened for exclusion with 71 patients meeting inclusion criteria (28 in the 4F-PCC group and 43 in the andexanet alfa group). For the primary objective of achieving clinical hemostasis between 4F-PCC and andexanet, 23/28 vs. 33/43 achieved the endpoint with rates of 82.14% vs. 76.74% (p=0.586) respectively. When grouped by the site of bleed, hemostasis rates were not significantly different between groups. Mortality was not significantly different between groups with 9 (32.14%) vs. 15 (34.88%) patients expiring. Rates of mortality were not significantly different when grouped by the site of bleed. Rates of thromboembolism were 3.57% vs. 2.33% (p=0.756) between groups. Rates of blood product use were not significantly different between groups.
Conclusions: This study showed no statistical difference in the rates of clinical hemostasis, in-hospital mortality, thromboembolism, or blood product consumption in the studied population. 4F-PCC and andexanet alfa have shown to be equally effective for treating factor Xa-associated major bleeding events with no difference in thromboembolism