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1213-209 / 209 - 30 DAY MORTALITY FOLLOWING ANDEXANET ALFA IN ANNEXA-4 COMPARED WITH PROTHROMBIN COMPLEX CONCENTRATE (PCC) THERAPY IN THE ORANGE STUDY FOR LIFE THREATENING NON-VITAMIN K ORAL ANTICOAGULANT (NOAC) RELATED BLEEDING
Authors
Alexander Thomas Cohen, Megan Lewis, Augusta Connor, Stuart Connolly, Patrick Yue, John Curnutte, Peter MacCallum, Joachim Tan, Laura Green, Guy's and St Thomas' Hospitals NHS Foundation Trust, London, United Kingdom
Abstract
Background: Life-threatening NOAC related major bleeding is associated with high mortality. Off-label PCC is currently recommended in some guidelines as well as the approved specific antidote, andexanet alfa (andexanet). There are no randomised controlled trials comparing these therapies and hence we undertook an indirect comparison using data from two studies. Methods: The ANNEXA-4 trial of andexanet enrolled patients with NOAC related life-threatening bleeding. The observational ORANGE study included patients with anticoagulant-related major bleeding, including life-threatening bleeding. Using propensity score (PS) matching we derived two cohorts with life-threatening bleeding, receiving NOACs and either andexanet or PCC. Matching covariates included age, bleed site, history of atrial fibrillation (AF), venous thromboembolism (VTE), stroke, renal dysfunction and cancer. Results: In the PS matched cohorts 322 andexanet patients were compared with 88 PCC patients. In the andexanet and PCC cohorts the mean age was 78 and 75; 84% and 79% had a history of AF, intracranial haemorrhage (ICH) was present in 65% and 67%; gastrointestinal bleeding (GIB) in 25% and 29% respectively. Thirty day mortality was lower in patients receiving andexanet overall and in the ICH subgroup (Table). Conclusion: The adjusted mortality rates were lower in patients receiving andexanet alfa than in matched patients receiving PCC. Unaccounted bias and confounding factors may occur in this type of comparison.
Adjusted 30 day mortality following NOAC related life-threatening bleeding