Siddharth Patel, MD, MPH: Abelacimab Could Help Reduce Procedure-Related Bleeding

New data from the AZALEA-TIMI 71 trial is shedding further light on the potential benefits of factor XI inhibition with abelacimab.

Presented at the European Society of Cardiology (ESC) Congress 2024, the analysis focused on periprocedural and procedural-related bleeding events, with results demonstrating use of abelacimab was associated with a reduced rate of major and clinically relevant nonmajor bleeding events.

“These results are encouraging and add to the growing body of evidence supporting the safety profile of abelacimab and suggest that long-acting factor XI inhibition is feasible in a contemporary atrial fibrillation patient population who commonly require invasive procedures,” said presenting investigator Siddharth Patel, MD, MPH, cardiologist at Brigham and Women’s Hospital.² “While traditionally the approach for DOACs (and warfarin) has been to interrupt anticoagulation for most elective procedures, these data suggest that such routine interruption may not be necessary with abelacimab for all elective procedures.”

In September 2023, Anthos Therapeutics announced the trial was being stopped on the recommendation of their independent data and safety monitoring committee as a result of an “overwhelming reduction” in the composite endpoint of major and clinically relevant nonmajor (CRNM) bleeding events with abelacimab relative to rivaroxaban among 1200 patients with atrial fibrillation.³

Just 2 months later, at the American Heart Association 2023 Scientific Sessions, the full presentation of data revealed use of abelacimab was associated with a 74% reduction in major bleeding alone with abelacimab 150 mg relative to rivaroxaban 20 mg (HR 0.26, 95% CI 0.11 to 0.61; P = .002), a 93% reduction in gastrointestinal bleeding with abelacimab 150 mg vs rivaroxaban 20 mg (HR 0.07, 95% Cl 0.01 to 0.50; P = .008), and 51% reduction in net clinical outcome with abelacimab 150 mg relative to rivaroxaban 20 mg (HR, 0.49; 95% CI, 0.33 to 0.71; P <.001).³

The ESC Congress data contained information from 1287 patients followed for a median of 2.1 years. Among this cohort, 920 invasive procedures occurred, with 34% occurring among the abelacimab arms and 36% occurring among the rivaroxaban arms.^1,2

Upon analysis, Patel and colleagues found procedure-related major or clinically relevant non-major bleeding occurred among 0.8% of patients randomized to abelacimab compared to 1.4% of patients randomized to rivaroxaban (RR, 0.58; 95% CI, 0.20 to 1.73). When assessed at a procedure level, results indicated 14 procedure-related major or clinically relevant non major bleeding events occurred, affecting 1.2% of procedures in the abelacimab arms and 2.2% of procedures in the rivaroxaban arm (RR, 0.54; 95% CI, 0.19 to 1.58).^1,2

For more on the study, check out our interview from ESC Congress 2024 with Patel.

Patel has no relevant disclosures to report.

References:

1. S Patel. Long-acting Factor XI Inhibition and Periprocedural Bleeding: A Secondary Analysis from AZALEA-TIMI 71. Presented at: European Society of Cardiology Congress 2024. August 30 - September 2, 2024. London, UK.
2. Anthos Therapeutics. Anthos Therapeutics unveils additional analysis from the landmark Azalea-TIMI 71 study demonstrating that the factor XI inhibitor Abelacimab was associated with remarkably low levels of periprocedural bleeding in patients with atrial fibrillation. Anthos Therapeutics. September 2, 2024. Accessed September 2, 2024. https://anthostherapeutics.com/press-release/anthos_2024-09-02_release/.
3. Iapoce C. Abelacimab significantly reduces bleeding in people with atrial fibrillation, study finds. HCP Live. November 12, 2023. Accessed September 2, 2024. https://hcplive.com/view/abelacimab-significantly-reduces-bleeding-people-atrial-fibrillation.