Abelacimab Shows Low Bleeding Risk During Procedures in AF Patients: AZALEA-TIMI 71 Trial
USA: A recent analysis from the AZALEA-TIMI 71 trial, published in the Journal of the American College of Cardiology (JACC), highlights that the novel long-acting factor XI inhibitor abelacimab may offer a safer bleeding profile for patients with atrial fibrillation (AF) undergoing invasive procedures. The study was conducted by Dr. Siddharth M. Patel and colleagues from the TIMI Study Group at Brigham and Women’s Hospital and Harvard Medical School.
Abelacimab is a monoclonal antibody that targets factor XI, an emerging therapeutic target in anticoagulation therapy. With a half-life of approximately 28 days, abelacimab allows for once-monthly subcutaneous administration. In the AZALEA-TIMI 71 trial, researchers evaluated two monthly doses of abelacimab (90 mg and 150 mg) against daily rivaroxaban in patients with AF to assess bleeding risks, particularly around the time of invasive procedures.
The key findings were as follows:
- The study followed patients for a median duration of 2.1 years.
- A total of 441 patients underwent 920 invasive procedures, including colonoscopies, coronary angiography, and orthopedic surgeries.
- Approximately one-third of participants in both the abelacimab and rivaroxaban groups had at least one invasive procedure.
- The majority of procedures (75.7%) were elective and categorized as low bleeding risk.
- Major or clinically relevant non-major (CRNM) bleeding within 30 days post-procedure occurred in 1.2% of procedures in the abelacimab group, compared to 2.2% in the rivaroxaban group.
- The risk ratio for bleeding between abelacimab and rivaroxaban was 0.54.
- For procedures conducted within 30 days of the last abelacimab dose, only 0.9% were associated with significant bleeding.
These findings are particularly relevant because managing anticoagulation around the time of surgery remains a clinical challenge. Traditional agents like warfarin and direct oral anticoagulants (DOACs) carry substantial bleeding risks, often necessitating treatment interruption. However, the data from AZALEA-TIMI 71 suggest that abelacimab’s bleeding risk is notably lower, even without routine discontinuation before low-risk procedures.
The authors propose that the need to pause anticoagulation therapy may not be universal when using long-acting factor XI inhibitors like abelacimab, especially for procedures with minimal bleeding risk. This could streamline periprocedural care and reduce the risk of thrombotic events associated with stopping anticoagulation.
The authors note, "As several factor XI inhibitors continue to be evaluated in clinical trials, these results bolster the potential of this class of medications to transform anticoagulant management, offering efficacy while minimizing bleeding complications."
"If approved for clinical use, abelacimab may emerge as a game-changer in the treatment of atrial fibrillation, particularly for patients undergoing frequent or unavoidable invasive procedures," they concluded.
Reference:
Patel SM, Giugliano RP, Morrow DA, et al. Long-acting factor XI inhibition and periprocedural bleeding: an analysis from AZALEA-TIMI 71. JACC. 2025;85:2288-2298.
