A new analysis of AZALEA-TIMI 71 suggests Anthos Therapeutics’ abelacimab is capable of reducing major bleeding in patients with AFib undergoing invasive procedures.
- Abelacimab is a factor XI inhibitor that helps lower the risk of bleeding in patients who need anticoagulation and usually lasts for over 28 days after a single dose.
- Currently, standard practice is to interrupt anticoagulation one to two days before most procedures for patients with AFib, but abelacimab could help avoid this.
The sub-analysis examined a total of 920 procedures across 441 patients taking either abelacimab or rivaroxaban, with approximately 1-in-3 patients undergoing an invasive procedure over a median follow-up of 2.1 years.
- Overall, periprocedural major or CRNM bleeding was low for both groups combined (<2% of all procedures).
- More specifically, major bleeding was almost half as likely to occur during procedures in the abelacimab group (1.2%) versus the rivaroxaban group (2.2%).
- The bleeding rate in the abelacimab group was even lower for procedures occurring within 30 days of an abelacimab dose (0.9%).
Researchers concluded that patients with AFib treated with abelacimab can undergo invasive procedures with low rates of bleeding and suggested that interrupting anticoagulation may not be necessary for all procedures where a patient is taking a factor XI inhibitor.
- However, as supportive as the data is on abelacimab, it still hasn’t received full regulatory approval.
- Where the bigger value lies is in the proof that abelacimab is safe, even if not discontinued before a procedure since it has such a long half-life.
The big ticket question is still whether or not abelacimab reduces the risk of stroke, noting that AZALEA-TIMI 71 didn’t show stroke improvements (and wasn’t designed for stroke outcomes), but the ongoing LILAC-TIMI 76 trial for high-risk patients with AFib might give deeper insights.
The Takeaway
Factor XI inhibition with abelacimab lasts a long time, so discontinuing it before a procedure isn’t really an option. Thankfully the results of this sub-analysis help underscore just how safe it is even if the patient is still on it during a complex or invasive procedure.
