Long-Acting Factor XI Inhibition and Periprocedural Bleeding: An Analysis From AZALEA-TIMI 71

Patel, SM; Giugliano, RP; Morrow, DA; Parkar, S; Shapiro, H; Hug, B; Kuder, JF; Goodrich, EL; Chen, SA; Goodman, SG; Joung, B; Kiss, RG; Wojakowski, W; Weitz, JI; Murphy, SA; Wiviott, SD; Bloomfield, D; Sabatine, MS; Ruff, CT

doi:10.1016/j.jacc.2025.04.018

Arrhythmias & electrophysiology

Long-Acting Factor XI Inhibition and Periprocedural Bleeding: An Analysis From AZALEA-TIMI 71

J Am Coll CardiolPublished 17 Jun 2025Secondary analysis of the AZALEA-TIMI 71 randomised trial

Primary result · Periprocedural major or CRNM bleeding (per procedure)ResultRelative risk 0.54 95% CI 0.19–1.58

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Authors' conclusion

These data illustrate that patients with AF treated with abelacimab, a long-acting factor XI inhibitor, can undergo invasive procedures with low rates of bleeding.

Study context

Population: Patients with atrial fibrillation (AF) undergoing invasive procedures during follow-up
Participants: 441 patients920 procedures

Comparison: Abelacimab vs rivaroxaban
Primary endpoint: Periprocedural major/CRNM bleeding (adjudicated, related to the procedure)
Follow-up: Within 30 days after a procedure

Methodological detailsmulticentre, active-controlled, blinded abelacimab doses, open-label rivaroxaban, Median follow-up 2.1 years, Most procedures low bleeding risk (n = 696, 75.7%) and elective (n = 686, 74.6%)

Multicentre
Active-controlled
Blinded abelacimab doses, open-label rivaroxaban
Median follow-up 2.1 years
Most procedures low bleeding risk (n = 696, 75.7%) and elective (n = 686, 74.6%)

Primary result

As reported in the abstract

Periprocedural major or CRNM bleeding (per procedure)

Relative risk

0.54

95% CI 0.19–1.58

By group

Abelacimab1.2%

Rivaroxaban2.2%

Abelacimabvs Rivaroxaban

RR 0.54 (95% CI 0.19–1.58)

Further findings

Major or clinically relevant nonmajor (CRNM) bleeding, procedures within 30 days of an abelacimab dose: 0.9% · 3 events
Time to procedure from last abelacimab dose: 29 · median · IQR 20–42 · days
Time to procedure from last abelacimab dose — Procedures in abelacimab arms within monthly dosing interval: 336 of the 602 (55.8%)

Major or CRNM bleeding, procedures within 30 days of an abelacimab dose: 3 of the 336 procedures

Original publication

Long-Acting Factor XI Inhibition and Periprocedural Bleeding: An Analysis From AZALEA-TIMI 71. J Am Coll Cardiol. Published 17 June 2025. doi:10.1016/j.jacc.2025.04.018

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