DOAC interruption in AF patients undergoing procedures with minimal to low bleeding risk appears to be safe

In a South Korean cohort study among AF patients receiving a factor Xa inhibitor who underwent endoscopy, dental procedure, or ocular surgery, use of a standardized periprocedural anticoagulation protocol was associated with a low major bleeding event rate (0.1%) and no thromboembolism at 30 days.

This summary is based on the publication of Lee SR, Lee KY, Park JS, et al. - Perioperative Factor Xa Inhibitor Discontinuation for Patients Undergoing Procedures With Minimal or Low Bleeding Risk. JAMA Netw Open. 2025 Feb 3;8(2):e2458742. doi: 10.1001/jamanetworkopen.2024.58742

Introduction and methods

Background

For patients with AF, clinical guidelines differ in their recommendations on perioperative DOAC management for procedures with minimal to low bleeding risk, such as gastrointestinal tract endoscopy, dental procedures, and ocular surgery [1-9]. This highlights the need for a standardized protocol on how to manage DOAC treatment during these types of procedures.

Aim of the study

The study aim was to investigate the effect of short-term perioperative discontinuation of factor Xa inhibitors on the incidence rates of major bleeding events and thromboembolism in AF patients undergoing procedures with minimal to low bleeding risk.

Methods

The PERIXa (Perioperative Factor Xa Inhibitor Discontinuation in Patients With Atrial Fibrillation Undergoing Minimal to Low Bleed Risk Procedures) study was a multicenter, prospective, single-arm cohort study conducted in South Korea. In total, 1902 AF patients receiving a factor Xa inhibitor (i.e., apixaban, edoxaban, or rivaroxaban) who underwent an elective procedure with minimal to low bleeding risk (i.e., endoscopy, dental procedure, or ocular surgery) between September 25, 2020, and April 5, 2024, were included. The PERIXa discontinuation protocol recommended giving patients the last factor Xa inhibitor dose 24 hours before the procedure and restarting treatment the next day.

Outcomes

The primary endpoint was the incidence of major bleeding events, as defined by the International Society on Thrombosis and Haemostasis, ≤30 days after the index procedure. Secondary endpoints comprised a composite outcome of thromboembolic events (stroke, TIA, systemic embolism, or MI) at 30 days and clinically relevant nonmajor bleeding, minor bleeding, and all bleeding events.

Main results

• The modified intention-to-treat analysis, which comprised all patients who underwent the intended procedure, showed there were 2 major bleeding events ≤30 days after the procedure (incidence rate: 0.1%). Both events occurred in patients on edoxaban undergoing a dental procedure, but there was no statistically significant difference in the primary endpoint by type of procedure (P=0.45) or DOAC type (P=0.12).
• There were no thromboembolic events after 30 days, whereas the 30-day event rates were 0.4% for clinically relevant nonmajor bleeding, 2.3% for minor bleeding, and 2.6% for all bleeding. Following dental procedures, more minor bleeding events were observed compared with after endoscopy or ocular surgery (P<0.001).
• Operators reported more bleeding during or immediately after dental procedures than expected in a general population of patients not receiving anticoagulation, compared with the other 2 procedures (P<0.001).
• In the per-protocol analysis of patients with periprocedural DOAC interruptions and resumptions according to the protocol (n=1615; adherence rate: 84.9%), the 30-day major bleeding event rate was also 0.1% (2 events after dental procedures) and no thromboembolic events occurred.

Conclusion

In this South Korean, prospective, single-arm cohort study among AF patients receiving a factor Xa inhibitor who underwent an elective procedure with minimal to low bleeding risk, use of the standardized PERIXa protocol was associated with a low 30-day rate of major bleeding events (0.1%) and no thromboembolism. The types of procedure (endoscopy, dental procedure, or ocular surgery) and factor Xa inhibitor (apixaban, edoxaban, or rivaroxaban) did not influence the major bleeding incidence.

Find this article online at JAMA Netw Open.

References

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