Journal of the American College of Cardiology (JACC)AZALEA-TIMI 71: Should Abelacimab Be Withdrawn Before Invasive Procedures?

This phase 2b dose-ranging trial analyzed periprocedural bleeding outcomes in patients with atrial fibrillation treated with abelacimab (factor XI inhibitor) versus rivaroxaban. The study provides initial evidence regarding the safety profile of factor XI inhibition during invasive procedures, though larger phase 3 trials are needed to establish definitive efficacy and safety recommendations.

⚕️ Key Clinical Considerations ⚕️

• Low bleeding incidence: Periprocedural major or clinically relevant non-major bleeding occurred in <2% of all procedures, with abelacimab showing numerically lower rates (1.2%) compared to rivaroxaban (2.2%, risk ratio 0.54).
• Procedure risk stratification: 76% of procedures were classified as low bleeding risk and 75% were elective, suggesting careful patient selection may have influenced the favorable bleeding outcomes observed.
• Limited high-risk procedure data: Only 24% of procedures were high bleeding risk, with major orthopedic, spinal, and abdominal surgeries being most common, limiting generalizability to higher-risk interventions.
• Hemostatic agent usage: Abelacimab patients required hemostatic therapies in 7% of procedures versus 3% with rivaroxaban, indicating potential need for enhanced bleeding management strategies despite overall low event rates.
• Long half-life considerations: Abelacimab’s 28-day half-life complicates traditional anticoagulation reversal strategies, requiring paradigm shifts in perioperative management protocols compared to shorter-acting direct oral anticoagulants.

🎯 Clinical Practice Impact 🎯

• Patient Communication: Inform patients that preliminary data suggests factor XI inhibitors may require less frequent anticoagulation interruption for low-risk procedures, but emphasize this represents early-phase evidence requiring validation in larger trials.
• Practice Integration: Consider developing institutional protocols for factor XI inhibitor management that differentiate between low and high bleeding risk procedures, while maintaining conservative approaches until phase 3 data becomes available.
• Risk Management: Establish enhanced bleeding monitoring protocols and ensure immediate access to hemostatic agents when performing procedures in patients on factor XI inhibitors, given the limited reversal options currently available.
• Action Items: Review current perioperative anticoagulation protocols to identify potential integration points for factor XI inhibitors, while maintaining evidence-based interruption strategies until definitive safety and efficacy data emerge from ongoing phase 3 trials.

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