Rationale and study design of the Italian Registry in the setting of Atrial Fibrillation Ablation with Rivaroxaban - IRIS

doi:10.23736/s2724-5683.21.05832-4

January 26, 2022Minerva Cardiology and Angiology

Rationale and study design of the Italian Registry in the setting of Atrial Fibrillation Ablation with Rivaroxaban - IRIS

View Full Paper

Ask AI

Bookmark

Share

Why the study?

Catheter ablation of AF should be performed during continuous oral anticoagulation, but real-life data on DOACs remain limited, especially in Italy.

Does rivaroxaban (uninterrupted or shortly uninterrupted) prevent death and systemic embolism without increasing major bleeding in patients undergoing catheter ablation for atrial fibrillation?

Structured PICO

Does rivaroxaban (uninterrupted or shortly uninterrupted) prevent death and systemic embolism without increasing major bleeding in patients undergoing catheter ablation for atrial fibrillation?

P

Population

Consecutive atrial fibrillation patients eligible for catheter ablation and treated with Rivaroxaban (expected n=250)

I

Intervention

Rivaroxaban (uninterrupted or shortly uninterrupted <24 hours) prior to catheter ablation, continued for 1 month post-procedure

O

Outcome

Cumulative incidence of all-cause death and systemic embolism (efficacy) and incidence of major bleeding events (safety) within 30 days after the procedurecomposite

The IRIS registry will provide prospective, real-world data on the safety and efficacy of rivaroxaban in patients undergoing catheter ablation for atrial fibrillation in Italy.

Implication

May inform periprocedural rivaroxaban use in AF ablation; leaves open need for randomized confirmation of safety and efficacy.

Abstract

BACKGROUND: Catheter ablation (CA) of atrial fibrillation (AF) is used routinely to establish rhythm control. There is mounting evidence that CA procedures should be performed during continuous oral anticoagulation and direct oral anticoagulants (DOACs) are considered the first anticoagulation strategy. Few real-life data are now available and even less in the Italian panorama. METHODS: IRIS is an Italian multicenter, non-interventional, prospective study which will be enrolled consecutive AF patients eligible for CA and treated with Rivaroxaban; patients in treatment with Rivaroxaban proceeded directly to CA while Rivaroxaban-naive patients were scheduled for CA after 4 weeks of uninterrupted anticoagulation unless the exclusion of atrial thrombi. Rivaroxaban was uninterrupted or shortly uninterrupted (<24 hours) prior CA, in line with routinely practice of each operator. Patients will be followed on continuous anticoagulation for 1 month after the ablation. The primary efficacy outcome is the cumulative incidence of all-cause death and systemic embolism while the primary safety outcome is the incidence of major bleeding events. The secondary outcomes are represented by non-major bleeding events. All events must be occurred within the first 30 days after the procedure. RESULTS: Two hundred fifty patients are expected to be enrolled and the study is estimated to be completed by the end of 2022. Up to now 56 patients have been enrolled. CONCLUSIONS: This study is the first large Italian prospective study on the management of Rivaroxaban in patients undergoing CA of AF. It aims to depict a comprehensive view of anticoagulation strategy prior CA in several Italian electrophysiology labs.