Access site bleeding complications comparing oral anticoagulation therapy with NOACs and VKAs in patients with atrial fibrillation undergoing cardiac implantable device intervention

Abstract

Abstract Funding Acknowledgements Type of funding sources: None. Background Atrial fibrillation is frequent in patients undergoing cardiac implantable electronic device (CIED) intervention. Such population require oral anticoagulation therapy, which increases risk of procedure related bleeding. There is a lack on data on procedure-related bleeding outcome with non-vitamin K antagonist anticoagulants (NOACs) vs vitamin K antagonist anticoagulants (VKAs) in patients with AF undergoing CIED intervention. Study purpose Aim of the present stud was to evaluate whether NOACs have a safety benefit compared to VKAs in terms of fewer hemorrhagic complications at the site of CIED implant. Methods Consecutive AF patients receiving NOACs or VKAs at the time of CIED procedure were included in this observational, retrospective, monocentric investigation. Primary endpoint was the incidence of post-intervention clinically significant pocket hematoma. Multivariate analysis was performed to investigate the association between covariates and the primary endpoint. Results A total of 311 patients were enrolled, 146 on NOACs and 165 on VKAs. The incidence of pocket hematoma was 3.4% in the NOAC vs 13.3% in the VKA group (p=0.002) (Figure 1). Primary outcome-free survival at 30-days was 96.6 % in patients on NOACs and 86.0% in those on VKAs (p=0.019) (Figure 2). Multivariate analysis, adjusted by propensity-score calculation of inverse-probability-weighting, showed a significantly lower occurrence of pocket hematoma in patients receiving NOACs vs VKAs (HR 0.35, 95% CI 0.13-0.96, p=0.042). Such NOACs benefit was confirmed vs patients on VKAs without peri-procedural bridging with low-molecular weight heparin (HR 0.34, 95% CI 0.11-0.99, p=0.048). The incidence of pocket infection, surgical pocket evacuation, ischemic events and major bleeding complications at 30 days (secondary endpoints) was similar in the two groups. Conclusion Among patients with AF undergoing implantable cardiac defibrillator or pace-maker intervention, the use of NOACs vs VKAs is associated with significant reduction of post-procedural pocket hematoma, regardless of bridging with low molecular-weight heparin in the VKA group.