X-Factor: Antithrombotic Coating Reduces Procedural Thromboembolic Events in Flow Redirection Endoluminal Device (FRED) Aneurysm Embolization.

Abstract

<h4>Background</h4>The Flow Redirection Endoluminal Device (FRED) is a dual-layer flow diverting stent with a dense inner mesh and outer braided support providing superior deployment control. Covalently bonded Poly(2-methoxyethyl acrylate) X coating was introduced to decrease metal-induced thrombogenicity in the newer FRED X variant. The objective of the current study is to evaluate procedural thromboembolic events associated with both variants.<h4>Methods</h4>A single-center retrospective analysis was undertaken comparing angiographically detected intraprocedural thromboembolic events, postprocedural magnetic resonance diffusion weighted imaging lesions (MR-DWI+), as well as a composite combined endpoint. Periprocedural (<24 hours) clinical events, demographics, aneurysm characteristics and platelet aggregation (using P2Y12 reactivity unit, PRU) were analyzed.<h4>Results</h4>Treatment was performed with 19 FRED procedures in 18 patients with 19 aneurysms, and with 37 FRED X procedures in 35 patients harboring 40 aneurysms. Both groups achieved therapeutic preprocedural platelet inhibition by PRU testing. Intraprocedural thromboembolic events including intraluminal filling defects and side-branch slowing or loss occurred in 7/19 (36.8%) FRED and 0/37 FRED X procedures (P = 0.0002), with all being successfully recanalized using intra-arterial platelet inhibitors, without symptomatic ischemic or hemorrhagic events. The composite endpoint was reached in 11/19 (57.9%) FRED and 5/37 (13.5%) FRED X cases (P = 0.001), with multivariable analysis identifying device type (P = 0.015) among age, gender, and PRU.<h4>Conclusions</h4>The surface modification of the FRED X device may be associated with improved thrombogenic risk profile in our cohort, with elimination of intraprocedural thrombus formation and reduction of composite thromboembolic events.