Preclinical results of DERIVO® 2heal® vs DERIVO® 2 flow diverters in rabbit model under single antiplatelet therapy using HF-OCT.

INTRODUCTION: Flow diverter (FD) stents are a major innovation in treating intracranial aneurysms. Despite their efficacy, up to 20% of aneurysms remain incompletely occluded at long-term follow-up. Newer FD generations focus on improving vessel healing, however thromboembolic risks require dual antiplatelet therapy (DAPT), which increases the probability of bleeding complications. Surface-modified FDs, such as the DERIVO® 2heal®, are designed to reduce thrombogenicity, enhance endothelialization and potentially allow single antiplatelet therapy (SAPT). This study evaluates the endothelialization and thrombogenic profile of the DERIVO® 2heal® compared to the uncoated DERIVO® 2 in the rabbit model. METHODS: Both DERIVO® 2heal® and DERIVO® 2 devices were implanted in the rabbit aorta. SAPT with aspirin was initiated prior to the procedure. Devices were analyzed on days 0, 3, 6, and 8 using digital subtraction angiography (DSA), cone-beam CT (CBCT), and high-frequency optical coherence tomography (HF-OCT). Post-mortem histomorphological evaluation was conducted to quantify neotissue formation and strut coverage. RESULTS: Twenty devices were implanted in ten rabbits. DERIVO® 2heal® exhibited significantly less thrombus formation on day 0 (0% vs. 42.7%, p<0.05). OCT and histological analyses demonstrated comparable strut coverage and neotissue formation between groups, with a non-significant trend toward higher neotissue cellularity in the DERIVO® 2heal® group. CONCLUSION: The DERIVO® 2heal® coating reduces early thrombogenicity following implantation with preserved endothelialization. These findings support its potential for safer FD use under SAPT, representing a promising step toward improving endovascular aneurysm treatment outcomes.