Abstract
BACKGROUND: The venous uptake following the application of Everolimus-coated balloons is under reported. We evaluated the feasibility, safety, and Everolimus (EVR) deliverability of a novel non-commercially available Everolimus-Coated Balloon (ECB) catheter in a swine healthy peripheral vein model. METHODS: In total 12 ECBs (5.0 μg/mm(2)) were inflated in 12 venous segments. The primary feasibility endpoint was the successful application of the ECB at the target venous sites. The primary efficacy endpoint was the successful drug uptake by the target venous tissue at 24 h and 7 days, assessed by High Performance Liquid Chromatography combined with tandem mass spectrometry. The primary safety endpoint was freedom from major adverse events. RESULTS: Everolimus was detected in 10 out of 12 (83.33%) tissue samples (all six tissue samples at 24 h post-intervention and in four out of six samples at 7 days). The mean weight of the examined tissue was 0.20604 ± 0.29822 g (range: 0.37475-0.02229 g). The average EVR tissue content detected at 24 h (135.67 ± 204.95 μg/g) was numerically superior, but non-statistically significant to the that detected 7 days post-procedure (96.85 ± 110.89 μg/g). The average quantity of EVR on the balloon after retrieval was 33.9% of the initial drug dose. No adverse events were recorded, and no abnormalities were noted during autopsy. CONCLUSIONS: The newly developed ECB successfully delivered Everolimus within the healthy venous wall. No adverse events were noted at a short-term follow-up. RELEVANCE STATEMENT: These safety and feasibility results justify further experimental and clinical research to demonstrate the safety efficacy the specific balloon catheter.