Safety and Efficacy of an Innovative Everolimus-Coated Balloon in a Swine Coronary Artery Model

• Published in: Life (Basel, Switzerland) Vol. 13; no. 10; p. 2053
• Main Authors: Katsouras, Christos S, Tousis, Alexandros, Vasilagkos, Georgios, Semertzioglou, Arsen, Vratimos, Athanassios, Samara, Ioanna, Karanasiou, Georgia, Loukas, Vasileios S, Tsigkas, Grigorios, Fotiadis, Dimitrios, Michalis, Lampros K, Davlouros, Periklis, Moulas, Anargyros N
• Format: Journal Article
• Language: English
• Published: Basel MDPI AG 01.10.2023; MDPI
• Subjects: Angioplasty; Animals; Balloon treatment; Biocompatibility; Biological effects; Care and treatment; Catheters; Cell cycle; Clinical trials; Coatings; coronary arteries; Coronary artery; Coronary heart disease; Coronary vessels; drug coated balloon; Drug delivery devices; Drug dosages; Effectiveness; everolimus; Health services; Hogs; Intubation; Medical equipment; Medical imaging; Medical research; Paclitaxel; Peripheral vascular diseases; porcine model; Rapamycin; Safety; Statistical analysis; Stenosis; Stents; Swine; Testing; Ultrasonic imaging; Vascular diseases; Veins & arteries; Greece; United States > US; Japan
• ISSN: 2075-1729; 2075-1729
• DOI: 10.3390/life13102053

Background: Drug-coated balloons have been used as a non-stenting treatment in coronary and peripheral artery disease. Until recently, only sirolimus- and paclitaxel-coated balloons have been investigated in clinical trials. We evaluated the safety and efficacy of an innovative everolimus-coated balloon (ECB) in a swine coronary artery model. Methods: thirty-two swine coronary arteries were prepared through dilatation with a non-coated angioplasty balloon in a closed-chest model. During a period of 90 days, the following four groups (four animals per group, two coronary arteries per animal) were compared for safety and efficacy: A, Rontis ECB with 2.5 μg/mm2 of drug per balloon surface; B, Rontis ECB with 7.5 μg/mm2; C, Rontis Europa Ultra bare balloon; and D, Magic Touch, Concept Medical, sirolimus-coated balloon with a drug load of 1.3 μg/mm2. Results: Differences in local biological effects (arterial reaction scores) and surface of intimal area (mm2) were not statistically significant between the treatment groups. Numerically, group A showed the lowest intimal area and intimal mean thickness, while group B showed the lowest stenosis among all groups. Conclusions: ECB was safe and effective in a porcine coronary artery model. The dose of everolimus may play a role in the biocompatibility of the balloon.