Safety and Efficacy of an Innovative Everolimus-Coated Balloon in a Swine Coronary Artery Model
Christos S. Katsouras,
Alexandros Tousis,
Georgios Vasilagkos,
Arsen Semertzioglou,
Athanassios Vratimos,
Ioanna Samara,
Georgia Karanasiou,
Vasileios S. Loukas,
Grigorios Tsigkas,
Dimitrios Fotiadis,
Lampros K. Michalis,
Periklis Davlouros,
Anargyros N. Moulas
Affiliations
Christos S. Katsouras
2nd Department of Cardiology, University Hospital of Ioannina, University of Ioannina, 45110 Ioannina, Greece
Alexandros Tousis
Department of Cardiology, University Hospital of Patras, 26504 Patras, Greece
Georgios Vasilagkos
Department of Cardiology, University Hospital of Patras, 26504 Patras, Greece
Arsen Semertzioglou
Rontis Hellas SA, 41500 Larissa, Greece
Athanassios Vratimos
Rontis Hellas SA, 41500 Larissa, Greece
Ioanna Samara
2nd Department of Cardiology, University Hospital of Ioannina, University of Ioannina, 45110 Ioannina, Greece
Georgia Karanasiou
Department of Biomedical Research, Institute of Molecular Biology and Biotechnology, Department of Materials Science and Engineering, Unit of Medical Technology and Intelligent Information Systems, University of Ioannina, 45110 Ioannina, Greece
Vasileios S. Loukas
Department of Biomedical Research, Institute of Molecular Biology and Biotechnology, Department of Materials Science and Engineering, Unit of Medical Technology and Intelligent Information Systems, University of Ioannina, 45110 Ioannina, Greece
Grigorios Tsigkas
Department of Cardiology, University Hospital of Patras, 26504 Patras, Greece
Dimitrios Fotiadis
Department of Biomedical Research, Institute of Molecular Biology and Biotechnology, Department of Materials Science and Engineering, Unit of Medical Technology and Intelligent Information Systems, University of Ioannina, 45110 Ioannina, Greece
Lampros K. Michalis
2nd Department of Cardiology, University Hospital of Ioannina, University of Ioannina, 45110 Ioannina, Greece
Periklis Davlouros
Department of Cardiology, University Hospital of Patras, 26504 Patras, Greece
Anargyros N. Moulas
General Department, University of Thessaly, 41500 Larissa, Greece
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.
