Long-term effects on vascular healing of bare metal stents delivered via paclitaxel-coated balloons in the porcine model of restenosis

• Published in: Catheterization and cardiovascular interventions Vol. 80; no. 4; pp. 603 - 610
• Main Authors: Cremers, Bodo, Milewski, Krzysztof, Clever, Yvonne P., Aboodi, Michael S., Biedermann, Melanie, Thim, Troels, Kelsch, Bettina, Kaluza, Greg L., Scheller, Bruno, Granada, Juan F.
• Format: Journal Article
• Language: English
• Published: Hoboken Wiley Subscription Services, Inc., A Wiley Company 01.10.2012
• Subjects: Angioplasty, Balloon, Coronary - instrumentation; Animals; Cardiac Catheters; Cardiovascular Agents - administration & dosage; Cell Proliferation; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis - diagnostic imaging; Coronary Restenosis - metabolism; Coronary Restenosis - pathology; Coronary Restenosis - therapy; Coronary Vessels - metabolism; Coronary Vessels - pathology; Disease Models, Animal; Drug-Eluting Stents; Endothelial Cells - metabolism; Endothelial Cells - pathology; Equipment Design; Metals; Neointima; Paclitaxel - administration & dosage; paclitaxel-coated balloon; porcine; Prosthesis Design; stent; Stents; Swine; Swine, Miniature; Time Factors; vascular healing; von Willebrand Factor - metabolism
• ISSN: 1522-1946; 1522-726X
• DOI: 10.1002/ccd.24305

Background Clinical trials have consistently demonstrated benefits of Paclitaxel‐coated balloons (PCB) in particular clinical situations such as in‐stent restenosis and peripheral vascular interventions. However, the long‐term vascular effects of bare metal stents (BMS) delivered via PCB (PCB+BMS) are still unknown. The aim of this study was to assess the long‐term effects of PCB+BMS on vascular healing and neointimal formation (NF). Methods A total of 208 stents: 56 BMS crimped on PCB, 50 BMS crimped on uncoated balloons (UCB+BMS), 52 Taxus and 50 Cypher stents were implanted in normal coronary arteries of 104 pigs using 1.2:1.0 stent‐to‐artery ratio. Follow‐up occurred at 3, 7, 28, 90, and 180 days. Vascular effects were assessed based on angiographic and histological analysis. Endothelialization was evaluated using an anti von‐Willebrand Factor stain. Results At 28 days, delivery of a BMS using a PCB led to a significant reduction in NF compared to the UCB+BMS and the Taxus stent (P < 0.01). Between 28 and 180 days, the progression of NF tended to be lower in the PCB+BMS compared to all DES groups. At 90 days, the PCB+BMS (2.56 ± 0.43) and the Taxus stents (2.60 ± 0.59) had a trend toward higher inflammatory scores compared to the UCB+BMS group (1.85 ± 1.13, P = 0.09). By 180 days, inflammation and NF had completely normalized between the groups. Expression of peristrut vWF was comparable among all tested groups at 28 days. Conclusion The long‐term pattern of vascular healing occurring following PCB+BMS deployment appears to be comparable to what has been reported with DES technologies. © 2012 Wiley Periodicals, Inc.