Excipient:Drug Dose Determination for Neointimal Hyperplasia as Assessed by Optical Coherence Tomography and Histopathology in Porcine Coronary Arteries after Sirolimus-Eluting Balloon Employment
| Autor: | Juliana Carvalho, Paulo Sampaio Gutierrez, Suzane Kiss Ferreira, Micheli Zanotti Galon, Vera Demarchi Aiello, Márcio José Figueira Chaves, Celso Kiyochi Takimura, Prakash Sojitra, Francisco R.M. Laurindo, Manish Doshi, Pedro A. Lemos |
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| Rok vydání: | 2012 |
| Předmět: |
medicine.medical_specialty
Coronary restenosis Materials science medicine.medical_treatment Urology Excipient Balloon Internal medicine medicine Reestenose coronária Sirolimus Neointimal hyperplasia Sirolimo Stent General Medicine Angioplastia coronária com balão medicine.disease Animal studies Coronary arteries medicine.anatomical_structure Experimentação animal Cardiology Stents Histopathology Angioplasty balloon coronary Cardiology and Cardiovascular Medicine medicine.drug |
| Zdroj: | Revista Brasileira de Cardiologia Invasiva English Version. 20(2):133-139 |
| ISSN: | 0104-1843 |
| DOI: | 10.1016/s0104-1843(12)50024-x |
| Popis: | BackgroundMagic Touch™ is a sirolimus-based nano-carrier eluting balloon. This study aimed to find the excipient:drug ratio with the greatest capacity to inhibit neointimal proliferation 28 days after the use of this balloon and following bare-metal stenting in porcine coronary arteries.MethodsFourteen domestic pigs who received coronary bare-metal stent implants followed by dilation (60seconds) using balloons with excipient:sirolimus ratios of 1:1, 0.5:1, 0.25:1, and 1:0 or a control balloon were evaluated. After 28 days, neointimal hyperplasia was assessed by optical coherence tomography and histopathology.ResultsThe rate of neointimal hyperplasia as assessed by optical coherence tomography and histomorphometry was 32.2% and 35.1%, 28.1% and 33.4%, 17.3% and 20.9%, 28.6% and 30.2%, and 37.9% and 42.3% in the 0.25:1, 0.5:1, 1:1, and 1:0 excipient:sirolimus ratio groups and the control balloon group, respectively (P=0.03 for excipient:sirolimus 1:1 versus control balloon). The neointimal interstrut thickness (mm) was 0.23, 0.30, 0.16, 0.24, and 0.30 in the 0.25:1, 0.5:1, 1:1, and 1:0 excipient:sirolimus ratio groups and the control balloon group, respectively (P < 0.01 for excipient:sirolimus 1:1 versus control balloon). The inflammation, injury, and fibrin deposition scores were low, and there were no significant differences among the groups.ConclusionsThere was a stepwise increase in the inhibitory efficacy of neointimal proliferation as the excipient concentration increased. The lowest efficacy was observed with the 0.25:1 excipient:sirolimus formulation, and the greatest inhibition was observed with the 1:1 excipient:sirolimus formulation. The 1:1 excipient:sirolimus formulation significantly reduced neointimal proliferation when compared to the control group, with low inflammation and injury scores. |
| Databáze: | OpenAIRE |
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