دورية أكاديمية
Safety and efficacy of local periadventitial delivery of sirolimus for improving hemodialysis graft patency: first human experience with a sirolimus-eluting collagen membrane (Coll-R)
| العنوان: | Safety and efficacy of local periadventitial delivery of sirolimus for improving hemodialysis graft patency: first human experience with a sirolimus-eluting collagen membrane (Coll-R) |
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| المؤلفون: | Paulson, William D., Kipshidze, Nicholas, Kipiani, Konstantine, Beridze, Nutsa, DeVita, Maria V., Shenoy, Surendra, Iyer, Sriram S. |
| بيانات النشر: | Oxford University Press |
| سنة النشر: | 2012 |
| المجموعة: | HighWire Press (Stanford University) |
| مصطلحات موضوعية: | Extracorporeal Treatments of Kidney Failure |
| الوصف: | Background. Neointimal hyperplasia causes a high rate of hemodialysis synthetic graft failure. Thus, therapies that inhibit neointimal hyperplasia are urgently needed. The Coll-R is a sirolimus-eluting collagen matrix designed for intra-operative perivascular implantation around the graft-venous anastomosis. Sirolimus is an anti-proliferative drug that has proven clinical utility in suppressing neointimal tissue growth in coronary artery disease when delivered locally to the vascular wall by an endovascular drug eluting stent. Methods. A cohort of 12 chronic hemodialysis patients underwent surgical placement of 13 polytetrafluoroethylene grafts + Coll-R and were followed for up to 24 months. The primary endpoint was safety (freedom from device related adverse events). Secondary endpoints were pharmacokinetics of sirolimus release, success of Coll-R implantation and primary unassisted graft patency. Results. There were no technical failures, infections, vascular anastomotic or wound-healing problems. Whole blood sirolimus levels rose to a mean peak of 4.8 ng/mL at 6 h and fell to <1 ng/mL at 1 week ( n = 5). Twelve and 24-month primary unassisted patencies were 76 and 38%, respectively, and the thrombosis rate was 0.37/patient-year. Conclusions. Perivascular implantation of the Coll-R during graft surgery safely delivered sirolimus to the vascular wall. Systemic sirolimus levels were sub-therapeutic for immunosuppression. This small first-in-human study supports the concept that the Coll-R can safely deliver sirolimus to the graft-venous anastomosis. Safety and patency in this small study were sufficiently encouraging to justify randomized controlled trials to further test the efficacy of the Coll-R. |
| نوع الوثيقة: | text |
| وصف الملف: | text/html |
| اللغة: | English |
| العلاقة: | http://ndt.oxfordjournals.org/cgi/content/short/27/3/1219Test; http://dx.doi.org/10.1093/ndt/gfr667Test |
| DOI: | 10.1093/ndt/gfr667 |
| الإتاحة: | https://doi.org/10.1093/ndt/gfr667Test http://ndt.oxfordjournals.org/cgi/content/short/27/3/1219Test |
| حقوق: | Copyright (C) 2012, European Renal Association - European Dialysis and Transplant Association |
| رقم الانضمام: | edsbas.8EBA61DD |
| قاعدة البيانات: | BASE |
| DOI: | 10.1093/ndt/gfr667 |
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