1. 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)
- Author
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Sriram S. Iyer, Konstantine Kipiani, Surendra Shenoy, William D. Paulson, Nicholas Kipshidze, Maria V. DeVita, and Nutsa Beridze
- Subjects
Adult ,Male ,medicine.medical_specialty ,Adolescent ,medicine.medical_treatment ,Anastomosis ,Coronary artery disease ,Blood Vessel Prosthesis Implantation ,Young Adult ,Drug Delivery Systems ,Coated Materials, Biocompatible ,Renal Dialysis ,medicine ,Humans ,Survival rate ,Polytetrafluoroethylene ,Vascular Patency ,Aged ,Neointimal hyperplasia ,Sirolimus ,Transplantation ,business.industry ,Thrombosis ,Middle Aged ,medicine.disease ,Surgery ,Survival Rate ,surgical procedures, operative ,Nephrology ,Drug-eluting stent ,Hypertension ,Microscopy, Electron, Scanning ,Female ,Hemodialysis ,Collagen ,Safety ,business ,medicine.drug ,Follow-Up Studies - Abstract
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 graftvenous 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 1 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
- Published
- 2012