Volume 66, Issue 5, Pages (November 2004)

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Volume 66, Issue 5, Pages 2061-2069 (November 2004) Inhibition of neointimal hyperplasia in vascular grafts by sustained perivascular delivery of paclitaxel Takahisa Masaki, Ramesh Rathi, Gaylen Zentner, John K. Leypoldt, Syed F. Mohammad, Gregory L. Burns, L.I. Li, Sergey Zhuplatov, Thanit Chirananthavat, Seung-Jung Kim, Steven Kern, John Holman, Sung Wan Kim, Alfred K. Cheung Kidney International Volume 66, Issue 5, Pages 2061-2069 (November 2004) DOI: 10.1111/j.1523-1755.2004.00985.x Copyright © 2004 International Society of Nephrology Terms and Conditions

Figure 1 Neointimal hyperplasia at the venous anastomosis of an untreated expanded polytetrafluoroethylene (ePTFE) graft explanted at eight weeks. The section stained with hematoxylin and eosin shows that the hyperplastic tissue was comprised of nucleated cells in disarray (A). These cells reacted strongly with anti-α actin, developed with a second antibody and alkaline phosphastase, appearing in brown color (B, 225× magnification). In addition, there were abundant extracellular matrices that stained prominently with trichrome (blue color in C), van Gieson (violet color in D), and alcian blue (periwinkle color in E). Kidney International 2004 66, 2061-2069DOI: (10.1111/j.1523-1755.2004.00985.x) Copyright © 2004 International Society of Nephrology Terms and Conditions

Figure 2 Arterial anastomosis of ePTFE grafts in animal #4 in response to ReGel alone or ReGel/paclitaxel (see Table 1). Two weeks after bilateral arteriovenous graft placement between the femoral vessels, 2 mL of ReGel in liquid form were injected percutaneously to the perivascular area around the anastomoses on one side, while 2 mL of ReGel in liquid form containing 0.26 mg of paclitaxel were injected to the anastomoses of the contralateral graft. The animal was sacrificed at 8 weeks, and both grafts were retrieved. The sections were stained with hematoxylin and eosin. Arterial anastomosis of graft that received ReGel alone (A). A nonocclusive thrombus can also be seen in the lumen. Arterial anastomosis of contralateral graft that received ReGel with 0.26 mg of paclitaxel (B). Kidney International 2004 66, 2061-2069DOI: (10.1111/j.1523-1755.2004.00985.x) Copyright © 2004 International Society of Nephrology Terms and Conditions

Figure 3 Venous anastomosis of ePTFE grafts in animal #1 in response to ReGel alone or ReGel/paclitaxel (see Table 1). Immediately after bilateral arteriovenous graft placement between the femoral vessels, 2 mL of ReGel in gel form were applied directly to the perivascular area around the anastomoses on one side, while 2 mL of ReGel in gel form containing 0.26 mg of paclitaxel were directly applied to the anastomoses of the contralateral graft intraoperatively. The animal was sacrificed at 8 weeks, and both grafts were retrieved. The sections were stained with hematoxylin and eosin. Venous anastomosis of graft that received ReGel alone (A). Venous anastomosis of contralateral graft that received ReGel with 0.26 mg of paclitaxel (B). Kidney International 2004 66, 2061-2069DOI: (10.1111/j.1523-1755.2004.00985.x) Copyright © 2004 International Society of Nephrology Terms and Conditions

Figure 4 Scores of neointimal hyperplasia at the arterial (red symbols) and venous (blue symbols) anastomoses in response to treatment using ReGel alone (labeled as control on the horizontal axis) or ReGel/paclitaxel (labeled as paclitaxel on the horizontal axis). The degree of neointimal hyperplasia at each available anastomosis was graded by 5 independent blinded reviewers. The 5 scores were then averaged and presented as a single composite value (either red or blue symbols connected by broken lines) for each animal. For both arterial and venous anastomoses, the hexagons represent animal #1 (as described in Table 1); squares represent animal #2; diamonds represent animal #3; triangles represent animal #4; and circles represent animal #5. The histology of the arterial anastomosis was unavailable for animal #1, and that of the venous anastomosis was unavailable for animal #4. Overall, ReGel/Paclitaxel decreased neointimal hyperplasia at both arterial and venous anastomoses from a median score of 1.80 to 0.95 (black solid line) (N = 8; P < 0.05). Kidney International 2004 66, 2061-2069DOI: (10.1111/j.1523-1755.2004.00985.x) Copyright © 2004 International Society of Nephrology Terms and Conditions