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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Abstract

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.

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Effect of clopidogrel on early failure of arteriovenous fistulas for hemodialysis: a randomized controlled trial.

Laura Dember, Gerald J Beck, Michael Allon … (2008)

The arteriovenous fistula is the preferred type of vascular access for hemodialysis because of lower thrombosis and infection rates and lower health care expenditures compared with synthetic grafts or central venous catheters. Early failure of fistulas due to thrombosis or inadequate maturation is a barrier to increasing the prevalence of fistulas among patients treated with hemodialysis. Small, inconclusive trials have suggested that antiplatelet agents may reduce thrombosis of new fistulas. To determine whether clopidogrel reduces early failure of hemodialysis fistulas. Randomized, double-blind, placebo-controlled trial conducted at 9 US centers composed of academic and community nephrology practices in 2003-2007. Eight hundred seventy-seven participants with end-stage renal disease or advanced chronic kidney disease were followed up until 150 to 180 days after fistula creation or 30 days after initiation of dialysis, whichever occurred later. Participants were randomly assigned to receive clopidogrel (300-mg loading dose followed by daily dose of 75 mg; n = 441) or placebo (n = 436) for 6 weeks starting within 1 day after fistula creation. The primary outcome was fistula thrombosis, determined by physical examination at 6 weeks. The secondary outcome was failure of the fistula to become suitable for dialysis. Suitability was defined as use of the fistula at a dialysis machine blood pump rate of 300 mL/min or more during 8 of 12 dialysis sessions. Enrollment was stopped after 877 participants were randomized based on a stopping rule for intervention efficacy. Fistula thrombosis occurred in 53 (12.2%) participants assigned to clopidogrel compared with 84 (19.5%) participants assigned to placebo (relative risk, 0.63; 95% confidence interval, 0.46-0.97; P = .018). Failure to attain suitability for dialysis did not differ between the clopidogrel and placebo groups (61.8% vs 59.5%, respectively; relative risk, 1.05; 95% confidence interval, 0.94-1.17; P = .40). Clopidogrel reduces the frequency of early thrombosis of new arteriovenous fistulas but does not increase the proportion of fistulas that become suitable for dialysis. Trial Registration clinicaltrials.gov Identifier: NCT00067119.

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Hemodialysis vascular access dysfunction: a cellular and molecular viewpoint.

Vikas P Sukhatme, Jackie K. Cheung, Prabir Roy-Chaudhury (2006)

Hemodialysis vascular access dysfunction is a major cause of morbidity and hospitalization in the hemodialysis population. The major cause of hemodialysis vascular access dysfunction is venous stenosis as a result of neointimal hyperplasia. Despite the magnitude of the clinical problem, however, there has been a paucity of novel therapeutic interventions in this field. This is in marked contrast to a recent plethora of targeted interventions for the treatment of arterial neointimal hyperplasia after coronary angioplasty. The reasons for this are two-fold. First there has been a relative lack of cellular and molecular research that focuses on venous neointimal hyperplasia in the specific setting of hemodialysis vascular access. Second, there have been inadequate efforts by the nephrology community to translate the recent advances in molecular and interventional cardiology into therapies for hemodialysis vascular access. This review therefore (1) briefly examines the different forms of hemodialysis vascular access that are available, (2) describes the pathology and pathogenesis of hemodialysis vascular access dysfunction in both polytetrafluoroethylene grafts and native arteriovenous fistulae, (3) reviews recent concepts about the pathogenesis of vascular stenosis that could potentially be applied in the setting of hemodialysis vascular access dysfunction, (4) summarizes novel experimental and clinical therapies that could potentially be used in the setting of hemodialysis vascular access dysfunction, and, finally, (5) offers some broad guidelines for future innovative translational and clinical research in this area that hopefully will reduce the huge clinical morbidity and economic costs that are associated with this condition.

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Why don't fistulas mature?

Groves Dixon (2006)

Fistula maturation requires a compliant and responsive vasculature capable of dilating in response to the increased velocity of blood flowing into the newly created low-resistance circuit. Successful maturation to a high volume flow circuit capable of sustaining hemodialysis typically occurs within the first few weeks after creation. Failure to achieve maturation within 4-8 weeks should prompt a search for reversible etiologies; however, an accepted definition of maturation, particularly for patients not yet on dialysis remains elusive. The most commonly identified etiology is neointimal hyperplasia typically occurring in the juxta-anastomotic vein. However, failed maturation has also been reported secondary to impaired arterial and venous dilation and accessory veins. The exact frequency of each of these etiologies is unclear. Understanding the etiologies of impaired fistula maturation will focus future studies of targeted interventions to improve the rate of fistula maturation and increase the number of dialysis patients with a functioning autogenous fistula.

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Author and article information

Journal

Title: Nephrology Dialysis Transplantation

Abbreviated Title: Nephrology Dialysis Transplantation

Publisher: Oxford University Press (OUP)

ISSN (Print): 0931-0509

ISSN (Electronic): 1460-2385

Publication date Created: February 29 2012

Publication date Created: March 01 2012

Publication date (Electronic): January 11 2012

Publication date (Print): March 01 2012

Volume: 27

Issue: 3

Pages: 1219-1224

Article

DOI: 10.1093/ndt/gfr667

PubMed ID: 22241793

SO-VID: 0b2325e3-152c-486f-b658-1c05e3f7c9c8

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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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Most cited references 38

Effect of clopidogrel on early failure of arteriovenous fistulas for hemodialysis: a randomized controlled trial.

Hemodialysis vascular access dysfunction: a cellular and molecular viewpoint.

Why don't fistulas mature?

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