Ticlopidine to prevent primary arteriovenous fistula failure in hemodialysis patients; a randomized controlled trial

*Corresponding Author: Ali Ghorbani, Department of Nephrology, Dialysis and Kidney Transplantation Golestan Hospital, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. E-mail: [email protected] Dear editor–in Chief, Performance of a successful hemodialysis procedure requires a functional vascular access. The preferred type of access is a native fistula because they have the lowest risk of complications, lowest need for intervention, and the best long-term patency (1). Once an arteriovenous fistula (AVF) is created, it must develop to the point that it is usable. Vascular access dysfunction is one of the most important causes of morbidity in the hemodialysis population (2). Primary failure of native fistulas occurs as a result of either thrombosis within the first several weeks following surgical creation (early thrombosis), or inadequate maturation of the vein (3). The primary AVF failure rate is approximately 9-50% (4-6). Fistula evaluation 4–6 weeks after creation should be considered mandatory (7). The clinical manifestations of early fistula failure are failure to develop adequately to permit repetitive cannulation for dialysis, inadequate flow to support dialysis, and thrombosis. The characteristic pathology that results in AVF failure is a juxtaanastomotic stenosis (8). Whether primary AVF failure can be prevented with pharmacologic agents has not been extensively examined. Several studies have indicated that the frequency of AVF failure and loss can be reduced with antiplatelet agents (9-18). Although those results are encouraging, they do not provide conclusive evidence of the efficacy of antiplatelet agents among patients with AVF. In the present study, we performed a randomized, doubleblind trial to test the hypothesis that ticlopidine, would prevent primary AVF failure among hemodialysis patients with AVF. The study was a randomized, double-blind trial. Patients eligible for enrollment in the study included at least 18 years age patients close to the initiation of chronic hemodialysis who required AVF and patients who were undergoing chronic hemodialysis but required a new AVF at a different site. Exclusion criteria included patients with a history of gastrointestinal bleeding or previous bleeding episodes about 6 months prior to initiation of study, patients already receiving chronic anticoagulation therapy (antiplatelet agents or warfarin), patients with terminal or life-threatening disease, pregnancy, or malignant hypertension, a platelet count of <100,000 /μL or known coagulation abnormalities and demonstrated other medical conditions that would make antiplatelet therapy dangerous. All patients were recruited from the outpatient hemodialysis program at Jundishapur University, and the same surgical team placed all fistulas. Randomization was performed centrally, by the coordinating center. The randomization was stratified according to medical center with a permuted block scheme, with a block size of four and equal allocation. After identifying and obtaining consent from eligible participants, the local study coordinator telephoned the coordinating center to obtain a randomization number, which corresponded to a specific medication bottle available in the local research pharmacy. Neither the details of the randomization sequence nor the identity of the medication assignment was known to the participant or any personnel Implication for health policy/practice/research/medical education: Primary arteriovenous fistula (AVF), failure remains a major problem for hemodialysis patients. Vascular access thrombosis prophylaxis needs to start early in the end-stage renal disease patient. Ticlopidine seems to be effective and safe for prevention of primary AVF failure in hemodialysis patients. A R T I C L E I N F O