Clinical and Economic Benefits of Stent Grafts in Dysfunctional and Thrombosed Hemodialysis Access Graft Circuits in the REVISE Randomized Trial.

PURPOSE: To compare reinterventions and associated costs to maintain arteriovenous graft hemodialysis access circuits after rescue with percutaneous transluminal angioplasty (PTA), with or without concurrent Viabahn stent grafts, over 24 months. MATERIALS AND METHODS: This multicenter (n = 30 sites) study evaluated reintervention number, type, and cost in 269 patients randomized to undergo placement of stent grafts or PTA alone. Outcomes were 24-month average cumulative number of reinterventions, associated costs, and total costs for all patients and in 4 groups based on index treatment and clinical presentation (thrombosed or dysfunctional). RESULTS: Over 24 months, the patients in the stent graft arm had a 27% significant reduction in the average number of reinterventions within the circuit compared to the PTA arm (3.7 stent graft vs 5.1 PTA; P = .005) and similar total costs ($27,483 vs $28,664; P = .49). In thrombosed grafts, stent grafts significantly reduced the number of reinterventions (3.7 stent graft vs 6.2 PTA; P = .022) and had significantly lower total costs compared to the PTA arm ($30,329 vs $37,206; P = .027). In dysfunctional grafts, no statistical difference was observed in the number of reinterventions or total costs (3.7 stent graft vs 4.4 PTA; P = .12, and $25,421 stent graft and $22,610 PTA; P = .14). CONCLUSIONS: Over 24 months, the use of stent grafts significantly reduced the number of reinterventions for all patients, driven by patients presenting with thrombosed grafts. Compared to PTA, stent grafts reduced overall treatment costs for patients presenting with thrombosed grafts and had similar costs for stenotic grafts.

Drug-eluting tibial stents: objective patency determination.

PURPOSE: Endovascular management of limb-threatening ischemia often requires treatment of tibial occlusive disease. This study was preformed to examine the patency of drug-eluting tibial stents. MATERIALS AND METHODS: The medical records of all patients undergoing drug-eluting tibial stent placement for limb-threatening ischemia from June 2004 to June 2008 were retrospectively reviewed. Postprocedural antiplatelet therapy included clopidogrel and aspirin. Patients were followed with serial arterial duplex ultrasonography and had selective subsequent angiographic evaluation based on noninvasive findings. Primary patency of the target lesion, limb salvage, and survival rates were reported. RESULTS: A total of 240 patients underwent 283 tibial angioplasty procedures to treat limb-threatening ischemia during the 4-year period. Fifty-two patients (22%) had a suboptimal balloon result and were treated with a drug-eluting tibial stent. Balloon-expandable paclitaxel-eluting stents were used in all patients (1.2 stents per patient; range, 1-3; median diameter, 2.75 mm; range, 2.5-3.5 mm; median length, 24 mm; range, 20-32 mm). Forty-eight of those 52 patients (92%) had simultaneous endovascular treatment of proximal lesions. Mean follow-up was 14.3 months (range, 1-48 months). Target lesion patency of the drug-eluting tibial stent was 73% at 24 months (SE < 10%). Limb salvage rate in patients treated with drug-eluting tibial stents was 86% at 26 months (SE < 10%), and the survival rate was 65% at 24 months (SE < 10%). CONCLUSIONS: Drug-eluting tibial stents are a viable option for the endovascular management of limb-threatening ischemia and have acceptable patency rates. The majority of patients require multilevel endovascular treatment, and close surveillance is required for limb salvage.