RESUMO
In this prospective randomized single-blinded study (reg. ISRCTN11414306), 76 patients with a dysfunctional dialysis fistula or graft due to a single de novo or recurrent stenosis in the access circuit were randomized to receive either conventional PTA (POBA) as a standard of care (n = 38) or PTA + adjunctive PTA with a drug-coated (paclitaxel-resveratrol matrix) SeQuent® Please OTW balloon (n = 38, DCB). Patients were scheduled for follow-up PTA at 3, 6, 9, and 12 months. The time of clinically driven target-lesion reintervention rate (primary patency rate) after the index procedure was analyzed using the log-rank test. The primary patency rates at 12 months after the index procedure were 17% (DCB) vs. 11% (POBA). At 3 months, they were 87% vs. 74%, at 6 months they were 53% vs. 26%, and at 9 months they were 22% vs. 11%. The hazard ratio for DCB was 0.55 (95%CI 0.32 to 0.95). The median time needed for target-lesion reintervention was longer in the DCB group (181 days) than in the conventional PTA group (98 days, p = 0.019). We conclude that PTA with the paclitaxel-resveratrol drug-coated SeQuent® Please OTW balloon in patients with de novo or recurrent stenosis in dialysis arteriovenous fistulas or grafts prolongs the time needed for target lesion reintervention and improves primary patency rates in the first year after the index procedure.
RESUMO
The objective of this prospective randomized single-center study was to compare primary and secondary patency rates, number of percutaneous transluminal angioplasty (PTA) interventions and cost-effectiveness among PTA, deployment of a stent, or a stent graft in the treatment of failing arteriovenous dialysis grafts (AVG) due to restenosis in the venous anastomosis or the outflow vein. Altogether 60 patients with failing AVG and restenosis in the venous anastomosis or the outflow vein were randomly assigned to either PTA, placement of a stent (E-Luminexx®) or stent graft (Fluency Plus®). After the procedure, patients with stent or stent graft received dual antiplatelet therapy for the next three months. Follow-up angiography was scheduled at 3, 6, and 12 months unless requested earlier due to suspected stenosis or malfunction of the access. Subsequently, angiography was performed only if requested by the clinician. During a median follow-up of 22.4 (IQR=5.7) months patients with PTA, stent, or stent graft required 3.1±1.7, 2.5±1.7, or 1.7±2.1 (P=0.031) secondary PTA interventions. The primary patency rates were 0, 18 and 65% at 12 months and 0, 18 and 37% at 24 months in the PTA, stent, and stent graft group respectively (P<0.0001). The cost of the procedures in the first two years was 7,900±3,300 in the PTA group, 8,500±4,500 in the stent group, and 7,500±6,200 in the stent graft group (P=0.45). We conclude that the treatment of failing dialysis vascular access by the deployment of a stent graft significantly improves its primary patency rates and decreases the number of secondary PTA interventions; however, the reduction in costs for maintaining AVG patency is not significant.
RESUMO
BACKGROUND: Reflux esophagitis (RE) may mimic symptoms requiring cross-sectional imaging. METHODS: From 565 patients who had CT and esophagogastroduodenoscopy within four days apart, CT scans of 72 patients with RE confirmed by esophagogastroduodenoscopy and 108 matched patients without RE were evaluated for distal esophageal wall characteristics. RESULTS: In RE patients the distal esophageal wall thickness was greater (5.2±2.0mm) compared to patients without RE (3.5±1.2mm, p<0.0001) with AUC of 0.78 and 56% sensitivity, 88% specificity for a 5.0mm cut-off. CONCLUSIONS: There is a moderate association between distal esophageal wall thickness on CT and RE diagnosed by esophagogastroduodenoscopy as the reference standard.