No abstract

Background Restenosis remains a problem in hemodialysis access interventions. Paclitaxel-coated balloons have shown promise in reducing access-related restenosis in small trials. The primary hypotheses for our multicenter trial were superior effectiveness at 180 days and noninferior safety at 30 days of a drug-coated balloon compared with conventional angioplasty for treatment of dysfunctional arteriovenous fistulas.Design, setting, participants, & measurements This randomized trial enrolled 285 patients with dysfunctional arteriovenous fistulas at 23 centers. Grafts, central venous stenoses, thrombosed fistulas, and immature fistulas were excluded. All patients received angioplasty of the lesion responsible for access dysfunction. After successful angioplasty (#30% residual stenosis), lesions were treated with either a paclitaxel-coated balloon or an uncoated control balloon of similar design to the drug-coated balloon. Access function during follow-up was determined per centers' usual protocols; reintervention was clinically driven. The primary efficacy outcome assessment was done at 6 months, and the safety assessment was done within 30 days of the procedure. Prespecified secondary end points included assessment of postintervention target lesion primary patency and access circuit primary patency at 6 months.Results The 180-day end point was not met with target lesion primary patency (71%64% for the drug-coated balloon and 63%64% for control; P=0.06), representing a difference of 8%66% (95% confidence interval, 23% to 20%). Access circuit primary patency did not differ between groups. Interventions to maintain target lesion patency were fewer for the drug-coated balloon at 6 months (0.31 versus 0.44 per patient; P=0.03). The primary safety noninferiority end point was met and did not differ between groups (P=0.002).Conclusions Paclitaxel-coated balloon-assisted angioplasty did not meet the primary effectiveness end point at 180 days compared with conventional angioplasty. Both arms showed equivalent safety (ClinicalTrials.gov number NCT02440022).

To present final, 2-year results of a randomized trial comparing paclitaxel-coated vs uncoated balloon angioplasty following vessel preparation with ultra-high-pressure percutaneous transluminal angioplasty (PTA) in hemodialysis arteriovenous fistulae (AVFs). Materials and Methods: Twenty-three sites enrolled 285 subjects with dysfunctional AVFs located in the arm. Before 1:1 randomization, successful vessel preparation was achieved (full waist effacement, < 30% residual stenosis). Follow-up was clinically driven except for a 6-month office visit. Results: Ninety-six of 141 subjects in the drug-coated balloon (DCB) arm and 111 of 144 in the control arm completed the study. Target lesion primary patency (TLPP) rates for the DCB and control groups were 58% ± 4 vs 46% ± 4 (P ¼ .02) at 9 months, 44% ± 5 vs 36% ± 4 (P ¼ .04) at 12 months, 34% ± 5 vs 28% ± 4 (P ¼ .06) at 18 months, and 27% ± 4 vs 24% ± 4 (P ¼ .09) at 24 months, respectively. Mean time to TLPP event for subjects with an event was longer for DCBs (322 vs 207 d; P < .0001). Fewer interventions were needed to maintain target lesion patency in the DCB group at 9 months (P ¼ .02) but not at 12 (P ¼ .08), 18 (P ¼ .13), or 24 months (P ¼ .19). The noninferiority safety target was met at all intervals (P < .01). Mortality did not differ between groups (P ¼ .27). Post hoc analyses showed equivalent DCB effect in all subgroups. Conclusions: Two-year results demonstrate long-term safety and variable efficacy of DCB angioplasty in AVFs. ABBREVIATIONS ACPP ¼ access circuit primary patency, AVF ¼ arteriovenous fistula, AVG ¼ arteriovenous graft, CONSORT ¼ Consolidated Standards of Reporting Trials, DCB ¼ drug-coated balloon, ESRD ¼ end-stage renal disease, RVD ¼ reference vessel diameter, TLP ¼ target lesion patency, TLPP ¼ target lesion primary patency Improving outcomes in access maintenance percutaneous transluminal angioplasty (PTA) is a highly desirable goal, given the modest outcomes afforded by standard PTA and the burgeoning cost of access creation and maintenance (1,2). Although it remains controversial whether maintenance PTA prolongs access life (3-6), maintenance PTA reduces the thrombosis rate and associated hospitalization, catheter placement, and missed dialysis sessions (7-9). In addition to

No abstract

Cardiovascular implantable electronic devices (CIEDs) are frequently utilized for management of cardiac dysrhythmias in patients with chronic kidney disease or end-stage renal disease receiving hemodialysis. The survival benefit from use of implantable cardioverter defibrillators in patients with CKD or ESRD is not as clear as in the general population, particularly when used for primary prevention of sudden cardiac death. Transvenous CIED leads are associated with central vein stenosis resulting in significant adverse consequences for existing or future arteriovenous access. Venous hypertension from CIED lead-related central vein stenosis is a challenging clinical problem and may require repeated percutaneous interventions, replacement of the CIED, or creation of alternative arteriovenous access. Infections associated with transvenous CIED leads are more frequent and associated with worse outcomes in patients with renal disease. Epicardial CIED leads or other nontransvenous devices may reduce complications of both central venous stenosis and endovascular infection in these vulnerable patients. Consensus recommendations are offered for avoidance and management of complications arising from the use of CIEDs and arteriovenous hemodialysis access.