A randomized pilot study to evaluate graft-first versus fistula-first vascular access strategy in older patients with advanced kidney disease: results of a feasibility study Pilot and Feasibility Studies

Abstract Background. Although older adults encompass 40% of patients with advanced chronic kidney disease (CKD), it remains unclear which long-term hemodialysis (HD) vascular access type, arteriovenous (AV) fistula (AVF) or AV graft (AVG), is optimal with respect to effectiveness and patient satisfaction. Clinical outcomes based on the initial AV access type have not been evaluated in randomized controlled trials. This pilot study tested the feasibility of randomizing older adults with CKD to initial AVF versus AVG vascular access surgery. Methods: Patients 65 years or older with pre-dialysis CKD or incident end-stage kidney disease (ESKD) and no prior AV vascular access intervention were randomized in a 1:1 ratio to undergo surgical placement of either AVF-first or AVG-first after providing informed consent. Trial feasibility was evaluated as (i) recruitment of ≥70% of eligible participants, (ii) ≥50% to 70% of participants undergo placement of index AV access within 90 to 180 days of enrollment, respectively, (iii) ≥80% adherence to study-related assessments, and (iv) ≥70% of participants who underwent index AV access placement will have a follow-up duration of ≥12 months after index surgery date. Results: Between September 2018 and October 2019, 81% (44/54) of eligible participants consented and were enrolled in the study; 11 had pre-dialysis CKD and 33 ESKD. After randomization, 100% (21/21) assigned to AVF-first surgery and 78% (18/23) assigned to AVG-first surgery underwent index AV access placement within a median (1st, 3rd quartile) of 5.0 (1.0, 14.0) days and 13.0 (5.0, 44.3) days, respectively, after referral to vascular surgery. The completion rates for study-specific assessments ranged between 40.0 and 88.6%. At median follow-up of 215.0 days, 5 participants expired, 7 completed 12 months of follow-up, and 29 are actively being followed. Assessments of grip strength, functional independence and vascular access satisfaction were completed by >85% of patients who reached pre-specified post-operative assessment time point. Conclusions: Results from this study reveal it is feasible to enroll and randomize older adults with CKD to one of two different HD vascular access placement surgeries. The study can progress with minimum protocol adjustments to a multisite clinical trial.