Combining Cutting and Drug-eluting Balloon for Resistant Arteriovenous Fistula Stenosis (CONCERTO)-A Pilot Study.

Purpose: To evaluate the feasibility and preliminary evidence of the efficacy of combined cutting balloon and drug-coated balloon angioplasty for the treatment of arteriovenous fistula stenoses resistant to conventional balloon angioplasty. Material and Methods: From August 2018 to January 2019, 19 patients (mean age = 64.9 ± 8.6 years; males = 63%) with resistant arteriovenous fistula stenosis, defined as >30% residual stenosis after conventional balloon angioplasty, were enrolled into this single-center prospective pilot study. The resistant arteriovenous fistula stenoses were treated with a cutting balloon followed by a drug-coated balloon. The primary outcome measure was 6-month target lesion patency. Results: The degree of residual stenosis after conventional balloon angioplasty was 48.8 ± 11.3%, decreasing to 18.7 ± 10.4% after combined cutting and drug-coated balloon angioplasty. Technical success, defined as < 30% residual stenosis, was achieved in 94.7% (18 of 19 stenoses). The 6-month target lesion patency was 100%, while the 6-month access circuit primary patency was 94.7% (n = 18/19) due to recurrent non-target lesion stenosis. No venous rupture or major complication was encountered. Conclusions: This pilot study provides evidence to support the conduct of a phase 3 randomized clinical trial to prove the superiority of a cutting balloon and drug-coated balloon combination for resistant arteriovenous fistula stenoses.