Vessel and balloon sizing in the IN.PACT AV access trial: post-hoc analysis of procedural characteristics and outcomes

Abstract Background Drug-coated balloons (DCBs) have demonstrated effectiveness and safety in the treatment of dysfunctional arteriovenous fistulas used for hemodialysis in larger randomized studies; however, the patient and lesion profiles that have the best DCB outcomes remain undefined. Pivotal trials with core lab adjudication are ideal to generate hypotheses for future studies of intra-procedural characteristics given they include both site-reported and independently assessed data. The IN.PACT AV Access Trial randomized 330 patients 1:1 to treatment with a DCB ( n = 170) or uncoated percutaneous transluminal angioplasty (PTA; n = 160). This exploratory post-hoc analysis investigated core lab adjudicated vessel sizing in the context of target lesion primary patency (TLPP) outcomes through 36 months. Participants were split into groups by median reference vessel diameter (RVD). Results The IN.PACT AV Access Trial randomized 330 patients 1:1 to treatment with a DCB ( n = 170) or uncoated percutaneous transluminal angioplasty (PTA; n = 160). This exploratory post-hoc analysis investigated core lab adjudicated vessel sizing in the context of target lesion primary patency (TLPP) outcomes through 36 months. Participants were split into groups by median reference vessel diameter (RVD). Conclusions This post hoc analysis identified that intra-procedural sizing decisions have the potential to positively impact outcomes in patients with dysfunctional fistula lesions. These findings warrant further prospective evaluation to define optimal DCB sizing strategies. Trial registration NCT03041467 . Registered 25 April 2017. Level of evidence 3 Graphical Abstract