Medtronic’s IN.PACT AV Access Study’s 24-Month Outcomes Presented

October 6, 2021—Robert Lookstein, MD, presented 24-month outcomes from the IN.PACT AV Access study in a late-breaking clinical trial session at VIVA 2021, the annual Vascular InterVentional Advances meeting held October 4-7 in Las Vegas, Nevada. The IN.PACT AV Access study is an independently adjudicated, prospective, global, multicenter, single-blinded study of the treatment of obstructive lesions of a native upper-extremity arteriovenous (AV) fistula using the In.Pact AV drug-coated balloon (DCB; Medtronic).

As summarized in the VIVA announcement, patients in the study were randomized to treatment with the In.Pact AV DCB (n = 170) or standard uncoated percutaneous transluminal angioplasty (PTA; n = 160). The effectiveness outcome through 24 months was the rate of target lesion primary patency (TLPP), defined as freedom from clinically driven target lesion revascularization or access circuit thrombosis.

Dr. Lookstein reported that several subgroups showed statistically significantly higher TLPP results with the DCB compared to PTA based on time-to-event analyses through 24 months, including restenotic lesions (46.0% vs 30.2%), radiocephalic AV fistulas (53.6% vs 43.0%), brachiocephalic AV fistulas (48.5% vs 27.3%), anastomotic lesions (48.4% vs 32.7%), and lesions in the cannulation zone (74.2% vs 18.9%)

Additionally, TLPP was significantly higher with DCB compared to PTA in subgroups determined by maximum treatment balloon diameters: > 6-mm subgroup (52.2% vs 38.9%) and ≤ 6-mm subgroup (52.1% vs 32.6%).

As noted in the VIVA press release, although sample sizes were small, superior TLPP through 24 months was observed with DCB in restenotic lesions, radiocephalic and brachiocephalic AV fistulas, and lesions in the anastomosis or in the cannulation zone.

Benefits were seen in all other subgroups, although the treatment effect was not statistically significant. With regard to treatment balloon size, the greatest TLPP benefit was in lesions treated with smaller balloon diameters.

These results demonstrate the sustained effectiveness of DCBs, suggesting the use of this therapy for patients at high risk of repeat interventions, concluded the study investigators in the VIVA press release.