November 5, 2019
Findings Presented From a Subgroup Analysis of Medtronic's In.Pact AV DCB
November 6, 2019—Medtronic announced that findings from a 6-month subgroup analysis from the IN.PACT AV Access trial were presented by Robert Lookstein, MD, in a late-breaking clinical trial session at VIVA 2019, the Vascular InterVentional Advances meeting held November 4–7 in Las Vegas, Nevada.
The analysis evaluated how the company’s investigational arteriovenous (AV) drug-coated balloon (DCB), the In.Pact AV DCB, performed in different target lesion types, AV fistula types, and target lesion locations in the arm. The goal of the analysis was to determine where the DCB may demonstrate the most clinical benefit to patients receiving hemodialysis. The In.Pact AV DCB is an investigational device not currently approved for use in the United States, advised Medtronic.
This analysis is a follow-up to the full 6-month clinical outcomes from the IN.PACT AV Access trial that was presented at CIRSE 2019, the annual conference of the Cardiovascular and Interventional Radiological Society of Europe held September 7–11 in Barcelona, Spain. The IN.PACT AV Access trial, which met its primary safety and effectiveness endpoints, is comparing the In.Pact AV DCB to percutaneous transluminal angioplasty (PTA) in end-stage renal disease patients with de novo or nonstented restenotic AVF lesions.
According to Medtronic, the analysis assessing target lesion primary patency (TLPP) in patients with de novo (30.3% [100/330]) and restenotic lesions (69.7% [230/330]) in comparison between the treatment of In.Pact AV DCB versus standard PTA control at 6 months found:
- In de novo lesions, a TLPP rate of 90.7% vs 75.6% (difference of 15.1%)
- In restenotic lesions, a TLPP rate of 78.9% vs 52.4% (difference of 26.5%)
In evaluation of the effectiveness of In.Pact AV DCB compared with the standard PTA control in patients with different AVF types and target lesion locations, the In.Pact AV DCB was favored in all cases, as follows:
- Patients with target lesions in different AV fistula types treated with In.Pact AV DCB, including radiocephalic, brachiocephalic, and brachiobasilic, had TLPP rates of 81.7%, 80.8%, and 84.6%, respectively.
- Patients with target lesions located in the anastomosis, cephalic arch, and swing point treated with DCB had TLPP rates of 84.6%, 84%, and 83.3%, respectively.
As stated in the company’s announcement, the conclusion of the analysis is that the consistent effectiveness performance was observed in all analyzed subgroups with superior TLPP achieved with In.Pact AV DCB in de novo and restenotic lesions and all studied types of AV access. Superior TLPP was also achieved at all studied anatomic locations, especially the anastomosis and cephalic arch, advised Medtronic.