Today Medtronic shared a six-month subgroup analysis from the IN.PACT AV Access trial, which evaluated how the IN.PACT AV DCB—an investigational device not currently approved for use in the USA—performed in different target lesion types, arteriovenous fistula (AVF) types, and target lesion locations in the arm with the goal of determining where the DCB may demonstrate the most clinical benefit to patients receiving haemodialysis.
This analysis, a follow-up to the full six-month clinical outcomes from the IN.PACT AV Access trial at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) meeting in September, was presented today by Robert Lookstein of Mount Sinai Hospital in the late-breaking clinical trials session at the Vascular and Interventional Advances (VIVA) meeting in Las Vegas, USA (4–7 November).
Target lesion types
The analysis assessed the six-month target lesion primary patency (TLPP) in participants with de novo (30.3% (100/330)) and restenotic lesions (69.7% [230/330]) in comparison between the treatment of IN.PACT AV DCB and standard PTA control:
- De novo lesions: At six months, participants in the IN.PACT AV DCB group demonstrated a 90.7% TLPP rate compared to a 75.6% TLPP rate in the Standard PTA control group (difference of 15.1%).
- Restenotic lesions: At six months, participants in the IN.PACT AV DCB group demonstrated a 78.9% TLPP rate compared to a 52.4% TLPP rate in the Standard PTA control group (difference of 26.5%).
AV fistula types and target lesion locations
Furthermore, the analysis evaluated the effectiveness of IN.PACT AV DCB compared to standard PTA in participants with different AVF types and target lesion locations. In all cases, IN.PACT AV DCB was favored compared to Standard PTA control:
- Participants 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%, 84.6% respectively.
- Participants with target lesions located in the anastomosis, cephalic arch, and swing point treated with DCB had TLPP rates of 84.6%, 84.0% and 83.3%, respectively.
In conclusion, the consistent effectiveness performance was observed in all analysed subgroups—superior target lesion primary patency was achieved with IN.PACT AV DCB in both de novo and restenotic lesions and all studied types of AV access. Superior target lesion primary patency was also achieved at all studied anatomic locations, especially the anastomosis and cephalic arch.