observed a significant reduction in the incidence of access circuit thrombosis at the 36-month follow-up period. There were no concerns regarding safety at 36 months when the two cohorts were evaluated.
What do you consider the impact of these findings? RL: The major findings were that the use of the
IN.PACT AV DCB demonstrated continued and sustained clinical benefit at 36 months as demonstrated by primary patency of the target lesion, primary patency of the hemodialysis access and freedom from access circuit thrombosis.
What has been the response to these results thus far? RL: Increasingly, vascular specialists who perform hemodialysis maintenance procedures are using these devices largely based on their clinical superiority as compared to plain balloon angioplasty.
What are the next steps? Any additional research planned? RL: There is currently a prospective multicenter registry evaluating real- world applications of this technology, including use in AV grafts, in central veins and in-stent stenosis.
Is there anything not outlined in the paper that readers should know? RL: This is the first prospective randomized trial with an independent core lab to demonstrate sustained clinical benefit of a DCB for AV fistula maintenance out to 36 months.
At a glance
The
IN.PACT AV Access study demonstrated a superior treatment effect of drug-coated balloons (DCBs) compared to percutaneous transluminal angioplasty (PTA) through 6 and 12 months, an effect durable through 24 and 36 months.
Access circuit thrombosis is significantly lower in the DCB group than in the PTA group through 36 months, which is clinically relevant given the impact thrombosis has on patients and their vascular access.
Two large, multicenter, adjudicated DCB trials (Lutonix AV and
IN.PACT AV Access) demonstrated similar mortality rates between the DCB and PTA groups through 24 and 36 months, respectively, creating a definitive reference demonstrating the safety of DCB for the treatment of patients with end-stage kidney disease.
Key insights pulled from JVIR.
18 IRQ | SPRING 2024
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40
