IN.PACT™ AV DCB Sub-analysis Data Shows Sustained Benefit Through 36 Months; No Difference in Mortality Through 48 Months

Thursday, April 27, 2023 -- Medtronic today shared additional 36-month data from the IN.PACT AV Access Study, as well as 48-month vital status outcomes. The data was presented by Professor Andrew Holden, director of interventional radiology and associate professor of radiology, Auckland University School of Medicine, as a podium first at the 2023 Charing Cross Symposium in London.
 
The IN.PACT AV Access study is a randomized controlled trial comparing IN.PACT AV DCB to standard percutaneous transluminal angioplasty (PTA) in participants with de novo or non-stented restenotic AV fistula lesions.
 
The presentation showed durable, long-term results that demonstrated the sustained and superior performance of DCB compared to PTA through 36 months, with no difference in mortality through 48 months and sustained benefit seen in several subgroups. Findings shared included:

The Kaplan-Meier estimated target lesion primary patency for several subgroups was reported through 36 months, demonstrating the continued sustained effectiveness with DCB:

• Peri-anastomotic lesion location: 40.4% in the DCB group and 31.1% in the PTA group (log-rank p=0.047)
• Restenotic lesion type: 40.5% in the DCB group and 22.7% in the PTA group (log-rank p<0.001)
• Forearm fistulas: 44.5% in the DCB group and 33.8% in the PTA group (log-rank p=0.039)
• Upper arm fistulas: 39.9% in the DCB group and 21.3% in the PTA group (log-rank p=0.011)

The Kaplan-Meier estimated cumulative incidence of all-cause mortality post vital status update through 48 months was 34.6% in the IN.PACT AV DCB group and 41.8% in the PTA control group (log-rank p=0.42).
 
The IN.PACT AV Access Study
Initial results of the IN.PACT AV Access study were published in The New England Journal of Medicine (NEJM) in August 2020.¹ The trial met both its primary safety and effectiveness endpoints— showing promise for the use of the IN.PACT AV DCB to treat AV fistula lesions in ESKD patients. 
 
Through 6 months, target lesion primary patency was 82.2% in the DCB group compared to 59.5% in the PTA group (log-rank p<0.001). Additionally, there was a 56% reduction in reinterventions through 6 months.
 
Since that time, results have continued to demonstrate a durable and sustained treatment effect of DCB compared to PTA through 12, 24, and 36 months. Publications have continued to be developed based on this data, with four new manuscripts coming from the 12-month time point to date:

• Clinical outcomes published in The Journal of Vascular and Interventional Radiology (JVIR) in August 2022²
• Economic outcomes published in JVIR in August 2022³
• Economic outcomes focused on the Japanese and South Korean health care system published in The Asian Pacific Society of Nephrology Journal in September 2022⁴
• Clinical outcomes of Japanese participations published in Therapeutic Apheresis and Dialysis in March 2023⁵ 

 
References
1. Lookstein R, Haruguchi H, Ouriel K, et al. Drug-Coated Balloons for Dysfunctional Dialysis Arteriovenous Fistulas. New England Journal of Medicine. 2020;383:733-742. doi:10.1056/NEJMoa1914617
2. Holden A, Haruguchi H, Suemitsu K, et al. IN.PACT AV Access Randomized Trial: 12-Month Clinical Results Demonstrating the Sustained Treatment Effect of Drug-Coated Balloons. J Vasc Interv Radiol. Aug 2022;33(8):884-894 e7. doi:10.1016/j.jvir.2022.03.606
3. Pietzsch JB, Geisler BP, Manda B, et al. IN.PACT AV Access Trial: Economic Evaluation of Drug-Coated Balloon Treatment for Dysfunctional Arteriovenous Fistulae Based on 12-Month Clinical Outcomes. J Vasc Interv Radiol. Aug 2022;33(8):895-902 e4. doi:10.1016/j.jvir.2022.04.014
4. Chun HJ, Cao KN, Haruguchi H, et al. Economics of drug-coated balloons for arteriovenous fistula stenosis in Japan and Korea based on the IN.PACT AV access trial. Nephrology (Carlton). Nov 2022;27(11):859-868. doi:10.1111/nep.14085
5. Haruguchi H, Suemitsu K, Isogai N, et al. IN.PACT AV access randomized trial: Japan cohort outcomes through 12 months. Ther Apher Dial. 2023;doi:10.1111/1744-9987.13966