News | Drug-Eluting Balloons | April 28, 2023

IN.PACT AV DCB Sub-analysis Data Shows Sustained Benefit Through 36 Months

The results of a long-term analysis show necessary adjustments in international guidelines as well as in diagnosis and treatment

Getty Images

April 28, 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 six 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 six 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  

For more information: 



  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 


Related Balloon Catheter Content: 

IN.PACT AV Drug-Coated Balloon First and Only to Show Sustained and Superior Performance Compared to PTA Through 36 Months 

Recent Developments in Drug-Coated Balloons 

VIDEO: Overview of Drug-coated Balloons — Interview with Juan F. Granada, M.D. 

New Angioplasty System Dilates Calcified and Fibrotic Vessels  

Balloon Catheter Comparison Chart (requires you to create login but it is free) 

VIDEO: Demonstration of Intravascular Lithotripsy Breaking Up Calcium 

Comparison Chart of Drug-eluting Balloons (requires login but is free to signup) 

FDA Clears Coronary Intravascular Lithotripsy to Breakup Calcified Lesions With Sound Waves  

VIDEO: SCAI Prospective on Key Takeaways at TCT 2019 — Interview with Chandan Devireddy, M.D., including discussion of the LEVANT study results

Related Content

News | Angiography

January 31, 2024 — Coronary artery calcification is increasing in prevalence, leading to greater risks both during ...

Home January 31, 2024
Feature | Angiography | By Bhvita Jani

The world market for interventional X-ray and mobile C-arm equipment is forecast to reach over $4.9 billion by 2026 ...

Home November 09, 2022
News | Angiography
April 6, 2022 – According to ARRS’ American Journal of Roentgenology (AJR), the 3-T Dixon gradient-recalled echo (GRE) ...
Home April 06, 2022
News | Angiography

April 7, 2021 — Philips Healthcare announced U.S. Food and Drug Administration (FDA) 510(k) clearance for its Philips ...

Home April 07, 2021
Feature | Angiography | By Bhvita Jani

January 19, 2021 – With the postponement of non-essential elective surgeries and medical procedures in 2020 to conserve ...

Home January 19, 2021
News | Angiography

December 3, 2020 — GE Healthcare is introducing a new version of its robotic driven angiography system for image guided ...

Home December 01, 2020
Feature | Angiography | Dave Fornell, Editor

Philips is working on a prototype cath lab angiographic imaging system that might be able to replace the current X-ray ...

Home March 12, 2020
News | Angiography

February 12, 2020 — The University of Wisconsin (UW) Health’s University Hospital in Madison, Wis., recently became the ...

Home February 12, 2020
News | Angiography

October 9, 2019 — In the complex and fast-paced world of healthcare, customers face the challenge of staying up-to-date ...

Home October 09, 2019
Technology | Angiography

September 17, 2019 — The U.S. Food and Drug Administration (FDA) has cleared the Artis icono, a high-precision family of ...

Home September 17, 2019
Subscribe Now