Late Breaking

Economic Impact Of Drug-Coated Balloon Usage For AV-Access Based On 12 Month Data From The IN.PACT AV Access Study

Presented During:

Sat, 6/13/2020: 12:32 PM  - 1:41 PM 
Room: Webinar  

Final ID:



R Lookstein1, B Geisler2, S Misra3, S Lyden4, B Manda5, T Pflederer6, J Pietzsch2


1Icahn School of Medicine at Mount SInai, New York, NY, 2Wing-tech Inc, Menlo Park, CA, 3Mayo Clinic & Foundation, Rochester, MN, 4Cleveland Clinic, Cleveland, OH, 5Medtronic, San Jose, CA, 6RenalCare Associates, PC, Peoria, IL

First Author:

Robert A. Lookstein, MD, MHCDL, FSIR  
Icahn School of Medicine at Mount SInai
New York, NY


Benjamin P Geisler, MD, MPH, MRCP  
Wing-tech Inc
Menlo Park, CA
Sanjay Misra, MD, FSIR  
Mayo Clinic & Foundation
Rochester, MN
Sean Lyden, MD  
Cleveland Clinic
Cleveland, OH
Bharati Manda, MS  
San Jose, CA
Timothy A. Pflederer, MD  
RenalCare Associates, PC
Peoria, IL
Jan B Pietzsch, PhD  
Wing-tech Inc
Menlo Park, CA

Presenting Author:

Robert A. Lookstein, MD, MHCDL, FSIR  
Icahn School of Medicine at Mount SInai
New York, NY


Arteriovenous fistula (AV) access dysfunction causes significant patient morbidity and costs, with Medicare spending on AV access approaching $3 billion annually. Recently, 12-month data from the IN.PACT AV Access study has shown a decreased number for reinterventions after drug-coated balloon (DCB) compared with standard percutaneous transluminal angioplasty (PTA). Our objective was to explore the economic value of DCB in the US healthcare system based on these data.


Cost differences between DCB and PTA at one year and longer duration will be estimated via two approaches: First, based on the trial-observed 12-month primary patency of the access circuit and previously published AV-access related costs for Medicare subjects with maintained vs. not maintained primary patency.. Second, via the mean absolute number of in-trial access circuit reinterventions at month 12 and current Medicare reimbursement amounts. The effect of key variables will be explored in sensitivity analyses. In addition, we will calculate the cost per reintervention avoided and the number needed to treat (NNT) to avoid one reintervention over the one-year follow-up horizon.


Using the primary patency approach, the IN.PACT DCB strategy (prior to consideration of DCB device cost) was associated with cost savings of $2,152 at one year and $3,894 at 2.5 years follow‐up. Using the absolute number of procedures approach resulted in estimated savings of $2,490 at 2.5 years. These findings suggest that DCB, at 2.5 years follow‐up, could be expected to be cost‐saving incremental costs for the DCB strategy are $2,400 or less. Over a one‐year horizon, cost per reintervention avoided ranged from $2,270 to $3,638 for assumed incremental DCB therapy cost of $2,000 and $2,500, respectively. The one‐year NNT of DCB compared to PTA was 2.48.


Endovascular drug‐coated balloon therapy for arteriovenous access stenosis with the IN.PACT balloon has a high likelihood of being cost-saving should longer follow‐up data confirm its clinical effectiveness.

Abstract Categories:

Dialysis Interventions


Dialysis intervention
drug coated balloon