IN.PACT AV Access Randomized Trial: 12-Month Clinical Results Demonstrating the Sustained Treatment Effect of Drug-Coated Balloons

IN.PACT AV Access Trial: Economic Evaluation of Drug-Coated Balloon Treatment for Dysfunctional Arteriovenous Fistulae Based on 12-Month Clinical Outcomes

“…This study and the underlying IN.PACT AV Access study were sponsored by Medtronic. Cost differences between the DCB and PTA strategies were estimated via 2 different analyses, both using the U.S. Medicare perspective for costs and the 12-month clinical results for outcomes (13). In the first analysis, the DCB-and PTA-specific total treatment costs (including index procedure and access circuit reinterventions) were calculated using the reintervention rates from the clinical trial and the applicable Medicare reimbursement amounts, projecting costs through 3 years of follow-up.…”

“…In the first analysis, the DCB-and PTA-specific total treatment costs (including index procedure and access circuit reinterventions) were calculated using the reintervention rates from the clinical trial and the applicable Medicare reimbursement amounts, projecting costs through 3 years of follow-up. In the second analysis, the cost difference between the DCB and PTA strategies was calculated on the basis of the trialobserved 12-month access circuit primary patency (ACPP) rates and previously published AV access-related costs over 2.5 years in Medicare beneficiaries, associated with maintained versus lost primary patency (6,13). In addition, the number needed to treat (NNT) was calculated.…”

“…Analysis inputs are shown in Table 1. Clinical data and resource utilization for the DCB and PTA strategies were obtained from the 12-month data of the IN.PACT AV Access study (13). In brief, this was a prospective multicenter randomized clinical trial that evaluated the IN.PACT AV DCB (Medtronic Inc., Santa Rosa, California) versus PTA in participants with de novo or nonstented restenotic lesions up to 100 mm in length in AV dialysis fistulae.…”

“…In that study (12), DCBs had a higher target lesion primary patency than PTA through 6 months (82.2% vs 59.5%; absolute risk difference 22.8%, with a 95% confidence interval (CI) of 12.8%-32.8%). The 12-month clinical outcomes have been reported in this issue of Journal of Vascular and Interventional Radiology (13). However, not much is known about the economic consequences of DCB use in this clinical indication.…”

Economics of drug‐coated balloons for arteriovenous fistula stenosis in Japan and Korea based on the IN.PACT AV access trial

“…Drug‐coated balloons (DCB) have emerged as a novel alternative to PTA using a standard balloon in the management of stenotic AV fistulas for HD patients, with the expectation that the lower reintervention burden associated with DCB use might not only benefit patients, but importantly also reduce clinical resource utilization and treatment expenses. The IN.PACT AV Access Study recently reported an improved target lesion primary patency for DCBs versus PTA at 12 months (63.8% [90 of 141] versus 43.6% [61 of 140], with an absolute difference in risk of 20.3%, 95% confidence interval [CI], 8.8–31.7%; p < .001), and access circuit reintervention events that were 38% lower in the DCB cohort (0.65 versus 1.05, p < .001) 10 …”