IN.PACT AV Access DCB Economic Analysis

The economic consequences of not having a patent arteriovenous (AV) access are not trivial, reported Robert Lookstein, MD, from Icahn School of Medicine at Mount Sinai, during an International Symposium on Endovascular Therapy (ISET) 2021 session.

Lookstein and colleagues used 12-month data from the IN.PACT AV Access Trial to assess the economic implications of drug-coated balloon (DCB) versus percutaneous transluminal angioplasty (PTA) in the U.S. healthcare system.

IN.PACT AV Access evaluated the safety and clinical benefit of the IN.PACT AV DCB compared to PTA for treatment of obstructive lesions of native AV fistulas.

Six-month results of the trial, published in 2020 in the New England Journal of Medicine, showed that DCB angioplasty was superior to standard PTA for the treatment of stenotic lesions in patients with end-stage renal disease with de novo or nonstented restenotic native arteriovenous (AV) fistula in the upper extremity.

In recently presented longer-term findings, this benefit was sustained through 2 years.

Lookstein and colleagues conducted two different cost analyses. The first used Markov modeling and looked at index and reintervention costs with a 12- and 36-month horizon. A second approach tapped Medicare claims data and considered comprehensive vascular access costs using a 30-month analysis horizon.

“For the first approach…with standard angioplasty, the reintervention rate per patient was 1.05 at one year. For the IN.PACT DCB, it was 0.65,” reported Dr. Lookstein. Given a reintervention cost of $3,475 per patient, the differences was statistically significant favoring DCB.

In the second analysis, total per-patient costs at 2.5 years using DCB were $16,315 compared to total costs of $34,511 using standard PTA. This accounted for the 53.8% 12-month primary patency seen with DCB, as compared to 32.4% for PTA (P<.001), and the costs of either maintaining or losing primary patency during the 2.5-year period.

“So, you're looking at pretty dramatic cost savings for the ability to maintain someone's patency as compared to if you lose their patency,” said Lookstein.

Savings varied by site of service. “If you're looking at an OBL, at 1 year you're saving $600 and at three years you're saving just under $1,800. If you're doing it in an ASC…and, again, this is based on Medicare claims data, you're saving $1000 in the first year and $2,700 at three-year follow-up,” reported Lookstein.

The savings were higher in an outpatient hospital setting ($2,085 at 1 year, $5,444 at 3 years) and the inpatient hospital setting ($5,557 and $14,509, respectively).

“Costs are relative based on where you are performing these procedures, but you can clearly see dramatic savings in the hospital setting, but there’s even savings in the ASL or OBL settings,” said Lookstein.

Reductions in reintervention, not surprisingly, also had an impact on clinical outcomes, reducing morbidity and improving quality of life.

“If increment DCB device reimbursement is implemented, the improved clinical outcomes could be achieved at overall costs savings at 2.5 years as long as device reimbursement is less than $2380,” Dr. Lookstein reported.

He noted that these findings are based on data from the IN.PACT DCB trial and may not apply to other DCB devices.