Two-Year Health Economic Data Support Use of Medtronic's In.Pact Admiral DCB

November 2, 2015—Two-year results from the IN.PACT SFA health economic study were presented by David Cohen, MD, during the first of two Late-Breaking Trials sessions at VIVA 15, the 13th annual Vascular InterVentional Advances meeting. The meeting, which is sponsored by VIVA Physicians, Inc., is being held November 2–5, 2015, at the Wynn Las Vegas in Las Vegas, Nevada. The session moderators are Michael R. Jaff, DO, and Krishna Rocha-Singh, MD.

As noted in the VIVA announcement, the background of the study is that recent trials have reported higher rates of primary patency after endovascular treatment of femoropopliteal stenoses with drug-coated balloons (DCBs) compared with standard percutaneous transluminal angioplasty (PTA). The study was conducted because initial costs of DCBs are higher than standard PTA balloons, so it is important to understand the relative cost-effectiveness of these alternative approaches.

A prospective economic study was performed alongside the IN.PACT SFA-II trial that randomized 181 patients in the United States with symptomatic femoropopliteal disease to the In.Pact Admiral DCB (Medtronic plc) versus standard PTA and followed them for a minimum of 24 months.

Medical resource utilization and cost data were collected for all patients. Cost-effectiveness was assessed in terms of cost per quality-adjusted life year (QALY) gained and cost per target limb revascularization avoided.

The investigators found that the initial hospital costs were $1,129 higher per patient in the DCB group than the PTA group, driven largely by the acquisition costs for the DCB itself.

Between discharge and 2 years, costs for follow-up care related to the target limb were $1,211 lower per patient in the DCB group, so that total 2-year costs were virtually identical for the two groups ($11,277 vs $11,359; P = .97).

Formal cost-effectiveness analyses based upon these results (and assuming similar long-term survival for the two treatments) demonstrated that DCB was an economically dominant strategy compared with standard PTA (lower costs, better outcomes) and that the probability that DCB was economically attractive compared with standard PTA was 70% using a threshold of $50,000 per QALY gained and 79% using a threshold of $150,000 per QALY gained.

In summary, PTA with the In.Pact Admiral DCB was associated with higher initial costs than standard PTA, but improved clinical outcomes and similar vascular-related costs through 2 years of follow-up. Based on these findings, use of the In.Pact Admiral DCB appears to be a highly cost-effective and possibly economically dominant strategy compared with standard PTA for femoropopliteal disease, advised Dr. Cohen in the VIVA presentation.