Cost-Effectiveness of Endovascular Femoropopliteal Intervention Using Drug-Coated Balloons Versus Standard Percutaneous Transluminal Angioplasty: Results From the IN.PACT SFA II Trial

Abstract

Objectives: The aim of this study was to evaluate the cost-effectiveness of drug-coated balloon (DCB) angioplasty versus standard percutaneous transluminal angioplasty (PTA).

Background: Recent trials have reported lower rates of target lesion revascularization with DCB angioplasty versus standard PTA. However, the cost-effectiveness of DCB angioplasty is unknown.

Methods: A prospective economic study was performed alongside the IN.PACT SFA II (IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery [SFA] and Proximal Popliteal Artery [PPA]) trial, which randomized 181 patients with femoropopliteal disease to the IN.PACT DCB versus standard PTA. Resource use data were collected over 2-year follow-up, and costs were assigned using resource-based accounting and billing data. Health utilities were assessed using the EuroQol 5-dimensions questionnaire. Cost-effectiveness was assessed as cost per quality-adjusted life-year (QALY) gained using a decision-analytic model on the basis of empirical data from the trial assuming identical long-term mortality.

Results: Initial costs were $1,129 per patient higher with DCB angioplasty than standard PTA, driven by higher costs for the DCB itself. Between discharge and 24 months, target limb-related costs were $1,212 per patient lower with DCB angioplasty such that discounted 2-year costs were similar for the 2 groups ($11,277 vs. $11,359, p = 0.97), whereas QALYs tended to be greater among patients treated with DCBs (1.53 ± 0.44 vs. 1.47 ± 0.42, p = 0.40). The probability that DCB angioplasty is cost-effective compared with standard PTA was 70% using a threshold of $50,000 per QALY gained and 79% at a threshold of $150,000 per QALY gained.

Conclusions: For patients with femoropopliteal disease, DCB angioplasty is associated with better 2-year outcomes and similar target limb-related costs compared with standard PTA. Formal cost-effectiveness analysis on the basis of these results suggests that use of the DCB angioplasty is likely to be economically attractive.

Keywords: angioplasty; cost-effectiveness; drug-coated balloon; femoropopliteal artery; peripheral arterial disease.