Economic impact and future directions: assessing value in peripheral revascularisation

A decision model simulating patency at 1 and 2 years for POBA, BMS, DCBs, and DESs in a Medicare population demonstrated that, at 2 years, DCBs emerged as the most cost-effective initial treatment strategy, with the lowest overall costs and the highest modelled patency over the study horizon⁵. However, such findings should be interpreted in light of the model assumptions regarding the relationship between patency, TLR, and subsequent costs. Similarly, a comparison of BMS, DESs, DCBs, and POBA within the German public healthcare system and a Medicare population found that DCBs and DESs were associated with lower overall costs than BMS and POBA, largely because of lower probabilities of TLR⁶.

In a single-state US model based in Florida, with a 5-year time horizon, DES adoption instead of BMS was predicted to generate cost savings, provided that the incremental cost of DES over BMS remained below $677.59⁷. Likewise, a French healthcare system-based analysis projected a net cumulative 5-year budget reduction of €6,807,202 for a population of 82,316 patients, including 21,361 patients treated with DESs⁸.

A budget impact analysis from Ontario, Canada, estimated annual savings of $470,000–640,000, based on the assumption that the use of DESs was associated with a lower risk of subsequent revascularisation⁹.

While most economic studies compared endovascular modalities, the randomised ZILVERPASS study also provides an important comparison with surgical bypass¹⁰. Its 3-year clinical and economic analysis, taking into account procedural, hospitalisation, and reintervention costs, demonstrated a clear cost benefit for DESs in both Germany and the US and confirmed that DESs can be considered a valid alternative to bypass surgery for long and complex femoropopliteal lesions.

Most of the studies discussed above evaluated populations with intermittent claudication. The economic implications may be substantially different in CLTI, where the costs associated with hospitalisation, prolonged wound care, infection, rehabilitation, major amputation, prosthetic provision, and loss of independence can substantially exceed those associated with the treatment of claudication. A pilot study co-sponsored by the CLI Global Society, evaluating the economic burden of CLTI in Germany, estimated total direct and indirect costs of approximately €9 billion, with an additional €1.6 billion attributable to the management of unhealed ulcers¹¹. For this reason, economic evaluations in CLTI should not rely primarily on patency or TLR. More clinically meaningful endpoints include major amputation avoided, amputation-free survival, time to wound closure, wound-free days, hospital and rehabilitation days, the need for prosthetic care, maintenance of independent living, quality of life, and QALYs. A recent UK modelling and budget impact analysis based on national registry data estimated that reducing the proportion of major lower-limb amputations performed as the initial procedure for CLTI from 10% to 3% could generate net savings of approximately €9.6 million for the NHS¹².

The economic evaluation of transcatheter arterialisation of the deep veins (TADV) provides an instructive example of how new technologies should be assessed in CLTI. In a recent analysis comparing TADV with conventional therapy in patients with no-option CLTI, TADV was associated with higher upfront costs but also with improved limb salvage, survival, and amputation-free survival at 1 year. Over a lifetime horizon, the model projected an additional 1.15 QALYs and 2.33 life-years, with an incremental cost of $24,738 and an ICER of approximately $21,600 per QALY gained¹³.

A subgroup analysis of the IN.PACT Global study specifically evaluating the cost-effectiveness of DCB use in the femoropopliteal segment in patients with CLTI showed that urea-excipient DCB therapy was associated with improved patient outcomes and expected overall cost savings for payers in the Dutch and German healthcare systems, resulting in a cost-effective and potentially dominant treatment strategy¹⁴. A large Medicare cohort of patients with CLTI compared three strategies: POBA with or without BMS, DCBs, and DESs¹⁵. Both DCBs and DESs were associated with reduced amputation and mortality rates, while DCBs appeared to provide clinical benefits without a corresponding increase in costs.

No cost-effectiveness studies evaluating DCB or DES use in the BTK segment have been identified in the literature, likely reflecting the historically limited evidence supporting these technologies in this anatomical territory.

The next generation of drug-coated technologies—including sirolimus-coated balloons and drug-eluting resorbable scaffolds—will therefore require economic evaluation alongside clinical efficacy. Prospective economic analyses should be embedded in randomised trials of new technologies, particularly in CLTI and below-the-knee disease.