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Research Article
2 December 2024

Clinical and economic implications of focal dissection treatment following percutaneous transluminal angioplasty of the superficial femoral artery: an exploratory analysis based on the TOBA II Study

Authors: Jan B Pietzsch https://orcid.org/0000-0002-5078-1939 [email protected], Benjamin P Geisler, Abigail M Garner, Anne M Ryschon, William A Gray, Masahiko Fujihara, and Peter A SchneiderAuthor Info & Affiliations
Volume 14, Number 1
https://doi.org/10.57264/cer-2024-0055
PDFFormats

Abstract

Aim: Percutaneous transluminal angioplasty (PTA) for peripheral artery disease (PAD) commonly leads to dissections which are associated with higher target lesion revascularization (TLR) rates. Clinical and economic consequences of dissection management in the femoropopliteal artery following PTA, and specifically the potential economic benefit of focal dissection repair using the novel Tack Endovascular System, remain unknown. Methods: A decision-analytic model was used to estimate 24-month clinical events, costs and quality-adjusted life year (QALY) gain for a Tack-supported versus status-quo PTA strategy. Patient and lesion characteristics and TLR rates were derived from the PTA cohort of the TOBA II clinical trial, an observational cohort, and literature. Cost–effectiveness was determined from a US payer and provider perspective separately for the non-severe (grade A or B), severe (grade C and higher) and the entire dissection cohort. Results: TLR rates were lower for the Tack-supported strategy compared with PTA (7.7 vs 27.4% in the non-severe, 13.9 vs 25.8% in the severe and 12.0 vs 26.3% in the entire dissection cohort). Cost and QALY differences were +$297/ + 0.0110 in the non-severe dissection cohort and -$1602/ + 0.0067 in the severe dissection cohort, resulting in an incremental cost–effectiveness ratio (ICER) of $25,622 in the non-severe cohort and dominance in the severe cohort and the entire cohort. Conclusion: Compared with a ‘status-quo’ approach, proactive focal stenting may lead to fewer reinterventions and improved quality of life. There appears to be a graded economic benefit of focal dissection treatment, being cost-effective in non-severe dissections and even cost saving in severe dissections.

Shareable abstract

This analysis explores the health-economic consequences of above-the-knee dissections and assesses the value of TACK treatment. TACK demonstrated to be a high-value intervention, with improved clinical outcomes and a cost-effective ICER.

Plain language summary

Clinical and economic implications of focal dissection following percutaneous transluminal angioplasty of the superficial femoral artery

What is this article about?

This analysis explores the clinical and economic implications of proactive focal stenting compared with standard treatment for dissections following percutaneous transluminal angioplasty, for dissections of different severity.

What were the results?

The cohort receiving proactive focal stenting was associated with lower target lesion revascularization rates (7.7 vs 27.4% in the non-severe, 13.9 vs 25.8% in the severe and 12.0 vs 26.3% in the entire dissection cohort). The resulting incremental cost–effectiveness ratio was $25,622/QALY in the non-severe dissection scenario, with spot stenting resulting in cost-savings in a severe cohort scenario.

What do the results mean?

The results of this analysis suggest spot stenting may contribute to improved clinical outcomes, while also being a cost-effective treatment option, regardless of dissection severity.

Supplementary Material

File (supplementary material.docx)

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