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 - PubMed (original) (raw)

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

Jan B Pietzsch et al. J Comp Eff Res. 2025 Jan.

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.

Keywords: adverse effects; angioplasty; balloon; costs and cost analysis; dissection; peripheral arterial disease.

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Conflict of interest statement

Competing interests disclosure

The authors have no competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Figures

A visual representation of a decision-analytic model for superficial femoral artery endovascular interventions showing a model structure.

Figure 1.. Model structure.

Depicted is a simplified version of the decision-analytic model, in this case a decision tree. Patients start in the model after a PTA for femoropopliteal (fem/pop) disease complicated by a dissection. The status quo strategy involves treatment of the dissection with a bare metal or drug-eluting stent or doing nothing (the probabilities of these interventions vary by dissection severity and are mentioned in Table 2. The combination of dissection severity and nature of the intervention or non-intervention determines the likelihood of a TLR which leads to additional costs for the reintervention and a quality-adjusted life year decrement. PTA: Percutaneous transluminal angioplasty; QALY: Quality-adjusted life year; TLR: Target lesion revascularization.

Comparison of quality-adjusted life year gain and costs for Tack-supported treatment strategy in non-severe and severe dissection cohorts.

Figure 2.. 24-month total costs and projected target lesion revascularizations for the percutaneous transluminal angioplasty ‘status quo’ versus Tack-supported strategies and projected 24-month incremental QALY gain with Tack.

(A) Non-severe dissection cohort. (B) Severe dissection cohort. (C) Total dissection cohort. 24M: Twenty-four months; QALY: Quality-adjusted life year.

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