Efficacy and costs of combined balloon dilation plus atherectomy versus combined balloon dilation plus stent for lower-limb peripheral arterial disease: a single-center propensity-matched retrospective cohort study.

OBJECTIVES: To compare one-year vessel patency, limb perfusion and function, and direct and indirect costs between combined balloon angioplasty with rotational atherectomy versus balloon angioplasty with drug-eluting stent placement in patients with lower-limb peripheral arterial disease. DESIGN: Single-center retrospective cohort study. METHODS: Patients treated between January 2020 and December 2023 with atherectomy plus balloon angioplasty (AB group) were propensity-score-matched 1:1 to patients treated with balloon angioplasty plus a paclitaxel-eluting nitinol stent (BS group). The matched cohort included 160 patients per group. The primary outcome was 12-month primary vessel patency. Secondary outcomes were target vessel re-occlusion, ankle-brachial index (ABI), six-minute walk distance, Rutherford classification, disease-specific quality of life (Peripheral Artery Questionnaire, PAQ), major adverse cardiovascular events, and direct and indirect costs at one year. RESULTS: In the matched cohort, 12-month primary patency was similarly high in both groups. Re-occlusion rates were comparable. The adjusted between-group ABI difference at 12 months was 0.010 (95% confidence interval -0.000 to 0.019; p = 0.060). The mean 6-minute walk distance improved by 121.1 m (AB) versus 122.5 m (BS) (p = 0.867). Rutherford category and PAQ score improved similarly in both groups (PAQ increase 25.6 vs. 26.2, p = 0.593). Major adverse cardiovascular events were rare [2 patients (1.3%) in each group by 3 months, none thereafter]. Mean total cost over one year was significantly lower in the AB group (93,189 CNY) than in the BS group (119,702 CNY; p < 0.001), driven by lower device/implant costs (27,574 vs. 54,536 CNY; p < 0.001). CONCLUSIONS: Atherectomy plus angioplasty was associated with 12-month patency and functional outcomes for which no significant difference from balloon angioplasty with drug-eluting stenting was detected, at significantly lower one-year cost. Because the design was powered for superiority rather than non-inferiority, these findings indicate absence of evidence of a difference rather than proven equivalence. The cost difference was driven almost entirely by the lower device price of the atherectomy-based strategy. LEVEL OF EVIDENCE: Therapeutic, Level III (retrospective matched cohort).