Efficacy and safety of excimer laser atherectomy plus drug-coated balloon for infrapopliteal occlusive disease: a retrospective analysis.

PURPOSE: Critical limb ischemia (CLI) due to infrapopliteal artery disease is a major cause of limb loss, prompting a shift toward endovascular therapy. This study compares the efficacy and safety of excimer laser atherectomy (ELA) combined with drug-coated balloon (DCB) angioplasty versus percutaneous transluminal angioplasty (PTA) with DCB in treating infrapopliteal lesions.

METHODS

In this retrospective analysis of 112 patients treated from 2019 to 2021, 59 received ELA + DCB and 53 underwent PTA + DCB. The primary endpoints were 1-year primary vessel patency and freedom from target lesion revascularization (FTLR). Secondary endpoints included changes in Rutherford classification, ankle-brachial index (ABI), and adverse events. Kaplan-Meier analysis and chi-square tests were employed.

RESULTS

Baseline characteristics were comparable (p > 0.05). At 12 months, primary patency was 79.7% in the ELA + DCB group versus 60.6% in the PTA + DCB group (p = 0.018). At 12 months, FTLR was significantly higher in the ELA + DCB group (88.1% vs. 73.6%, p = 0.049); at 6 months, FTLR rates were 93.2% vs. 79.3% (p = 0.303) for the ELA + DCB and PTA + DCB groups, respectively. Moreover, 88.1% of patients in the ELA + DCB group achieved ≥ 1 Rutherford category improvement versus 71.7% in the PTA + DCB group (p = 0.029) by 12 months. ABI values were significantly higher in the ELA + DCB group at both 6 months (0.80 ± 0.10 vs. 0.71 ± 0.14, p < 0.001) and 12 months (0.69 ± 0.21 vs. 0.61 ± 0.21, p = 0.044).

CONCLUSION

ELA + DCB angioplasty provides superior mid-term vessel patency and reduces reintervention compared with PTA + DCB, supporting its role as a promising, minimally invasive treatment for infrapopliteal disease in patients with advanced symptomatic infrapopliteal disease, including those with CLTI. These findings contribute robust evidence to the evolving literature, though larger, multicenter studies with extended follow-up are warranted. CLINICAL TRIAL NUMBER: Not applicable.