Intravascular lithotripsy of the femoropopliteal arteries: analysis of a prospective two-center pilot study

Introduction
Intravascular lithotripsy (IVL) is an emerging option for endovascular treatment of calcified lesions of the peripheral arteries. However, its clinical significance has not yet been firmly established. It is also hypothesized that IVL may improve long-term outcomes of drug-coated balloon (DCB) angioplasty by disrupting calcified barriers, thereby enabling improved drug penetration.

Aim
The aim of this pilot study was to clarify the feasibility and safety of IVL in calcified femoropopliteal stenoses. Another objective was to determine whether IVL can potentiate the long-term effect of DCB angioplasty in calcified femoropopliteal lesions.

Material and methods
Patients with significant calcified stenoses of the femoral and/or popliteal arteries were enrolled and assigned to two groups. The DCB plus group (DCB+) received IVL and subsequent DCB angioplasty, while the DCB minus group (DCB–) underwent IVL and, if necessary, plain balloon angioplasty.

Results
A total of 45 procedures were performed: 22 in the DCB+, 23 in the DCB– group. Angiographic success rates were 90.9% in the DCB+ group and 87.0% in the DCB– group. At the 24-month follow-up, cumulative patency did not differ significantly between the groups (65.22% for DCB–, 58.85% for DCB+). No amputations were required during follow-up.

Conclusions
IVL has proven to be a safe approach, yielding favorable immediate results. Regarding long-term patency, our study found no significant differences between the DCB+ and DCB– groups. However, the smaller number of patients in each group may have limited the ability to draw definitive conclusions.