Aim: It is supposed that calcification in arterial plaques may reduce an antiproliferative effect of drug-coated balloons (DCB) causing a mechanical barrier. Intravascular lithotripsy (IVL), where emitters producing pressure waves are integrated within a balloon catheter, has the potential to disrupt these calcified lesions.
The basic hypotheses of our study were as follows: 1) Is the combination of IVL and subsequent DCB angioplasty superior over the combination of IVL and plain balloon angioplasty concerning long-term patency? 2) Could IVL improve long-term results in comparison with DCB angioplasty without previous IVL?
Methodology: Patients with symptomatic peripheral arterial disease and with calcified stenosis of femoropopliteal arteries were included. They were randomized in two groups: “DCB plus group” (DCB+) treated with IVL and subsequent DCB angioplasty and “DCB minus group” (DCB-) treated after IVL with a plain balloon angioplasty. The Control group, created retrospectively, consists of patients with calcified femoropopliteal stenosis treated using DCB catheters without previous IVL. Patients were followed up both clinically and with duplex ultrasonography at 6-month intervals within 24 months after procedure. The primary endpoint was a comparison of long-term patency among these three groups
Results: 61 procedures were performed – 22 in the group DCB+, 23 in the group DCB- and 16 in the Control group. Baseline and procedural characteristics, angiographic success and safety results do not statistically differ among these three groups. There was also no statistical significance in cumulative patency among these cohorts.
Conclusions: Although there is a tendency towards better long-term results in procedures managed with IVL, statistical significance was not found. Further evaluation of IVL is needed.