Peripheral embolism and microcirculation during revascularization of the superficial femoral artery with native and drug-coated balloons over a one-year follow-up period

Abstract

Relevance. The embolic effect of drug-coated balloons has only been demonstrated in preclinical studies.Aim: To identify intraoperative distal embolism when using drug-coated balloons during revascularization of the superficial femoral artery. To evaluate the effect of drug embolism on microcirculation of the lower extremities within 12 months after treatment.Material and Methods. Prospective, randomized, single-center pilot study. Twenty patients with symptomatic atherosclerotic femoro-popliteal above the knee lesions were included in the study. The first group underwent percutaneous transluminal angioplasty (PTA) using a drug-coated balloon (DCB), the second group – using a non-drug-coated conventional balloon (CB).Results. During intraoperative detection of emboli, distal microembolism was recorded in 10 patients (100%) in the DCB group (median number of emboli = 200) and in 8 patients (80%) in the CB group (median number of emboli = 135), p = 0.47. Primary patency in the DCB group was 100%, in the CB group 60% (p log-rank = 0.02). In the shin there was increase in TcPO2 by 12.2% in the DCB group (p = 0.42), and by 37.1% in the CB group (p = 0.001). At the same time, according to the results of TcPO2 on the shin in the DCB group, there was first a slight decrease in indicators compared to the preoperative level by 6% (p = 0.64), followed by an increase of 12.2% after 12 months of observation (p = 0.22). In the DCB group, the sum of SF-36 questionnaire points increased by 22.7% (p = 0.017), and by 25.3% in the CB group, compared to baseline values respectively (p = 0.04).Conclusion. When using DCB, there is a tendency towards a higher incidence of intraoperative distal embolism and the number of emboli compared with CB. The results of microcirculation studies suggest the presence of distal drug-coated embolism in DCB group.