The aim of this study was to determine the safety and efficacy of a novel, microcrystalline, biocompatible polymer paclitaxel-coated balloon (mcPCB) including mortality, restenosis and repeated revascularization rates in the treatment of femoropopliteal lesions at long-term follow-up

In this first-in-man, prospective, controlled, randomized trial, 66 patients with femoropopliteal, symptomatic (Rutherford 2B-5) occlusive arterial disease were randomized to either mcPCB (Study Group) or POBA (Control Group) on a 1:1 basis. Late lumen loss (LLL) at six months was the primary endpoint of the study, whereas Serious Adverse Events (SAE: death, amputation, repeated revascularization) were considered a composite secondary endpoint. Routine angiography was scheduled for all study subjects at 6-month follow-up; outpatient appointments were scheduled at 12 and 36 months after intervention.

At 6 months, the LLL was by 62% lower in the mcPCB compared to POBA group (0,52±1,3 vs. 1,39±1,1mm; p_sup<0,01). Binary restenosis occurred in 23% vs 52% patients (p=0,02). At three years, the prevalence of SAE was significantly lower in the mcPCB group (33,3 vs. 63,3%; p=0,02), which mainly resulted from a 2-fold reduction in target vessel revascularization rate (28,6 vs. 59,3%; p=0,02). There was no difference in mortality (7,4 vs 14,3%; p=0,42).Patients with mcPCB were less symptomatic and less likely to adhere to secondary prevention measures.

In this pivotal trial, a novel mcPCB was superior to POBA concerning LLL at six-month follow-up, and SAE at twelve months. This result was sustained up to 3 years. There was no difference between groups regarding mortality.