Lots of interesting abstracts and cases were submitted for TCTAP 2021 Virtual. Below are accepted ones after thoroughly reviewed by our official reviewers. Don’t miss the opportunity to explore your knowledge and interact with authors as well as virtual participants by sharing your opinion!

TCTAP A-042 . Presentation


Przemek Nowakowski


Przemek Nowakowski1


University of Technology Katowice, Poland1
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Peripheral Vascular Disease and Intervention

Microcrystalline Paclitaxel Coated Balloon for Revascularization of Femoro-popliteal Artery Disease: Three-year Outcomes of the Randomized BIOPAC Trial

Przemek Nowakowski1

University of Technology Katowice, Poland1


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; psup<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.

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TCTAP 2021 Virtual Apr 12, 2021
Good strategy! Congratulations on the great result!