Second generation PCB coatings have shown improved outcomes in experimental setting, however clinical data are missing.
Lots of interesting abstracts and cases were submitted for TCTAP & AP VALVES 2020 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!
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ABS20191023_0004
| Peripheral Vascular Disease and Intervention | |
| 3 Year Follow-Up in BIOPAC Trial – Treating Lesions in Femoro-Popliteal Segment Using Microcrystalline and Biocompatible Polymer Paclitaxel Coated Balloon vs. Plain Balloon Angioplasty | |
| Przemek Nowakowski1, Buszman Piotr2 | |
| University of Technology, Katowice, Poland1, Cracow Academy, Poland2 | |
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Background:
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Methods:
In this first-in-man, prospective, controlled and randomized trial, patients with femoro-popliteal symptomatic (Rutherford 2B-4), occlusive arterial disease were randomized 1:1 to either to PBA or PBA followed by mcPCB inflation. Late lumen loss (LLL) was the primary endpoint of the study. Serious Adverse Events (SAE, death, amputation, repeated revascularization) were considered secondary endpoints. Routine angiography was scheduled at 6 months and ambulatory follow-up at twelve in all subjects. Current follow-up time and ambulatory control is 3 years.
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Results:
In total 66 patients were included: 33 randomized to mcPCB and 33 to PBA. Mean lesion length was 58¡¾49 vs. 63¡¾45 mm, most classified as TASC B (50,0 vs. 54,3%) and C category (29,4 vs. 20,0%). At 6 months, the LLL was lower by 62% (0,52¡¾1,3 vs. 1,39¡¾1,1 mm) in the mcPCB when compared to POBA, psup<0,01. Binary restenosis occurred in 23% vs. 52% patients subsequently (p=0,02). ABI was significantly higher in patients in the studied group (0,97¡¾0,3 vs. 0,83¡¾0,1; p=0,01). At one year, the incidence of SAE was significantly lower in the mcPCB group (25,0 vs. 58,0%; p<0,01) driven by 2-fold reduction of target vessel revascularization (25,0 vs. 52,2%; p=0,02) in the mcPCB group. In 3 years follow up mortality rate and incidence of SAE was higher in plain balloon angioplasty group p<0.05. |
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Conclusion:
In this pivotal trial, mcPCB was superior when compared to PBA in restenosis inhibition and reduction of recurrent revascularizations in patients with femoro-popliteal arterial disease. Results analysed for mortality rate not confirm information from publication suggested higher mortality rate in DCB balloon group. Trial was registered on ClinicalTrials.gov Identifier: NCT02145065. |
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