TY - JOUR
T1 - Microcrystalline paclitaxel-coated balloon for revascularization of femoropopliteal artery disease
T2 - Three-year outcomes of the randomized BIOPAC trial
AU - Nowakowski, Przemysław
AU - Uchto, Wojciech
AU - Hrycek, Eugeniusz
AU - Kachel, Mateusz
AU - Ludyga, Tomasz
AU - Polczyk, Filip
AU - Żurakowski, Aleksander
AU - Kaźmierczak, Paweł
AU - Granada, Juan F.
AU - Nowakowska, Iwona
AU - Kiesz, Radosław S.
AU - Milewski, Krzysztof P.
AU - Buszman, Paweł E.
AU - Buszman, Piotr P.
N1 - Funding Information:
This study was funded from the unrestricted grant provided by the Balton Company, Warsaw, Poland. Balton company did not have any role in the study execution, data analysis, or manuscript creation.
Publisher Copyright:
© The Author(s) 2021.
PY - 2021/8
Y1 - 2021/8
N2 - The aim of the BIOPAC trial was to determine long-term safety and efficacy of a novel microcrystalline paclitaxel-coated balloon (mcPCB) with a biocompatible polymer as an excipient in the treatment of occlusive femoropopliteal lesions. In this first-in-human prospective controlled randomized trial, 66 patients with femoropopliteal, symptomatic (Rutherford stages 2B to 5) occlusive arterial disease were randomized to either mcPCB (study group) or POBA (plain old balloon angioplasty) (control group) on a 1:1 basis. Late lumen loss (LLL) at 6 months was the primary endpoint of the study and 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 63% lower in the mcPCB group compared to the POBA group (0.52 ± 1.2 vs 1.39 ± 1.1 mm; psup < 0.01). Binary restenosis occurred in 23% vs 52% of patients (p = 0.02). At 3 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 twofold reduction in target vessel revascularization rate (28.6 vs 59.3%; p = 0.02). The difference in mortality was nonsignificant (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 proved superior to POBA concerning LLL at 6-month follow-up, and SAE at 12 months. This result was sustained up to 3 years. There was no difference between groups regarding mortality. ClinicalTrials.gov Identifier: NCT02145065.
AB - The aim of the BIOPAC trial was to determine long-term safety and efficacy of a novel microcrystalline paclitaxel-coated balloon (mcPCB) with a biocompatible polymer as an excipient in the treatment of occlusive femoropopliteal lesions. In this first-in-human prospective controlled randomized trial, 66 patients with femoropopliteal, symptomatic (Rutherford stages 2B to 5) occlusive arterial disease were randomized to either mcPCB (study group) or POBA (plain old balloon angioplasty) (control group) on a 1:1 basis. Late lumen loss (LLL) at 6 months was the primary endpoint of the study and 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 63% lower in the mcPCB group compared to the POBA group (0.52 ± 1.2 vs 1.39 ± 1.1 mm; psup < 0.01). Binary restenosis occurred in 23% vs 52% of patients (p = 0.02). At 3 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 twofold reduction in target vessel revascularization rate (28.6 vs 59.3%; p = 0.02). The difference in mortality was nonsignificant (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 proved superior to POBA concerning LLL at 6-month follow-up, and SAE at 12 months. This result was sustained up to 3 years. There was no difference between groups regarding mortality. ClinicalTrials.gov Identifier: NCT02145065.
KW - drug-eluting balloon
KW - femoropopliteal disease
KW - innovation
KW - paclitaxel
UR - http://www.scopus.com/inward/record.url?scp=85102304396&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85102304396&partnerID=8YFLogxK
U2 - 10.1177/1358863X20988360
DO - 10.1177/1358863X20988360
M3 - Article
C2 - 33686879
AN - SCOPUS:85102304396
VL - 26
SP - 401
EP - 408
JO - Vascular Medicine
JF - Vascular Medicine
SN - 0738-4580
IS - 4
ER -