Paclitaxel-Coated Balloon Angioplasty in the Real World: Jack-of-all-Trades?
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COMMENTARY
COMMENTARY
Paclitaxel-Coated Balloon Angioplasty in the Real World: Jack-of-all-Trades? Ulf Teichgra¨ber1
Received: 16 November 2020 / Accepted: 25 November 2020 The Author(s) 2020
Efficacy of drug-coated balloon (DCB) angioplasty is well established for femoropopliteal lesions. However, clinical benefit differs considerably across DCB types [1]. Superiority of Passeo-18 lx DCB over standard balloon angioplasty (POBA) regarding the primary endpoint of 6-month late lumen loss and the secondary endpoint of 6-month binary restenosis had been demonstrated earlier by the BIOLUX P-I randomized controlled trial (RCT). However, the small-scale study had not been powered to compare clinical endpoints, and thus, difference in the incidence of clinically driven target lesion revascularization (TLR) between groups did not reach statistical significance (DCB 15.4% vs. POBA 41.7%, p = 0.06) [2]. The BIOLUX P-II RCT on below-the-knee (BTK) lesions showed similar clinical outcomes after DCB angioplasty and POBA. In this issue of CVIR, Tepe et al. [3] present 24-month results of the real-world BIOLUX P-III registry on performance and safety of infrainguinal Passeo-18 lx DCB angioplasty in 877 participants, providing specific information on femoropopliteal lesions, long lesions (C 15 cm), and in-stent restenosis (ISR). Results on the BTK lesion subgroup had been presented earlier in CVIR. Overall, the study population included a considerably high proportion of participants at increased risk (femoropopliteal subgroup: 43% diabetes, 33% renal disease, 41% current smoker, 35% critical limb ischemia [CLI], 25% chronic total occlusions, 17% severe calcification, and 14% in-stent restenosis). Mean femoropopliteal lesion length was
& Ulf Teichgra¨ber [email protected] 1
Department of Radiology, Jena University Hospital, Friedrich-Schiller-University Jena, Am Klinikum 1, 07747 Jena, Germany
96 ± 78 mm. Investigators predilated 89% of femoropopliteal lesions with POBA and conducted bailout stenting in 20%. At 24 months, in the femoropopliteal subgroup, primary patency was 67% (imaging cohort) and freedom from TLR 89%, with considerably worse results in the long lesion- and ISR subgroups, both including BTK lesions. Previous RCTs reported on 24-month primary patency of 57–90%, and on freedom from TLR of 64–97% after femoropopliteal DCB angioplasty [1, 4]. However, in most cases, study populations differed considerably from the BIOLUX P-III registry, particularly regarding the share of CLI participants, and thus, direct comparison is not appropriate. However, the AcoArt I [5] trial has some similarities in the study population which may enable a vague orientation on Passeo-18 lx DCB performance. AcoArt I was characterized by comparable proportions of diabetes, CLI, and bailout stenting, but higher shares of long lesions, total occlusions, and ISR. Finally, 24-month primary patency and freedom from TLR in AcoArt I were about the same order of magnitude (65%, 87%, respectively) as in the BIOLUX P-III registry.
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