Results of New Dual-Drug Coated Balloon Angioplasty versus POBA for Femoropopliteal Lesions

Marianna Sallustro; Antonio Peluso; Davide Turchino; Isidoro Maione; Flavia Vita; Eugenio Martelli; Raffaele Serra; Umberto Marcello Bracale

doi:10.1016/j.avsg.2022.09.047

Results of New Dual-Drug Coated Balloon Angioplasty versus POBA for Femoropopliteal Lesions

Ann Vasc Surg. 2023 Feb:89:52-59. doi: 10.1016/j.avsg.2022.09.047. Epub 2022 Oct 28.

Authors

Marianna Sallustro¹, Antonio Peluso¹, Davide Turchino¹, Isidoro Maione¹, Flavia Vita², Eugenio Martelli³, Raffaele Serra², Umberto Marcello Bracale⁴

Affiliations

¹ Department of Public Health, Vascular Surgery Unit, University Federico II of Naples, Naples, Italy.
² Department of Medical and Surgical Sciences, University Magna Graecia of Catanzaro, Catanzaro, Italy.
³ Division of Vascular Surgery, Azienda Ospedaliera S. Anna e S. Sebastiano, Caserta, Italy.
⁴ Department of Public Health, Vascular Surgery Unit, University Federico II of Naples, Naples, Italy. Electronic address: umbertomarcello.bracale@unina.it.

PMID: 36374662
DOI: 10.1016/j.avsg.2022.09.047

Abstract

Background: The study aimed to assess the 24-month safety and effectiveness of a new generation drug-coated balloon (DCB) (Elutax; AR Baltic Medical, Vilnius Lithuania-also marketed as Emperor in some European countries; Aachen Resonance, Germany, and AB Medica, Italy) for the treatment of patients with femoropopliteal lesions.

Methods: From January 2019 to January 2020, DCB angioplasties using Elutax were performed on 53 consecutive patients (53 limbs) with femoropopliteal lesions (group A) and compared with a noncontemporary control group (group B) consisting of 71 patients (71 limbs) treated with plain old balloon angioplasty (POBA) between January 2017 and January 2018. Before performing the angioplasty, both groups underwent clinical examination, ultrasound evaluation, and computed tomography angiography to delineate subject clinical and baseline lesion characteristics. Primary end point was primary patency rate at 24 months. Secondary end points included clinically driven target lesion revascularization (CD-TLR), overall survival and limb salvage rates.

Results: In both groups technical success rate was 100% with bailout stenting performed in 16.9% (9/53) of lesions in group A, while stenting was necessary in 22.5% of lesions (16/71) in group B. Patients treated with Elutax exhibited lower 24-month restenosis/reocclusion rate and improved primary patency compared to those treated with POBA (restenosis/reocclusion rate: 9.4% vs. 25.3%, CI 95% 0.01-0.30, P = 0.034; primary patency: 88.2% vs. 71.5%, log rank P = 0.03). Twenty-four-month CD-TLR rate was 7.5% for DCB versus 18.3% for POBA. No device or procedure-related deaths occurred, and no 30-day mortality was observed in either group. During the follow-up period, the limb salvage rate was 94.9% for A group and 92.1% for B group. All minor amputations occurred in limbs presented with chronic limb threatening ischemia (CLTI). Overall survival was 91.7% for group A and 89.4% for group B.

Conclusions: Paclitaxel + Dextran DCB angioplasty proved safe and effective in managing chronic lesions of femoropopliteal arteries. Our experience has shown superior primary patency rate for Elutax when compared to POBA.

MeSH terms

Angioplasty, Balloon*
Femoral Artery / surgery
Humans
Peripheral Arterial Disease* / diagnostic imaging
Peripheral Arterial Disease* / therapy
Popliteal Artery
Treatment Outcome