Aim To assess the 24-month safety and effectiveness of a new generation drug-coated balloon (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 femoro-popliteal lesions. Materials and Methods From January 2019 to January 2020, Drug Coated Balloon (DCB) angioplasties using Elutax were performed on 53 consecutive patients (53 limbs) with femoro-popliteal lesions (group A) and compared with a non-contemporary 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 (CT) angiography to delineate subject clinical and baseline lesion characteristics. Primary endpoint was primary patency rate at 24-months. Secondary endpoints 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%, CI95% 0.01-0.30, p=0.043; primary patency: 88.2% vs 71.5%, log rank p=0.03). Twenty-four-month CD-TLR rate was 7.5% for DCB vs 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 femoro-popliteal arteries. Our experience has shown superior primary patency rate for Elutax when compared to POBA.
Results of new dual-drug coated balloon angioplasty vs POBA for femoropopliteal lesions / Sallustro, Marianna; Peluso, Antonio; Turchino, Davide; Maione, Isidoro; Vita, Flavia; Martelli, Eugenio; Serra, Raffaele; Bracale, Umberto Marcello. - In: ANNALS OF VASCULAR SURGERY. - ISSN 0890-5096. - (2022). [10.1016/j.avsg.2022.09.047]
Results of new dual-drug coated balloon angioplasty vs POBA for femoropopliteal lesions
Sallustro, Marianna;Peluso, Antonio;Turchino, Davide;Bracale, Umberto Marcello
2022
Abstract
Aim To assess the 24-month safety and effectiveness of a new generation drug-coated balloon (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 femoro-popliteal lesions. Materials and Methods From January 2019 to January 2020, Drug Coated Balloon (DCB) angioplasties using Elutax were performed on 53 consecutive patients (53 limbs) with femoro-popliteal lesions (group A) and compared with a non-contemporary 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 (CT) angiography to delineate subject clinical and baseline lesion characteristics. Primary endpoint was primary patency rate at 24-months. Secondary endpoints 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%, CI95% 0.01-0.30, p=0.043; primary patency: 88.2% vs 71.5%, log rank p=0.03). Twenty-four-month CD-TLR rate was 7.5% for DCB vs 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 femoro-popliteal arteries. Our experience has shown superior primary patency rate for Elutax when compared to POBA.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
