One-Year Outcomes of Two Different Paclitaxel-Eluting Stents (Zilver PTX and Eluvia) for Trans-Atlantic Inter-Society Consensus Document (TASC) C/D Obstructive Femoropopliteal Lesions

Abstract

Background: Endovascular therapy is one of the standard treatment options for patients with peripheral arterial disease. Paclitaxel-eluting stents (PES) have shown promising results in the treatment of obstructive femoropopliteal lesions. Two types of PES, namely, Zilver PTX (Cook Medical, USA) and Eluvia (Boston Scientific, USA), are available worldwide. However, no study has yet compared the outcomes of applying both PES types in the real world. Objectives: This study aimed to assess the one-year outcomes of two different types of PES for Trans-Atlantic Inter-Society Consensus Document (TASC) C/D obstructive femoropopliteal lesions following suboptimal angioplasty. Patients and Methods: This single-center, retrospective, observational study examined 37 limbs of 34 patients (30 males and four females) with the mean age of 71.9 ± 9.1 years (range, 53-90 years), who were included consecutively from February 2017 to May 2018. In all patients, either a Zilver PTX (Cook Medical) or an Eluvia (Boston Scientific) PES was used for TASC C/D obstructive femoropopliteal lesions following suboptimal angioplasty. Moreover, the patients’ one-year primary patency rate, freedom from clinically driven target lesion revascularization (TLR), and event-free survival rates were determined. Results: The mean lesion length was measured to be 24.6 ± 6.6 cm (range, 9 - 46 cm). Based on the results, 78% of the lesions (29 limbs) showed occlusion, and 46% (17 limbs) showed more than moderate calcification. According to the TASC classification, type D lesions were detected in 25 (68%) limbs, while type C lesions were detected in 12 (32%) limbs. The mean number of stents used was 2.5 ± 0.7 per limb (range, 1 - 3) to cover a mean length of 24.3 ± 7.9 cm (range, 6-35 cm). Overall, 56 Zilver PTX stents for 23 limbs and 36 Eluvia stents for 14 limbs were used. The Kaplan-Meier estimates of one-year primary patency and freedom from TLR were 78% and 88%, respectively (Zilver PTX stent, 76.3% and 81.2%, respectively; Eluvia stent, 91.7% and 100%, respectively). Major adverse events were reported in two patients (2/37, 5.4%), including acute thrombotic occlusion of the treated lesions. Conclusion: Both types of PES showed promising one-year outcomes for TASC C/D lesions regarding safety and efficacy, without any significant differences; therefore, they can be considered as an alternative therapeutic approach for surgery.