Early Clinical Safety and Performance of a Novel Paclitaxel-Coated Balloon Catheter in Superficial Femoral and Popliteal Arteries

Abstract

This study aimed to assess the clinical safety and performance of the novel paclitaxel-coated balloon (PCB) catheter in the superficial femoral artery (SFA) and/or the popliteal artery (PA) in patients with de novo or non-stented restenotic lesions during routine clinical practice. This retrospective, observational, multicenter, single-arm, investigator-initiated, postmarket study was conducted between August 2022 and December 2023 at 13 centers in India. Patients aged ≥18 years with Rutherford class II–V who underwent treatment for peripheral artery disease in the SFA and/or PA with at least one Peripherics PCB catheter were included. The primary endpoint was freedom from major adverse events (MAEs), defined as a composite of freedom from all-cause mortality, freedom from major target limb amputation, and freedom from clinically driven target lesion revascularization (CD-TLR) at 30-day follow-up. A total of 137 patients with either de novo or non-stented restenotic lesions were enrolled, with a mean age of 62.31 ± 11.95 years. Rutherford class III was observed in the majority of patients (48.9%). In total, 99 (72.3%) lesions were located in the SFA and 38 (27.7%) in PA. Presence of thrombus was identified in 29 (21.2%) lesions and total occlusion in 27 (19.7%) lesions. Procedural success was achieved in 133 (97.1%) lesions. The mean ankle-brachial index data improved from 0.72 ± 0.15 at baseline to 0.94 ± 0.16 at 30-day follow-up. At 30 days, freedom from MAEs was reported in 133 (97.1%) patients. All-cause mortality and CD-TLR were reported in one (0.7%) and three (2.2%) patients, respectively, during hospitalization, and no other events were reported thereafter up to 30-day follow-up. No major target limb amputations occurred during the follow-up period. An improvement of at least one Rutherford class was noted in 115 (89.2%) patients at 30-day follow-up. The high rate of freedom from MAEs at 30-day follow-up highlights the favorable clinical safety and performance of the novel PCB catheter in treating de novo or non-stented restenotic lesions in the SFA and/or PA.