Amputation Free Survival in Patients with Critical Limb Ischemia Treated with Paclitaxel-eluting Stents and Paclitaxel-coated Balloons

Abstract Objective The aim of this study was to evaluate the performance of paclitaxel-eluting stents (PES) and paclitaxel-coated balloons (PCB) on amputation free survival in patients with critical limb ischemia (CLI). Methods A retrospective review of all patients with Rutherford stage 5 and 6 limb ischemia undergoing endovascular revascularization with paclitaxel related technology, both PES and PCB was carried out over a 4-year period. Clinical grading was determined by Rutherford classification, and the Society for Vascular Surgery’s Wound, Ischemia and Foot Infection (WIFi) scoring system. Clinical and angiographic follow-up was reviewed based on intention-to-treat analysis. The primary endpoint of this study was amputation free survival at 12 months. Secondary endpoints included wound healing, freedom from target lesion revascularization and patency of target vessels at 12 months. Follow up occurred at 3, 6 and 12 months post-operatively. Target lesion patency was defined as Results A total of 88 limbs were revascularized in 88 patients. DES was used as the sole drug technology in 56 patients (60.7% male, median age 70.5 years), DCB was used as the sole drug technology in 32 patients (46.9% male, median age 66 years). Baseline demographics were well matched except for a higher prevalence of occluded target lesions in the DES group (41.1% vs. 12.5%; p=0.004). Limbs were treated for Rutherford stage 5 CLI in 71.6% and stage 6 CLI in 28.4%. Univariate analysis identified no dependent factors affecting limb salvage, except for the use of drug coated balloons. After 12 months of follow up, amputation free survival was significantly higher in the DES group compared to the DCB (88.5% vs. 71.1%; p=0.0443). Wound healing rates after 1 year were also higher in the DES group (83.9% vs. 59.4%; p=0.0198). Freedom from target lesion revascularization was no different between patients treated with DES compared to patients treated with DCB (90.6% vs. 85.7%; p=0.518. Primary patency at 12 months in patients treated with DES was significantly higher than patients treated with PCB (80.4% vs. 58.1%; p=0.0255). Conclusions Overall, drug technology represents a viable option for patients with CLI; a cohort not represented in major randomized trials. In our experience, femoropopliteal lesions treated with DES have higher primary patency rates than those treated with DCB. This was found to support higher amputation free survival rates in patients treated with paclitaxel DES compared to paclitaxel DCB. The use of paclitaxel DES for CLI was also associated with significantly improved wound healing compared to DCB. Our data suggests improved outcomes with DES compared to DCB, however, these patients represent a non-randomized, heterogenous group that were treated with the operator’s best judgement.