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

Objective: The aim of this study was to evaluate the performance of paclitaxel-eluting stents (PESs) and paclitaxel-coated balloons (PCBs) 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 postoperatively. Target lesion patency was defined as <50% stenosis, based on a duplex velocity ratio of less than or equal to 2. Postoperative ankle-brachial index (ABI) and duplex ultrasound were performed to verify successful treatment. Outcomes were evaluated using Kaplan-Meier and Cox proportional-hazards models.
Results: A total of 88 limbs were revascularized in 88 patients. Drug-eluting stent (DES) was used as the sole drug technology in 56 patients (60.7% men, median age 70.5 years) and drug-coated balloon (DCB) was used as the sole drug technology in 32 patients (46.9% men, 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 DCBs. After 12 months of follow-up, amputation-free survival was significantly higher in the DES group than in the DCB group (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 DESs and patients treated with DCBs (90.6% vs. 85.7%; P = 0.518). Primary patency at 12 months in patients treated with DESs was significantly higher than in patients treated with PCBs (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 DESs have higher primary patency rates than those treated with DCBs. This was found to support higher amputation-free survival rates in patients treated with paclitaxel DESs than those treated with paclitaxel DCB. The use of paclitaxel DESs for CLI was also associated with significantly improved wound healing compared with DCBs. Our data suggest improved outcomes with DESs compared with DCBs; however, these patients represent a nonrandomized, heterogenous group that were treated with the operator's best judgment.
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