PMID- 36754247 OWN - NLM STAT- MEDLINE DCOM- 20230526 LR - 20230528 IS - 1097-6809 (Electronic) IS - 0741-5214 (Linking) VI - 77 IP - 6 DP - 2023 Jun TI - Outcome after revascularization with paclitaxel-coated devices in patients with chronic limb-threatening ischemia. PG - 1742-1750 LID - S0741-5214(23)00279-3 [pii] LID - 10.1016/j.jvs.2023.01.195 [doi] AB - OBJECTIVE: Data regarding the safety and efficacy of paclitaxel (PTX)-coated peripheral arterial devices for femoropopliteal artery (FPA) atherosclerotic disease is derived from studies that mainly evaluated patients with claudication. Outcomes of PTX treatment for patients with chronic limb-threatening ischemia (CLTI) is incompletely defined. This study compares outcome in patients with CLTI treated with and without PTX. METHODS: We retrospectively studied patients who underwent FPA intervention for an indication of CLTI in the Vascular Quality Initiative peripheral vascular intervention database from 2016 to 2020. Patients who had concomitant iliac or tibial interventions were included. One limb per patient was studied. Propensity score matching based on demographics, comorbidities, indication, and pharmacological therapy was performed to generate balanced cohorts. Kaplan-Meier survival analysis and multivariate Cox regression compared limb salvage, overall survival, primary patency, and major adverse limb events (MALE) between patients treated with and without PTX. RESULTS: Demographics, comorbidities, indications, and procedural details were similar between 14,065 PTX and 14,065 non-PTX propensity-matched patients. Kaplan-Meier analysis at 18-month follow-up demonstrated that the PTX group compared with the non-PTX group had a significantly higher rates of limb salvage (89.2% vs 86.5%; P < .001), primary patency (80.3% vs 76.9%; P < .001), and freedom from MALE (72.6% vs 67.9%; P < .001). Multivariate analysis also showed that PTX treatment was associated with a lower risk of major amputation (hazard ratio [HR], 0.74; 95% confidence interval [CI], 0.67-0.82; P < .001), loss of primary patency (HR, 0.80; 95% CI, 0.74-0.87; P < .001), and MALE (HR, 0.77; 95% CI, 0.72-0.82; P < .001). Overall, 21% of patients had a prior ipsilateral peripheral vascular intervention. Removing these patients from the analysis yielded similar results at 18 months. Overall survival at 54 months was not statistically different between the PTX and non-PTX groups in the overall cohort (73.5 vs 71.3%; P = .07), but significant in the de-novo treated patients (73.9% vs 70.7%; P = .02).Multivariate analyses showed a lower mortality risk in the PTX patients (HR, 0.93; 95% CI, 0.87-0.98; P = .02). CONCLUSIONS: FPA intervention with a PTX-coated device is associated with improved limb salvage, primary patency, and freedom from MALE at the 18-month follow-up compared with uncoated devices. This benefit was not associated with an increase in all-cause mortality out to 4.5 years. Further study is necessary to determine the optimal role for PTX in the treatment of the FPA for patients with CLTI and to understand its long-term outcome. CI - Copyright (c) 2023 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved. FAU - Smith, Justin A AU - Smith JA AD - Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, University Hospitals Cleveland Medical Center and Case Western Reserve University, Cleveland, OH. FAU - So, Kristine L AU - So KL AD - Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, University Hospitals Cleveland Medical Center and Case Western Reserve University, Cleveland, OH. FAU - Kashyap, Vikram S AU - Kashyap VS AD - Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, University Hospitals Cleveland Medical Center and Case Western Reserve University, Cleveland, OH. FAU - Cho, Jae S AU - Cho JS AD - Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, University Hospitals Cleveland Medical Center and Case Western Reserve University, Cleveland, OH. FAU - Colvard, Benjamin AU - Colvard B AD - Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, University Hospitals Cleveland Medical Center and Case Western Reserve University, Cleveland, OH. FAU - Kumins, Norman H AU - Kumins NH AD - Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, University Hospitals Cleveland Medical Center and Case Western Reserve University, Cleveland, OH. Electronic address: kuminsn@ccf.org. LA - eng PT - Journal Article DEP - 20230206 PL - United States TA - J Vasc Surg JT - Journal of vascular surgery JID - 8407742 RN - P88XT4IS4D (Paclitaxel) SB - IM MH - Humans MH - *Chronic Limb-Threatening Ischemia MH - *Peripheral Arterial Disease/diagnostic imaging/therapy MH - Paclitaxel/adverse effects MH - Retrospective Studies MH - Ischemia/diagnostic imaging/therapy MH - Treatment Outcome MH - Risk Factors MH - Femoral Artery MH - Limb Salvage MH - Vascular Patency OTO - NOTNLM OT - Angioplasty OT - Chronic limb-threatening ischemia OT - Femoropopliteal arterial disease OT - Paclitaxel OT - Paclitaxel-coated balloon EDAT- 2023/02/09 06:00 MHDA- 2023/05/26 06:42 CRDT- 2023/02/08 19:26 PHST- 2022/11/10 00:00 [received] PHST- 2023/01/17 00:00 [revised] PHST- 2023/01/20 00:00 [accepted] PHST- 2023/05/26 06:42 [medline] PHST- 2023/02/09 06:00 [pubmed] PHST- 2023/02/08 19:26 [entrez] AID - S0741-5214(23)00279-3 [pii] AID - 10.1016/j.jvs.2023.01.195 [doi] PST - ppublish SO - J Vasc Surg. 2023 Jun;77(6):1742-1750. doi: 10.1016/j.jvs.2023.01.195. Epub 2023 Feb 6.