PMID- 34090989 OWN - NLM STAT- MEDLINE DCOM- 20211220 LR - 20221207 IS - 1097-6809 (Electronic) IS - 0741-5214 (Linking) VI - 74 IP - 5 DP - 2021 Nov TI - Paclitaxel-coated peripheral arterial devices are associated with improved overall survival and limb salvage in patients with chronic limb-threatening ischemia. PG - 1682-1688.e1 LID - S0741-5214(21)00851-X [pii] LID - 10.1016/j.jvs.2021.05.035 [doi] AB - OBJECTIVE: Paclitaxel (PTX)-coated peripheral arterial devices have been shown to decrease femoropopliteal artery restenosis and the need for reintervention compared with non-PTX-coated devices. The data regarding PTX efficacy and safety come from randomized controlled trials that almost exclusively enrolled patients with claudication. The outcomes of PTX treatment in patients who present with chronic limb-threatening ischemia (CLTI) are unknown. This study compares long-term outcomes in patients with CLTI treated with and without PTX. METHODS: We retrospectively reviewed 983 patients with CLTI treated with femoropopliteal artery angioplasty, atherectomy, stent, or combination between 2011 and 2019. Procedures were performed with additional proximal or distal tibial interventions as needed. Kaplan-Meier survival analysis and multivariable Cox-regression analysis compared overall survival (OS), amputation-free survival (AFS), freedom from major amputation (ff-MA), and freedom from target vessel revascularization (ff-TVR) between patients treated with and without PTX. RESULTS: Demographics, comorbidities, and Rutherford class were similar between 574 PTX (58.5%) and 409 non-PTX (41.6%) patients except that non-PTX patients were more likely to be male (56.2% vs 49.7%), dialysis dependent (19.6% vs 14.3%), and have higher average creatinine (2.3 vs 1.8 mg/dL). Through 4-year follow-up, the PTX group demonstrated a significant increase in OS (56.2% vs 43.9%, P = .013), AFS (52.6% vs 36.1%, P < .0001), ff-MA (87.4% vs 78.7%, P = .0007), and ff-TVR (77.6% vs 70.6%, P = .012). Multivariable Cox-regression analysis demonstrated that PTX treatment was associated with improved OS, AFS, ff-MA, and ff-TVR. CONCLUSIONS: In patients with CLTI, treatment with a PTX-coated device is associated with improved OS, AFS, ff-MA, and ff-TVR through 4-year follow-up. PTX-coated devices may be especially beneficial in patients who present with CLTI. CI - Copyright (c) 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved. 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, Ohio. Electronic address: norman.kumins@uhhospitals.org. FAU - King, Alexander H AU - King AH AD - Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, University Hospitals Cleveland Medical Center and Case Western Reserve University, Cleveland, Ohio. FAU - Ambani, Ravi N AU - Ambani RN AD - Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, University Hospitals Cleveland Medical Center and Case Western Reserve University, Cleveland, Ohio. 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, Ohio. FAU - Harth, Karem C AU - Harth KC AD - Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, University Hospitals Cleveland Medical Center and Case Western Reserve University, Cleveland, Ohio. FAU - Wong, Virginia L AU - Wong VL AD - Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, University Hospitals Cleveland Medical Center and Case Western Reserve University, Cleveland, Ohio. 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, Ohio. FAU - Bose, Saideep AU - Bose S AD - Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, University Hospitals Cleveland Medical Center and Case Western Reserve University, Cleveland, Ohio. FAU - Thomas, Jones P AU - Thomas JP AD - Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, University Hospitals Cleveland Medical Center and Case Western Reserve University, Cleveland, Ohio. 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, Ohio. LA - eng PT - Journal Article PT - Multicenter Study DEP - 20210606 PL - United States TA - J Vasc Surg JT - Journal of vascular surgery JID - 8407742 RN - 0 (Cardiovascular Agents) RN - 0 (Coated Materials, Biocompatible) RN - P88XT4IS4D (Paclitaxel) SB - IM MH - Aged MH - Aged, 80 and over MH - Amputation, Surgical MH - Angioplasty, Balloon/adverse effects/*instrumentation/mortality MH - Cardiovascular Agents/*administration & dosage/adverse effects MH - Chronic Disease MH - *Coated Materials, Biocompatible MH - Equipment Design MH - Female MH - Humans MH - Ischemia/diagnosis/mortality/physiopathology/*therapy MH - Limb Salvage MH - Male MH - Middle Aged MH - Paclitaxel/*administration & dosage/adverse effects MH - Peripheral Arterial Disease/diagnosis/mortality/physiopathology/*therapy MH - Progression-Free Survival MH - Retrospective Studies MH - Risk Assessment MH - Risk Factors MH - Time Factors OTO - NOTNLM OT - Angioplasty OT - Chronic limb-threatening ischemia OT - Femoropopliteal arterial disease OT - Paclitaxel OT - Paclitaxel-coated balloon EDAT- 2021/06/07 06:00 MHDA- 2021/12/21 06:00 CRDT- 2021/06/06 20:48 PHST- 2020/12/02 00:00 [received] PHST- 2021/05/07 00:00 [accepted] PHST- 2021/06/07 06:00 [pubmed] PHST- 2021/12/21 06:00 [medline] PHST- 2021/06/06 20:48 [entrez] AID - S0741-5214(21)00851-X [pii] AID - 10.1016/j.jvs.2021.05.035 [doi] PST - ppublish SO - J Vasc Surg. 2021 Nov;74(5):1682-1688.e1. doi: 10.1016/j.jvs.2021.05.035. Epub 2021 Jun 6.