title: A single center experience of Zilver PTX for femoro-popliteal lesions.
abstract: BACKGROUND
  Clinical trial data show overall favorable outcomes of paclitaxel-eluting stents for treatment of femoro-popliteal (FP) occlusive disease. However, external validity of trial results may be restricted to less complex FP lesions, and limited data on outcomes of paclitaxel-eluting stents in real world practice have been published.
  
  
  METHODS
  This is a retrospective analysis of data of all patients who received Zilver® PTX® for FP lesion from February 2013 to October 2014 at our center. The primary endpoint was primary patency, defined as peak systolic velocity ratio <2.0 by Doppler ultrasound, or angiographic diameter stenosis <50%, or freedom from clinically driven target lesion revascularization.
  
  
  RESULTS
  Seventy-eight patients received Zilver® PTX® for FP lesions in the pre-specified time period. Of them, 63 had follow-up data and were included in this study. Mean patient age was 66.3±9.4years, and 57.1% of the patients were men. Participants had a high prevalence of diabetes (49.2%), hypertension (93.7%), hyperlipidemia (93.7%), previous coronary revascularization (52.4%), or previous peripheral arterial disease (77.8%). Critical limb ischemia was present in 25.4% of the patients, Trans-Atlantic Inter-Society Consensus (TASC) class C or D in 76.2%, in-stent restenosis (ISR) in 36.5%, and total occlusion in 69.8%. Mean lesion length was 218.9±128.3mm, mean number of stents was 2.02±1.0, and total stent length was 189.0±128.5mm. Mean follow-up was 270.4±190.3days. Primary patency rate at 1year was 66.7% by Kaplan-Meier survival curve. When compared with patients with primary patency at follow up, those with an adverse outcome had higher prevalence of TASC II class C or D lesions (100% vs. 68.8%, p=0.013), and were more likely to have ISR (66.7% vs. 27.1%, p=0.012), longer lesion (291.3±138.7 vs. 195.7±117.1, p=0.011), and incomplete coverage of the lesion (full coverage of lesions: 40% vs. 77.1%, p=0.011).
  
  
  CONCLUSIONS
  Post marketing use of Zilver® PTX® for the treatment of FP lesions is associated with lower patency rates compared with clinical trial data. This may be related to the high prevalence of TASC II class C or D lesions and ISR in real world practice. Future studies should be more representative of contemporary clinical practice.
authors: Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC.
authors: Won Yu
authors: WY
authors: Kang
authors: Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC.
authors: Umberto
authors: U
authors: Campia
authors: Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC.
authors: Romain J
authors: RJ
authors: Didier
authors: Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC.
authors: Sarkis
authors: S
authors: Kiramijyan
authors: Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC.
authors: Edward
authors: E
authors: Koifman
authors: Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC.
authors: Smita I
authors: SI
authors: Negi
authors: Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC.
authors: Michael J
authors: MJ
authors: Lipinski
authors: Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC.
authors: Nevin C
authors: NC
authors: Baker
authors: Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC.
authors: Ricardo O
authors: RO
authors: Escarcega
authors: Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC.
authors: Rebecca
authors: R
authors: Torguson
authors: Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC.
authors: Ron
authors: R
authors: Waksman
authors: Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC. Electronic address: nbernardo@gmail.com.
authors: Nelson L
authors: NL
authors: Bernardo
mesh_terms: D000368:Aged; D000792:Angiography; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation*; D002317:Cardiovascular Agents / Q000008:administration & dosage; D003251:Constriction, Pathologic; D004219:District of Columbia; D054855:Drug-Eluting Stents; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage; D058729:Peripheral Arterial Disease / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D011150:Popliteal Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D011474:Prosthesis Design; D012189:Retrospective Studies; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D018608:Ultrasonography, Doppler; D014654:Vascular Patency
chemical_list: D002317:Cardiovascular Agents; D017239:Paclitaxel
keywords: Femoro-popliteal; Paclitaxel; Patency; Stent