title: Outcomes of polytetrafluoroethylene-covered stent versus bare-metal stent in the primary treatment of severe iliac artery obstructive lesions.
abstract: OBJECTIVE
  This study compared early and midterm outcomes of polytetrafluoroethylene-covered stents (CSs) vs bare-metal stents (BMSs) in the primary treatment of severe TransAtlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) C and D iliac artery obstructive lesions.
  
  
  METHODS
  Between January 2009 and June 2014, 128 patients underwent stenting of 167 iliac arteries; CSs were implanted in 82 iliac arteries (49%) and BMSs in 85 (51%). All patients were prospectively enrolled in a dedicated database. Thirty-day outcomes, mid-term patency, limb salvage, and survival were compared, and follow-up results were analyzed with Kaplan-Meier curves. Clinical presentation, lesion site, extension, and laterality were evaluated for their association with patency in the two groups using multiple logistic regressions.
  
  
  RESULTS
  Patients were a mean age of 70 ± 10.3 years, The Society for Vascular Surgery comorbidity score was 0.89 ± 0.57, with no differences after stratification by CS and BMS (P = .17). Iliac lesions were classified by limb as TASC II C in 86 (51%) and D in 81 (49%). Comparing CS and BMS, technical success was 99% in both groups (P = 1.0); the 30-day cumulative surgical complications rate (7.3% vs 4.7%; P = .53), mortality (1.8% vs 0%; P = .45), and morbidity (1.8% vs 1.4%; P = .99) were equivalent. At 24 months (average 22 months; range, 30 days-56 months), primary patency of CS vs BMS was similar (93% vs 80%; P = .14), and this finding was maintained after stratification by TASC II C (97% vs 93%; P = .59) and D (88% vs 61%; P = .07); secondary patency was 98% vs 92% (P = .22), and limb salvage was 99% and 95% (P = .35) respectively. Multivariate analysis indicated that BMS in long-segment stenosis involving the common and external iliac arteries was a negative predictor of patency (odds ratio, 0.16; 95% confidence interval, 0.04-0.62; P = .007); within this subgroup of TASC II D lesions, primary patency at 24 months was significantly higher for CS than for BMS (88% vs 57%; P = .03).
  
  
  CONCLUSIONS
  Overall, the use of CSs for severe iliac lesions has similar early and midterm outcomes compared with BMS. In a subcategory of TASC II D lesions with long-segment severe stenosis of both the common and external iliac arteries, CS should be considered as the primary line of treatment.
authors.affiliation: Vascular and Endovascular Surgery Division, School of Medicine, Padova University, Padova, Italy. Electronic address: mikpia79@hotmail.com.
authors.forename: Michele
authors.initials: M
authors.lastname: Piazza
authors.affiliation: Vascular and Endovascular Surgery Division, School of Medicine, Padova University, Padova, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Squizzato
authors.affiliation: Department of Surgery, Oncology, and Gastroenterology, School of Medicine, Padova University, Padova, Italy.
authors.forename: Gaya
authors.initials: G
authors.lastname: Spolverato
authors.affiliation: Vascular and Endovascular Surgery Division, School of Medicine, Padova University, Padova, Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Milan
authors.affiliation: Vascular and Endovascular Surgery Division, School of Medicine, Padova University, Padova, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Bonvini
authors.affiliation: Vascular and Endovascular Surgery Division, School of Medicine, Padova University, Padova, Italy.
authors.forename: Mirko
authors.initials: M
authors.lastname: Menegolo
authors.affiliation: Vascular and Endovascular Surgery Division, School of Medicine, Padova University, Padova, Italy.
authors.forename: Franco
authors.initials: F
authors.lastname: Grego
authors.affiliation: Vascular and Endovascular Surgery Division, School of Medicine, Padova University, Padova, Italy.
authors.forename: Michele
authors.initials: M
authors.lastname: Antonello
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D020099:Coated Materials, Biocompatible; D003251:Constriction, Pathologic; D016208:Databases, Factual; D005260:Female; D006801:Humans; D007083:Iliac Artery / Q000503:physiopathology; D007558:Italy; D053208:Kaplan-Meier Estimate; D023821:Limb Salvage; D016015:Logistic Models; D008297:Male; D008670:Metals; D008875:Middle Aged; D015999:Multivariate Analysis; D016017:Odds Ratio; D058729:Peripheral Arterial Disease / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D011138:Polytetrafluoroethylene; D011474:Prosthesis Design; D012189:Retrospective Studies; D012307:Risk Factors; D012720:Severity of Illness Index; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D014654:Vascular Patency
chemical_list: D020099:Coated Materials, Biocompatible; D008670:Metals; D011138:Polytetrafluoroethylene