title: The impact of sex on angioplasty and primary stenting for femoropopliteal occlusive disease: results of the DURABILITY II trial.
abstract: BACKGROUND
  This study investigates the impact of sex on angioplasty and primary stenting for the treatment of claudicants with femoropopliteal occlusive disease (FPOD).
  
  
  METHODS
  Two hundred eighty-seven patients enrolled in the Safety and Effectiveness Study of EverFlex Stent to Treat Symptomatic Femoral-popliteal Atherosclerosis (DURABILITY II) trial (a prospective, nonrandomized, core laboratory audited, and independently adjudicated investigational device exemption trial) were stratified by sex (190 men and 97 women) and reviewed.
  
  
  RESULTS
  Women presented with FPOD at an older age than men (71.3 ± 11.2 vs. 65.9 ± 9.9 years; P < 0.001). Men were more likely to be hyperlipidemic (89.5% vs. 79.4%; P = 0.030). No other statistically significant differences were observed with regard to periprocedural comorbidities and demographics. Clinically, women presented more often with severe claudication (64.9% vs. 51.1%; P = 0.033) as compared with men that had more moderate claudication (44.2% vs. 29.9%; P = 0.022). The incidence of rest pain and tissue loss was low and did not vary between sexes. Angiographically, women had smaller reference vessels (4.4 ± 0.8 mm vs. 5.0 ± 0.9 mm; P < 0.001). Longer lesions (91.6 ± 46.8 mm vs. 87.8 ± 43.9 mm) and higher primary (79.0% vs. 76.5%), primary-assisted (90.6% vs. 85.1%), and secondary patency (90.6% vs. 85.7%) rates in women did not achieve statistical significance (P = NS). Mean percent stenosis and occlusion rates were similar between groups, but men were more likely to have severe calcification (47.9% vs. 34.0%; P = 0.020). Inter-Society Consensus for the Management of Peripheral Arterial Disease II classifications were similar between groups. The target lesion revascularization, major adverse event, and mortality rates were similar between groups. At baseline, the absolute claudication distance was 0.29 miles for men, while women only reached 0.14 miles (P < 0.0001). Walking improvement questionnaire scores were also compared; women had significantly lower scores at baseline and at 1 year.
  
  
  CONCLUSIONS
  Despite presenting with FPOD at a later age, with more severe claudication, a shorter absolute claudication distance, and smaller vessels than men, women achieved equal patency rates using angioplasty and primary stenting with similar target lesion revascularization, major adverse event, and mortality rates. Despite these findings, women subjectively have worse symptoms at baseline and at 1 year.
authors.affiliation: Division of Vascular Surgery, The Mount Sinai Medical Center, New York, NY.
authors.forename: Rami O
authors.initials: RO
authors.lastname: Tadros
authors.affiliation: Division of Vascular Surgery, The Mount Sinai Medical Center, New York, NY.
authors.forename: Peter L
authors.initials: PL
authors.lastname: Faries
authors.affiliation: Division of Vascular Surgery, St. John's Hospital, Springfield, IL.
authors.forename: Krishna J
authors.initials: KJ
authors.lastname: Rocha-Singh
authors.affiliation: Division of Vascular Surgery, The Mount Sinai Medical Center, New York, NY.
authors.forename: Sung yup
authors.initials: Sy
authors.lastname: Kim
authors.affiliation: Division of Vascular Surgery, The Mount Sinai Medical Center, New York, NY.
authors.forename: Rajesh K
authors.initials: RK
authors.lastname: Malik
authors.affiliation: Division of Vascular Surgery, The Mount Sinai Medical Center, New York, NY.
authors.forename: Sharif H
authors.initials: SH
authors.lastname: Ellozy
authors.affiliation: Division of Vascular Surgery, The Mount Sinai Medical Center, New York, NY.
authors.forename: Michael L
authors.initials: ML
authors.lastname: Marin
authors.affiliation: Division of Vascular Surgery, The Mount Sinai Medical Center, New York, NY. Electronic address: ageliki.vouyouka@mountsinai.org.
authors.forename: Ageliki G
authors.initials: AG
authors.lastname: Vouyouka
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation*; D003251:Constriction, Pathologic; D005060:Europe; D017079:Exercise Tolerance; D005260:Female; D005263:Femoral Artery / Q000503:physiopathology; D006801:Humans; D007383:Intermittent Claudication / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D058729:Peripheral Arterial Disease / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D011150:Popliteal Artery / Q000503:physiopathology; D011446:Prospective Studies; D020127:Recovery of Function; D012307:Risk Factors; D012720:Severity of Illness Index; D012737:Sex Factors; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D014654:Vascular Patency; D016138:Walking