title: Pooled analysis of the CONFIRM registries: impact of gender on procedure and angiographic outcomes in patients undergoing orbital atherectomy for peripheral artery disease.
abstract: OBJECTIVE
  To compare the acute procedure and angiographic outcomes of peripheral artery disease (PAD) patients treated with orbital atherectomy stratified by gender.
  
  
  METHODS
  The CONFIRM I, II, and III registries are US multicenter, nonrandomized, all-comers registries of PAD patients who were treated with orbital atherectomy. All patients with gender specified in the registry database were included in the current analysis, which compared the final residual stenosis achieved after atherectomy and the rate of acute complications in female and male patients. The 3 registries included 3131 patients with 4761 lesions: 1261 women (mean age 73.2 ± 10.7 years) with 1874 lesions and 1870 men (mean age 70.4 ± 10.2) with 2887 lesions.
  
  
  RESULTS
  The women were older (p < 0.001) and had a higher but nonsignificant prevalence of critical limb ischemia (p = 0.075). After treatment, the final residual stenosis in women vs. men was 9% ± 11% vs. 11% ± 11%, respectively (p < 0.001). Women had a higher rate of all types of dissection (13.3% vs. 9.9%, p<0.001). However, both genders had similar rates of flow-limiting dissections (1.6% vs. 1.4%, p = 0.61), perforation, slow flow, vessel closure, spasm, embolism, and thrombus formation.
  
  
  CONCLUSIONS
  The gender analysis of the CONFIRM registries revealed that there was successful lesion modification with orbital atherectomy in both men and women; however, women had a higher rate of dissection (all types). This difference is likely because of the older age and higher percentage of critical limb ischemia in women in this cohort. These results, however, suggest that additional studies should be completed to further understand the increased risks for women vs. men during endovascular procedures.
authors.affiliation: UCLA Medical Center, Los Angeles, CA, USA mslee@mednet.ucla.edu.
authors.forename: Michael S
authors.initials: MS
authors.lastname: Lee
authors.affiliation: UCLA Medical Center, Los Angeles, CA, USA.
authors.forename: Timothy
authors.initials: T
authors.lastname: Canan
authors.affiliation: Korea University Guro Hospital, Seoul, Korea.
authors.forename: Seung-Woon
authors.initials: SW
authors.lastname: Rha
authors.affiliation: Metro Health Hospital, Wyoming, MI, USA.
authors.forename: Jihad
authors.initials: J
authors.lastname: Mustapha
authors.affiliation: Rex Healthcare, Raleigh, NC, USA.
authors.forename: George L
authors.initials: GL
authors.lastname: Adams
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000792:Angiography; D055109:Ankle Brachial Index; D017073:Atherectomy / Q000009:adverse effects / Q000379:methods; D005260:Female; D006801:Humans; D007511:Ischemia; D035002:Lower Extremity / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D058729:Peripheral Arterial Disease / Q000175:diagnosis* / Q000000981:diagnostic imaging / Q000453:epidemiology / Q000628:therapy*; D015995:Prevalence; D012042:Registries; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D017678:Sex Distribution; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology
keywords: atherectomy; calcification; dissection; female gender; peripheral artery disease; procedure-related complications; stenosis