title: Pooled analysis of the CONFIRM registries: safety outcomes in diabetic patients treated with orbital atherectomy for peripheral artery disease.
abstract: OBJECTIVE
  To compare the acute outcomes of orbital atherectomy treatment in diabetic vs. non-diabetic patients with peripheral artery disease (PAD).
  
  
  METHODS
  The CONFIRM registry series contained 1842 diabetic patients (1111 men; mean age 70.6±10.2 years) with 2819 lesions and 1247 non-diabetic patients (732 men; mean age 72.9±10.7 years) with 1885 lesions. The composite rate of procedure-related complications, including dissection, perforation, slow flow, vessel closure, spasm, embolism, and thrombus formation, was analyzed for the diabetic and non-diabetic groups.
  
  
  RESULTS
  Diabetics were younger but had a higher prevalence of coronary artery disease (p<0.001), renal disease (p<0.001), hypertension (p<0.001), hyperlipidemia (p<0.001), and lower ankle-brachial index scores (p=0.007). Diabetics had more severe PAD (Rutherford category 4-6; p<0.001), longer lesions (p<0.001), more infrapopliteal lesions (58% vs. 46%, p<0.001), and more lesions with severe and moderate calcium (86% vs. 78%, p<0.001). Diabetic and non-diabetic patients had the same (21.8%) composite rate of procedure-related complications, as well as similar rates of dissection (11.4% vs. 10.8%, p=0.68), embolism (2.2% vs. 2.4%, p=0.67), and thrombus formation (1.3% vs. 1.1%, p=0.75). However, diabetics had lower rates of perforation (0.5% vs. 1.1%, p=0.03) and spasm (5.5% vs. 7.6%, p=0.005), but a higher rate of slow flow (5.0% vs. 3.5%, p=0.02) and a tendency toward increased vessel closure (1.7% vs. 0.9%, p=0.06).
  
  
  CONCLUSIONS
  Plaque modification with orbital atherectomy resulted in similar low procedure-related complication rates in both the diabetic and non-diabetic groups, despite diabetics having more unfavorable baseline clinical and lesion characteristics. This study suggests that orbital atherectomy is a safe and effective treatment modality in both the diabetic and the non-diabetic populations.
authors.affiliation: 1 UCLA Medical Center, Los Angeles, California, USA.
authors.forename: Michael S
authors.initials: MS
authors.lastname: Lee
authors.forename: Tae
authors.initials: T
authors.lastname: Yang
authors.forename: George
authors.initials: G
authors.lastname: Adams
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D017073:Atherectomy / Q000009:adverse effects; D015897:Comorbidity; D003925:Diabetic Angiopathies / Q000175:diagnosis / Q000453:epidemiology / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D058729:Peripheral Arterial Disease / Q000175:diagnosis / Q000453:epidemiology / Q000628:therapy*; D011446:Prospective Studies; D012042:Registries; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology; D061205:Vascular Calcification / Q000175:diagnosis / Q000453:epidemiology / Q000628:therapy*