title: A prospective, randomized study of saphenous vein patching versus synthetic patching during carotid endarterectomy.
abstract: OBJECTIVE
  The objective of this study was the determination of whether the choice of either autogenous saphenous vein (ASV) or synthetic material for patch angioplasty significantly influences the results after carotid endarterectomy (CEA).
  
  
  METHODS
  With Institutional Review Board approval, 195 patients (145 men and 50 women; mean age, 69 years) who underwent 207 CEAs were prospectively randomized to arteriotomy closure with ASV or synthetic patches from July 1996 to January 2000. One hundred and one patients (52%) were randomized to the ASV cohort, and 94 (48%) were randomized to the synthetic cohort. Aside from a slight gender imbalance (70% versus 79% male in the ASV versus the synthetic group), there were no clinically important differences in baseline demographic variables, risk factors, or surgical indications between the ASV and synthetic groups.
  
  
  RESULTS
  With all 207 randomized procedures on an intent-to-treat basis, there were two early (<30 days) postoperative deaths (1%). There were three perioperative strokes in the ASV cohort (3.0%) and two in the synthetic cohort (2.1%; P =.99). Two of these early strokes occurred in a subset of nine patients who received neither patch material, all after randomization but before CEA. Two patients in each group had late strokes. The cumulative freedom from stroke rate at 1 year (ASV, 94%; synthetic, 95%) was virtually identical for both cohorts. With the 125 patients who had at least one postoperative duplex scan, the incidence rate of recurrent (>or=60%) carotid stenosis was 4.8% (three of 62) for the ASV group and 6.3% (four of 63) for the synthetic group (P =.99).
  
  
  CONCLUSIONS
  No significant differences in the stroke, mortality, or restenosis rates were shown between the ASV and the synthetic cohorts. While conceding the power limitations inherent in this study, we conclude that CEA may be safely performed with similar early results with ASV or synthetic patches.
authors.affiliation: Department of Vascular Surgery, The Cleveland Clinic Foundation, Ohio 44195, USA. oharap@ccf.org
authors.forename: Patrick J
authors.initials: PJ
authors.lastname: O'Hara
authors.forename: Norman R
authors.initials: NR
authors.lastname: Hertzer
authors.forename: Edward J
authors.initials: EJ
authors.lastname: Mascha
authors.forename: Leonard P
authors.initials: LP
authors.lastname: Krajewski
authors.forename: Daniel G
authors.initials: DG
authors.lastname: Clair
authors.forename: Kenneth
authors.initials: K
authors.lastname: Ouriel
mesh_terms: D000368:Aged; D002343:Carotid Artery, Internal / Q000601:surgery; D016893:Carotid Stenosis / Q000150:complications / Q000401:mortality / Q000601:surgery; D016894:Endarterectomy, Carotid / Q000379:methods; D005260:Female; D005500:Follow-Up Studies; D006083:Graft Occlusion, Vascular / Q000209:etiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009820:Ohio / Q000453:epidemiology; D011446:Prospective Studies; D012501:Saphenous Vein / Q000601:surgery*; D020521:Stroke / Q000209:etiology; D016019:Survival Analysis; D013997:Time Factors; D016896:Treatment Outcome