title: Complication rates and center enrollment volume in the carotid revascularization endarterectomy versus stenting trial.
abstract: OBJECTIVE
  Evidence indicates that center volume of cases affects outcomes for both carotid endarterectomy and stenting. We evaluated the effect of enrollment volume by site on complication rates in the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST).
  
  
  METHODS
  The primary composite end point was any stroke, myocardial infarction, or death within 30 days or ipsilateral stroke in follow-up. The 477 approved surgeons performed >12 procedures per year with complication rates <3% for asymptomatic patients and <5% for symptomatic patients; 224 interventionists were certified after a rigorous 2 step credentialing process. CREST centers were divided into tertiles based on the number of patients enrolled into the study, with Group 1 sites enrolling <25 patients, Group 2 sites enrolling 25 to 51 patients, and Group 3 sites enrolling >51 patients. Differences in periprocedural event rates for the primary composite end point and its components were compared using logistic regression adjusting for age, sex, and symptomatic status within site-volume level.
  
  
  RESULTS
  The safety of carotid angioplasty and stenting and carotid endarterectomy did not vary by site-volume during the periprocedural period as indicated by occurrence of the primary end point (P=0.54) or by stroke and death (P=0.87). A trend toward an inverse relationship between center enrollment volume and complications was mitigated by adjustment for known risk factors.
  
  
  CONCLUSIONS
  Complication rates were low in CREST and were not associated with center enrollment volume. The data are consistent with the value of rigorous training and credentialing in trials evaluating endovascular devices and surgical procedures.
  
  
  BACKGROUND
  http://www.clinicaltrials.gov. Unique identifier: NCT00004732.
authors.affiliation: From the Department of Neurology, University of Texas Science Health Center, Houston (N.R.G.); Department of Neurology, Mayo Clinic, Scottsdale, AZ (B.M.D.); Department of Neurosciences, Medical University of South Carolina, Medical University of South Carolina Stroke Center, Charleston (J.H.V.); Department of Surgery, New Jersey Medical School, Rutgers, The State University of New Jersey, Newark (M.T., A.J.S., T.G.B.); Department of Epidemiology, University of Alabama at Birmingham (G.H.); Division of Cardiology and Vascular Medicine, Interventional Cardiology, Steward St. Elizabeth's Medical Center, Boston, MA (L.G.); Department of Vascular Surgery, Cleveland Clinic, Cleveland, OH (D.G.C.); Departments of Radiology and Neurological Surgery, University of Texas Southwestern Medical Center, Dallas (J.B.); Department of Cardiology, Northern Indiana Research Alliance, Lutheran Hospital of Indiana, Ft. Wayne (S.O.); and Department of Neurology, Mayo Clinic, Jacksonville, FL (T.G.B.).
authors.forename: Nicole R
authors.initials: NR
authors.lastname: Gonzales
authors.affiliation: From the Department of Neurology, University of Texas Science Health Center, Houston (N.R.G.); Department of Neurology, Mayo Clinic, Scottsdale, AZ (B.M.D.); Department of Neurosciences, Medical University of South Carolina, Medical University of South Carolina Stroke Center, Charleston (J.H.V.); Department of Surgery, New Jersey Medical School, Rutgers, The State University of New Jersey, Newark (M.T., A.J.S., T.G.B.); Department of Epidemiology, University of Alabama at Birmingham (G.H.); Division of Cardiology and Vascular Medicine, Interventional Cardiology, Steward St. Elizabeth's Medical Center, Boston, MA (L.G.); Department of Vascular Surgery, Cleveland Clinic, Cleveland, OH (D.G.C.); Departments of Radiology and Neurological Surgery, University of Texas Southwestern Medical Center, Dallas (J.B.); Department of Cardiology, Northern Indiana Research Alliance, Lutheran Hospital of Indiana, Ft. Wayne (S.O.); and Department of Neurology, Mayo Clinic, Jacksonville, FL (T.G.B.).
authors.forename: Bart M
authors.initials: BM
authors.lastname: Demaerschalk
authors.affiliation: From the Department of Neurology, University of Texas Science Health Center, Houston (N.R.G.); Department of Neurology, Mayo Clinic, Scottsdale, AZ (B.M.D.); Department of Neurosciences, Medical University of South Carolina, Medical University of South Carolina Stroke Center, Charleston (J.H.V.); Department of Surgery, New Jersey Medical School, Rutgers, The State University of New Jersey, Newark (M.T., A.J.S., T.G.B.); Department of Epidemiology, University of Alabama at Birmingham (G.H.); Division of Cardiology and Vascular Medicine, Interventional Cardiology, Steward St. Elizabeth's Medical Center, Boston, MA (L.G.); Department of Vascular Surgery, Cleveland Clinic, Cleveland, OH (D.G.C.); Departments of Radiology and Neurological Surgery, University of Texas Southwestern Medical Center, Dallas (J.B.); Department of Cardiology, Northern Indiana Research Alliance, Lutheran Hospital of Indiana, Ft. Wayne (S.O.); and Department of Neurology, Mayo Clinic, Jacksonville, FL (T.G.B.).
authors.forename: Jenifer H
authors.initials: JH
authors.lastname: Voeks
authors.affiliation: From the Department of Neurology, University of Texas Science Health Center, Houston (N.R.G.); Department of Neurology, Mayo Clinic, Scottsdale, AZ (B.M.D.); Department of Neurosciences, Medical University of South Carolina, Medical University of South Carolina Stroke Center, Charleston (J.H.V.); Department of Surgery, New Jersey Medical School, Rutgers, The State University of New Jersey, Newark (M.T., A.J.S., T.G.B.); Department of Epidemiology, University of Alabama at Birmingham (G.H.); Division of Cardiology and Vascular Medicine, Interventional Cardiology, Steward St. Elizabeth's Medical Center, Boston, MA (L.G.); Department of Vascular Surgery, Cleveland Clinic, Cleveland, OH (D.G.C.); Departments of Radiology and Neurological Surgery, University of Texas Southwestern Medical Center, Dallas (J.B.); Department of Cardiology, Northern Indiana Research Alliance, Lutheran Hospital of Indiana, Ft. Wayne (S.O.); and Department of Neurology, Mayo Clinic, Jacksonville, FL (T.G.B.).
authors.forename: MeeLee
authors.initials: M
authors.lastname: Tom
authors.affiliation: From the Department of Neurology, University of Texas Science Health Center, Houston (N.R.G.); Department of Neurology, Mayo Clinic, Scottsdale, AZ (B.M.D.); Department of Neurosciences, Medical University of South Carolina, Medical University of South Carolina Stroke Center, Charleston (J.H.V.); Department of Surgery, New Jersey Medical School, Rutgers, The State University of New Jersey, Newark (M.T., A.J.S., T.G.B.); Department of Epidemiology, University of Alabama at Birmingham (G.H.); Division of Cardiology and Vascular Medicine, Interventional Cardiology, Steward St. Elizabeth's Medical Center, Boston, MA (L.G.); Department of Vascular Surgery, Cleveland Clinic, Cleveland, OH (D.G.C.); Departments of Radiology and Neurological Surgery, University of Texas Southwestern Medical Center, Dallas (J.B.); Department of Cardiology, Northern Indiana Research Alliance, Lutheran Hospital of Indiana, Ft. Wayne (S.O.); and Department of Neurology, Mayo Clinic, Jacksonville, FL (T.G.B.).
authors.forename: George
authors.initials: G
authors.lastname: Howard
authors.affiliation: From the Department of Neurology, University of Texas Science Health Center, Houston (N.R.G.); Department of Neurology, Mayo Clinic, Scottsdale, AZ (B.M.D.); Department of Neurosciences, Medical University of South Carolina, Medical University of South Carolina Stroke Center, Charleston (J.H.V.); Department of Surgery, New Jersey Medical School, Rutgers, The State University of New Jersey, Newark (M.T., A.J.S., T.G.B.); Department of Epidemiology, University of Alabama at Birmingham (G.H.); Division of Cardiology and Vascular Medicine, Interventional Cardiology, Steward St. Elizabeth's Medical Center, Boston, MA (L.G.); Department of Vascular Surgery, Cleveland Clinic, Cleveland, OH (D.G.C.); Departments of Radiology and Neurological Surgery, University of Texas Southwestern Medical Center, Dallas (J.B.); Department of Cardiology, Northern Indiana Research Alliance, Lutheran Hospital of Indiana, Ft. Wayne (S.O.); and Department of Neurology, Mayo Clinic, Jacksonville, FL (T.G.B.).
authors.forename: Alice J
authors.initials: AJ
authors.lastname: Sheffet
authors.affiliation: From the Department of Neurology, University of Texas Science Health Center, Houston (N.R.G.); Department of Neurology, Mayo Clinic, Scottsdale, AZ (B.M.D.); Department of Neurosciences, Medical University of South Carolina, Medical University of South Carolina Stroke Center, Charleston (J.H.V.); Department of Surgery, New Jersey Medical School, Rutgers, The State University of New Jersey, Newark (M.T., A.J.S., T.G.B.); Department of Epidemiology, University of Alabama at Birmingham (G.H.); Division of Cardiology and Vascular Medicine, Interventional Cardiology, Steward St. Elizabeth's Medical Center, Boston, MA (L.G.); Department of Vascular Surgery, Cleveland Clinic, Cleveland, OH (D.G.C.); Departments of Radiology and Neurological Surgery, University of Texas Southwestern Medical Center, Dallas (J.B.); Department of Cardiology, Northern Indiana Research Alliance, Lutheran Hospital of Indiana, Ft. Wayne (S.O.); and Department of Neurology, Mayo Clinic, Jacksonville, FL (T.G.B.).
authors.forename: Lawrence
authors.initials: L
authors.lastname: Garcia
authors.affiliation: From the Department of Neurology, University of Texas Science Health Center, Houston (N.R.G.); Department of Neurology, Mayo Clinic, Scottsdale, AZ (B.M.D.); Department of Neurosciences, Medical University of South Carolina, Medical University of South Carolina Stroke Center, Charleston (J.H.V.); Department of Surgery, New Jersey Medical School, Rutgers, The State University of New Jersey, Newark (M.T., A.J.S., T.G.B.); Department of Epidemiology, University of Alabama at Birmingham (G.H.); Division of Cardiology and Vascular Medicine, Interventional Cardiology, Steward St. Elizabeth's Medical Center, Boston, MA (L.G.); Department of Vascular Surgery, Cleveland Clinic, Cleveland, OH (D.G.C.); Departments of Radiology and Neurological Surgery, University of Texas Southwestern Medical Center, Dallas (J.B.); Department of Cardiology, Northern Indiana Research Alliance, Lutheran Hospital of Indiana, Ft. Wayne (S.O.); and Department of Neurology, Mayo Clinic, Jacksonville, FL (T.G.B.).
authors.forename: Daniel G
authors.initials: DG
authors.lastname: Clair
authors.affiliation: From the Department of Neurology, University of Texas Science Health Center, Houston (N.R.G.); Department of Neurology, Mayo Clinic, Scottsdale, AZ (B.M.D.); Department of Neurosciences, Medical University of South Carolina, Medical University of South Carolina Stroke Center, Charleston (J.H.V.); Department of Surgery, New Jersey Medical School, Rutgers, The State University of New Jersey, Newark (M.T., A.J.S., T.G.B.); Department of Epidemiology, University of Alabama at Birmingham (G.H.); Division of Cardiology and Vascular Medicine, Interventional Cardiology, Steward St. Elizabeth's Medical Center, Boston, MA (L.G.); Department of Vascular Surgery, Cleveland Clinic, Cleveland, OH (D.G.C.); Departments of Radiology and Neurological Surgery, University of Texas Southwestern Medical Center, Dallas (J.B.); Department of Cardiology, Northern Indiana Research Alliance, Lutheran Hospital of Indiana, Ft. Wayne (S.O.); and Department of Neurology, Mayo Clinic, Jacksonville, FL (T.G.B.).
authors.forename: John
authors.initials: J
authors.lastname: Barr
authors.affiliation: From the Department of Neurology, University of Texas Science Health Center, Houston (N.R.G.); Department of Neurology, Mayo Clinic, Scottsdale, AZ (B.M.D.); Department of Neurosciences, Medical University of South Carolina, Medical University of South Carolina Stroke Center, Charleston (J.H.V.); Department of Surgery, New Jersey Medical School, Rutgers, The State University of New Jersey, Newark (M.T., A.J.S., T.G.B.); Department of Epidemiology, University of Alabama at Birmingham (G.H.); Division of Cardiology and Vascular Medicine, Interventional Cardiology, Steward St. Elizabeth's Medical Center, Boston, MA (L.G.); Department of Vascular Surgery, Cleveland Clinic, Cleveland, OH (D.G.C.); Departments of Radiology and Neurological Surgery, University of Texas Southwestern Medical Center, Dallas (J.B.); Department of Cardiology, Northern Indiana Research Alliance, Lutheran Hospital of Indiana, Ft. Wayne (S.O.); and Department of Neurology, Mayo Clinic, Jacksonville, FL (T.G.B.).
authors.forename: Steven
authors.initials: S
authors.lastname: Orlow
authors.affiliation: From the Department of Neurology, University of Texas Science Health Center, Houston (N.R.G.); Department of Neurology, Mayo Clinic, Scottsdale, AZ (B.M.D.); Department of Neurosciences, Medical University of South Carolina, Medical University of South Carolina Stroke Center, Charleston (J.H.V.); Department of Surgery, New Jersey Medical School, Rutgers, The State University of New Jersey, Newark (M.T., A.J.S., T.G.B.); Department of Epidemiology, University of Alabama at Birmingham (G.H.); Division of Cardiology and Vascular Medicine, Interventional Cardiology, Steward St. Elizabeth's Medical Center, Boston, MA (L.G.); Department of Vascular Surgery, Cleveland Clinic, Cleveland, OH (D.G.C.); Departments of Radiology and Neurological Surgery, University of Texas Southwestern Medical Center, Dallas (J.B.); Department of Cardiology, Northern Indiana Research Alliance, Lutheran Hospital of Indiana, Ft. Wayne (S.O.); and Department of Neurology, Mayo Clinic, Jacksonville, FL (T.G.B.).
authors.forename: Thomas G
authors.initials: TG
authors.lastname: Brott
mesh_terms: D000368:Aged; D017130:Angioplasty / Q000009:adverse effects / Q000639:trends*; D016893:Carotid Stenosis / Q000453:epidemiology* / Q000601:surgery; D002548:Cerebral Revascularization / Q000009:adverse effects / Q000639:trends*; D016894:Endarterectomy, Carotid / Q000009:adverse effects / Q000639:trends*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000175:diagnosis / Q000453:epidemiology*; D011446:Prospective Studies; D012307:Risk Factors; D016037:Single-Blind Method; D015607:Stents / Q000009:adverse effects / Q000639:trends*; D016896:Treatment Outcome
keywords: carotid endarterectomy; carotid stenosis; randomized controlled trial; stenting; stroke; training