title: Temporal Changes in Periprocedural Events in the Carotid Revascularization Endarterectomy Versus Stenting Trial.
abstract: OBJECTIVE
  Post-hoc, we hypothesized that over the recruitment period of the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST), increasing experience and improved patient selection with carotid stenting, and to a lesser extent, carotid endarterectomy would contribute to lower periprocedural event rates.
  
  
  METHODS
  Three study periods with approximately the same number of patients were defined to span recruitment. Composite and individual rates of periprocedural stroke, myocardial infarction, and death rate were calculated separately by treatment assignment (carotid stenting/carotid endarterectomy). Temporal changes in unadjusted event rates, and rates after adjustment for temporal changes in patient characteristics, were assessed.
  
  
  RESULTS
  For patients randomized to carotid stenting, there was no significant temporal change in the unadjusted composite rates that declined from 6.2% in the first period, to 4.9% in the second, and 4.6% in the third (P=0.28). Adjustment for patient characteristics attenuated the rates to 6.0%, 5.9%, and 5.6% (P=0.85). For carotid endarterectomy-randomized patients, both the composite and the combined stroke and death outcome decreased between periods 1 and 2 and then increased in period 3.
  
  
  CONCLUSIONS
  The hypothesized temporal reduction of stroke+death events for carotid stenting-treated patients was not observed. Further adjustment for changes in patient characteristics between periods, including the addition of asymptomatic patients and a >50% decrease in proportion of octogenarians enrolled, resulted in practically identical rates.
  
  
  BACKGROUND
  URL: http://www.clinicaltrials.gov. Unique identifier: NCT00004732.
authors.affiliation: From the Departments of Biostatistics (G.H.) and Epidemiology (V.J.H.), School of Public Health, and Department of Surgery, School of Medicine (M.R.H.), University of Alabama at Birmingham; Department of Neurosurgery, University of Buffalo, NY (L.N.H.); Division of Vascular and Endovascular Surgery, University of California, Los Angeles (W.S.M.); Miami Cardiac and Vascular Institute, Baptist Health South Florida (B.T.K.); Department of Cardiology, Clara Maass Medical Center, Baptist Health System, Belleville, NJ (E.C.); Department of Cardiology, Beth Israel Medical Center, Newark, NJ (E.C.); Department of Radiology, Foothills Medical Center, University of Calgary, Calgary, Alberta, Canada (W.F.M.); Department of Radiology, MetroHealth Medical Center, Cleveland, OH (R.D.F.); Department of Surgery, Kaiser Permanente, San Diego, CA (R.J.H.); Department of Cardiology, Washington Adventist Hospital, Takoma Park, MD (F.A.S.); Department of Neurosciences, Medical University of South Carolina, MUSC Stroke Center, Charleston (J.H.V.); Department of Vascular Surgery, University of Maryland School of Medicine, Baltimore (B.K.L.); Department of Neurology, Mayo Clinic, Jacksonville, FL (J.F.M., T.G.B.); and Department of Surgery, New Jersey Medical School, Rutgers, The State University of New Jersey, Newark (T.G.B.).
authors.forename: George
authors.initials: G
authors.lastname: Howard
authors.affiliation: From the Departments of Biostatistics (G.H.) and Epidemiology (V.J.H.), School of Public Health, and Department of Surgery, School of Medicine (M.R.H.), University of Alabama at Birmingham; Department of Neurosurgery, University of Buffalo, NY (L.N.H.); Division of Vascular and Endovascular Surgery, University of California, Los Angeles (W.S.M.); Miami Cardiac and Vascular Institute, Baptist Health South Florida (B.T.K.); Department of Cardiology, Clara Maass Medical Center, Baptist Health System, Belleville, NJ (E.C.); Department of Cardiology, Beth Israel Medical Center, Newark, NJ (E.C.); Department of Radiology, Foothills Medical Center, University of Calgary, Calgary, Alberta, Canada (W.F.M.); Department of Radiology, MetroHealth Medical Center, Cleveland, OH (R.D.F.); Department of Surgery, Kaiser Permanente, San Diego, CA (R.J.H.); Department of Cardiology, Washington Adventist Hospital, Takoma Park, MD (F.A.S.); Department of Neurosciences, Medical University of South Carolina, MUSC Stroke Center, Charleston (J.H.V.); Department of Vascular Surgery, University of Maryland School of Medicine, Baltimore (B.K.L.); Department of Neurology, Mayo Clinic, Jacksonville, FL (J.F.M., T.G.B.); and Department of Surgery, New Jersey Medical School, Rutgers, The State University of New Jersey, Newark (T.G.B.).
authors.forename: L Nelson
authors.initials: LN
authors.lastname: Hopkins
authors.affiliation: From the Departments of Biostatistics (G.H.) and Epidemiology (V.J.H.), School of Public Health, and Department of Surgery, School of Medicine (M.R.H.), University of Alabama at Birmingham; Department of Neurosurgery, University of Buffalo, NY (L.N.H.); Division of Vascular and Endovascular Surgery, University of California, Los Angeles (W.S.M.); Miami Cardiac and Vascular Institute, Baptist Health South Florida (B.T.K.); Department of Cardiology, Clara Maass Medical Center, Baptist Health System, Belleville, NJ (E.C.); Department of Cardiology, Beth Israel Medical Center, Newark, NJ (E.C.); Department of Radiology, Foothills Medical Center, University of Calgary, Calgary, Alberta, Canada (W.F.M.); Department of Radiology, MetroHealth Medical Center, Cleveland, OH (R.D.F.); Department of Surgery, Kaiser Permanente, San Diego, CA (R.J.H.); Department of Cardiology, Washington Adventist Hospital, Takoma Park, MD (F.A.S.); Department of Neurosciences, Medical University of South Carolina, MUSC Stroke Center, Charleston (J.H.V.); Department of Vascular Surgery, University of Maryland School of Medicine, Baltimore (B.K.L.); Department of Neurology, Mayo Clinic, Jacksonville, FL (J.F.M., T.G.B.); and Department of Surgery, New Jersey Medical School, Rutgers, The State University of New Jersey, Newark (T.G.B.).
authors.forename: Wesley S
authors.initials: WS
authors.lastname: Moore
authors.affiliation: From the Departments of Biostatistics (G.H.) and Epidemiology (V.J.H.), School of Public Health, and Department of Surgery, School of Medicine (M.R.H.), University of Alabama at Birmingham; Department of Neurosurgery, University of Buffalo, NY (L.N.H.); Division of Vascular and Endovascular Surgery, University of California, Los Angeles (W.S.M.); Miami Cardiac and Vascular Institute, Baptist Health South Florida (B.T.K.); Department of Cardiology, Clara Maass Medical Center, Baptist Health System, Belleville, NJ (E.C.); Department of Cardiology, Beth Israel Medical Center, Newark, NJ (E.C.); Department of Radiology, Foothills Medical Center, University of Calgary, Calgary, Alberta, Canada (W.F.M.); Department of Radiology, MetroHealth Medical Center, Cleveland, OH (R.D.F.); Department of Surgery, Kaiser Permanente, San Diego, CA (R.J.H.); Department of Cardiology, Washington Adventist Hospital, Takoma Park, MD (F.A.S.); Department of Neurosciences, Medical University of South Carolina, MUSC Stroke Center, Charleston (J.H.V.); Department of Vascular Surgery, University of Maryland School of Medicine, Baltimore (B.K.L.); Department of Neurology, Mayo Clinic, Jacksonville, FL (J.F.M., T.G.B.); and Department of Surgery, New Jersey Medical School, Rutgers, The State University of New Jersey, Newark (T.G.B.).
authors.forename: Barry T
authors.initials: BT
authors.lastname: Katzen
authors.affiliation: From the Departments of Biostatistics (G.H.) and Epidemiology (V.J.H.), School of Public Health, and Department of Surgery, School of Medicine (M.R.H.), University of Alabama at Birmingham; Department of Neurosurgery, University of Buffalo, NY (L.N.H.); Division of Vascular and Endovascular Surgery, University of California, Los Angeles (W.S.M.); Miami Cardiac and Vascular Institute, Baptist Health South Florida (B.T.K.); Department of Cardiology, Clara Maass Medical Center, Baptist Health System, Belleville, NJ (E.C.); Department of Cardiology, Beth Israel Medical Center, Newark, NJ (E.C.); Department of Radiology, Foothills Medical Center, University of Calgary, Calgary, Alberta, Canada (W.F.M.); Department of Radiology, MetroHealth Medical Center, Cleveland, OH (R.D.F.); Department of Surgery, Kaiser Permanente, San Diego, CA (R.J.H.); Department of Cardiology, Washington Adventist Hospital, Takoma Park, MD (F.A.S.); Department of Neurosciences, Medical University of South Carolina, MUSC Stroke Center, Charleston (J.H.V.); Department of Vascular Surgery, University of Maryland School of Medicine, Baltimore (B.K.L.); Department of Neurology, Mayo Clinic, Jacksonville, FL (J.F.M., T.G.B.); and Department of Surgery, New Jersey Medical School, Rutgers, The State University of New Jersey, Newark (T.G.B.).
authors.forename: Elie
authors.initials: E
authors.lastname: Chakhtoura
authors.affiliation: From the Departments of Biostatistics (G.H.) and Epidemiology (V.J.H.), School of Public Health, and Department of Surgery, School of Medicine (M.R.H.), University of Alabama at Birmingham; Department of Neurosurgery, University of Buffalo, NY (L.N.H.); Division of Vascular and Endovascular Surgery, University of California, Los Angeles (W.S.M.); Miami Cardiac and Vascular Institute, Baptist Health South Florida (B.T.K.); Department of Cardiology, Clara Maass Medical Center, Baptist Health System, Belleville, NJ (E.C.); Department of Cardiology, Beth Israel Medical Center, Newark, NJ (E.C.); Department of Radiology, Foothills Medical Center, University of Calgary, Calgary, Alberta, Canada (W.F.M.); Department of Radiology, MetroHealth Medical Center, Cleveland, OH (R.D.F.); Department of Surgery, Kaiser Permanente, San Diego, CA (R.J.H.); Department of Cardiology, Washington Adventist Hospital, Takoma Park, MD (F.A.S.); Department of Neurosciences, Medical University of South Carolina, MUSC Stroke Center, Charleston (J.H.V.); Department of Vascular Surgery, University of Maryland School of Medicine, Baltimore (B.K.L.); Department of Neurology, Mayo Clinic, Jacksonville, FL (J.F.M., T.G.B.); and Department of Surgery, New Jersey Medical School, Rutgers, The State University of New Jersey, Newark (T.G.B.).
authors.forename: William F
authors.initials: WF
authors.lastname: Morrish
authors.affiliation: From the Departments of Biostatistics (G.H.) and Epidemiology (V.J.H.), School of Public Health, and Department of Surgery, School of Medicine (M.R.H.), University of Alabama at Birmingham; Department of Neurosurgery, University of Buffalo, NY (L.N.H.); Division of Vascular and Endovascular Surgery, University of California, Los Angeles (W.S.M.); Miami Cardiac and Vascular Institute, Baptist Health South Florida (B.T.K.); Department of Cardiology, Clara Maass Medical Center, Baptist Health System, Belleville, NJ (E.C.); Department of Cardiology, Beth Israel Medical Center, Newark, NJ (E.C.); Department of Radiology, Foothills Medical Center, University of Calgary, Calgary, Alberta, Canada (W.F.M.); Department of Radiology, MetroHealth Medical Center, Cleveland, OH (R.D.F.); Department of Surgery, Kaiser Permanente, San Diego, CA (R.J.H.); Department of Cardiology, Washington Adventist Hospital, Takoma Park, MD (F.A.S.); Department of Neurosciences, Medical University of South Carolina, MUSC Stroke Center, Charleston (J.H.V.); Department of Vascular Surgery, University of Maryland School of Medicine, Baltimore (B.K.L.); Department of Neurology, Mayo Clinic, Jacksonville, FL (J.F.M., T.G.B.); and Department of Surgery, New Jersey Medical School, Rutgers, The State University of New Jersey, Newark (T.G.B.).
authors.forename: Robert D
authors.initials: RD
authors.lastname: Ferguson
authors.affiliation: From the Departments of Biostatistics (G.H.) and Epidemiology (V.J.H.), School of Public Health, and Department of Surgery, School of Medicine (M.R.H.), University of Alabama at Birmingham; Department of Neurosurgery, University of Buffalo, NY (L.N.H.); Division of Vascular and Endovascular Surgery, University of California, Los Angeles (W.S.M.); Miami Cardiac and Vascular Institute, Baptist Health South Florida (B.T.K.); Department of Cardiology, Clara Maass Medical Center, Baptist Health System, Belleville, NJ (E.C.); Department of Cardiology, Beth Israel Medical Center, Newark, NJ (E.C.); Department of Radiology, Foothills Medical Center, University of Calgary, Calgary, Alberta, Canada (W.F.M.); Department of Radiology, MetroHealth Medical Center, Cleveland, OH (R.D.F.); Department of Surgery, Kaiser Permanente, San Diego, CA (R.J.H.); Department of Cardiology, Washington Adventist Hospital, Takoma Park, MD (F.A.S.); Department of Neurosciences, Medical University of South Carolina, MUSC Stroke Center, Charleston (J.H.V.); Department of Vascular Surgery, University of Maryland School of Medicine, Baltimore (B.K.L.); Department of Neurology, Mayo Clinic, Jacksonville, FL (J.F.M., T.G.B.); and Department of Surgery, New Jersey Medical School, Rutgers, The State University of New Jersey, Newark (T.G.B.).
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Hye
authors.affiliation: From the Departments of Biostatistics (G.H.) and Epidemiology (V.J.H.), School of Public Health, and Department of Surgery, School of Medicine (M.R.H.), University of Alabama at Birmingham; Department of Neurosurgery, University of Buffalo, NY (L.N.H.); Division of Vascular and Endovascular Surgery, University of California, Los Angeles (W.S.M.); Miami Cardiac and Vascular Institute, Baptist Health South Florida (B.T.K.); Department of Cardiology, Clara Maass Medical Center, Baptist Health System, Belleville, NJ (E.C.); Department of Cardiology, Beth Israel Medical Center, Newark, NJ (E.C.); Department of Radiology, Foothills Medical Center, University of Calgary, Calgary, Alberta, Canada (W.F.M.); Department of Radiology, MetroHealth Medical Center, Cleveland, OH (R.D.F.); Department of Surgery, Kaiser Permanente, San Diego, CA (R.J.H.); Department of Cardiology, Washington Adventist Hospital, Takoma Park, MD (F.A.S.); Department of Neurosciences, Medical University of South Carolina, MUSC Stroke Center, Charleston (J.H.V.); Department of Vascular Surgery, University of Maryland School of Medicine, Baltimore (B.K.L.); Department of Neurology, Mayo Clinic, Jacksonville, FL (J.F.M., T.G.B.); and Department of Surgery, New Jersey Medical School, Rutgers, The State University of New Jersey, Newark (T.G.B.).
authors.forename: Fayaz A
authors.initials: FA
authors.lastname: Shawl
authors.affiliation: From the Departments of Biostatistics (G.H.) and Epidemiology (V.J.H.), School of Public Health, and Department of Surgery, School of Medicine (M.R.H.), University of Alabama at Birmingham; Department of Neurosurgery, University of Buffalo, NY (L.N.H.); Division of Vascular and Endovascular Surgery, University of California, Los Angeles (W.S.M.); Miami Cardiac and Vascular Institute, Baptist Health South Florida (B.T.K.); Department of Cardiology, Clara Maass Medical Center, Baptist Health System, Belleville, NJ (E.C.); Department of Cardiology, Beth Israel Medical Center, Newark, NJ (E.C.); Department of Radiology, Foothills Medical Center, University of Calgary, Calgary, Alberta, Canada (W.F.M.); Department of Radiology, MetroHealth Medical Center, Cleveland, OH (R.D.F.); Department of Surgery, Kaiser Permanente, San Diego, CA (R.J.H.); Department of Cardiology, Washington Adventist Hospital, Takoma Park, MD (F.A.S.); Department of Neurosciences, Medical University of South Carolina, MUSC Stroke Center, Charleston (J.H.V.); Department of Vascular Surgery, University of Maryland School of Medicine, Baltimore (B.K.L.); Department of Neurology, Mayo Clinic, Jacksonville, FL (J.F.M., T.G.B.); and Department of Surgery, New Jersey Medical School, Rutgers, The State University of New Jersey, Newark (T.G.B.).
authors.forename: Mark R
authors.initials: MR
authors.lastname: Harrigan
authors.affiliation: From the Departments of Biostatistics (G.H.) and Epidemiology (V.J.H.), School of Public Health, and Department of Surgery, School of Medicine (M.R.H.), University of Alabama at Birmingham; Department of Neurosurgery, University of Buffalo, NY (L.N.H.); Division of Vascular and Endovascular Surgery, University of California, Los Angeles (W.S.M.); Miami Cardiac and Vascular Institute, Baptist Health South Florida (B.T.K.); Department of Cardiology, Clara Maass Medical Center, Baptist Health System, Belleville, NJ (E.C.); Department of Cardiology, Beth Israel Medical Center, Newark, NJ (E.C.); Department of Radiology, Foothills Medical Center, University of Calgary, Calgary, Alberta, Canada (W.F.M.); Department of Radiology, MetroHealth Medical Center, Cleveland, OH (R.D.F.); Department of Surgery, Kaiser Permanente, San Diego, CA (R.J.H.); Department of Cardiology, Washington Adventist Hospital, Takoma Park, MD (F.A.S.); Department of Neurosciences, Medical University of South Carolina, MUSC Stroke Center, Charleston (J.H.V.); Department of Vascular Surgery, University of Maryland School of Medicine, Baltimore (B.K.L.); Department of Neurology, Mayo Clinic, Jacksonville, FL (J.F.M., T.G.B.); and Department of Surgery, New Jersey Medical School, Rutgers, The State University of New Jersey, Newark (T.G.B.).
authors.forename: Jenifer H
authors.initials: JH
authors.lastname: Voeks
authors.affiliation: From the Departments of Biostatistics (G.H.) and Epidemiology (V.J.H.), School of Public Health, and Department of Surgery, School of Medicine (M.R.H.), University of Alabama at Birmingham; Department of Neurosurgery, University of Buffalo, NY (L.N.H.); Division of Vascular and Endovascular Surgery, University of California, Los Angeles (W.S.M.); Miami Cardiac and Vascular Institute, Baptist Health South Florida (B.T.K.); Department of Cardiology, Clara Maass Medical Center, Baptist Health System, Belleville, NJ (E.C.); Department of Cardiology, Beth Israel Medical Center, Newark, NJ (E.C.); Department of Radiology, Foothills Medical Center, University of Calgary, Calgary, Alberta, Canada (W.F.M.); Department of Radiology, MetroHealth Medical Center, Cleveland, OH (R.D.F.); Department of Surgery, Kaiser Permanente, San Diego, CA (R.J.H.); Department of Cardiology, Washington Adventist Hospital, Takoma Park, MD (F.A.S.); Department of Neurosciences, Medical University of South Carolina, MUSC Stroke Center, Charleston (J.H.V.); Department of Vascular Surgery, University of Maryland School of Medicine, Baltimore (B.K.L.); Department of Neurology, Mayo Clinic, Jacksonville, FL (J.F.M., T.G.B.); and Department of Surgery, New Jersey Medical School, Rutgers, The State University of New Jersey, Newark (T.G.B.).
authors.forename: Virginia J
authors.initials: VJ
authors.lastname: Howard
authors.affiliation: From the Departments of Biostatistics (G.H.) and Epidemiology (V.J.H.), School of Public Health, and Department of Surgery, School of Medicine (M.R.H.), University of Alabama at Birmingham; Department of Neurosurgery, University of Buffalo, NY (L.N.H.); Division of Vascular and Endovascular Surgery, University of California, Los Angeles (W.S.M.); Miami Cardiac and Vascular Institute, Baptist Health South Florida (B.T.K.); Department of Cardiology, Clara Maass Medical Center, Baptist Health System, Belleville, NJ (E.C.); Department of Cardiology, Beth Israel Medical Center, Newark, NJ (E.C.); Department of Radiology, Foothills Medical Center, University of Calgary, Calgary, Alberta, Canada (W.F.M.); Department of Radiology, MetroHealth Medical Center, Cleveland, OH (R.D.F.); Department of Surgery, Kaiser Permanente, San Diego, CA (R.J.H.); Department of Cardiology, Washington Adventist Hospital, Takoma Park, MD (F.A.S.); Department of Neurosciences, Medical University of South Carolina, MUSC Stroke Center, Charleston (J.H.V.); Department of Vascular Surgery, University of Maryland School of Medicine, Baltimore (B.K.L.); Department of Neurology, Mayo Clinic, Jacksonville, FL (J.F.M., T.G.B.); and Department of Surgery, New Jersey Medical School, Rutgers, The State University of New Jersey, Newark (T.G.B.).
authors.forename: Brajesh K
authors.initials: BK
authors.lastname: Lal
authors.affiliation: From the Departments of Biostatistics (G.H.) and Epidemiology (V.J.H.), School of Public Health, and Department of Surgery, School of Medicine (M.R.H.), University of Alabama at Birmingham; Department of Neurosurgery, University of Buffalo, NY (L.N.H.); Division of Vascular and Endovascular Surgery, University of California, Los Angeles (W.S.M.); Miami Cardiac and Vascular Institute, Baptist Health South Florida (B.T.K.); Department of Cardiology, Clara Maass Medical Center, Baptist Health System, Belleville, NJ (E.C.); Department of Cardiology, Beth Israel Medical Center, Newark, NJ (E.C.); Department of Radiology, Foothills Medical Center, University of Calgary, Calgary, Alberta, Canada (W.F.M.); Department of Radiology, MetroHealth Medical Center, Cleveland, OH (R.D.F.); Department of Surgery, Kaiser Permanente, San Diego, CA (R.J.H.); Department of Cardiology, Washington Adventist Hospital, Takoma Park, MD (F.A.S.); Department of Neurosciences, Medical University of South Carolina, MUSC Stroke Center, Charleston (J.H.V.); Department of Vascular Surgery, University of Maryland School of Medicine, Baltimore (B.K.L.); Department of Neurology, Mayo Clinic, Jacksonville, FL (J.F.M., T.G.B.); and Department of Surgery, New Jersey Medical School, Rutgers, The State University of New Jersey, Newark (T.G.B.).
authors.forename: James F
authors.initials: JF
authors.lastname: Meschia
authors.affiliation: From the Departments of Biostatistics (G.H.) and Epidemiology (V.J.H.), School of Public Health, and Department of Surgery, School of Medicine (M.R.H.), University of Alabama at Birmingham; Department of Neurosurgery, University of Buffalo, NY (L.N.H.); Division of Vascular and Endovascular Surgery, University of California, Los Angeles (W.S.M.); Miami Cardiac and Vascular Institute, Baptist Health South Florida (B.T.K.); Department of Cardiology, Clara Maass Medical Center, Baptist Health System, Belleville, NJ (E.C.); Department of Cardiology, Beth Israel Medical Center, Newark, NJ (E.C.); Department of Radiology, Foothills Medical Center, University of Calgary, Calgary, Alberta, Canada (W.F.M.); Department of Radiology, MetroHealth Medical Center, Cleveland, OH (R.D.F.); Department of Surgery, Kaiser Permanente, San Diego, CA (R.J.H.); Department of Cardiology, Washington Adventist Hospital, Takoma Park, MD (F.A.S.); Department of Neurosciences, Medical University of South Carolina, MUSC Stroke Center, Charleston (J.H.V.); Department of Vascular Surgery, University of Maryland School of Medicine, Baltimore (B.K.L.); Department of Neurology, Mayo Clinic, Jacksonville, FL (J.F.M., T.G.B.); and Department of Surgery, New Jersey Medical School, Rutgers, The State University of New Jersey, Newark (T.G.B.). Brott.Thomas@mayo.edu.
authors.forename: Thomas G
authors.initials: TG
authors.lastname: Brott
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D016893:Carotid Stenosis / Q000175:diagnosis* / Q000601:surgery*; D002548:Cerebral Revascularization / Q000379:methods / Q000639:trends*; D016894:Endarterectomy, Carotid / Q000379:methods / Q000639:trends*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D019990:Perioperative Care / Q000379:methods / Q000639:trends*; D015607:Stents / Q000639:trends*; D013997:Time Factors; D016896:Treatment Outcome
keywords: carotid endarterectomy; carotid stenting; myocardial infarction; random allocation; stroke; temporal trends