George Howard1, L Nelson Hopkins1, Wesley S Moore1, Barry T Katzen1, Elie Chakhtoura1, William F Morrish1, Robert D Ferguson1, Robert J Hye1, Fayaz A Shawl1, Mark R Harrigan1, Jenifer H Voeks1, Virginia J Howard1, Brajesh K Lal1, James F Meschia1, Thomas G Brott2. 1. 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.). 2. 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.
Abstract
BACKGROUND AND PURPOSE: 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. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00004732.
RCT Entities:
BACKGROUND AND PURPOSE: 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. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00004732.
Authors: Thomas G Brott; Robert W Hobson; George Howard; Gary S Roubin; Wayne M Clark; William Brooks; Ariane Mackey; Michael D Hill; Pierre P Leimgruber; Alice J Sheffet; Virginia J Howard; Wesley S Moore; Jenifer H Voeks; L Nelson Hopkins; Donald E Cutlip; David J Cohen; Jeffrey J Popma; Robert D Ferguson; Stanley N Cohen; Joseph L Blackshear; Frank L Silver; J P Mohr; Brajesh K Lal; James F Meschia Journal: N Engl J Med Date: 2010-05-26 Impact factor: 91.245
Authors: Jenifer H Voeks; George Howard; Gary S Roubin; Mahmoud B Malas; David J Cohen; W Charles Sternbergh; Herbert D Aronow; Mark K Eskandari; Alice J Sheffet; Brajesh K Lal; James F Meschia; Thomas G Brott Journal: Stroke Date: 2011-10-06 Impact factor: 7.914
Authors: L Nelson Hopkins; Gary S Roubin; Elie Y Chakhtoura; William A Gray; Robert D Ferguson; Barry T Katzen; Kenneth Rosenfield; Jonathan Goldstein; Donald E Cutlip; William Morrish; Brajesh K Lal; Alice J Sheffet; MeeLee Tom; Susan Hughes; Jenifer Voeks; Krishna Kathir; James F Meschia; Robert W Hobson; Thomas G Brott Journal: J Stroke Cerebrovasc Dis Date: 2010-03 Impact factor: 2.136
Authors: A J Sheffet; G Roubin; G Howard; V Howard; W Moore; J F Meschia; R W Hobson; T G Brott Journal: Int J Stroke Date: 2010-02 Impact factor: 5.266
Authors: Virginia J Howard; Jenifer H Voeks; Helmi L Lutsep; Ariane Mackey; Genevieve Milot; Albert D Sam; Meelee Tom; Susan E Hughes; Alice J Sheffet; Mary Longbottom; Jason B Avery; Robert W Hobson; Thomas G Brott Journal: Stroke Date: 2009-02-10 Impact factor: 7.914
Authors: Jörg Ederle; Joanna Dobson; Roland L Featherstone; Leo H Bonati; H Bart van der Worp; Gert J de Borst; T Hauw Lo; Peter Gaines; Paul J Dorman; Sumaira Macdonald; Philippe A Lyrer; Johanna M Hendriks; Charles McCollum; Paul J Nederkoorn; Martin M Brown Journal: Lancet Date: 2010-02-25 Impact factor: 79.321
Authors: Paul T L Chiam; Gary S Roubin; Sriram S Iyer; Richard M Green; Daniel E Soffer; Christina Brennan; Jiri J Vitek Journal: Catheter Cardiovasc Interv Date: 2008-09-01 Impact factor: 2.692
Authors: Mandy D Müller; Stefanie von Felten; Ale Algra; Jean-Pierre Becquemin; Richard Bulbulia; David Calvet; Hans-Henning Eckstein; Gustav Fraedrich; Alison Halliday; Jeroen Hendrikse; George Howard; John Gregson; Olav Jansen; Martin M Brown; Jean-Louis Mas; Thomas G Brott; Peter A Ringleb; Leo H Bonati Journal: Circ Cardiovasc Interv Date: 2019-08-05 Impact factor: 6.546