Stroke 2015 Aug 14;46(8):2183-9. Epub 2015 Jul 14.
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.).
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.