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Published on: May 14, 2013
Temporal Changes in Periprocedural Events in the Carotid Revascularization Endarterectomy Versus Stenting Trial
George Howard1, L Nelson Hopkins1, Wesley S Moore1
1From 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.).
Insights
Temporal trends in carotid stenting and endarterectomy showed no significant reduction in periprocedural stroke, myocardial infarction, or death rates for stenting. Carotid endarterectomy outcomes initially improved but later worsened.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Clinical Trials
Background:
- The Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST) investigated outcomes for carotid artery disease treatment.
- Hypotheses posited that increasing experience and improved patient selection would lower periprocedural event rates over time for both carotid stenting and endarterectomy.
Purpose of the Study:
- To evaluate temporal trends in periprocedural stroke, myocardial infarction, and death rates for carotid stenting versus carotid endarterectomy.
- To assess the impact of increasing experience and patient selection on procedural outcomes.
Main Methods:
- Analysis of three distinct patient recruitment periods within the CREST trial.
- Calculation of composite and individual event rates (stroke, myocardial infarction, death) stratified by treatment (stenting/endarterectomy).
- Assessment of temporal changes in unadjusted event rates and rates adjusted for patient characteristics.
Main Results:
- For carotid stenting, unadjusted composite event rates showed a non-significant decline from 6.2% to 4.6% across periods. Adjusted rates remained stable (6.0% to 5.6%).
- Carotid endarterectomy patients experienced a decrease in composite and stroke+death rates between periods 1 and 2, followed by an increase in period 3.
- Adjustment for patient characteristics, including enrollment of asymptomatic patients and fewer octogenarians, did not alter the observed temporal trends for stenting.
Conclusions:
- The study did not observe a hypothesized temporal reduction in stroke+death events for carotid stenting.
- Temporal trends for carotid endarterectomy were variable, with initial improvement followed by a later increase in adverse events.
- Changes in patient demographics and selection criteria did not account for the lack of observed temporal improvement in stenting outcomes.
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.
