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A Murine Model of Stent Implantation in the Carotid Artery for the Study of Restenosis
Published on: May 14, 2013
Complication rates and center enrollment volume in the carotid revascularization endarterectomy versus stenting trial
Nicole R Gonzales1, Bart M Demaerschalk1, Jenifer H Voeks1
1From 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.).
Insights
Center volume did not impact complication rates in the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST). Rigorous training and credentialing ensured low complication rates for carotid endarterectomy and stenting procedures.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Clinical Trials
Background:
- Center volume of cases is known to influence outcomes for carotid endarterectomy and stenting.
- The Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST) investigated this relationship.
- Rigorous training and credentialing processes were implemented for participating physicians.
Purpose of the Study:
- To evaluate the effect of site enrollment volume on complication rates in the CREST trial.
- To determine if higher case volumes at participating centers correlate with better patient outcomes.
- To assess the safety and efficacy of carotid revascularization procedures based on center experience.
Main Methods:
- The primary composite endpoint included stroke, myocardial infarction, or death within 30 days, or ipsilateral stroke during follow-up.
- CREST centers were categorized into tertiles based on patient enrollment: <25 (Group 1), 25-51 (Group 2), and >51 patients (Group 3).
- Logistic regression was used to compare periprocedural event rates, adjusting for age, sex, and symptomatic status.
Main Results:
- Carotid angioplasty and stenting, and carotid endarterectomy safety did not vary significantly by center enrollment volume.
- The primary endpoint occurrence (P=0.54) and rates of stroke and death (P=0.87) showed no association with site volume.
- A potential inverse relationship between volume and complications was observed but was mitigated by adjusting for known risk factors.
Conclusions:
- Complication rates in the CREST trial were low and not associated with center enrollment volume.
- These findings support the importance of rigorous training and credentialing in trials involving endovascular devices and surgical procedures.
- The study demonstrates consistent safety and efficacy across different site experience levels in carotid revascularization.
Background And Purpose:
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.
Clinical Trial Registration Url:
http://www.clinicaltrials.gov. Unique identifier: NCT00004732.
