Complication rates and center enrollment volume in the carotid revascularization endarterectomy versus stenting trial

Nicole R. Gonzales, Bart M. Demaerschalk, Jenifer H. Voeks, Mee Lee Tom, George Howard, Alice J. Sheffet, Lawrence Garcia, Daniel G. Clair, John Barr, Steven Orlow, Thomas G. Brott

Research output: Contribution to journalArticle

10 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)3320-3324
Number of pages5
JournalStroke
Volume45
Issue number11
DOIs
StatePublished - 2014

Fingerprint

Carotid Endarterectomy
Stroke
Credentialing
Angioplasty
Logistic Models
Myocardial Infarction
Clinical Trials
Safety
Equipment and Supplies

Keywords

  • Carotid endarterectomy
  • Carotid stenosis
  • Randomized controlled trial
  • Stenting
  • Stroke
  • Training

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Clinical Neurology
  • Advanced and Specialized Nursing
  • Medicine(all)

Cite this

Gonzales, N. R., Demaerschalk, B. M., Voeks, J. H., Tom, M. L., Howard, G., Sheffet, A. J., ... Brott, T. G. (2014). Complication rates and center enrollment volume in the carotid revascularization endarterectomy versus stenting trial. Stroke, 45(11), 3320-3324. https://doi.org/10.1161/STROKEAHA.114.006228

Complication rates and center enrollment volume in the carotid revascularization endarterectomy versus stenting trial. / Gonzales, Nicole R.; Demaerschalk, Bart M.; Voeks, Jenifer H.; Tom, Mee Lee; Howard, George; Sheffet, Alice J.; Garcia, Lawrence; Clair, Daniel G.; Barr, John; Orlow, Steven; Brott, Thomas G.

In: Stroke, Vol. 45, No. 11, 2014, p. 3320-3324.

Research output: Contribution to journalArticle

Gonzales, NR, Demaerschalk, BM, Voeks, JH, Tom, ML, Howard, G, Sheffet, AJ, Garcia, L, Clair, DG, Barr, J, Orlow, S & Brott, TG 2014, 'Complication rates and center enrollment volume in the carotid revascularization endarterectomy versus stenting trial', Stroke, vol. 45, no. 11, pp. 3320-3324. https://doi.org/10.1161/STROKEAHA.114.006228
Gonzales, Nicole R. ; Demaerschalk, Bart M. ; Voeks, Jenifer H. ; Tom, Mee Lee ; Howard, George ; Sheffet, Alice J. ; Garcia, Lawrence ; Clair, Daniel G. ; Barr, John ; Orlow, Steven ; Brott, Thomas G. / Complication rates and center enrollment volume in the carotid revascularization endarterectomy versus stenting trial. In: Stroke. 2014 ; Vol. 45, No. 11. pp. 3320-3324.
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AU - Howard, George

AU - Sheffet, Alice J.

AU - Garcia, Lawrence

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AU - Brott, Thomas G.

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AB - 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.

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