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

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.

journal_name

Stroke

journal_title

Stroke

authors

Gonzales NR,Demaerschalk BM,Voeks JH,Tom M,Howard G,Sheffet AJ,Garcia L,Clair DG,Barr J,Orlow S,Brott TG,CREST Investigators.

doi

10.1161/STROKEAHA.114.006228

subject

Has Abstract

pub_date

2014-11-01 00:00:00

pages

3320-4

issue

eissn

0039-2499

issn

1524-4628

pii

STROKEAHA.114.006228

journal_volume

pub_type

杂志文章,多中心研究,随机对照试验

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