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首页> 外文期刊>Journal of stroke and cerebrovascular diseases: The official journal of National Stroke Association >The Carotid Revascularization Endarterectomy versus Stenting Trial: credentialing of interventionalists and final results of lead-in phase.
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The Carotid Revascularization Endarterectomy versus Stenting Trial: credentialing of interventionalists and final results of lead-in phase.

机译:颈动脉血运重建内膜切除术与支架试验的比较:介入治疗师的证书和导入阶段的最终结果。

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The success of carotid artery stenting in preventing stroke requires a low risk of periprocedural stroke and death. A comprehensive training and credentialing process was prerequisite to the randomized Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) to assemble a competent team of interventionalists with low periprocedural event rates. Interventionalists submitted cases to a multidisciplinary Interventional Management Committee. This committee evaluated 427 applicants. Of these, 238 (56%) were selected to participate in the training program and the lead-in phase, 73 (17%) who had clinical registry experience and satisfactory results with the devices used in CREST were exempt from training and were approved for the randomized phase, and 116 (27%) did not qualify for training. At 30 days in the lead-in study, stroke, myocardial infarction, or death occurred in 6.1% of symptomatic subjects and 4.8% of asymptomatic subjects. Stroke or death occurred in 5.8% of symptomatic subjects and 3.8% of asymptomatic subjects. Outcomes were better for younger subjects and varied by operator training. Based on experience, training, and lead-in results, the Interventional Management Committee selected 224 interventionalists to participate in the randomized phase of CREST. We believe that the credentialing and training of interventionalists participating in CREST have been the most rigorous reported to date for any randomized trial evaluating endovascular treatments. The study identified competent operators, which ensured that the randomized trial results fairly contrasted outcomes between endarterectomy and stenting.
机译:颈动脉支架置入术在预防中风方面的成功需要较低的围手术期中风和死亡风险。进行全面的培训和认证程序是进行颈动脉血运重建术联合支架试验(CREST)的先决条件,以组建一支具有低围手术期事件发生率的干预专家团队。介入专家向多学科介入管理委员会提交了案例。该委员会评估了427名申请人。其中,有238名(56%)被选择参加培训计划,并且处于导入阶段,其中具有临床注册经验并且使用CREST的设备获得满意结果的73名(17%)被免除培训并获得批准随机阶段,有116(27%)人没有资格参加培训。在导入研究的第30天,有6.1%的有症状受试者和4.8%的无症状受试者发生中风,心肌梗塞或死亡。中风或死亡发生于有症状的受试者的5.8%和无症状的受试者的3.8%。结果对于年轻的受试者更好,并且因操作员培训而异。根据经验,培训和导入结果,干预管理委员会选择了224名介入医师参加CREST的随机阶段。我们认为,迄今为止,对于评估血管内治疗的任何随机试验,参加CREST的干预专家的资格证书和培训都是最严格的。该研究确定了合格的操作者,这确保了随机试验的结果与动脉内膜切除术和支架置入之间的结果形成了相当的对比。

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