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Everolimus-Eluting Bioresorbable Scaffolds for Coronary Artery Disease

Everolimus-Eluting Bioresorbable Scaffolds for Coronary Artery Disease

  • 分类:学术论文
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  • 发布时间:2016-08-12 09:24
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【概要描述】 In patients with coronary artery disease who receive metallic drug-eluting coronary stents, adverse events such as late target-lesion failure may be related in part to the persistent presence of the metallic stent frame in the coronary-vessel wall. Bioresorbable vascularscaffolds have been developed to attempt to improve long-term outcomes.

Everolimus-Eluting Bioresorbable Scaffolds for Coronary Artery Disease

【概要描述】 In patients with coronary artery disease who receive metallic drug-eluting coronary stents, adverse events such as late target-lesion failure may be related in part to the persistent presence of the metallic stent frame in the coronary-vessel wall. Bioresorbable vascularscaffolds have been developed to attempt to improve long-term outcomes.

  • 分类:学术论文
  • 作者:
  • 来源:
  • 发布时间:2016-08-12 09:24
  • 访问量:
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  BACKGROUND: In patients with coronary artery disease who receive metallic drug-eluting coronary stents, adverse events such as late target-lesion failure may be related in part to the persistent presence of the metallic stent frame in the coronary-vessel wall. Bioresorbable vascularscaffolds have been developed to attempt to improve long-term outcomes.

  METHODS: In this large, multicenter, randomized trial, 2008 patients with stable or unstable angina were randomly assigned in a 2:1 ratio to receive an everolimus-eluting bioresorbable vascular (Absorb) scaffold (1322 patients) or an everolimus-eluting cobalt-chromium (Xience) stent (686 patients). The primary end point, which was tested for both noninferiority (margin, 4.5 percentage points for the risk difference) and superiority, was target-lesion failure (cardiac death, target-vessel myocardial infarction, or ischemia-driven target-lesion revascularization) at 1 year.

  RESULTS: Target-lesion failure at 1 year occurred in 7.8% of patients in the Absorb group and in 6.1% of patients in the Xience group (difference, 1.7 percentage points; 95% confidence interval, -0.5 to 3.9; P=0.007 for noninferiority and P=0.16 for superiority). There was no significant difference between the Absorb group and the Xience group in rates of cardiac death (0.6% and 0.1%, respectively; P=0.29), target-vessel myocardial infarction (6.0% and 4.6%, respectively; P=0.18), or ischemia-driven target-lesion revascularization (3.0% and 2.5%, respectively; P=0.50). Device thrombosis within 1 year occurred in 1.5% of patients in the Absorb group and in 0.7% of patients in the Xience group (P=0.13).

  CONCLUSIONS: In this large-scale, randomized trial, treatment of noncomplex obstructive coronary artery disease with an everolimus-elutingbioresorbable vascular scaffold, as compared with an everolimus-eluting cobalt-chromium stent, was within the prespecified margin for noninferiority with respect to target-lesion failure at 1 year.

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北京阿迈特医疗器械有限公司

Beijing Advanced Medical Technologies,Ltd.Inc.

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地址:北京市大兴区永旺西路26号院中关村医疗器械园11号楼

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邮箱:amt@ametcorp.com