新闻资讯
科思
/
/
/
A randomized trial evaluating everolimus-eluting Absorb bioresorbable scaffolds vs. everolimuseluting metallic stents in patients with coronary artery disease: ABSORB Japan

A randomized trial evaluating everolimus-eluting Absorb bioresorbable scaffolds vs. everolimuseluting metallic stents in patients with coronary artery disease: ABSORB Japan

  • 分类:学术论文
  • 作者:
  • 来源:
  • 发布时间:2015-08-03 08:52
  • 访问量:

【概要描述】superior long-term results compared with permanent metallic drug-eluting stents (DESs). However, whether BVSs are as safe and effective as metallic DESs prior to complete bioresorption is unknown.

A randomized trial evaluating everolimus-eluting Absorb bioresorbable scaffolds vs. everolimuseluting metallic stents in patients with coronary artery disease: ABSORB Japan

【概要描述】superior long-term results compared with permanent metallic drug-eluting stents (DESs). However, whether BVSs are as safe and effective as metallic DESs prior to complete bioresorption is unknown.

  • 分类:学术论文
  • 作者:
  • 来源:
  • 发布时间:2015-08-03 08:52
  • 访问量:
详情

  AIMS: Theoretically, bioresorbable vascular scaffolds (BVSs) may provide

  superior long-term results compared with permanent metallic drug-eluting stents (DESs). However, whether BVSs are as safe and effective as metallic DESs prior to complete bioresorption is unknown.

  METHODS AND RESULTS: ABSORB Janpan was a single-blind, multicentre, active-controlled, randomized trial designed to support regulatory approval of the Absorb BVS in Japan. Eligible patients with one or two de novo lesions in different epicardial vessels were randomized at 38 Japanese sites in a 2:1 ratio to Absorb BVS vs. obalt-chromium everoliums-eluting stents (CoCr-EESs). The primary endpoint was target lesion failure [TLF: a composite of cardiac death, myocardial infarction attributable to target vessel, or ischaemia-driven target lesion revascularization (ID-TLR)] at 12 months, powered for non-inferiority. The major secondary endpoint was angiographic in-segment late lumen loss (LLL) at 13 months. A total of 400 patients were randomized to BVSs (266 patients and 275 lesions) or CoCr-EESs (134 patients and 137 lesions). TLF through 12 months was 4.2% with BVSs and 3.8% with CoCr-EESs [difference (upper one-sided 95% confidence limit) = 0.39% (3.95%); Pnon-inferiority < 0.0001]. Definite/probable stent/scaffold thrombosis at 12 months occurred in 1.5% of the patients with both devices (P = 1.0), and ID-TLR for restenosis was infrequent (1.1% with BVSs and 1.5% with CoCr-EESs, P = 1.0). With 96.0% angiographic follow-up, in-segment LLL at 13 months was 0.13 ± 0.30 mm with BVSs and 0.12 ± 0.32 mm with CoCr-EESs [difference (upper one-sided 95% confidence limit) = 0.01 (0.07); Pnon-inferiority < 0.0001).

  CONCLUSION: In the ABSORB Japan randomized trial, 12-month clinical and 13-month angiographic outcomes of BVSs were comparable to CoCr-EESs

中国生物材料学会材料生物力学分会换届大会圆满召开
2022 12-08

中国生物材料学会材料生物力学分会换届大会圆满召开

精准植入 完美心舒——冠脉支架定位系统
2022 11-27

精准植入 完美心舒——冠脉支架定位系统

北京阿迈特与北京航空航天大学联合参与生物医疗器械国家急需高层次人才培养专项
2022 11-26

北京阿迈特与北京航空航天大学联合参与生物医疗器械国家急需高层次人才培养专项

公司信息

北京阿迈特医疗器械有限公司

Beijing Advanced Medical Technologies,Ltd.Inc.

联系我们

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

电话:010-6297-7955             邮箱:amt@ametcorp.com

联系我们

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

电话:010-6297-7955             

邮箱:amt@ametcorp.com