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临床试验/NCT01466634
NCT01466634已完成不适用

Bioabsorbable Versus Permanent Polymer Bare Metal Stents in Saphenous Vein Graft Disease: Insights From a Meta-analysis of 6221 Patients

Azienda Ospedaliero Universitaria Maggiore della Carita1 个研究点 分布在 1 个国家目标入组 6,221 人开始时间: 2011年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
6,221
试验地点
1
主要终点
late coronary lumen loss

研究概览

简要总结

Evidence supporting use of bioabsorbable polymer drug eluting stents (BP-DES) is uncertain. Thus the investigators planned a meta-analysis to compare outcomes of BP-DES versus PP-DES in obstructive coronary artery disease.

详细描述

Evidence supporting use of bioabsorbable polymer drug eluting stents (BP-DES) is uncertain. Previous studies suggested that BP-DES are at least as effective as durable polymer drug eluting stents (PP-DES). Thus the investigators planned a meta-analysis to compare outcomes of BP-DES versus PP-DES in obstructive coronary artery disease. Medline and Web databases were searched for studies comparing BP-DES and PP-DES for obstructive coronary disease, reporting rates of overall mortality, target lesion revascularization (TLR), myocardial infarction (MI), binary restenosis and late lumen loss (LLL) with a follow-up ≥ 6 months. Odds ratios (ORs) will be computed from individual studies and pooled according to a fixed effect (e.g. inverse variance weighting) or random effect model in case of statistical heterogeneity. Given the a priori heterogeneous nature of the observational analyses, separate subgroup analysis of studies with PLA bioabsorbable polymer loaded with biolimus A19 (BP-BES) is prespecified.

研究设计

研究类型
Observational
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • randomized studies
  • studies reporting clinical outcomes as overall death and/or acute myocardial infarction and/or late stent thrombosis (ARC definition)[**] and/or target lesion revascularization and/or late lumen loss
  • follow up period longer than 6 months.

排除标准

  • duplicate reporting (in which case the manuscript reporting the largest sample or the longest follow-up was selected)
  • inability to compute risk estimates due to absence of clinical event in one of the groups
  • studies presenting composite major adverse cardiac event (MACE) and not individual end points.

结局指标

主要结局

late coronary lumen loss

时间窗: 9 month

target lesion revascularization

时间窗: 9 month

overall mortality

时间窗: 1 year

Late stent thrombosis

时间窗: 1 year

Myocardial Infarction

时间窗: 1 year

次要结局

  • Binary restenosis(9 months)

研究者

发起方
Azienda Ospedaliero Universitaria Maggiore della Carita
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lupi Alessandro

Dr

Azienda Ospedaliero Universitaria Maggiore della Carita

研究点 (1)

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