Bioabsorbable Versus Permanent Polymer Bare Metal Stents in Saphenous Vein Graft Disease: Insights From a Meta-analysis of 6221 Patients
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
- 否
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
Lupi Alessandro
Dr
Azienda Ospedaliero Universitaria Maggiore della Carita
