Bioabsorbable Versus Permanent Polymer Bare Metal Stents in Saphenous Vein Graft Disease: Insights From a Meta-analysis of 6221 Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Restenosis
- Sponsor
- Azienda Ospedaliero Universitaria Maggiore della Carita
- Enrollment
- 6221
- Locations
- 1
- Primary Endpoint
- late coronary lumen loss
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Lupi Alessandro
Dr
Azienda Ospedaliero Universitaria Maggiore della Carita
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
late coronary lumen loss
Time Frame: 9 month
target lesion revascularization
Time Frame: 9 month
overall mortality
Time Frame: 1 year
Late stent thrombosis
Time Frame: 1 year
Myocardial Infarction
Time Frame: 1 year
Secondary Outcomes
- Binary restenosis(9 months)