Bioabsorbable Versus Durable Polymer Drug Eluting Stent (DES): a Meta-analysis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Restenosis, Myocardial Infarction

Intervention / Treatment
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* Procedure: percutaneous coronary intervention with stent


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| permanent polymer DES<br> | Procedure: percutaneous coronary intervention with stent<br>* patients with coronary artery disease treated by percutaneous coronary intervention with BP-DES are compared with patients with coronary artery disease treated by percutaneous coronary intervention with PP-DES<br>|
| bioabsorbable polymer DES<br> | Procedure: percutaneous coronary intervention with stent<br>* patients with coronary artery disease treated by percutaneous coronary intervention with BP-DES are compared with patients with coronary artery disease treated by percutaneous coronary intervention with PP-DES<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| late coronary lumen loss |  | 9 month | 
| target lesion revascularization |  | 9 month | 
| overall mortality |  | 1 year | 
| Late stent thrombosis |  | 1 year | 
| Myocardial Infarction |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binary restenosis |  | 9 months |