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

Completed

• Conditions: Restenosis; Myocardial Infarction
• Interventions: Procedure: percutaneous coronary intervention with stent

• Registration Number: NCT01466634
• Lead Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita

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.

Study Timeline

• Study Start: 2011-08
• Primary Completion: 2011-09
• Study Completion: 2011-10
• Study First Submitted: 2011-10-24
• Status Verified: 2011-11
• Study First Submitted QC: 2011-11-04
• Last Update Submitted: 2011-11-04
• Study First Posted: 2011-11-08
• Last Update Posted: 2011-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6221

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
permanent polymer DES	percutaneous coronary intervention with stent	-
bioabsorbable polymer DES	percutaneous coronary intervention with stent	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Binary restenosis	9 months

Trial Locations

Locations (1)

Ospedale Maggiore della Carità; 🇮🇹 Novara, Italy