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

University Hospital Maggiore della Carità of Novara

Status: Completed

Conditions: Restenosis; Myocardial Infarction

Treatments: Procedure: percutaneous coronary intervention with stent

Study type: Observational

Funder types: Other

Identifiers

NCT01466634

010101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6,221 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

6,221 participants in 2 patient groups

permanent polymer DES

Treatment:

Procedure: percutaneous coronary intervention with stent

bioabsorbable polymer DES

Treatment:

Procedure: percutaneous coronary intervention with stent