Clinical Trials Directory

Trials / Completed

CompletedNCT01466634

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
6,221 (actual)
Sponsor
Azienda Ospedaliero Universitaria Maggiore della Carita · Academic / Other
Sex
All
Age
18 Years – 90 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREpercutaneous coronary intervention with stentpatients 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

Timeline

Start date
2011-08-01
Primary completion
2011-09-01
Completion
2011-10-01
First posted
2011-11-08
Last updated
2011-11-08

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT01466634. Inclusion in this directory is not an endorsement.