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

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01466634
• Other study ID #: 010101
• Status: Completed
• Phase: N/A
• First received: October 24, 2011
• Last updated: November 4, 2011
• Start date: August 2011
• Est. completion date: October 2011

Study information

• Verified date: November 2011
• Source: Azienda Ospedaliero Universitaria Maggiore della Carita
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Institute of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6221
• Est. completion date: October 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Myocardial Infarction
• Restenosis

Intervention

Procedure:
• percutaneous coronary intervention with stent
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

Locations

Country	Name	City	State
Italy	Ospedale Maggiore della Carità	Novara

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero Universitaria Maggiore della Carita

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	late coronary lumen loss		9 month	No
Primary	target lesion revascularization		9 month	No
Primary	overall mortality		1 year	No
Primary	Late stent thrombosis		1 year	No
Primary	Myocardial Infarction		1 year	No
Secondary	Binary restenosis		9 months	No