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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lupi Alessandro, Azienda Ospedaliero Universitaria Maggiore della Carita
ClinicalTrials.gov Identifier:
NCT01466634
First received: October 24, 2011
Last updated: November 4, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention
Restenosis
Myocardial Infarction
Procedure: percutaneous coronary intervention with stent

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Bioabsorbable Versus Permanent Polymer Bare Metal Stents in Saphenous Vein Graft Disease: Insights From a Meta-analysis of 6221 Patients

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliero Universitaria Maggiore della Carita:

Primary Outcome Measures:
  • late coronary lumen loss [ Time Frame: 9 month ] [ Designated as safety issue: No ]
  • target lesion revascularization [ Time Frame: 9 month ] [ Designated as safety issue: No ]
  • overall mortality [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Late stent thrombosis [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Myocardial Infarction [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Binary restenosis [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Enrollment: 6221
Study Start Date: August 2011
Study Completion Date: October 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
permanent polymer DES 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
bioabsorbable polymer DES 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with coronary artery disease with indication to percutaneous coronary intervention

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01466634

Locations
Italy
Ospedale Maggiore della Carità
Novara, Italy, 28100
Sponsors and Collaborators
Azienda Ospedaliero Universitaria Maggiore della Carita
Investigators
Principal Investigator: Alessandro Lupi, MD AOU Maggiore della Carita
  More Information

No publications provided

Responsible Party: Lupi Alessandro, Dr, Azienda Ospedaliero Universitaria Maggiore della Carita
ClinicalTrials.gov Identifier: NCT01466634     History of Changes
Other Study ID Numbers: 010101
Study First Received: October 24, 2011
Last Updated: November 4, 2011
Health Authority: Italy: National Institute of Health

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014