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
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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 by Azienda Ospedaliero Universitaria Maggiore della Carita

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 October 01, 2014