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

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ClinicalTrials.gov Identifier: NCT01466634
Recruitment Status : Completed
First Posted : November 8, 2011
Last Update Posted : November 8, 2011
Sponsor:
Information provided by (Responsible Party):
Lupi Alessandro, Azienda Ospedaliero Universitaria Maggiore della Carita

Brief 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.

Condition or disease Intervention/treatment
Restenosis Myocardial Infarction Procedure: percutaneous coronary intervention with stent

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.

Study Type : Observational
Actual Enrollment : 6221 participants
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
Study Start Date : August 2011
Actual Primary Completion Date : September 2011
Actual Study Completion Date : October 2011

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. late coronary lumen loss [ Time Frame: 9 month ]
  2. target lesion revascularization [ Time Frame: 9 month ]
  3. overall mortality [ Time Frame: 1 year ]
  4. Late stent thrombosis [ Time Frame: 1 year ]
  5. Myocardial Infarction [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Binary restenosis [ Time Frame: 9 months ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: November 8, 2011    Key Record Dates
Last Update Posted: November 8, 2011
Last Verified: November 2011

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