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

NCT ID: NCT01466634

Last Updated: 2011-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6221 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-31

Study Completion Date

2011-10-31

Brief Summary

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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

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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

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Restenosis Myocardial Infarction

Study Design

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Study Time Perspective

RETROSPECTIVE

Study Groups

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permanent polymer DES

percutaneous coronary intervention with stent

Intervention Type PROCEDURE

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

percutaneous coronary intervention with stent

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliero Universitaria Maggiore della Carita

OTHER

Sponsor Role lead

Responsible Party

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Lupi Alessandro

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alessandro Lupi, MD

Role: PRINCIPAL_INVESTIGATOR

AOU Maggiore della Carita

Locations

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Ospedale Maggiore della Carità

Novara, , Italy

Site Status

Countries

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Italy

References

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Lupi A, Rognoni A, Secco GG, Lazzero M, Nardi F, Fattori R, Bongo AS, Agostoni P, Sheiban I. Biodegradable versus durable polymer drug eluting stents in coronary artery disease: insights from a meta-analysis of 5,834 patients. Eur J Prev Cardiol. 2014 Apr;21(4):411-24. doi: 10.1177/2047487312467745. Epub 2012 Nov 14.

Reference Type DERIVED
PMID: 23152364 (View on PubMed)

Other Identifiers

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010101

Identifier Type: -

Identifier Source: org_study_id