Clinical trial NCT01466634: Bioabsorbable Versus Durable Polymer Drug Eluting Stent (DES): a Meta-analysis
Official title: Bioabsorbable Versus Permanent Polymer Bare Metal Stents in Saphenous Vein Graft Disease: Insights From a Meta-analysis of 6221 Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Restenosis
Myocardial Infarction
Lead sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita
Sponsor class: OTHER
First posted: 2011-11-08
Enrollment: 6221
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with coronary artery disease with indication to percutaneous coronary intervention

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.

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 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.

Primary outcomes:
measure: late coronary lumen loss
timeFrame: 9 month
measure: target lesion revascularization
timeFrame: 9 month
measure: overall mortality
timeFrame: 1 year
measure: Late stent thrombosis
timeFrame: 1 year
measure: Myocardial Infarction
timeFrame: 1 year
Secondary outcomes:
measure: Binary restenosis
timeFrame: 9 months
Other outcomes:
Locations:
city: Novara
country: Italy
facility: Ospedale Maggiore della Carità
Study officials:
affiliation: AOU Maggiore della Carita
name: Alessandro Lupi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.