Ignite Creation Date:
2024-05-06 @ 1:15 AM
Last Modification Date:
2024-10-26 @ 11:01 AM
Study NCT ID:
NCT01760200
Status:
COMPLETED
Last Update Posted:
2013-01-04
First Post:
2012-12-16
Brief Title:
Drug Eluting Balloon Versus Drug Eluting Stent in PCI
Sponsor:
Azienda Ospedaliero Universitaria Maggiore della Carita
Organization:
Azienda Ospedaliero Universitaria Maggiore della Carita
Study Overview
Official Title:
Drug Eluting Balloon Versus Drug Eluting Stent in Coronary Artery Disease PCI Insights From a Meta-analysis of 1462 Patients
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Drug eluting balloons DEB have been developed to overcome the limitations of drug eluting stent DES but clinical results of different studies about DEB are not consistent
Thus we planned a meta-analysis to compare outcomes of DEB and DES in coronary artery disease CAD
Thus we planned a meta-analysis to compare outcomes of DEB and DES in coronary artery disease CAD
Detailed Description:
Drug eluting balloons DEB have been developed to overcome the limitations of drug eluting stent DES but clinical results of different studies about DEB are not consistent Thus we performed a meta-analysis to compare outcomes of DEB and DES in coronary artery disease CAD
The meta-analysis was performed according to the recommended methods 14-15 A systematic search for eligible studies involved MEDLINE CENTRAL Embase Highwire Press Scopus and Google Scholar databases and was conducted without language restriction by two independent investigators AL and AR using the following keywords drug eluting balloons DEB coronary angioplasty Divergences were resolved by consensus Endnote software v 10 was used to build up libraries of results that were combined after erasing duplicates The references of retrieved studies were searched manually for additional trials and efforts to contact authors were performed to obtain further study details or additional references The search is updated to December 2012
Selection criteria citations were screened at title and abstract level and retrieved as full reports
Inclusion criteria were 1 randomized studies or cohort studies reporting a comparison between a DEB treated group and a DES treated group 2 availability of reports of late lumen loss LLL andor overall death andor myocardial infarction MI andor stent thrombosis ST andor target lesion revascularization TLR
Exclusion criteria were 1 duplicate reporting in which case the manuscript reporting the largest sample or the longest follow-up was selected 2 follow up of at least 6 months 3 studies presenting composite major adverse cardiac events MACE without mentioning individual end points Data were abstracted on pre-specified forms by 2 unblinded reviewers divergences were resolved by consensus
Internal validity the present meta-analysis was performed according to the Guidelines for randomized controlled trials of the Cochrane Collaboration and for non randomized studies in compliance with the Guidelines of the MOOSE group Quality of included studies was appraised by 2 unblinded investigators The risk of selection performance detection and attrition bias expressed as low risk of bias A moderate risk of bias B high risk of bias C or incomplete reporting leading to inability to ensure the underlying risk of bias D were evaluated separately as recommended Non-randomized studies were evaluated using the Newcastle-Ottawa Scale a validated technique in assessing the quality of non-randomized studies
Data analysis and synthesis Odds ratios ORs were computed from individual studies and pooled according to a fixed effect eg inverse variance weighting or random effect model in case of statistical heterogeneity Two separate subgroup analysis were pre-specified 1 exclusion of studies with small vessel and bifurcation PCI 2 exclusion of non-randomized studies 3 exclusion of studies in which DEBs were not used together with BMS deployment
Results will be presented as overall meta-analysis and subgroups meta-analyses for DEB vs DES comparisons Outcomes appraised were in-stent LLL overall death MI ST and TLR We used the Mantel-Haenszel method for combining ORs a validated method to pool the data in a meta-analysis of binary outcomes For the in-stent LLL outcome the mean difference of 6-month LLL compared with baseline was used and the overall weighted mean difference WMD was built with the inverse variance method Heterogeneity was assessed by Cochrans Q test with 2-tailed p01 Statistical inconsistency test I2 was also employed to overcome the low statistical power of Cochrans Q test The potential publication bias was examined by constructing a funnel plot in which sample size was plotted against odds ratios In addition a mathematical estimate of the asymmetry of this plot was provided by a linear regression approach Asymmetry was considered to be present if the intercept of the regression line did deviate significantly from zero To explore and mitigate heterogeneity pre-specified covariates prevalence of diabetes in the study population and reference coronary vessel diameter as potential confounders were considered in the meta-regression analysis
Pooling of data subgroup analyses and publication bias tests were performed with Review Manager 51 The Nordic Cochrane Center Købehvn Denmark and StatsDirect v 278 StatsDirect Ltd Cheshire WA UK Meta-regression analyses were builded with Comprehensive Meta-analysis Version 2 Biostat Englewood New Jersey United States
The meta-analysis was performed according to the recommended methods 14-15 A systematic search for eligible studies involved MEDLINE CENTRAL Embase Highwire Press Scopus and Google Scholar databases and was conducted without language restriction by two independent investigators AL and AR using the following keywords drug eluting balloons DEB coronary angioplasty Divergences were resolved by consensus Endnote software v 10 was used to build up libraries of results that were combined after erasing duplicates The references of retrieved studies were searched manually for additional trials and efforts to contact authors were performed to obtain further study details or additional references The search is updated to December 2012
Selection criteria citations were screened at title and abstract level and retrieved as full reports
Inclusion criteria were 1 randomized studies or cohort studies reporting a comparison between a DEB treated group and a DES treated group 2 availability of reports of late lumen loss LLL andor overall death andor myocardial infarction MI andor stent thrombosis ST andor target lesion revascularization TLR
Exclusion criteria were 1 duplicate reporting in which case the manuscript reporting the largest sample or the longest follow-up was selected 2 follow up of at least 6 months 3 studies presenting composite major adverse cardiac events MACE without mentioning individual end points Data were abstracted on pre-specified forms by 2 unblinded reviewers divergences were resolved by consensus
Internal validity the present meta-analysis was performed according to the Guidelines for randomized controlled trials of the Cochrane Collaboration and for non randomized studies in compliance with the Guidelines of the MOOSE group Quality of included studies was appraised by 2 unblinded investigators The risk of selection performance detection and attrition bias expressed as low risk of bias A moderate risk of bias B high risk of bias C or incomplete reporting leading to inability to ensure the underlying risk of bias D were evaluated separately as recommended Non-randomized studies were evaluated using the Newcastle-Ottawa Scale a validated technique in assessing the quality of non-randomized studies
Data analysis and synthesis Odds ratios ORs were computed from individual studies and pooled according to a fixed effect eg inverse variance weighting or random effect model in case of statistical heterogeneity Two separate subgroup analysis were pre-specified 1 exclusion of studies with small vessel and bifurcation PCI 2 exclusion of non-randomized studies 3 exclusion of studies in which DEBs were not used together with BMS deployment
Results will be presented as overall meta-analysis and subgroups meta-analyses for DEB vs DES comparisons Outcomes appraised were in-stent LLL overall death MI ST and TLR We used the Mantel-Haenszel method for combining ORs a validated method to pool the data in a meta-analysis of binary outcomes For the in-stent LLL outcome the mean difference of 6-month LLL compared with baseline was used and the overall weighted mean difference WMD was built with the inverse variance method Heterogeneity was assessed by Cochrans Q test with 2-tailed p01 Statistical inconsistency test I2 was also employed to overcome the low statistical power of Cochrans Q test The potential publication bias was examined by constructing a funnel plot in which sample size was plotted against odds ratios In addition a mathematical estimate of the asymmetry of this plot was provided by a linear regression approach Asymmetry was considered to be present if the intercept of the regression line did deviate significantly from zero To explore and mitigate heterogeneity pre-specified covariates prevalence of diabetes in the study population and reference coronary vessel diameter as potential confounders were considered in the meta-regression analysis
Pooling of data subgroup analyses and publication bias tests were performed with Review Manager 51 The Nordic Cochrane Center Købehvn Denmark and StatsDirect v 278 StatsDirect Ltd Cheshire WA UK Meta-regression analyses were builded with Comprehensive Meta-analysis Version 2 Biostat Englewood New Jersey United States
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None