Drug Eluting Balloon Versus Drug Eluting Stent in PCI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT01760200

Recruitment Status : Completed

First Posted : January 4, 2013

Last Update Posted : January 4, 2013

Sponsor:

Information provided by (Responsible Party):

Lupi Alessandro, Azienda Ospedaliero Universitaria Maggiore della Carita

Study Description

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).

Condition or disease
Coronary Artery Disease

Show detailed description

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 (A.L. and A.R.), using the following keywords: "drug", "eluting" "balloon(s)", "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) and/or overall death and/or myocardial infarction (MI) and/or stent thrombosis (ST) and/or 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 (e.g. 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 Cochran's Q test, with 2-tailed p=0.1. Statistical inconsistency test (I2) was also employed to overcome the low statistical power of Cochran's 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 5.1 (The Nordic Cochrane Center, Købehvn, Denmark) and StatsDirect v 2.7.8 (StatsDirect Ltd, Cheshire WA, UK). Meta-regression analyses were builded with Comprehensive Meta-analysis Version 2 (Biostat, Englewood, New Jersey, United States).

Study Design

Layout table for study information

Study Type :	Observational
Actual Enrollment :	1462 participants
Time Perspective:	Retrospective
Official Title:	Drug Eluting Balloon Versus Drug Eluting Stent in Coronary Artery Disease PCI: Insights From a Meta-analysis of 1462 Patients
Study Start Date :	August 2012
Actual Primary Completion Date :	December 2012
Actual Study Completion Date :	December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Coronary Artery Disease

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Drug eluting balloon angioplasty Drug eluting balloon angioplasty
Drug eluting stent group Drug eluting stent intervention

Outcome Measures

Primary Outcome Measures :

Overall mortality [ Time Frame: 1 year ]
mortality rate from all cause

Secondary Outcome Measures :

Myocardial infarction rates [ Time Frame: 1 year ]
Myocardial infarction rates
Target vessel revascularization [ Time Frame: 1 year ]
symptoms or ischemia driven new revascularization of the coronary artery already treated with DEB at baseline

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	18 Years to 89 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patient with CAD treated by coronary angiogrphy

Criteria

Inclusion Criteria:

randomized studies or cohort studies reporting a comparison between a DEB treated group and a DES treated group
availability of reports of late lumen loss (LLL) and/or overall death and/or myocardial infarction (MI) and/or stent thrombosis (ST) and/or target lesion revascularization (TLR).

Exclusion Criteria:

duplicate reporting (in which case the manuscript reporting the largest sample or the longest follow-up was selected)
follow up of at least 1 year
studies presenting composite major adverse cardiac events (MACE) without mentioning individual end points.

Contacts and Locations

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): NCT01760200

Locations

Layout table for location information

Italy
Azienda Ospedaliero Universitaria Maggiore della Carita
Novara, Piedmont, Italy, 28100

Sponsors and Collaborators

Azienda Ospedaliero Universitaria Maggiore della Carita

Investigators

Layout table for investigator information

Principal Investigator:	Alessandro Lupi, MD	AO Maggiore della Carita

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lupi A, Rognoni A, Secco GG, Porto I, Nardi F, Lazzero M, Rossi L, Parisi R, Fattori R, Genoni G, Rosso R, Stella PR, Sheiban I, Bolognese L, Liistro F, Bongo AS, Agostoni P. Drug eluting balloon versus drug eluting stent in percutaneous coronary interventions: insights from a meta-analysis of 1462 patients. Int J Cardiol. 2013 Oct 12;168(5):4608-16. doi: 10.1016/j.ijcard.2013.07.161. Epub 2013 Jul 26.

Layout table for additonal information

Responsible Party:	Lupi Alessandro, M.D., Azienda Ospedaliero Universitaria Maggiore della Carita
ClinicalTrials.gov Identifier:	NCT01760200
Other Study ID Numbers:	0000003
First Posted:	January 4, 2013 Key Record Dates
Last Update Posted:	January 4, 2013
Last Verified:	January 2013

Keywords provided by Lupi Alessandro, Azienda Ospedaliero Universitaria Maggiore della Carita:


Coronary angioplasty Coronary stent paclitaxel drug-eluting stent drug eluting balloon

Additional relevant MeSH terms:

Layout table for MeSH terms

Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases	Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases

To Top