Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
BASKET (BAsel Stent KostenEffektivitaets Trial)
Study hypothesis
Drug Eluting Stents (DES) are not cost-effective in a real world setting when compared to bare metal stents.
Ethics approval
Approved by the local ethics committee of the University of Basel, March 27, 2003.
Study design
Prospective randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Coronary artery disease
Intervention
PCI in a real world setting (chronic and acute disease). Patients randomised 2:1 to drug eluting versus bare metal stents.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Six month cost-effectiveness with effectiveness defined as reduction of major adverse cardiac events - i.e., cardiac death, non-fatal myocardial infarction and target vessel revascularisation.
Secondary outcome measures
1. Mortality from other cause, target vessel ischemia by myocardial perfusion Single Photon Emission Computed Tomography (SPECT).
2. Effectiveness of DES in patients with myocardial infarction and saphenous vein graft disease.
3. Cost-effectiveness as defined above after 18 and 36 months.
Overall trial start date
01/05/2003
Overall trial end date
31/05/2004
Reason abandoned
Eligibility
Participant inclusion criteria
Coronary artery disease suitable for interventional therapy.
All patients referred for cardiac catheterisation and subsequent Percutaneous Coronary Intervention (PCI) irrespective of clinical indication, who are able to provide written informed consent.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
826
Participant exclusion criteria
1. In-stent-restenosis
2. Target vessel diameter equal to or greater than 4 mm
3. No informed consent
Recruitment start date
01/05/2003
Recruitment end date
31/05/2004
Locations
Countries of recruitment
Switzerland
Trial participating centre
Cardiology Department
Basel
CH-4031
Switzerland
Sponsor information
Organisation
University Hospital Basel (Switzerland)
Sponsor details
Petersgraben 4
Basel
CH-4031
Switzerland
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
University Hospital, Basel (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Cardiac Research Foundation, Basel (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results in: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=16154019
18-month cost-effectiveness analysis: http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17980734&ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum
Publication citations
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Results
Kaiser C, Brunner-La Rocca HP, Buser PT, Bonetti PO, Osswald S, Linka A, Bernheim A, Zutter A, Zellweger M, Grize L, Pfisterer ME, , Incremental cost-effectiveness of drug-eluting stents compared with a third-generation bare-metal stent in a real-world setting: randomised Basel Stent Kosten Effektivitäts Trial (BASKET)., Lancet, 366, 9489, 921-929, doi: 10.1016/S0140-6736(05)67221-2.
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Brunner-La Rocca HP, Kaiser C, Bernheim A, Zellweger MJ, Jeger R, Buser PT, Osswald S, Pfisterer M, , Cost-effectiveness of drug-eluting stents in patients at high or low risk of major cardiac events in the Basel Stent KostenEffektivitäts Trial (BASKET): an 18-month analysis., Lancet, 2007, 370, 9598, 1552-1559, doi: 10.1016/S0140-6736(07)61660-2.