Condition category
Circulatory System
Date applied
26/10/2006
Date assigned
03/11/2006
Last edited
15/11/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Matthias Pfisterer

ORCID ID

Contact details

Cardiology Department
University Hospital
Petersgraben 4
Basel
CH-4031
Switzerland

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

http://www.universitaetsspital-basel.ch/

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

  1. 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.

  2. 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.

Additional files

Editorial Notes