BAsel Stent KostenEffektivitaets Trial (Basel Stent cost-effectiveness trial)

ISRCTN	ISRCTN75663024
DOI	https://doi.org/10.1186/ISRCTN75663024
Protocol serial number	N/A
Sponsor	University Hospital Basel (Switzerland)
Funders	University Hospital, Basel (Switzerland), Cardiac Research Foundation, Basel (Switzerland)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Matthias Pfisterer
Scientific

Cardiology Department
University Hospital
Petersgraben 4
Basel
CH-4031
Switzerland

Primary study design	Interventional
Study design	Prospective randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	BASKET (BAsel Stent KostenEffektivitaets Trial)
Study objectives	Drug Eluting Stents (DES) are not cost-effective in a real world setting when compared to bare metal stents.
Ethics approval(s)	Approved by the local ethics committee of the University of Basel, March 27, 2003.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	31/05/2004

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	826
Key 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.
Key exclusion criteria	1. In-stent-restenosis 2. Target vessel diameter equal to or greater than 4 mm 3. No informed consent
Date of first enrolment	01/05/2003
Date of final enrolment	31/05/2004

Cardiology Department

Basel
CH-4031
Switzerland

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	01/09/2005		Yes	No
Other publications	-month cost-effectiveness analysis:	03/11/2007		Yes	No