Evaluation of late clinical events after drug-eluting versus bare-metal stents in patients at risk

ISRCTN	ISRCTN72444640
DOI	https://doi.org/10.1186/ISRCTN72444640
Protocol serial number	N/A
Sponsor	University Hospital Basel (Switzerland)
Funders	The Swiss National Foundation for Research (Switzerland) (study grant applied for), Additional funding by unrestricted grants from third parties will be searched for.

Submission date: 18/01/2007
Registration date: 01/02/2007
Last edited: 17/12/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Mattias Pfisterer
Scientific

Department of Cardiology
University Hospital
Petersgraben 4
Basel
4031
Switzerland

Email	pfisterer@email.ch

Study information

Primary study design	Interventional
Study design	Prospective randomised open-label muticentre trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Evaluation of late clinical events after drug-eluting versus bare-metal stents in patients at risk: BAsel Stent Kosten Effektivitäts Trial - PROspective Validation Examination
Study acronym	BASKET-PROVE
Study objectives	The recent findings and analyses of the BAsel Stent Kosten Effektivitäts Trial (BASKET) and the Basel Stent Cost-effectiveness Trial - LAte Thrombotic Events trial (BASKET-LATE) are the basis for two relevant questions which will be addressed prospectively in BASKET-PROVE. The aims of BASKET-PROVE are therefore: 1. To validate findings of BASKET/BASKET-LATE, i.e. that patients with large native vessel stenting (more than or equal to 3.0 mm stents only) do not clinically benefit from Drug Eluting Stents (DES) regarding cardiac death/non-fatal Myocardial Infarction (MI) compared to a third generation Bare Metal Stent (BMS) over an 18 months observation period and may be associated even with a certain small late harm (i.e. comparison of Cypher-Select® versus Vision® stents) 2. To evaluate whether a stent with the same cobalt-chromium platform as Vision® but with a lower dose of a limus drug (Xience®, coated with Everolimus) has a similar late outcome as the third generation BMS Vision® stent (no increase in late cardiac death/MI)
Ethics approval(s)	Local Ethics Committee (Ethikkommission beider Basel), 11/01/2007, ref: 327/06
Health condition(s) or problem(s) studied	Coronary artery disease
Intervention	Patients will be randomised to: 1. 1:1 to PCI and Stent placement with Cypher-Select® (standard first generation DES) versus Vision® (third generation cobalt-chromium BMS) 2. 1:1 to Xience® (DES with a lower dose of a limus drug, i.e. Everolimus [Abbott Vascular, Abbott Laboratories, Illinois, US]).
Intervention type	Other
Primary outcome measure(s)	Freedom of combination of: 1. Cardiac death (all death not clearly of extra cardiac origin) 2. Documented non-fatal MI (according to the current European Society of Cardiology [ESC]-guidelines after 24 months
Key secondary outcome measure(s)	1. Non-MI related Target Vessel Revascularisation (TVR) 2. Major Adverse Cardiac Events (MACE) = primary outcomes and non-MI related TVR 3. Primary outcomes up to 18 and 36 months (for comparison with BASKET and BASKET-LATE) 4. Components of the primary outcomes 5. Non-cardiac death (total death) 6. Major non-Coronary Artery Bypass Graft (CABG) bleeding (need for surgery, blood transfusions, cerebral haemorrhages) during dual antiplatelet therapy (up to twelve months) - net clinical benefit = primary outcomes and bleeding 7. Subgroups with: a. diabetes b. acute coronary syndrome c. ST-elevation MI d. need for GlycoProtein (GP) IIb/IIIa inhibitors e. lesions more than 25 mm
Completion date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	2400
Key inclusion criteria	1. All comers, 24 hours a day, seven days a week, irrespective of indication for Percutaneous Coronary Intervention (PCI) 2. With the need for large (more than or equal to 3.0 mm stents only) native vessel stenting
Key exclusion criteria	1. In-stent-restenosis 2. Bypass graft disease 3. Main stem disease to be stented 4. Cardiogenic shock 5. Planned surgery within the next six months 6. Oral anticoagulation needed (artificial heart valves, atrial fibrillation) 7. No compliance expected 8. Enrolled in another study 9. No consent
Date of first enrolment	01/02/2007
Date of final enrolment	16/05/2008

Locations

Countries of recruitment

Denmark
Norway
Switzerland

Study participating centre

University Hospital Basel

Basel
4031
Switzerland

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	03/10/2013		Yes	No
Results article	results	01/10/2015		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes