Late clinical events after paclitaxel- vs. zotarolimus-eluting stents in patients with small vessel stenting

ISRCTN	ISRCTN09125734
DOI	https://doi.org/10.1186/ISRCTN09125734
Protocol serial number	N/A
Sponsor	University Hospital Basel
Funder	Foundation for Cardiovascular Research (Switzerland)

Submission date: 31/01/2007
Registration date: 06/03/2007
Last edited: 09/05/2016

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Raban Jeger
Scientific

Department of Cardiology
University Hospital Basel
Petersgraben 4
Basel
4031
Switzerland

Phone	+41 61 265 52 14
Email	raban.jeger@usb.ch

Study information

Primary study design	Interventional
Study design	Prospective randomized open-label single-center trial
Secondary study design	Randomised controlled trial
Scientific title	BAsel Stent Kosten Effektivitäts Trial - late clinical events in patients with SMALL vessel stenting
Study acronym	BASKET-SMALL
Study objectives	Hypothesis as of 09/05/2016: The question, whether late outcome may be improved further by a new generation of drug-eluting stent (DES), the zotarolimus-eluting Endeavor® stent compared to a first generation DES, the Taxus® stent, is not known and will be addressed in the prospective randomized BASKET-SMALL pilot study. Specific aims of BASKET-SMALL pilot will, therefore, be: 1. To compare two drug-eluting stents, the first generation Taxus® stent with the second generation Endeavor® stent in patients with at least one stent <3.0 mm on clinical outcome after 24 months. 2. To compare these data to the findings of similar patients in BASKET-LATE (historical control) treated with the BMS Vision®. Original hypothesis: The question, whether late outcome may be improved further by a new generation of drug-eluting stent (DES) with a totally absorbable polymer such as the Co-Star® stent (Conor Med System, Menlow Park, CA, USA) which is CE marketed and in use in Basel since 2006 compared to a first generation DES with the same drug coating, the Taxus® stent, is not known and will be addressed in the prospective randomized BASKET-SMALL pilot study. Specific aims of BASKET-SMALL pilot will, therefore, be: 1. To compare two paclitaxel-eluting stents, the first generation Taxus® stent with the second generation Co-Star® stent with a totally absorbable polymer in patients with at least one stent <3.0 mm on clinical outcome after 18 months. 2. To compare these data to the findings of similar patients in BASKET-LATE (historical control) treated with the BMS Vision®.
Ethics approval(s)	Ethikkommission beider Basel, 11/12/2006, ref: 326/06
Health condition(s) or problem(s) studied	Coronary artery diesease
Intervention	Interventions as of 09/05/2016: Randomization will be 1:1 to Taxus® (standard 1st generation DES with paclitaxel) versus Endeavor® (2nd generation DES with zotarolimus). Origianl interventions: Randomization will be 1:1 to: Taxus® (standard 1st generation DES) versus Co-Star® (DES with biodegradable polymer)
Intervention type	Other
Primary outcome measure(s)	Primary outcome measures as of 09/05/2016: Absence of both major adverse cardiac events (MACE), i.e., of the following: 1. Cardiac death (all death not clearly of extra cardiac origin) 2. Documented non-fatal Myocardial Infarction (MI) (according to the current European Society of Cardiology [ESC]-guidelines) 3. Non-MI-related target vessel revascularization (TVR) All after 18 months Original primary outcome measures: Absence of both of the following: 1. Cardiac death (all death not clearly of extra cardiac origin) 2. Documented non-fatal Myocardial Infarction (MI) (according to the current European Society of Cardiology [ESC]-guidelines) after 18 months
Key secondary outcome measure(s)	Secondary outcome measures as of 09/05/2016: 1. Primary end-point events up to 12 and 24 months 2. Non-cardiac death (total death) 3. Major non-coronary artery bypass graft (CABG) bleeding (need for surgery, blood transfusions, cerebral hemorrhages) during dual antiplatelet therapy (up to 12 months) 4. Net clinical benefit = primary end-point + bleeding Subgroups with: a. Diabetes b. Acute coronary syndrome c. ST-elevation myocardial infarction (MI) d. Need for glycoprotein (GP) IIb/IIIa inhibitors e. Lesions >25 mm f. All stents < 3mm Original secondary outcome measures: 1. Non-MI related target vessel revascularization (TVR) 2. Major adverse cardiac events (MACE) = primary end-point events + non-MI related TVR 3. Primary end-point events up to 12 and 24 months 4. Non-cardiac death (total death) 5. Major non-coronary artery bypass graft (CABG) bleeding (need for surgery, blood transfusions, cerebral hemorrhages) during dual antiplatelet therapy (up to 12 months) net clinical benefit = primary end-point + bleeding. 6. Subgroups with: a. Diabetes b. Acute coronary syndrome c. ST-elevation myocardial infarction (MI) d. Need for glycoprotein (GP) IIb/IIIa inhibitors e. Lesions >25 mm f. All stents < 3mm
Completion date	31/12/2009

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	200
Key inclusion criteria	1. All comers, 24 hours a day, 7 days a week, irrespective of indication for percutaneous coronary intervention (PCI) 2. With the need of small vessel stenting (at least one stent <3.0 mm)
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 6 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	01/03/2007
Date of final enrolment	31/12/2009

Locations

Countries of recruitment

Switzerland

Study participating centre

Department of Cardiology

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

Editorial Notes

09/05/2016: A public title has been added and the study contact has been updated from Prof Matthias Pfisterer to Prof Raban Jeger. In addition, the hypothesis, interventions and outcome measures fields have been updated.