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Basel Stent Kosten Effektivitäts Trial Drug Eluting Balloons vs. Drug Eluting Stents in Small Vessel Interventions (BASKET-SMALL2)

Primary Purpose

Coronary Heart Disease

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Drug eluting balloon
Drug eluting stent
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Heart Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Angina pectoris Canadian Cardiovascular Society (CCS) 2 to 4 or silent ischemia as assessed by stress echocardiography, stress cardiac magnetic resonance, myocardial perfusion scintigraphy, or fractional flow reserve
  • PCI of de-novo stenosis in vessels ≥2.0 to <3.0 mm in diameter irrespective of the indication (concomitant PCI of a vessel ≥3.0 mm in diameter is permitted if the stenosis is located in a coronary artery other than the culprit vessel)
  • No flow-limiting dissection (TIMI ≤2) or residual stenosis >30% after initial dilatation with a standard or non-compliant balloon, as assessed by the physician in charge
  • Written informed consent

Exclusion Criteria:

  • Concomitant large-diameter PCI in the same coronary artery (LAD, Ramus circumflexus (RCX), RCA)
  • PCI of instent-restenosis (culprit lesion)
  • Life expectancy <12 months
  • Pregnancy
  • Enrolled in another coronary intervention study
  • Unable to give informed consent

Sites / Locations

  • Medizinische Universität Graz Kardiologie
  • Cardiology, Zentralklinik Bad Berka
  • Unfallkrankenhaus Berlin, Dept. Internal Medicine
  • Charité Universitätsmedizin Berlin, Kardiologie
  • Immanuel Klinikum Bernau Herzzentrum Brandenburg
  • Klinikum Westfalen GmbH Knappschaftskrankenhaus
  • Universitätsklinikum des Saarlandes - Kardiologie, Angiologie und internistische Intensivmedizin
  • University Hospital Jena
  • Herzzentrum Leipzig GmbH, Universitätsklinik
  • Department of Internal Medicine/Cardiology, University Hospital Ulm
  • Cardiology, University Hospital Basel
  • Cardiology Cantonal Hospital Baselland Liestal
  • Luzerner Kantonsspital
  • Cardiology, Kantonsspital St. Gallen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Drug eluting balloon

Drug eluting stent

Arm Description

paclitaxel-eluting SeQuent® Please balloon, B.Braun Melsungen AG, Berlin, Germany

paclitaxel-eluting Taxus Element® stent, Boston Scientific Corp, Natick MA or everolimus-eluting Xience® stent Abbott Vascular, Santa Clara, California, USA

Outcomes

Primary Outcome Measures

Major adverse cardiac events
Major adverse cardiac events (MACE), defined as cardiac death, non-fatal myocardial infarction, and target vessel revascularization after 12 months.

Secondary Outcome Measures

MACE
MACE after 24 and 36 months
Revascularization
The single components of the primary endpoint including target lesion revascularization after 12, 24, and 36 months
Stent Thrombosis
Possible, probable, and definite stent thrombosis defined according to the ARC criteria after 12, 24, and 36 months; all stent thromboses defined according to the ARC criteria after 12, 24, and 36 months
Thrombolysis In Myocardial Infarction
Thrombolysis In Myocardial Infarction (TIMI) major bleeding after 12, 24, and 36 months Net clinical benefit consisting of the primary endpoint and the TIMI major bleeding after 12, 24, and 36 months
Cost-effectiveness
Cost-effectiveness of DEB vs. DES after 12, 24, and 36 months
Quantitative Coronary Analysis (QCA)
QCA of patients who had events which required CAG/PCI after Baseline PCI
Outcome in patients with high bleeding risk including patients on OAC
Outcome analyis of patients with high bleeding risk with regard to Major bleeding events (BARC)
Outcome in acute versus stable CAD
Difference of the Population with acute versus stable CAD with regard to baseline characteristics, primary and secondary outcome measures (MACE, stent thrombosis, major bleeding)
Outcome in diabetics vs non diabetics
Difference of the diabetic versus non-diabetic population regarding baseline characteristics and primary and secondary outcome measures (MACE, stent thrombosis, major bleeding)
sex specific inequalities in the use of drug coated balloons for small coronary artery disease
sex specific difference in baseline charchteristics, Impact of sex on safety and efficacy in the stent-free strategy regarding primary and secondary endpoint (MACE, stent thrombosis, major bleeding)

Full Information

First Posted
April 8, 2012
Last Updated
June 23, 2020
Sponsor
University Hospital, Basel, Switzerland
Collaborators
Clinical Trial Unit, University Hospital Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT01574534
Brief Title
Basel Stent Kosten Effektivitäts Trial Drug Eluting Balloons vs. Drug Eluting Stents in Small Vessel Interventions
Acronym
BASKET-SMALL2
Official Title
A Prospective, Randomized, Controlled, Open Label, Multicenter Trial to Test the Non-inferiority of Drug Eluting Balloon vs. Drug Eluting Stent Treatment in de Novo Stenoses of Small Native Vessels Regarding Efficacy and Safety
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
February 1, 2018 (Actual)
Study Completion Date
January 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
Collaborators
Clinical Trial Unit, University Hospital Basel, Switzerland

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators hypothesize that in a real-world population undergoing percutaneous coronary intervention (PCI) for de-novo stenoses in small native vessels with a diameter <3 mm, drug eluting balloons (DEB) are non inferior to third-generation drug eluting stents (DES).
Detailed Description
Drug-eluting balloons are an established treatment for in-stent stenoses and showed good results in small vessels. Moreover, the available data suggest that DEB are a promising new technique for the treatment of de-novo stenoses in small vessels if pre-dilatation is performed and geographical mismatch is avoided. The aim of this study is to demonstrate that DEB is non-inferior to DES in a real-world population with respect to the combined clinical endpoint Major adverse cardiac events (MACE), defined as cardiac death, non-fatal myocardial infarction, and target vessel revascularization after 12 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
758 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drug eluting balloon
Arm Type
Experimental
Arm Description
paclitaxel-eluting SeQuent® Please balloon, B.Braun Melsungen AG, Berlin, Germany
Arm Title
Drug eluting stent
Arm Type
Active Comparator
Arm Description
paclitaxel-eluting Taxus Element® stent, Boston Scientific Corp, Natick MA or everolimus-eluting Xience® stent Abbott Vascular, Santa Clara, California, USA
Intervention Type
Device
Intervention Name(s)
Drug eluting balloon
Intervention Description
PCI using paclitaxel-eluting SeQuent® Please balloon, B. Braun Melsungen AG, Berlin, Germany
Intervention Type
Device
Intervention Name(s)
Drug eluting stent
Intervention Description
PCI using paclitaxel-eluting Taxus Element® stent, Boston Scientific Corp, Natick MA
Primary Outcome Measure Information:
Title
Major adverse cardiac events
Description
Major adverse cardiac events (MACE), defined as cardiac death, non-fatal myocardial infarction, and target vessel revascularization after 12 months.
Time Frame
12 month
Secondary Outcome Measure Information:
Title
MACE
Description
MACE after 24 and 36 months
Time Frame
24/36 month
Title
Revascularization
Description
The single components of the primary endpoint including target lesion revascularization after 12, 24, and 36 months
Time Frame
12/24/36 month
Title
Stent Thrombosis
Description
Possible, probable, and definite stent thrombosis defined according to the ARC criteria after 12, 24, and 36 months; all stent thromboses defined according to the ARC criteria after 12, 24, and 36 months
Time Frame
12/24/36 month
Title
Thrombolysis In Myocardial Infarction
Description
Thrombolysis In Myocardial Infarction (TIMI) major bleeding after 12, 24, and 36 months Net clinical benefit consisting of the primary endpoint and the TIMI major bleeding after 12, 24, and 36 months
Time Frame
12/24/36 month
Title
Cost-effectiveness
Description
Cost-effectiveness of DEB vs. DES after 12, 24, and 36 months
Time Frame
12/24/36 month
Title
Quantitative Coronary Analysis (QCA)
Description
QCA of patients who had events which required CAG/PCI after Baseline PCI
Time Frame
12 months
Title
Outcome in patients with high bleeding risk including patients on OAC
Description
Outcome analyis of patients with high bleeding risk with regard to Major bleeding events (BARC)
Time Frame
12 months
Title
Outcome in acute versus stable CAD
Description
Difference of the Population with acute versus stable CAD with regard to baseline characteristics, primary and secondary outcome measures (MACE, stent thrombosis, major bleeding)
Time Frame
12 months
Title
Outcome in diabetics vs non diabetics
Description
Difference of the diabetic versus non-diabetic population regarding baseline characteristics and primary and secondary outcome measures (MACE, stent thrombosis, major bleeding)
Time Frame
12 months
Title
sex specific inequalities in the use of drug coated balloons for small coronary artery disease
Description
sex specific difference in baseline charchteristics, Impact of sex on safety and efficacy in the stent-free strategy regarding primary and secondary endpoint (MACE, stent thrombosis, major bleeding)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Angina pectoris Canadian Cardiovascular Society (CCS) 2 to 4 or silent ischemia as assessed by stress echocardiography, stress cardiac magnetic resonance, myocardial perfusion scintigraphy, or fractional flow reserve PCI of de-novo stenosis in vessels ≥2.0 to <3.0 mm in diameter irrespective of the indication (concomitant PCI of a vessel ≥3.0 mm in diameter is permitted if the stenosis is located in a coronary artery other than the culprit vessel) No flow-limiting dissection (TIMI ≤2) or residual stenosis >30% after initial dilatation with a standard or non-compliant balloon, as assessed by the physician in charge Written informed consent Exclusion Criteria: Concomitant large-diameter PCI in the same coronary artery (LAD, Ramus circumflexus (RCX), RCA) PCI of instent-restenosis (culprit lesion) Life expectancy <12 months Pregnancy Enrolled in another coronary intervention study Unable to give informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raban V Jeger, PD Dr
Organizational Affiliation
Cardiology, University Hospital Basel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medizinische Universität Graz Kardiologie
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Cardiology, Zentralklinik Bad Berka
City
Bad Berka
ZIP/Postal Code
99437
Country
Germany
Facility Name
Unfallkrankenhaus Berlin, Dept. Internal Medicine
City
Berlin
ZIP/Postal Code
12683
Country
Germany
Facility Name
Charité Universitätsmedizin Berlin, Kardiologie
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Immanuel Klinikum Bernau Herzzentrum Brandenburg
City
Bernau
ZIP/Postal Code
16321
Country
Germany
Facility Name
Klinikum Westfalen GmbH Knappschaftskrankenhaus
City
Dortmund
ZIP/Postal Code
44309
Country
Germany
Facility Name
Universitätsklinikum des Saarlandes - Kardiologie, Angiologie und internistische Intensivmedizin
City
Homburg/Saar
Country
Germany
Facility Name
University Hospital Jena
City
Jena
ZIP/Postal Code
07747
Country
Germany
Facility Name
Herzzentrum Leipzig GmbH, Universitätsklinik
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
Facility Name
Department of Internal Medicine/Cardiology, University Hospital Ulm
City
Ulm
Country
Germany
Facility Name
Cardiology, University Hospital Basel
City
Basel
Country
Switzerland
Facility Name
Cardiology Cantonal Hospital Baselland Liestal
City
Liestal
ZIP/Postal Code
4410
Country
Switzerland
Facility Name
Luzerner Kantonsspital
City
Luzern
ZIP/Postal Code
6000
Country
Switzerland
Facility Name
Cardiology, Kantonsspital St. Gallen
City
St. Gallen
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
29527709
Citation
Gilgen N, Farah A, Scheller B, Ohlow MA, Mangner N, Weilenmann D, Wohrle J, Jamshidi P, Leibundgut G, Mobius-Winkler S, Zweiker R, Krackhardt F, Butter C, Bruch L, Kaiser C, Hoffmann A, Rickenbacher P, Mueller C, Stephan FP, Coslovsky M, Jeger R; BASKET-SMALL 2 Investigators. Drug-coated balloons for de novo lesions in small coronary arteries: rationale and design of BASKET-SMALL 2. Clin Cardiol. 2018 May;41(5):569-575. doi: 10.1002/clc.22942. Epub 2018 May 10.
Results Reference
background
PubMed Identifier
30170854
Citation
Jeger RV, Farah A, Ohlow MA, Mangner N, Mobius-Winkler S, Leibundgut G, Weilenmann D, Wohrle J, Richter S, Schreiber M, Mahfoud F, Linke A, Stephan FP, Mueller C, Rickenbacher P, Coslovsky M, Gilgen N, Osswald S, Kaiser C, Scheller B; BASKET-SMALL 2 Investigators. Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2): an open-label randomised non-inferiority trial. Lancet. 2018 Sep 8;392(10150):849-856. doi: 10.1016/S0140-6736(18)31719-7. Epub 2018 Aug 28.
Results Reference
result
PubMed Identifier
35411792
Citation
Scheller B, Rissanen TT, Farah A, Ohlow MA, Mangner N, Wohrle J, Mobius-Winkler S, Weilenmann D, Leibundgut G, Cuculi F, Gilgen N, Coslovsky M, Mahfoud F, Jeger RV; BASKET-SMALL 2 Investigators. Drug-Coated Balloon for Small Coronary Artery Disease in Patients With and Without High-Bleeding Risk in the BASKET-SMALL 2 Trial. Circ Cardiovasc Interv. 2022 Apr;15(4):e011569. doi: 10.1161/CIRCINTERVENTIONS.121.011569. Epub 2022 Apr 12.
Results Reference
derived
PubMed Identifier
35000455
Citation
Mangner N, Farah A, Ohlow MA, Mobius-Winkler S, Weilenmann D, Wohrle J, Linke A, Stachel G, Markovic S, Leibundgut G, Rickenbacher P, Cattaneo M, Gilgen N, Kaiser C, Scheller B, Jeger RV; BASKET-SMALL 2 Investigators. Safety and Efficacy of Drug-Coated Balloons Versus Drug-Eluting Stents in Acute Coronary Syndromes: A Prespecified Analysis of BASKET-SMALL 2. Circ Cardiovasc Interv. 2022 Feb;15(2):e011325. doi: 10.1161/CIRCINTERVENTIONS.121.011325. Epub 2022 Jan 10.
Results Reference
derived
PubMed Identifier
34412797
Citation
Wohrle J, Scheller B, Seeger J, Farah A, Ohlow MA, Mangner N, Mobius-Winkler S, Weilenmann D, Stachel G, Leibundgut G, Rickenbacher P, Cattaneo M, Gilgen N, Kaiser C, Jeger RV; BASKET-SMALL 2 Investigators. Impact of Diabetes on Outcome With Drug-Coated Balloons Versus Drug-Eluting Stents: The BASKET-SMALL 2 Trial. JACC Cardiovasc Interv. 2021 Aug 23;14(16):1789-1798. doi: 10.1016/j.jcin.2021.06.025.
Results Reference
derived
PubMed Identifier
33091360
Citation
Jeger RV, Farah A, Ohlow MA, Mangner N, Mobius-Winkler S, Weilenmann D, Wohrle J, Stachel G, Markovic S, Leibundgut G, Rickenbacher P, Osswald S, Cattaneo M, Gilgen N, Kaiser C, Scheller B; BASKET-SMALL 2 Investigators. Long-term efficacy and safety of drug-coated balloons versus drug-eluting stents for small coronary artery disease (BASKET-SMALL 2): 3-year follow-up of a randomised, non-inferiority trial. Lancet. 2020 Nov 7;396(10261):1504-1510. doi: 10.1016/S0140-6736(20)32173-5. Epub 2020 Oct 19. Erratum In: Lancet. 2020 Nov 7;396(10261):1490.
Results Reference
derived
PubMed Identifier
31993736
Citation
Fahrni G, Scheller B, Coslovsky M, Gilgen N, Farah A, Ohlow MA, Mangner N, Weilenmann D, Wohrle J, Cuculi F, Leibundgut G, Mobius-Winkler S, Zweiker R, Twerenbold R, Kaiser C, Jeger R; BASKET-SMALL 2 Investigators. Drug-coated balloon versus drug-eluting stent in small coronary artery lesions: angiographic analysis from the BASKET-SMALL 2 trial. Clin Res Cardiol. 2020 Sep;109(9):1114-1124. doi: 10.1007/s00392-020-01603-2. Epub 2020 Jan 29.
Results Reference
derived

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Basel Stent Kosten Effektivitäts Trial Drug Eluting Balloons vs. Drug Eluting Stents in Small Vessel Interventions

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