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

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

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).

Study Overview

• Status: Completed
• Conditions: Coronary Heart Disease
• Intervention / Treatment: Device: Drug eluting balloon; Device: Drug eluting stent

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.

• Study Type: Interventional
• Enrollment (Actual): 758
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
    • Medizinische Universität Graz Kardiologie
• Germany
  • Bad Berka, Germany, 99437
    • Cardiology, Zentralklinik Bad Berka
  • Berlin, Germany, 12683
    • Unfallkrankenhaus Berlin, Dept. Internal Medicine
  • Berlin, Germany, 13353
    • Charite Universitatsmedizin Berlin, Kardiologie
  • Bernau, Germany, 16321
    • Immanuel Klinikum Bernau Herzzentrum Brandenburg
  • Dortmund, Germany, 44309
    • Klinikum Westfalen GmbH Knappschaftskrankenhaus
  • Homburg/Saar, Germany
    • Universitätsklinikum des Saarlandes - Kardiologie, Angiologie und internistische Intensivmedizin
  • Jena, Germany, 07747
    • University Hospital Jena
  • Leipzig, Germany, 04289
    • Herzzentrum Leipzig GmbH, Universitätsklinik
  • Ulm, Germany
    • Department of Internal Medicine/Cardiology, University Hospital Ulm
• Switzerland
  • Basel, Switzerland
    • Cardiology, University Hospital Basel
  • Liestal, Switzerland, 4410
    • Cardiology Cantonal Hospital Baselland Liestal
  • Luzern, Switzerland, 6000
    • Luzerner Kantonsspital
  • St. Gallen, Switzerland
    • Cardiology, Kantonsspital St. Gallen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Drug eluting balloon; paclitaxel-eluting SeQuent® Please balloon, B.Braun Melsungen AG, Berlin, Germany	Device: Drug eluting balloon; PCI using paclitaxel-eluting SeQuent® Please balloon, B. Braun Melsungen AG, Berlin, Germany
Active Comparator: Drug eluting stent; paclitaxel-eluting Taxus Element® stent, Boston Scientific Corp, Natick MA or everolimus-eluting Xience® stent Abbott Vascular, Santa Clara, California, USA	Device: Drug eluting stent; PCI using paclitaxel-eluting Taxus Element® stent, Boston Scientific Corp, Natick MA

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACE	MACE after 24 and 36 months	24/36 month
Revascularization	The single components of the primary endpoint including target lesion revascularization after 12, 24, and 36 months	12/24/36 month
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	12/24/36 month
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	12/24/36 month
Cost-effectiveness	Cost-effectiveness of DEB vs. DES after 12, 24, and 36 months	12/24/36 month
Quantitative Coronary Analysis (QCA)	QCA of patients who had events which required CAG/PCI after Baseline PCI	12 months
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)	12 months
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)	12 months
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)	12 months
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)	12 months

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: Clinical Trial Unit, University Hospital Basel, Switzerland
• Investigators: Principal Investigator: Raban V Jeger, PD Dr, Cardiology, University Hospital Basel

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): January 15, 2020

Study Registration Dates

• First Submitted: April 8, 2012
• First Submitted That Met QC Criteria: April 9, 2012
• First Posted (Estimate): April 10, 2012

Study Record Updates

• Last Update Posted (Actual): June 24, 2020
• Last Update Submitted That Met QC Criteria: June 23, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: BASKET-SMALL2