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

• ClinicalTrials.gov Identifier: NCT01574534
• Recruitment Status: Completed
• First Posted: April 10, 2012
• Last Update Posted: June 24, 2020
• Sponsor: University Hospital, Basel, Switzerland
• Collaborator: Clinical Trial Unit, University Hospital Basel, Switzerland
• Information provided by (Responsible Party): University Hospital, Basel, Switzerland

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).

Condition or disease	Intervention/treatment	Phase
Coronary Heart Disease	Device: Drug eluting balloon; Device: Drug eluting stent	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 758 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: April 2012
• Actual Primary Completion Date: February 1, 2018
• Actual Study Completion Date: January 15, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Major adverse cardiac events [ Time Frame: 12 month ]
   Major adverse cardiac events (MACE), defined as cardiac death, non-fatal myocardial infarction, and target vessel revascularization after 12 months.

Secondary Outcome Measures :

1. MACE [ Time Frame: 24/36 month ]
   MACE after 24 and 36 months
2. Revascularization [ Time Frame: 12/24/36 month ]
   The single components of the primary endpoint including target lesion revascularization after 12, 24, and 36 months
3. Stent Thrombosis [ Time Frame: 12/24/36 month ]
   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
4. Thrombolysis In Myocardial Infarction [ Time Frame: 12/24/36 month ]

   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

5. Cost-effectiveness [ Time Frame: 12/24/36 month ]
   Cost-effectiveness of DEB vs. DES after 12, 24, and 36 months
6. Quantitative Coronary Analysis (QCA) [ Time Frame: 12 months ]
   QCA of patients who had events which required CAG/PCI after Baseline PCI
7. Outcome in patients with high bleeding risk including patients on OAC [ Time Frame: 12 months ]
   Outcome analyis of patients with high bleeding risk with regard to Major bleeding events (BARC)
8. Outcome in acute versus stable CAD [ Time Frame: 12 months ]
   Difference of the Population with acute versus stable CAD with regard to baseline characteristics, primary and secondary outcome measures (MACE, stent thrombosis, major bleeding)
9. Outcome in diabetics vs non diabetics [ Time Frame: 12 months ]
   Difference of the diabetic versus non-diabetic population regarding baseline characteristics and primary and secondary outcome measures (MACE, stent thrombosis, major bleeding)
10. sex specific inequalities in the use of drug coated balloons for small coronary artery disease [ Time Frame: 12 months ]
    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)

Eligibility Criteria

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

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

Contacts and Locations

Locations

Austria

Medizinische Universität Graz Kardiologie

Graz, Austria, 8036

Germany

Cardiology, Zentralklinik Bad Berka

Bad Berka, Germany, 99437

Unfallkrankenhaus Berlin, Dept. Internal Medicine

Berlin, Germany, 12683

Charité Universitätsmedizin Berlin, Kardiologie

Berlin, Germany, 13353

Immanuel Klinikum Bernau Herzzentrum Brandenburg

Bernau, Germany, 16321

Klinikum Westfalen GmbH Knappschaftskrankenhaus

Dortmund, Germany, 44309

Universitätsklinikum des Saarlandes - Kardiologie, Angiologie und internistische Intensivmedizin

Homburg/Saar, Germany

University Hospital Jena

Jena, Germany, 07747

Herzzentrum Leipzig GmbH, Universitätsklinik

Leipzig, Germany, 04289

Department of Internal Medicine/Cardiology, University Hospital Ulm

Ulm, Germany

Switzerland

Cardiology, University Hospital Basel

Basel, Switzerland

Cardiology Cantonal Hospital Baselland Liestal

Liestal, Switzerland, 4410

Luzerner Kantonsspital

Luzern, Switzerland, 6000

Cardiology, Kantonsspital St. Gallen

St. Gallen, Switzerland

Sponsors and Collaborators

University Hospital, Basel, Switzerland

Clinical Trial Unit, University Hospital Basel, Switzerland

Investigators

• Principal Investigator: Raban V Jeger, PD Dr; Cardiology, University Hospital Basel

More Information

Publications of Results:

Jeger RV, Farah A, Ohlow MA, Mangner N, Möbius-Winkler S, Leibundgut G, Weilenmann D, Wöhrle 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.

Other Publications:

Gilgen N, Farah A, Scheller B, Ohlow MA, Mangner N, Weilenmann D, Wöhrle J, Jamshidi P, Leibundgut G, Möbius-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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Jeger RV, Farah A, Ohlow MA, Mangner N, Möbius-Winkler S, Weilenmann D, Wöhrle 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, Wöhrle J, Cuculi F, Leibundgut G, Möbius-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.

• Responsible Party: University Hospital, Basel, Switzerland
• ClinicalTrials.gov Identifier: NCT01574534
• Other Study ID Numbers: BASKET-SMALL2
• First Posted: April 10, 2012
• Last Update Posted: June 24, 2020
• Last Verified: June 2020

Additional relevant MeSH terms:

Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases