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

Tracking Information

• First Submitted Date: April 8, 2012
• First Posted Date: April 10, 2012
• Last Update Posted Date: June 24, 2020
• Study Start Date: April 2012
• Actual Primary Completion Date: February 1, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 18, 2013)

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.

Original Primary Outcome Measures (submitted: April 9, 2012)

Major adverse cardiac events [ Time Frame: 12m ]

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

Current Secondary Outcome Measures (submitted: June 21, 2019)

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

Original Secondary Outcome Measures (submitted: April 9, 2012)

• MACE [ Time Frame: 24/36m ]
  MACE after 24 and 36 months
• Revascularization [ Time Frame: 12/24/36m ]
  The single components of the primary endpoint including target lesion revascularization after 12, 24, and 36 months
• Stent Thrombosis [ Time Frame: 12/24/36m ]
  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 [ Time Frame: 12/24/36m ]
  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 [ Time Frame: 12/24/36m ]
  Cost-effectiveness of DEB vs. DES after 12, 24, and 36 months

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Basel Stent Kosten Effektivitäts Trial Drug Eluting Balloons vs. Drug Eluting Stents in Small Vessel Interventions
• 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Coronary Heart Disease

Intervention

• Device: Drug eluting balloon
  PCI using paclitaxel-eluting SeQuent® Please balloon, B. Braun Melsungen AG, Berlin, Germany
• Device: Drug eluting stent
  PCI using paclitaxel-eluting Taxus Element® stent, Boston Scientific Corp, Natick MA

Study Arms

• Experimental: Drug eluting balloon
  paclitaxel-eluting SeQuent® Please balloon, B.Braun Melsungen AG, Berlin, Germany
  Intervention: Device: Drug eluting balloon
• 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
  Intervention: Device: Drug eluting stent

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.
• 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.
• Wöhrle J, Scheller B, Seeger J, Farah A, Ohlow MA, Mangner N, Möbius-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, 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 20, 2014): 758
• Original Estimated Enrollment (submitted: April 9, 2012): 649
• Actual Study Completion Date: January 15, 2020
• Actual Primary Completion Date: February 1, 2018 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Austria, Germany, Switzerland

Administrative Information

• NCT Number: NCT01574534
• Other Study ID Numbers: BASKET-SMALL2
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: University Hospital, Basel, Switzerland
• Study 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

• PRS Account: University Hospital, Basel, Switzerland
• Verification Date: June 2020