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BAsel Stent Kosten Effektivitäts Trial - Drug Eluting Balloons vs. Drug Eluting Stents in Small Vessel Interventions (BASKET-SMALL 2)

Applicant Jeger Raban
Number 140956
Funding scheme Project funding (Div. I-III)
Research institution Klinik für Kardiologie Bereich Medizin Universitätsspital Basel
Institution of higher education University of Basel - BS
Main discipline Clinical Cardiovascular Research
Start/End 01.04.2012 - 31.12.2017
Approved amount 315'000.00
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Keywords (6)

Coronary artery disease; Drug-eluting balloon; Drug-eluting stent; Clinical research; Outcome; Long-term follow-up

Lay Summary (English)

Lead
Lay summary

In small native coronary vessels, target lesion restenosis after percutaneous coronary intervention remains an unresolved issue. Despite the use of drug-eluting stents, instent-restenosis is a clinical problem because lumen loss after stent implantation comprises a larger percentage of the total lumen diameter in small than large vessels. Based on preliminary data, drug-eluting balloons are a promising new technique for the treatment of de-novo stenosis in small vessels. This hypothesis needs to be tested in a prospective randomized controlled trial. The proposed project is a randomized, controlled, open-label, multicentric project of more than 600 patients to be enrolled in Germany and Switzerland and randomized between a modern third generation drug-eluting stent and drug-eluting balloons. Based on inclusion and exclusion criteria, an all-comer population with relevant small vessel coronary disease will be enrolled, with a combined endpoint of cardiac death, myocardial infarction and target vessel revascularization to be assessed at 12 months. If drug-eluting balloons proved non-inferiority over drug-eluting stents, a paradigm shift in clinical cardiology might take place regarding the management of symptomatic small-vessel disease. In this case, the implantation of stents in small vessels would only be needed if dissections or residual stenoses after initial balloon inflation occurred, but not if the result was good. Therefore, in app. 75% of all percutaneous coronary interventions in small vessels, a strategy of balloon inflation would be sufficient to treat patients with stenoses in small vessels. Potential benefits of an approach with balloon inflation only include the absence of instent-restenoses, instent-thromboses, and long-term dual antiplatelet therapy which would affect many patients worldwide.

Direct link to Lay Summary Last update: 21.02.2013

Responsible applicant and co-applicants

Publications

Publication
Drug-coated balloons for small coronary artery disease (BASKET SMALL 2): an open-label randomised non-inferiority trial
Reger V RabanFarah Ahmed (2018), Drug-coated balloons for small coronary artery disease (BASKET SMALL 2): an open-label randomised non-inferiority trial, in The Lancet, 1-8.
Drug-coated balloons for de novo lesions in small coronary: Rationale and design od BASKET SMALL 2
GilgenNicole (2018), Drug-coated balloons for de novo lesions in small coronary: Rationale and design od BASKET SMALL 2, in Clinical Cardiology, 2018(41), 569-575.

Collaboration

Group / person Country
Types of collaboration
Klinikum Westfalen, Dortmund Germany (Europe)
- Research Infrastructure
Cardiology University Hospital Ulm Germany (Europe)
- Research Infrastructure
Herzzentrum Brandenburg, Bernau Germany (Europe)
- Research Infrastructure
Cardiology University Hospital Jena Germany (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
- Research Infrastructure
Cardiology Zentralklinik Bad Berka Germany (Europe)
- Research Infrastructure
Cardiology Heart Center Leipzig Germany (Europe)
- Research Infrastructure
Cardiology University Hospital Graz Austria (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
- Research Infrastructure
Cardiology, Charité Berlin Germany (Europe)
- Research Infrastructure
Unfallkrankhenhaus Berlin Germany (Europe)
- Research Infrastructure
Cardiology University Hospital Saarland Homburg/Saar Germany (Europe)
- Research Infrastructure
Cardiology Kantonsspital St. Gallen Switzerland (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Research Infrastructure
- Exchange of personnel
Cardiology Kantonsspital Luzern Switzerland (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Research Infrastructure
- Exchange of personnel
Cardiology Kantonsspital Liestal Switzerland (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Exchange of personnel

Scientific events

Active participation

Title Type of contribution Title of article or contribution Date Place Persons involved
ESC Congress 2018 European Society of Cardiology Talk given at a conference Drug-Coated Balloons for Small Coronary Artery Disease: BASKET-SMALL 2 28.08.2018 München, Germany Jeger Raban;


Associated projects

Number Title Start Funding scheme
116382 Evaluation of late clinical events after drug-eluting versus bare-metal stents in patients at risk. BAsel Stent Kosten Effektivitäts Trial - PROspective Validation examination (BASKET-PROVE) 01.04.2007 Project funding (Div. I-III)
120029 BAsel Stent Kosten Effektivitäts Trial - SAphenous Venous graft Angioplasty using Glycoprotein IIb/IIIa receptor inhibitors and drug-Eluting stents 01.04.2008 Project funding (Div. I-III)

Abstract

Background: The BAsel Stent Kosten Effektivitäts Trial (BASKET) tested the cost-effectiveness of drug-eluting stents (DES) against bare metal stents (BMS) in percutaneous coronary interventions (PCI) irrespective of the indication and showed that patients with interventions in bypass grafts and small native vessels, i.e., less than 3.0 mm, benefited most from DES, not only by reducing target vessel revascularization (TVR), but also rates of cardiac death and non-fatal myocardial infarction. Therefore, additional trials in large native vessels (BASKET-PROVE and BASKET-PROVE II), bypass grafts (BASKET-SAVAGE), and small native vessels (BASKET-SMALL) were initiated. The present trial is a follow-up study of BASKET-SMALL that tested two different DES, i.e., the first-generation TAXUS® stent, a paclitaxel-eluting stainless steel stent with a durable polymer, against the second-generation Endeavor® stent, a zotarolimus-eluting cobalt-chromium stent with a biocompatible polymer in terms of major adverse clinical events (cardiac death, non-fatal myocardial infarction) after 18 months. Follow-up will end in late 2011.Hypothesis: In a real-world population undergoing PCI for de-novo stenoses in small native vessels with a diameter of less than 3.0 mm, drug eluting balloons (DEB) are able to reduce clinical event rates compared with third-generation DES.Design: Prospective, randomized, controlled, open-label, multicenter non-inferiority trial. Concomitant registry of patients with suitable inclusion criteria but flow-limiting dissections (Thrombolysis In Myocardial Infarction [TIMI] flow less or equal 2) or residual stenoses more or equal 30% after initial balloon inflation (see below)Inclusion criteria: PCI of de-novo stenoses in vessels less than 3.0 mm in diameter without a flow-limiting dissection (TIMI flow less or equal 2) or a residual stenosis more or equal 30% with the need for stent implantation after initial balloon inflation. Main exclusion criteria: Instent-restenosis, concomitant PCI of larger vessels, oral anticoagulation, planned surgery in the following 12 months.Intervention: Randomization 1:1 for a third-generation DES (paclitaxel-eluting Taxus Element® stent, Boston Scientific Corp, Natick MA) vs. DEB (paclitaxel-eluting SeQuent® Please balloon, B. Braun Melsungen AG, Berlin, Germany). Patients without exclusion criteria but flow-limiting dissections and residual stenoses more or equal 30% after the initial balloon inflation will receive the same DES as in the randomized trial and enter a prospective registry.Primary endpoint: Major adverse cardiac events (MACE), defined as cardiac death, myocardial infarction, and TVR after 12 months.Secondary endpoints:MACE after 24 and 36 months; single components of the primary endpoint, target lesion revascularization, stent thrombosis (possible, probable, definite), overall mortality, TIMI major bleeding, net clinical benefit endpoint (primary endpoint and TIMI major bleeding), and cost-effectiveness after 12, 24, and 36 months. Sample size: This non-inferiority trial aims to enroll 649 patients to ensure 616 evaluable patients. Assuming a dissection/residual stenosis rate of 33% and a drop-out rate of 5%, a total of 969 patients will need to be consented.
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