Basel Stent Kosten Effektivitäts Trial Drug Eluting Balloons vs. Drug Eluting Stents in Small Vessel Interventions
- Conditions
- Coronary Heart Disease
- Interventions
- Device: Drug eluting balloonDevice: Drug eluting stent
- Registration Number
- NCT01574534
- Lead Sponsor
- University Hospital, Basel, Switzerland
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 758
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Drug eluting balloon Drug eluting balloon paclitaxel-eluting SeQuent® Please balloon, B.Braun Melsungen AG, Berlin, Germany Drug eluting stent Drug eluting stent paclitaxel-eluting Taxus Element® stent, Boston Scientific Corp, Natick MA or everolimus-eluting Xience® stent Abbott Vascular, Santa Clara, California, USA
- Primary Outcome Measures
Name Time Method Major adverse cardiac events 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
Name Time Method Cost-effectiveness 12/24/36 month Cost-effectiveness of DEB vs. DES after 12, 24, and 36 months
Quantitative Coronary Analysis (QCA) 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 12 months Outcome analyis of patients with high bleeding risk with regard to Major bleeding events (BARC)
Outcome in acute versus stable CAD 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 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 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)
MACE 24/36 month MACE after 24 and 36 months
Revascularization 12/24/36 month The single components of the primary endpoint including target lesion revascularization after 12, 24, and 36 months
Stent Thrombosis 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 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
Trial Locations
- Locations (14)
Medizinische Universität Graz Kardiologie
🇦🇹Graz, Austria
Cardiology, University Hospital Basel
🇨🇭Basel, Switzerland
Luzerner Kantonsspital
🇨🇭Luzern, Switzerland
Cardiology, Kantonsspital St. Gallen
🇨🇭St. Gallen, Switzerland
Cardiology, Zentralklinik Bad Berka
🇩🇪Bad Berka, Germany
Immanuel Klinikum Bernau Herzzentrum Brandenburg
🇩🇪Bernau, Germany
Unfallkrankenhaus Berlin, Dept. Internal Medicine
🇩🇪Berlin, Germany
Charité Universitätsmedizin Berlin, Kardiologie
🇩🇪Berlin, Germany
University Hospital Jena
🇩🇪Jena, Germany
Klinikum Westfalen GmbH Knappschaftskrankenhaus
🇩🇪Dortmund, Germany
Department of Internal Medicine/Cardiology, University Hospital Ulm
🇩🇪Ulm, Germany
Herzzentrum Leipzig GmbH, Universitätsklinik
🇩🇪Leipzig, Germany
Universitätsklinikum des Saarlandes - Kardiologie, Angiologie und internistische Intensivmedizin
🇩🇪Homburg/Saar, Germany
Cardiology Cantonal Hospital Baselland Liestal
🇨🇭Liestal, Switzerland