Basel Stent Kosten Effektivitäts Trial Drug Eluting Balloons vs. Drug Eluting Stents in Small Vessel Interventions

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Coronary Heart Disease

Intervention / Treatment
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* Device: Drug eluting balloon
* Device: Drug eluting stent


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug eluting balloon<br>paclitaxel-eluting SeQuent® Please balloon, B.Braun Melsungen AG, Berlin, Germany | Device: Drug eluting balloon<br>* PCI using paclitaxel-eluting SeQuent® Please balloon, B. Braun Melsungen AG, Berlin, Germany<br>|
| Active Comparator: Drug eluting stent<br>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<br>* PCI using paclitaxel-eluting Taxus Element® stent, Boston Scientific Corp, Natick MA<br>|

What is the study measuring?
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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 |