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

Coronary Heart Disease Clinical Trial

— BASKET-SMALL2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01574534
• Other study ID #: BASKET-SMALL2
• Status: Completed
• Phase: N/A
• Start date: April 2012
• Est. completion date: January 15, 2020

Study information

• Verified date: June 2020
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 758
• Est. completion date: January 15, 2020
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
Austria	Medizinische Universität Graz Kardiologie	Graz
Germany	Cardiology, Zentralklinik Bad Berka	Bad Berka
Germany	Charité Universitätsmedizin Berlin, Kardiologie	Berlin
Germany	Unfallkrankenhaus Berlin, Dept. Internal Medicine	Berlin
Germany	Immanuel Klinikum Bernau Herzzentrum Brandenburg	Bernau
Germany	Klinikum Westfalen GmbH Knappschaftskrankenhaus	Dortmund
Germany	Universitätsklinikum des Saarlandes - Kardiologie, Angiologie und internistische Intensivmedizin	Homburg/Saar
Germany	University Hospital Jena	Jena
Germany	Herzzentrum Leipzig GmbH, Universitätsklinik	Leipzig
Germany	Department of Internal Medicine/Cardiology, University Hospital Ulm	Ulm
Switzerland	Cardiology, University Hospital Basel	Basel
Switzerland	Cardiology Cantonal Hospital Baselland Liestal	Liestal
Switzerland	Luzerner Kantonsspital	Luzern
Switzerland	Cardiology, Kantonsspital St. Gallen	St. Gallen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Clinical Trial Unit, University Hospital Basel, Switzerland

Countries where clinical trial is conducted

Austria,  Germany,  Switzerland, 

References & Publications (2)

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. — View Citation

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 Inves — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	MACE	MACE after 24 and 36 months	24/36 month
Secondary	Revascularization	The single components of the primary endpoint including target lesion revascularization after 12, 24, and 36 months	12/24/36 month
Secondary	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
Secondary	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
Secondary	Cost-effectiveness	Cost-effectiveness of DEB vs. DES after 12, 24, and 36 months	12/24/36 month
Secondary	Quantitative Coronary Analysis (QCA)	QCA of patients who had events which required CAG/PCI after Baseline PCI	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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