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

Conditions

Coronary Heart Disease

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.

María Rubini Giménez, Bruno Scheller, Ahmed Farah, Marc‐Alexander Ohlow, Norman Mangner et al. (14 authors)

Clinical Research in Cardiology2023-07-267 citations

10.1007/s00392-023-02249-6

Drug-Coated Balloon for Small Coronary Artery Disease in Patients With and Without High-Bleeding Risk in the BASKET-SMALL 2 Trial

Bruno Scheller, Tuomas T. Rissanen, Ahmed Farah, Marc‐Alexander Ohlow, Norman Mangner et al. (15 authors)

Circulation Cardiovascular Interventions2022-04-0164 citations

10.1161/circinterventions.121.011569

Drug-coated balloons for small coronary artery disease in patients with chronic kidney disease: a pre-specified analysis of the BASKET-SMALL 2 trial.

Mahfoud F, Farah A, Ohlow MA, Mangner N, Wöhrle J, Möbius-Winkler S, Weilenmann D, Leibundgut G, Cuculi F, Gilgen N, Kaiser C, Cattaneo M, Scheller B, Jeger RV.

2022-02-275 citations

10.1007/s00392-022-01995-3

Safety and Efficacy of Drug-Coated Balloons Versus Drug-Eluting Stents in Acute Coronary Syndromes: A Prespecified Analysis of BASKET-SMALL 2

Norman Mangner, Ahmed Farah, Marc-Alexander Ohlow, Sven Möbius-Winkler, Daniel Weilenmann et al. (17 authors)

Circulation Cardiovascular Interventions2022-01-1037 citations

10.1161/circinterventions.121.011325

Impact of Diabetes on Outcome With Drug-Coated Balloons Versus Drug-Eluting Stents: The BASKET-SMALL 2 Trial.

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.

2021-08-0141 citations

10.1016/j.jcin.2021.06.025

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.

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.

2020-10-19192 citations

10.1016/s0140-6736(20)32173-5

Drug-coated balloon versus drug-eluting stent in small coronary artery lesions: angiographic analysis from the BASKET-SMALL 2 trial.

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.

2020-01-2922 citations

10.1007/s00392-020-01603-2

Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2): an open-label randomised non-inferiority trial.

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.

2018-08-28311 citations

10.1016/s0140-6736(18)31719-7

Interventions

DEVICEDrug eluting balloon

PCI using paclitaxel-eluting SeQuent® Please balloon, B. Braun Melsungen AG, Berlin, Germany

DEVICEDrug eluting stent

PCI using paclitaxel-eluting Taxus Element® stent, Boston Scientific Corp, Natick MA

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
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)
Quantitative Coronary Analysis (QCA)	12 months	QCA of patients who had events which required CAG/PCI after Baseline PCI
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)
Cost-effectiveness	12/24/36 month	Cost-effectiveness of DEB vs. DES after 12, 24, and 36 months

Countries

Austria, Germany, Switzerland

Outcome results

None listed