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

University Hospital, Basel, Switzerland758 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

758

Conditions

Coronary Heart Disease

Interventions

Drug eluting balloonDEVICE

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

Drug eluting stentDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (14)

Medizinische Universität Graz Kardiologie

Graz, Austria

Cardiology, Zentralklinik Bad Berka

Bad Berka, Germany

Unfallkrankenhaus Berlin, Dept. Internal Medicine

Outcomes

Primary Outcomes

Major adverse cardiac events

Major adverse cardiac events (MACE), defined as cardiac death, non-fatal myocardial infarction, and target vessel revascularization after 12 months.

Time frame: 12 month

Secondary Outcomes

MACE

MACE after 24 and 36 months

Time frame: 24/36 month

Revascularization

The single components of the primary endpoint including target lesion revascularization after 12, 24, and 36 months

Time frame: 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

Time frame: 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

Time frame: 12/24/36 month

Cost-effectiveness

Cost-effectiveness of DEB vs. DES after 12, 24, and 36 months

Time frame: 12/24/36 month

Quantitative Coronary Analysis (QCA)

QCA of patients who had events which required CAG/PCI after Baseline PCI

Time frame: 12 months

Outcome in patients with high bleeding risk including patients on OAC

Data from ClinicalTrials.gov

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