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

Launched by UNIVERSITY HOSPITAL, BASEL, SWITZERLAND · Apr 9, 2012

Keywords

ClinConnect Summary

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 aft...

Gender

ALL

Eligibility criteria

• 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