Bare Metal Stent Versus Drug Coated Balloon With Provisional Stenting in Non-ST-Elevation Myocardial Infarction

Bare Metal Stent Versus Drug Coated Balloon With Provisional Stenting in Non-ST-Elevation Myocardial Infarction

The aim of the present trial is to assess the efficacy of the standalone use of SeQuent(R) Please coated balloon compared to a bare metal stent (BMS) in patients with NSTEMI.

The aim of the present trial is to assess the efficacy of the standalone use of SeQuent(R) Please coated balloon compared to a bare metal stent (BMS) in patients with NSTEMI. Primary efficacy endpoint will be MACE (cardiac mortality, reinfarction, and target lesion revascularization) after 9 months.

Inclusion Criteria:

• NSTEMI with
• Ischemic symptoms (angina pectoris) > 30 minutes
• Last symptoms within 72 hours before randomization
• Positive cardiac troponin T, I, or hs-Troponin above 99th percentile
• age > 18 years
• Identifiable culprit lesion without angiographic evidence of large thrombus with intended early PCI (treatment of up to two lesions allowed)

Exclusion Criteria:

• Cardiogenic shock
• ST-elevation myocardial infarction
• No identifiable culprit lesion, Indication for acute bypass surgery
• Comorbidity with limited life expectancy < 9-12 months
• Contraindication for treatment with heparin, ASA and thienopyridines