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Assessment of ‘safety’ refers to the side-effect profile and clinical events experienced (eg stroke, myocardial infarction, unplanned revascularisation). BMS, bare-metal stent; DAPT, dual antiplatelet therapy; MACCE, major adverse cardiac and cerebral events; MACE, major adverse coronary events; MCB, major or clinically relevant non-major bleeding; NACE, net adverse clinical endpoints; OFDI, optical frequency domain imaging; PCI, percutaneous coronary intervention; STEMI, ST-segment elevation myocardial infarction; TLF, target lesion failure.
Data on file: Ultimaster clinical data for specific indications, Annex to PS-6079, Clinical evaluation report, prepared November 2016; Data on file at Terumo Europe