Background
Small coronary vessel diameter is associated with high restenosis rates and adverse clinical outcomes. The platinum chromium PROMUS Element everolimus-eluting stent (EES, Boston Scientific, Natick, MA, USA) demonstrated low event rates and noninferior clinical outcomes compared to the XIENCE V EES (Abbott, Santa Clara, CA, USA) in arteries ≥2.50 mm. The PLATINUM Japan Small Vessel (SV) study assessed results in small-caliber arteries <2.50 mm in Japan.
Methods
One de novo target lesion ≤28 mm long with reference diameter ≥2.25 to <2.50 mm could be treated with a 2.25-mm-diameter stent. Patients were randomized 1:1 to undergo/not undergo angiographic assessment after the 12-month clinical follow-up. The primary end point, 9-month major adverse cardiac event [MACE, a composite of cardiac death, myocardial infarction (MI), and ischemia-driven target lesion revascularization (TLR)], was compared to a performance goal (PG) of 24.1% based on historical outcomes with plain balloon angioplasty. Clinical follow-up is at 1, 9, and 12 months and annually to 5 years.
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