The prospective, single-arm study showed safety and effectiveness outcomes for the Promus system to treat de novo coronary lesions in small coronary vessels.

The Promus system’s study previously met its primary endpoint of target lesion failure (TLF) at 12 months with a rate of 2.4% compared to a pre-specified performance goal of 21.1% (p<0.001) based on historical outcomes for the 2.25 mm Taxus Express Paclitaxel-Eluting Stent.

The TLF rate at two years was 4.7% with the 2.25 mm PROMUS Element Stent, while the rate of target lesion revascularization (TLR) was 2.5%.

Platinum clinical program principal investigator and MonashHeart director Ian Meredith said the Platinum Small Vessel data continue to demonstrate very low revascularization rates, with no myocardial infarction or stent thrombosis through two years of follow up in patients treated with the 2.25 mm PROMUS Element Stent.

"These long-term results are impressive, especially considering the small vessel diameters that were evaluated in this study," Meredith added.