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Boston Scientific Corp's PROMUS Element Platinum Chromium Stent Demonstrates Continued Low Event Rates Through Three Years


Sunday, 10 Mar 2013 11:30am EDT 

Boston Scientific Corp announced clinical endpoint data from the PLATINUM workhorse clinical trial comparing the safety and effectiveness of the PROMUS Element Everolimus-Eluting Platinum Chromium (PtCr) Coronary Stent System to the Cobalt Chromium (CoCr) Xience V Everolimus-Eluting Coronary Stent System. At three years, the PROMUS Element Stent continued to demonstrate advantages over the Xience V Stent. The trial reported a three-year target lesion revascularization (TLR) rate of 3.5% for the PROMUS Element Stent, the lowest TLR rate in any pivotal FDA approval trial, compared to 4.9% for the Xience V Stent (p=0.21). Both the PROMUS Element and Xience V Stents demonstrated low rates of ARC/Definite stent thrombosis of 0.7% and 0.5% respectively (p=0.76). Trial results also confirmed a previously reported significant reduction in unplanned (bail-out or emergency) stenting with the PROMUS Element Stent compared to the Xience V Stent (5.9% vs. 9.8%, p=0.004), including a significantly lower rate of inadequate lesion coverage (1.4% vs. 3.4%, p=0.01). These clinical observations reinforce the results of comparative bench and pre-clinical studies, which have demonstrated the enhanced visibility and deliverability of the PROMUS Element Stent relative to the Xience V Stent. The reduction in bail-out stenting has also been tied to cost savings per procedure. 

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