Stent demonstrates low event rates through three years

NATICK, Massachusetts, USA -- Boston Scientific Corporation (NYSE: BSX) reported 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 (Abbott Laboratories). 

Data were presented by Ian Meredith, M.D., Monash University, Melbourne, Australia, at the 62nd Annual Scientific Session of the American College of Cardiology in San Francisco on 10th March.

Around the world, approximately four million people with cardiovascular disease are treated each year with stents used to help keep vessels open.  Stents, which are placed and expanded to fit the size, shape and bend of the artery, may also be coated with a drug.  Boston Scientific is continuously studying product performance in an effort to offer innovations that provide a positive impact on patient care and lower the costs of healthcare.

"The PROMUS Element Platinum Chromium Stent continues to demonstrate excellent safety and effectiveness with low rates of cardiac death, myocardial infarction, stent thrombosis and repeat revascularization," said Professor Meredith.  "These three-year results confirm that this device benefits patients with symptomatic coronary artery disease requiring Percutaneous Coronary Intervention."

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.

"With its outstanding deliverability, conformability and visibility, the PROMUS Element Stent offers interventional cardiologists an exceptional stenting option for patients with coronary artery disease," said Kevin Ballinger, president, Interventional Cardiology, Boston Scientific. "These data confirm consistent long term performance which supports our efforts to improve the lives of patients around the world."

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