Boston Scientific's PLATINUM Trial Completes Enrollment

September 18, 2009—Boston Scientific Corporation (Natick, MA) announced the completion of patient enrollment in the workhorse portion of its PLATINUM clinical program. PLATINUM is a global, randomized, pivotal controlled trial designed to support US Food and Drug Administration and Japanese Ministry of Health, Labour and Welfare approval of the platinum chromium Promus Element everolimus-eluting coronary stent system. The trial enrolled 1,532 patients with up to two de novo lesions at more than 140 sites worldwide, and completed enrollment 2 months ahead of schedule. Gregg W. Stone, MD, is the principal investigator of the PLATINUM trial. The company advised that the Promus Element, Taxus Element, and bare-metal Element stents are investigational devices, limited to investigational use only and are not available for sale.

According to the company, the PLATINUM workhorse trial is evaluating the new Promus Element everolimus-eluting coronary stent in comparison with the current Promus stent, which uses the same drug dose and polymer on an earlier cobalt-chromium alloy stent design. Two parallel subtrials will evaluate the Promus Element stent in small vessels and long lesions. In addition to the Promus Element everolimus-eluting stent, the company is developing additional variations of a bare-metal and paclitaxel-eluting stent on the Element platform. The pivotal PERSEUS clinical trial is comparing the Taxus Element stent to the Taxus Express² stent. The PERSEUS trial completed enrollment in October 2008, and the primary endpoint will be reported at the American College of Cardiology conference in 2010.