Boston Scientific Completes Enrollment in PLATINUM Trials for Small Vessels and Long Lesions

March 16, 2010—Boston Scientific Corporation (Natick, MA) announced the completion of patient enrollment in the Small Vessel and Long Lesion trials of its PLATINUM clinical program. The trials are designed to compare the platinum chromium Promus Element everolimus-eluting coronary stent system to matched historical control groups of patients treated with the company's Taxus Express² paclitaxel-eluting stent system.

The Small Vessel trial enrolled 94 patients with de novo lesions > 2.25 to < 2.5 mm in diameter and < 28 mm in length. The Long Lesion trial enrolled 102 patients with de novo lesions > 24 to < 34 mm in length and > 2.5 to < 4.25 mm in diameter. Both trials enrolled patients at more than 30 sites worldwide.

According to the company, PLATINUM is a pivotal, randomized, controlled clinical trial program designed to support approval of the Promus Element stent by the US Food and Drug Administration and Japanese Ministry of Health, Labour and Welfare. The company received CE Mark approval for the device in October 2009. The PLATINUM Workhorse trial, which compares the Promus Element stent to the Promus stent, completed enrollment of 1,531 patients at 133 sites worldwide in September 2009. Boston Scientific expects that results will be presented in early 2011.

"Data from clinical studies have shown that small vessels and long lesions each represent an estimated 10% of percutaneous coronary interventions," commented Gregg W. Stone, MD, who is principal investigator for the PLATINUM program. "The availability of everolimus-based small-vessel and long-lesion stents will allow physicians greater flexibility in treating a broad range of complex coronary lesions. We look forward to the results of these important trials."