The Promus Element everolimus-eluting coronary stent.
April 5, 2010 – Patient enrollment was recently completed in the Small Vessel and Long Lesion trials of the PLATINUM clinical program. It is designed to compare the platinum chromium Promus Element Everolimus-Eluting Stent to matched historical control groups of patients treated with the Taxus Express2 Paclitaxel-Eluting Stent.
The Small Vessel trial enrolled 94 patients with de novo lesions greater than or equal to 2.25 to less than 2.5 mm in diameter and less than or equal to 28 mm in length. The Long Lesion trial enrolled 102 patients with de novo lesions greater than 24 to less than or equal to 34 mm in length, and greater than or equal to 2.5 to less than or equal to 4.25 mm in diameter. Both trials enrolled patients at more than 30 sites worldwide.
"Data from clinical studies have shown that small vessels and long lesions each represent an estimated 10 percent of percutaneous coronary interventions," said Gregg W. Stone, M.D., professor of medicine and the director of research and education at the Center for Interventional Vascular Therapy at the Columbia University/New York-Presbyterian Hospital. He is also 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."
PLATINUM is a pivotal, randomized, controlled clinical trial program designed to support U.S. Food and Drug Administration and Japanese Ministry of Health, Labor and Welfare approval of the Promus Element Stent. Boston Scientific received CE mark European approval for this product in Oct. 2009.
Another key trial is the PLATINUM Workhorse trial, which compares the Promus Element Stent to the Promus stent (the same as the Xience stent made by Abbott). The study completed enrollment of 1,531 patients at 133 sites worldwide in September 2009. Results are expected in early 2011.
For more information: www.bostonscientific.com