Boston Scientific Commences Postapproval Study of Taxus Liberté Stent

January 4, 2010—Boston Scientific Corporation (Natick, MA) announced that it has enrolled the first patient in its TAXUS Liberte postapproval study. The study is designed to evaluate real-world clinical outcomes data for the company's Taxus Liberté paclitaxel-eluting coronary stent system in combination with a dual-antiplatelet drug regimen that includes aspirin and the oral antiplatelet agent Effient (Daiichi Sankyo Company, Ltd, [Parsippany, NJ] and Eli Lilly and Company [Indianapolis, IN]), which was recently approved by the US Food and Drug Administration. Daiichi Sankyo and Eli Lilly were cosponsors of the study for a new antiplatelet medication. Kirk Garratt, MD, and David P. Lee, MD, are the primary investigators for the TAXUS Liberte study. Joel Cohn, MD, enrolled the first patient in the study.

According to Boston Scientific, TAXUS Liberte is a prospective surveillance study that will enroll approximately 4,200 consecutive patients at up to 65 sites in the United States. The study will evaluate clinical outcomes in a broad range of patients with coronary artery disease who receive a Taxus Liberté Stent followed by the use of aspirin and Effient. The primary endpoint of the study is the rate of cardiac death or myocardial infarction at 12 months. Secondary endpoints will be analyzed out to 5 years and include rates of stent thrombosis using the Academic Research Consortium definition, target vessel failure, target vessel revascularization, myocardial infarction, bleeding events, and stroke.

Boston Scientific noted that the company plans to contribute data on the first 1,524 eligible patients from the TAXUS Liberte study to the DAPT study. DAPT is a 4-year public health study conducted by the Harvard Clinical Research Institute in collaboration with the US Food and Drug Administration and drug and device manufacturers. DAPT will investigate the appropriate duration of dual-antiplatelet therapy following drug-eluting stent implantation.