Boston Scientific Corporation has enrolled the first patient in its Taxus Liberte post-approval study. The study is designed to evaluate real-world clinical outcomes data for the Taxus Liberte Paclitaxel-Eluting Coronary Stent System in combination with a dual antiplatelet therapy drug regimen that includes aspirin and Effient, a new antiplatelet medication. Co-sponsors of the study include Eli Lilly and Company and Daiichi Sankyo, Inc, manufacturers of Effient, which was recently approved by the US Food and Drug Administration (FDA). The first patient was enrolled by Joel Cohn, FACC, at the Ingham Regional Medical Center in Lansing, Michigan.
Taxus Liberte is a prospective surveillance study that will enroll approximately 4,200 consecutive patients at up to 65 US sites. The study will evaluate clinical outcomes in a broad range of patients with coronary artery disease who receive a Taxus Liberte Stent followed by the use of aspirin and Effient. The primary endpoint of the study is the rate of cardiac death or myocardial infarction (MI) at 12 months. Secondary endpoints will be analyzed out to five years and include rates of stent thrombosis using the Academic Research Consortium (ARC) definition, target vessel failure (TVF), target vessel revascularization (TVR), MI, bleeding events and stroke.
"The Taxus Liberte Stent has been studied extensively in the Atlas and Olympia clinical programs with impressive results," said Keith D Dawkins, senior vice president and associate chief medical officer at Boston Scientific. "The Taxus Liberte post-approval study will allow us to further assess the second-generation Taxus Liberte Stent -- along with the use of Effient and aspirin -- in a variety of complex lesions."
Boston Scientific plans to contribute data on the first 1,524 eligible patients from the Taxus Liberte study to the DAPT Study, a landmark collaboration among the FDA, drug and device manufacturers, and the Harvard Clinical Research Institute (HCRI). This four-year public health study will investigate the appropriate duration of dual antiplatelet therapy following drug-eluting stent implantation. HCRI is responsible for the scientific management and independent analysis of the overall study.
"Boston Scientific is proud to participate in this important public health study," added Dawkins. "The value of antiplatelet drugs in reducing events such as myocardial infarction and stent thrombosis after stent implantation has been demonstrated but the optimal duration of this therapy is less clear. The results of the DAPT Study should provide new insights into the use of dual antiplatelet medication with drug-eluting stents and help establish more definitive guidelines for clinical practice."
The Taxus Liberte Stent employs an advanced stent design for more consistent drug distribution and greater stent deliverability to the target lesion. When compared to the Taxus Express Stent, Boston Scientific's Taxus Liberte Stent features a hybrid cell design with more uniform stent architecture, a 27 percent reduction in strut thickness and superior results when treating patients with small diameter vessels or long lesions, as demonstrated in the Taxus Atlas Small Vessel and Long Lesion studies.
The primary investigators of the Taxus Liberte study are Kirk Garratt, from Lenox Hill Hospital in New York, and David P Lee, MD, from Stanford University Medical Center.
Effient is a registered trademark of Eli Lilly and Company.
The Taxus Liberte Stent received CE Mark approval in 2005, US FDA approval in 2008 and Japanese approval in 2009.
The DAPT Study concept was developed by a group of major stent manufacturers and the manufacturers of thienopyridine/antiplatelet medications who came together to address an FDA request for this post-market study.
Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties.