To evaluate real-world clinical outcomes data for the TAXUS
Boston Scientific 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.
TAXUS Liberte is a prospective surveillance study that enrolls 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 four-year public health study will investigate the appropriate duration of dual antiplatelet therapy following drug-eluting stent implantation. Harvard Clinical Research Institute (HCRI) is responsible for the scientific management and independent analysis of the overall study.
The company said that 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, TAXUS Liberte Stent features a hybrid cell design with more uniform stent architecture, a 27% 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).