Boston Scientific Corp.’s Taxus Liberté stent is not safe and effective as it has a higher risk of major cardiac events, according to a new study.
Taxus Liberté stent which uses anti-cancer agent paclitaxel as coating shouldn’t be used in everyday clinical practice because it can lead major heart problems and worse restoration of blood flow after one year.
A study comparing Taxus Liberté stent with Abbott’s Xience V stent found that the everolimus-eluting stent Xience prevented heart attacks and repeat surgeries more than Boston Scientific’s Taxus.
On the basis of these results, the researchers suggest that paclitaxel-eluting stents should no longer be used in everyday clinical practice.
The everolimus-eluting stent is better than the second- generation paclitaxel-eluting stent in unselected patients in terms of safety and efficacy, the researchers, led by Pieter Smits of the Department of Cardiology at Maasstad hospital in Rotterdam, wrote in the published in Lancet medical journal.
Boston Scientific Corporation has already begun 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 will enroll approximately 4,200 consecutive patients at up to 65 U.S. 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,” stated Keith D. Dawkins, M.D., Senior Vice President and Associate Chief Medical Officer at Boston Scientific.
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.
The TaxusLiberte 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 Taxus Liberte Stent received CE Mark approval in 2005, U.S. FDA approval in 2008 and Japanese approval in 2009.
Boston reported Taxus stents sales of $1.32 billion, or 16 percent, of Boston Scientific’s 2008 sales, according to a company filing with the U.S. Securities and Exchange Commission.
What are stents?
Stents are tiny metal mesh tubes which can keep blocked arteries open. Stents are used in a procedure called a balloon angioplasty. Latest devices are coated with chemical polymers and drugs like everolimus or paclitaxel to prevent the growth of tissue which can lead to re-blocking of the arteries. Re-occlusion is the main complication of older bare-metal models.
Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties.