Trial Results Support Safety for Taxus Liberté Stent System
Boston Scientific has released promising 30-day safety data from its ATLAS clinical trial, the first trial using the company's next-generation Liberté coronary stent as a platform for its paclitaxel-eluting coronary stent system.
The ATLAS trial results support safety, as demonstrated by a low overall major adverse cardiac events (MACE) rate. Thirty-day MACE was 3.3 percent in Group X and 2.8 percent in Group Y (the study remains blinded through the primary endpoint at nine months). Cardiac deaths were 0.2 percent in both groups. The overall myocardial infarction rate was 3 percent in Group X and 2.6 percent in Group Y. The overall target vessel revascularization rate was 0.4 percent in Group X and 0.2 percent in Group Y. Stent thromboses were also low, with a rate of 0.5 percent in Group X and 0.2 percent in Group Y.
The ATLAS trial is a global, multicenter pivotal study designed to support FDA approval of Taxus Liberté. It is assessing the safety and efficacy of a slow-release dose formulation paclitaxel-eluting Taxus Liberté for the treatment of coronary artery disease.
The results include 871 patients at 61 sites in the U.S., Canada, Australia, New Zealand, Singapore, Hong Kong and Taiwan. The primary endpoint for the study is target vessel revascularization at nine months.