NATICK, Mass. and Munich, Germany - Boston Scientific Corporation announced positive one-year results from the European and Intercontinental launch phases of its global TAXUS OLYMPIA registry, the world's largest post-approval, prospective registry for a single drug-eluting stent (DES). OLYMPIA is designed to analyze real-world clinical outcomes data for Boston Scientific's second-generation TAXUS® Liberte® Paclitaxel-Eluting Coronary Stent System in the treatment of patients with coronary artery disease. Results from the 22,000-patient study were presented by Oscar Mendiz, M.D., at the European Society of Cardiology Congress in Munich, Germany.

The TAXUS OLYMPIA registry uses a consecutive enrollment process and is made up of diverse and high-risk patient populations, imaging real-world usage patterns found in everyday clinical practice. One-year data were collected for a total of 22,345 patients to date in 57 countries. A large majority of patients (75%) were considered "expanded use" cases consisting of complex lesions or complex clinical characteristics. The overall OLYMPIA population in these two phases included patients with multivessel disease (56.5%), prior PCI (27.9%), prior myocardial infarction (MI) (34.1%), multiple stents (32.3%), and medically treated diabetes (27.0%).

The one-year results demonstrated a low overall 3.8 percent rate of TAXUS Liberte stent-related composite cardiac events, including cardiac death (1.2%), MI (0.8%), and re-intervention (TLR) (2.5%). The definite stent thrombosis rate was 0.8 percent after one year, which is consistent with safety data from other DES registries. In the more complex expanded use patient population, the rates of stent-related composite cardiac events and stent thrombosis were 4.3 percent and 0.9 percent respectively. The TAXUS Liberte Stent also exhibited a high degree of procedural success at 99.7 percent.

In the medically treated diabetic subset of 5,692 patients, OLYMPIA reported a 4.6 percent rate of overall TAXUS Liberte stent-related cardiac events and 0.8 percent definite stent thrombosis. The diabetic patient subset is typically considered to be at high risk for adverse events associated with bare-metal stenting.

The TAXUS Liberte Stent is currently pending approval by the U.S. Food and Drug Administration and is not available for sale in the United States.

For more information, please visit: www.bostonscientific.com.

More Voices