September 2, 2008 – Boston Scientific Corp. today 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 company said the TAXUS OLYMPIA registry employs a consecutive enrollment process and consists of diverse and high-risk patient populations, reflecting real-world usage patterns found in everyday clinical practice. One-year data was collected for a total of 22,345 patients to date in 57 countries. The majority of patients (75 percent) were considered “expanded use” cases consisting of complex lesions or complex clinical characteristics. The overall OLYMPIA population in these two phases included patients with multi-vessel disease (56.5 percent), prior PCI (27.9 percent), prior myocardial infarction (MI) (34.1 percent), multiple stents (32.3 percent), and medically treated diabetes (27 percent).
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 percent), MI (0.8 percent), and re-intervention (TLR) (2.5 percent). 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.
“The TAXUS OLYMPIA registry shows impressive results in the largest, prospective DES patient population ever studied for an individual stent,” said Dr. Mendiz, Fundacion Favaloro, Buenos Aires, Argentina. “The low occurrence of cardiac events and stent thrombosis is noteworthy, especially given the high degree of complex patients and lesions from real-world practice in this study.”
In the medically treated diabetic subset of 5,692 patients, OLYMPIA reported 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 one-year OLYMPIA results reinforce the success of the TAXUS Liberte Stent in effectively treating a wide-range of patients routinely seen in the cath lab,” said Donald S. Baim, M.D., chief medical and scientific officer of Boston Scientific. “This second-generation platform offers exceptional deliverability and a stent geometry designed specifically for drug elution.”
The TAXUS Liberte Stent is currently pending FDA approval.
For more information: www.bostonscientific.com