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news.Boston Scientific, a manufacturer and marketer of medical devices, has 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.
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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.
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 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 percutaneous coronary intervention (27.9%), prior myocardial infarction (34.1%), multiple stents (32.3%), and medically treated diabetes (27%).
The one-year results demonstrated a low overall 3.8% rate of Taxus Liberte stent-related composite cardiac events, including cardiac death (1.2%), myocardial infarction (0.8%), and re-intervention (TLR) (2.5%). The definite stent thrombosis rate was 0.8% after one year, which is consistent with safety data from other drug-eluting stent (DES) registries.
In the more complex expanded use patient population, the rates of stent-related composite cardiac events and stent thrombosis were 4.3% and 0.9% respectively. The Taxus Liberte stent also exhibited a high degree of procedural success at 99.7%.
In the medically treated diabetic subset of 5,692 patients, Olympia reported a 4.6% rate of overall Taxus Liberte stent-related cardiac events and 0.8% 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 FDA and is not available for sale in the US.