NATICK, Mass. and VIENNA, Austria, Sept. 2 Boston Scientific Corporation (NYSE: BSX) today announced one-year resultsfrom the European and Intercontinental launch phases of its TAXUS OLYMPIAregistry. The first 7,124 patient cohort of the nearly 23,000 enrolledprovided positive safety data on the TAXUS(R) Liberate(TM) coronary stentsystem in complex, real-world patients, as announced at the European Societyof Cardiology Congress in Vienna, Austria.
The one-year results demonstrated a low overall 3.9 percent rate of TAXUSLiberte stent related cardiac events, including cardiac death (1.1 percent),myocardial infarction (0.9 percent), and TAXUS Liberte stent relatedre-intervention of the target vessel (2.5 percent). The one-year stentthrombosis rate was 0.8 percent, which is consistent with safety data fromother DES registries.
In the diabetic subset (2,380 patients), OLYMPIA reported a low 4.4percent rate of overall TAXUS Liberte stent related cardiac events, includingcardiac death (1.9 percent), and myocardial infarction (0.8 percent). TAXUSLiberte stent related re-interventions (2.3 percent) and stent thrombosis (0.7percent) were both lower for the high-risk diabetic patient group than therates for the overall population.
"The OLYMPIA registry continues to show impressive results, especiallygiven the high degree of complex patient and lesions from real-worldpractice," said Martyn Thomas, M.D., F.R.C.P., Director of InvasiveCardiology, Kings College Hospital, London, and one of the coordinatinginvestigators of the registry. "The data show consistency with initialresults and with data from other TAXUS clinical trials and registries,offering further evidence that the TAXUS Liberte stent system continues toshow positive safety outcomes in real-world use."
"The one-year OLYMPIA data show excellent outcomes with the TAXUS Libertestent system across a large patient population with a broad range of lesioncomplexity, including diabetics who have typically demonstrated increasedevent rates," said Jeff Goodman, President of Boston Scientific International."Our second-generation stent platform - TAXUS Liberte - offers exceptionaldeliverability and is the only current drug-eluting stent geometry designedspecifically for drug elution. The strong clinical results, excellentperformance in diabetics and solid physician preference have allowed TAXUSLiberte to take a clear leadership role in European and Intercontinentalmarkets."
The global, prospective OLYMPIA registry is the world's largest DESregistry and plans to enroll up to 26,000 patients from more than 400 centersworldwide. OLYMPIA is designed to analyze real-world clinical outcomes datafor Boston Scientific's second-generation TAXUS Liberte paclitaxel-elutingstent system in the treatment of patients with coronary artery disease.
The OLYMPIA European and Intercontinental launch phases consisted ofdiverse and high-risk patient populations, reflecting complex usage patternsin "real-world" clinical practices. A majority of patients exhibited complexlesions or clinical characteristics, including, multi-vessel disease (57.7percent), prior myocardial infarction (MI) (37.3 percent), acute MI (17.8percent), multiple stents (32.9 percent), type B2/C lesions (56.6 percent) anddiabetes (33.4 percent). Of the first 7,124 patients enrolled, 92.5 percent(6,593 patients) were available for evaluation at one year.
Patients with a single vessel treated with only one TAXUS Liberte stentwere considered simple use patients and comprised 27.6 percent of the total.Complex use patients comprised 72.4 percent of the population (5,157 patients)and included patients with acute MI, small vessels, long lesions, in-stentrestenosis, and bifurcations, representing lesions not studied in the TAXUS IVand TAXUS ATLAS pivotal randomized controlled trials. Despite the highercomplexity, patients in t