Usage Patterns and 1-Year Outcomes With the TAXUS Liberte Stent: Results of the TAXUS OLYMPIA Registry

Objectives: The TAXUS OLYMPIA registry is a prospective, global, post-approval program designed to collect clinical outcome data through 1 year from patients receiving the TAXUS Liberte paclitaxel-eluting stent in routine interventional cardiology practice. Background: The thin-strut TAXUS Liberte stent has been studied in ongoing clinical trials with specific inclusion/exclusion criteria. Methods: Between September 2005 and April 2007, a total of 21,954 patients from 365 sites in 57 countries eligible to receive a TAXUS Liberte stent were enrolled in the TAXUS OLYMPIA registry. Baseline characteristics and procedure patterns were collected and clinical follow-up is available for 1 year. The primary endpoint was the composite cardiac event (cardiac death, MI, and reintervention of the target vessel) rate related to the TAXUS Liberte stent at 1 year. All cardiac events were monitored and all endpoints were independently adjudicated. Results: Complex patients and lesions were prevalent, including: 27% medically-treated diabetes, 58% ACC/AHA type B2/C lesions, 32% multiple stenting, 13% long lesions (> 28mm), and 10% small vessels (<2.5 mm). At 1 year, the composite cardiac event rate was 4.4%, including 1.4% cardiac death, 1.0% MI, and 3.2% TVR. Stent thrombosis (ST, angiographically confirmed) occurred in 0.8% of patients, with 0.4% ST occurring > 30 days postprocedure. The composite cardiac event rate related to the TAXUS Liberte stent was 3.8% at 1 year. Conclusions: Low 1-year cardiac event rates were reported with TAXUS Liberte in a broad spectrum of patients, thereby confirming the technical and clinical performance of this stent in a "real-world" setting.