One-Year Outcomes with the TAXUS Liberte Stent in the Real World: The TAXUS OLYMPIA Registry (Phase I)

Background: The TAXUS OLYMPIA registry is a prospective, postapproval registry collecting clinical outcomes data on patients receiving the TAXUS Liberte paclitaxel-eluting stent during routine interventional cardiology practice. Methods: Between February and July 2005, 529 patients receiving the TAXUS Liberte stent at 16 centers in the Middle East, South/Central America, and Asia/Pacific regions were enrolled in Phase I of OLYMPIA. The primary end-point was TAXUS Liberte stent-related cardiac events (cardiac death, MI, and revascularization) at 30 days postimplant. Additional clinical assessment was conducted at 6 and 12 months. OLYMPIA phases II and III are in clinical follow-up and will be reported separately. Results: One-year clinical follow-up is available for 98% of patients. Complex patients and lesions were prevalent, including: 50% diabetes mellitus, 49% multivessel disease, 30% multiple stenting, 48% AHA/ACC type B2/C lesions, 19% long lesions (> 26 mm), and 40% small vessels (<= 2.75 mm). At 1 year, the cardiac event rate was 4.1%, including 1.5% cardiac death, 1.5% MI, and 2.3% target vessel revascularization (TVR). The TAXUS Liberte stent-related cardiac event rate was 3.7% at 1 year. Stent thrombosis (ST) occurred in 1.7% of patients, with three cases occurring > 30 days postprocedure. One-year cardiac event rates among complex subpopulations (diabetics 5.0%, multiple stents 3.8%, long lesions 3.1%, and small vessels 2.9%) were comparable to the overall study population. Conclusions: In conclusion, this first report of real-world experience with the TAXUS Liberte stent demonstrates the safety and clinical utility of this stent in the broader spectrum of coronary disease treated in everyday practice. (J Interven Cardiol 2008;21:512-518).