A Medical Device Daily
Boston Scientific (Natick, Massachusetts) reported positive one-year results from the Intercontinental and European launch phases of its global Taxus OLYMPIA registry, which it said is the world's largest prospective, post-approval 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.
Outcomes from the 22,000-patient study are focused on high-risk lesion subgroups and patients with serious co-morbid conditions.
Results were presented by Waqar Ahmed, MD, at the Transcatheter Cardiovascular Therapeutics (TCT 2008) symposium in Washington.
Boston Sci said the Taxus OLYMPIA registry employs a consecutive enrollment process and consists of diverse and high-risk patient populations, reflecting real-world patients found in everyday clinical practice.
One-year data were collected for a total of 22,345 patients to date in 57 countries, with cardiac events validated by independent medical review. A large majority of patients (75%) were considered "expanded use" cases consisting of challenging lesions or complex clinical characteristics.
The overall OLYMPIA population included patients with multi-vessel disease (56.5%), prior percutaneous coronary intervention (27.9%), multiple stents (32.3%) and medically treated diabetes (27%).
The company said one-year data demonstrated "excellent outcomes" for the Taxus Liberte stent in patients with high-risk lesions (small vessels, long lesions, B2/C lesions) and patients with co-morbid conditions (prior stroke, acute MI, chronic renal disease).
Results demonstrated a low overall 4.4% rate of Taxus Liberte stent-related composite cardiac events, including cardiac death (1.4%), myocardial infarction (0.9%), and re-intervention (3.1%). The definite stent thrombosis rate was 0.8% after one year. The Taxus Liberte stent also exhibited a high degree of procedural success at 99.7%.
In other news from TCT:
• Elixir Medical (Sunnyvale, California) reported results from three multi-center, first-in-human studies of novolimus- and myolimus-eluting coronary stent systems.
At the 12-month clinical follow-up, the novolimus-eluting coronary stent system demonstrated sustained efficacy and clinical safety with no MACE events or incidents of stent thrombosis.
Six-month clinical, angiographic and IVUS results from the myolimus-eluting coronary stent system with Elixir's bioabsorbable polymer revealed that one patient experienced a non Q-wave myocardial infarction and one patient experienced a target lesion revascularization.
Six-month angiographic and IVUS results from the first cohort of 15 patients demonstrated an in-stent late lumen loss of 0.37 0.44 mm and a volume obstruction of 14.2 7.7%. There were no incidents of stent thrombosis.
• Volcano (San Diego) reported the launch of its PrimeWire pressure guide wire, and the s5-FFR option for its existing installed base of s5 and s5i imaging consoles in the U.S.
The PrimeWire is Volcano's newest pressure guide wire, capable of measuring pressure gradients across a lesion to determine the ischemic nature of the stenosis, and also can help determine the extent to which the blockage is flow-limiting.
The PrimeWire measures intracoronary pressure to derive an FFR index. FFR expresses maximum achievable blood flow in a coronary artery with the presence of an abnormal stenosis as a fraction of maximum blood flow achievable in the absence of a stenosis.
The company said FFR is "100% specific in identifying lesions actually restricting blood flow enough to cause ischemia."