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SYNTAX Substudy Shows Positive Outcomes for Left Main Patients Treated With TAXUS(R) Express2(R) Stent System
Date:5/19/2009

NATICK, Mass. and BARCELONA, Spain, May 19 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX) today announced positive outcomes from a substudy of patients with left main coronary disease who were treated with the TAXUS(R) Express2(R) Paclitaxel-Eluting Coronary Stent System. SYNTAX-LE MANS is a substudy of the landmark SYNTAX trial, the first randomized, controlled clinical trial to compare percutaneous coronary intervention (PCI) using the TAXUS Stent to coronary artery bypass graft (CABG) surgery in patients with left main disease and/or significant narrowing of all three coronary arteries (three-vessel disease). The substudy data were presented by A. Pieter Kappetein, M.D., Ph.D., at the annual EuroPCR Scientific Program in Barcelona.

SYNTAX-LE MANS compares late angiographic and clinical outcomes in 263 patients with left main disease (149 treated with the TAXUS Stent and 114 treated with CABG). It is designed to assess 15-month patency (vessel openness) and the safety of stents and grafts in this high-risk population; it includes separate primary endpoints for each treatment arm. For PCI patients, the primary endpoint is the rate of long-term patency (defined here as <50% stenosis) of the treated lesion sites. For CABG patients, the primary endpoint is the ratio of obstructed/occluded grafts (defined here as greater than or equal to 50% stenosis) to total placed grafts. Results were presented separately for each group, and no formal statistical inferences between the two groups were made due to the different primary endpoints. Results were also broken out by left main lesion location, including distal and non-distal.

For those patients receiving a TAXUS Stent, the patency rate for the treated lesion was 92 percent. Restenosis was more common with distal lesions (90% patency) compared with non-distal
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SOURCE Boston Scientific Corporation
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