Liberté stent performance update
This article was originally published in The Gray Sheet
Executive Summary
Boston Scientific's Taxus Liberté paclitaxel-eluting stent demonstrates 3.7% cardiac event rate at 12 months in phase one of the firm's Olympia trial (529 patients), and a 3% cardiac event rate at six months in phase three (2,066 patients). The registry-based study, for which preliminary results were released Oct. 25 at TCT, will include up to 27,000 patients and is designed to reflect evolving "real world" usage patterns, including use in diabetics, multi-vessel disease, small vessels and complex lesions, says investigator Martyn Thomas, MD, King's College Hospital, London. Separately, the 871-patient Atlas Workhorse trial demonstrates noninferiority of Liberté to the Taxus Express paclitaxel-eluting stent, based on nine-month target vessel revascularization (TVR) rates of 8% and 7.1%, respectively, and equally low cardiac event and stent thrombosis rates, Boston Scientific says. Nine-month data from the 247-patient Direct trial with Liberté show that direct stenting without balloon predilation of the vessel is safe and effective when compared with predilation. Direct stenting has a 97.6% delivery success rate and "less target lesion revascularization, TVR and major adverse cardiac events," according to investigator John Ormiston, MD, Auckland City Hospital, New Zealand. In May, the firm gained expanded CE mark indications for Liberté, making it the only drug-eluting stent cleared for treating restenotic lesions and total occlusions in patients with coronary artery disease 1("The Gray Sheet" May 22, 2006, p. 14). The company expects to launch Liberté in the U.S. in 2007...