Boston Scientific Reports on ATLAS Small Vessel and Long Lesion Trial

September 22, 2009—Boston Scientific Corporation (Natick, MA) announced comprehensive data from the TAXUS ATLAS clinical program, a series of global, prospective, single-arm trials evaluating the company's Taxus Liberté paclitaxel-eluting stent system in a variety of lesions and patient groups. The 3-year results from the TAXUS ATLAS Small Vessel (SV) and Long Lesion (LL) trials continue to show significant advantages for the newer Taxus Liberté stent when compared to the first-generation Taxus Express stent. The data were presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2009 scientific symposium in San Francisco.

The TAXUS ATLAS SV trial was designed to evaluate the long-term safety and efficacy of the 2.25-mm-diameter Taxus Liberté Atom stent in small coronary vessels. The TAXUS ATLAS LL trial was designed to assess the long-term safety and efficacy of the Taxus Liberté Long 38-mm stent in patients with long coronary lesions.

Three-year results from the ATLAS SV trial demonstrated a statistically significant reduction in the rate of target lesion revascularization in small vessels treated with the Liberté Atom stent as compared to the Express Atom stent (10% vs 22.1%; P = .008), representing a 55% relative risk reduction. Additionally, the 3-year major adverse cardiac events rate for the Liberté Atom stent was 19.5% as compared to 32.4% for the Express Atom stent (P = .03), a relative reduction of 40%. The composite safety measure of cardiac death or myocardial infarction (MI) remained numerically lower at 3 years for the Liberté Atom Stent as compared to the Express Atom stent (6.5% vs 7.4%; P = .79).

"The ATLAS SV trial showed a sustained and significantly reduced risk of revascularization in small vessels for the Liberté Atom stent as compared to the Express Atom stent out to 3 years," commented coprincipal investigator Mark A. Turco, MD. "Positive 3-year data from the ATLAS LL trial showed the Liberté Long stent significantly reduces the risk of MI and cardiac death in long lesions compared to the Express Stent, while reporting 0% rate of stent thrombosis. These data, combined with the previously reported reduction in 9-month late loss, suggest that these improvements are likely the result of the thinner struts and improved stent geometry of the Liberté stent."

In the ATLAS LL trial, the Liberté Long stent demonstrated significantly improved safety outcomes when treating long lesions compared to the Express stent. The rate of cardiac death showed a significant 78% reduction in patients treated with the Liberté Long stent compared to the Express stent (1.5% vs 6.7%; P = .03). Overall MI showed a significant 72% reduction at 3 years in patients receiving a single Liberté Long stent compared to a single Express stent (2.9% vs 10.4%; P = .01). This improvement was primarily driven by a significant reduction in non-Q wave MI. The Liberté Long stent had a 0% stent thrombosis rate at 3 years using either the protocol definition or the Academic Research Consortium definite/probable definition, and the control Express stent reported 0.8% stent thrombosis (P = .49) using the protocol definition and 3.9% (P = .03) using the Academic Research Consortium definition, Boston Scientific stated.