Three-Year TAXUS ATLAS Data Shows Safety, Efficacy Over TAXUS Liberté
October 6, 2009 – Boston Scientific Corp. released data during TCT 2009 from the TAXUS ATLAS clinical program, a series of global, prospective, single-arm trials evaluating the TAXUS Liberté Paclitaxel-Eluting Stent System in a variety of lesions and patient groups. Three-year results from the TAXUS ATLAS Small Vessel and Long Lesion Trials continue to show significant advantages for the newer TAXUS Liberté Stent when compared to the first-generation TAXUS Express Stent.
The TAXUS ATLAS Small Vessel 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 Long Lesion 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. Boston Scientific remains the only company to offer both 2.25 mm diameter and 38 mm length drug-eluting coronary stents in the United States.
Three-year results from the TAXUS ATLAS Small Vessel Trial demonstrated a statistically significant reduction in the rate of target lesion revascularization (TLR) in small vessels treated with the TAXUS Liberté Atom as compared to the TAXUS Express Atom Stent (10 vs. 22.1 percent), representing a 55 percent relative risk reduction. Additionally, the three-year MACE rate for the TAXUS Liberté Atom was 19.5 percent as compared to 32.4 percent for the TAXUS Express Atom, a relative reduction of 40 percent. The composite safety measure of cardiac death or myocardial infarction (MI) remained numerically lower at three years for the TAXUS Liberté Atom as compared to the TAXUS Express Atom (6.5 vs. 7.4 percent).
“The TAXUS ATLAS Small Vessel Trial showed a sustained and significantly reduced risk of revascularization in small vessels for the TAXUS Liberté Atom Stent as compared to the TAXUS Express Atom Stent out to three years,” said Mark A. Turco, M.D., director of the Center for Cardiac and Vascular Research, Washington Adventist Hospital, and coprincipal investigator of the trial. “Positive three-year data from the TAXUS ATLAS Long Lesion Trial showed the TAXUS Liberté Long Stent significantly reduces the risk of MI and cardiac death in long lesions compared to the TAXUS Express Stent, while reporting zero percent stent thrombosis. These data, combined with the previously reported reduction in nine-month late-loss, suggest that these improvements are likely the result of the thinner struts and improved stent geometry of the TAXUS Liberté Stent.”
In the TAXUS ATLAS Long Lesion Trial, the TAXUS Liberte Long demonstrated significantly improved safety outcomes when treating long lesions compared to the TAXUS Express. The rate of cardiac death showed a significant 78 percent reduction in patients treated with the TAXUS Liberté Long compared to the TAXUS Express (1.5 vs. 6.7 percent). Overall MI showed a significant 72 percent reduction at three years in patients receiving a single TAXUS Liberté Long compared to a single TAXUS Express (2.9 vs. 10.4 percent). This improvement was primarily driven by a significant reduction in non-Q wave MI. The TAXUS Liberté Long had zero stent thrombosis at three years using either the Protocol definition or the ARC definite/probable definition, while the control TAXUS Express reported 0.8 percent stent thrombosis using the Protocol definition and 3.9 percent using the ARC definition.
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