Boston Scientific announced on 22 September 2009 comprehensive data from the Taxus ATLAS clinical programme, a series of global, prospective, single-arm trials evaluating the Taxus Liberte 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 Liberte when compared to the first-generation Taxus Express.
The data were presented at the Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in San Francisco, US.
The Taxus ATLAS Small Vessel Trial was designed to evaluate the long-term safety and efficacy of the 2.25mm diameter Taxus Liberte 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 Liberte Long 38mm stent in patients with long coronary lesions. Boston Scientific is the only company to offer both 2.25mm diameter and 38mm length drug-eluting coronary stents in the US.
Three-year results from the Taxus ATLAS Small Vessel Trial demonstrated a statistically significant reduction in the rate of target lesion revascularisation (TLR) in small vessels treated with the Taxus Liberte Atom as compared to the Taxus Express Atom (10% vs. 22.1%, p=0.008), representing a 55% relative risk reduction. Additionally, the three-year major adverse cardiac events rate for the Taxus Liberte Atom was 19.5% as compared to 32.4% for the Taxus Express Atom (p=0.03), a relative reduction of 40%. The composite safety measure of cardiac death or myocardial infarction remained numerically lower at three years for the Taxus Liberte Atom stent as compared to the Taxus Express Atom (6.5% vs. 7.4%, p=0.79).
“The Taxus ATLAS Small Vessel Trial showed a sustained and significantly reduced risk of revascularisation in small vessels for the Taxus Liberte Atom Stent as compared to the Taxus Express Atom Stent out to three years,” said Mark A Turco, director of the Center for Cardiac and Vascular Research, Washington Adventist Hospital, and co-principal investigator of the trial. “Positive three-year data from the Taxus ATLAS Long Lesion Trial showed the Taxus Liberte Long Stent significantly reduces the risk of myocardial infarction 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 Liberte Stent.”
In the Taxus ATLAS Long Lesion Trial, the Taxus Liberte Long Stent demonstrated significantly improved safety outcomes when treating long lesions compared to the Taxus Express. The rate of cardiac death showed a significant 78% reduction in patients treated with the Taxus Liberte compared to the Taxus Express (1.5% vs. 6.7%, p=0.03). Overall myocardial infarctions showed a significant 72% reduction at three years in patients receiving a single Taxus Liberte Long Stent compared to a single Taxus Express (2.9% vs. 10.4%, p=0.01). This improvement was primarily driven by a significant reduction in non-Q wave myocardial infarction. The Taxus Liberte Long Stent had zero stent thrombosis at three years using either the Protocol definition or the ARC definite/probable definition while the control Taxus Express Stent reported 0.8% stent thrombosis (p=0.49) using the Protocol definition and 3.9% (p=0.03) using the ARC definition.