Long-Term Results of TAXUS ATLAS Clinical Program Presented

September 22, 2010—Boston Scientific Corporation (Natick, MA) announced that coprincipal investigators Mark A. Turco, MD, and John A. Ormiston, MD, presented comprehensive data from the TAXUS ATLAS clinical program at the Transcatheter Cardiovascular Therapeutics scientific symposium in Washington, DC. The TAXUS ATLAS program is 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.

According to Boston Scientific, 5-year results from the TAXUS ATLAS trial and 4-year results from the TAXUS ATLAS Small Vessel and TAXUS ATLAS Long Lesion trials continue to show significant advantages for the thin-strut Taxus Liberté stent when compared to the first-generation Taxus Express stent.

“The TAXUS ATLAS trials continue to reinforce the long-term safety and efficacy of the TAXUS Liberté stent in a variety of complex lesions,” commented Dr. Turco. “The data showed sustained positive outcomes in workhorse lesions, significantly reduced rates of reintervention in small vessels, and important safety differences in long lesions. The ATLAS data suggest that improvements in stent design and a reduction in strut thickness may contribute to improved clinical outcomes for patients treated with the Taxus Liberté stent."

The company reported that data from 871 patients in the TAXUS ATLAS trial demonstrated that the durable safety and efficacy profile of the Taxus Liberté stent is maintained at 5 years in de novo coronary ("workhorse") lesions. With more complex patients treated with the Taxus Liberté stent, the unadjusted data showed comparable clinical outcomes between the Taxus Liberté stent and a historical case-matched Taxus Express stent control group.

The study reported similar rates of target lesion revascularization (TLR) for the Taxus Liberté stent and the Taxus Express stent (11% vs 11.5%; P = .72). Five-year data also showed comparable rates of cardiac death for the Liberté and the Express (5.1% vs 4.4%; P = .49) and overall myocardial infarction (MI) (7.6% vs 8.4%: P = .57). The rate of Academic Research Consortium (ARC) definite/probable stent thrombosis at 5 years was 3% versus 2.7% (P = .76).

Four-year data were presented for the TAXUS ATLAS Small Vessel trial, which is designed to evaluate the long-term safety and efficacy of the Taxus Liberté Atom 2.25-mm stent compared to lesion-matched patients from the TAXUS V trial treated with either 2.25- or 2.5-mm bare-metal Express stents or the Taxus Express 2.25-mm stent.

The Taxus Liberté 2.25-mm stent showed significantly lower rates of TLR (10.8% vs 23.8%; P = .008), target vessel revascularization (16.5% vs 31.7%; P = .007), target lesion failure (15.4% vs 30.2%; P = .007), and major adverse cardiac events (21.6% vs 36.5%; P = .02) sustained at 4 years compared with the Taxus Express 2.25-mm stent and similar significant reductions compared to the bare-metal Express Stent group. All stents showed comparable rates of total death, cardiac death, MI, and ARC definite/probable stent thrombosis.

“The Taxus Liberté 2.25-mm stent significantly reduced restenosis and maintained safety outcomes in small vessels compared to the Taxus Express 2.25-mm stent and Express bare-metal stents,” commented Dr. Ormiston. “Since Taxus Liberté uses the same drug/polymer coating as Taxus Express, I believe these improved clinical outcomes in small vessels likely result from the thinner struts and improved stent geometry of the Taxus Liberté stent.”

Four-year data were presented from the TAXUS ATLAS Long Lesion trial, which is designed to assess the safety and efficacy of the Taxus Liberté Long 38-mm stent in patients with long coronary lesions compared to a case-matched patient cohort from the TAXUS IV and V trials treated with Taxus Express Stents. In a subgroup analysis of patients treated with a single stent, the Taxus Liberté Long stent showed significantly reduced rates of target-vessel MI (2.6% vs 12.9%; P = .02) and target-vessel non-Q-wave MI (2.6% vs 11.3%; P = .03) compared to the Taxus Express stent at 4 years. Both stent groups demonstrated comparable rates of TLR, major adverse cardiac events, and ARC definite/probable stent thrombosis.

“The Taxus Liberté Long stent maintained a continued long-term safety benefit in patients with long lesions, resulting in lower target vessel–related MI and a numerically lower rate of cardiac death compared to the Taxus Express stent,” stated Dr. Turco.