Abstract 2154: TAXUS ATLAS SMALL VESSEL: First Report of 9-Month Clinical and Angiographic Outcomes - Evaluation of the TAXUS Liberté 2.25 mm Stent, a Drug-Eluting Stent Specifically Designed for Small Vessels
Background: The thin-strut TAXUS Liberté (TL) stent was designed to increase flexibility and uniformity of drug distribution, and its safety and efficacy has been established in vessels 2.5–4.0 mm in diameter. However, small vessels are a risk factor for restenosis following coronary stent implantation. Thus, TAXUS ATLAS Small Vessel (SV) assessed both superiority of TL to bare metal Express stents (BMS) and non-inferiority of TL to TAXUS Express (TE) stents based on 9m % diameter stenosis (%DS), by QCA, in smaller vessels.
Methods: TAXUS ATLAS SV is a prospective, non-randomized trial enrolling 261 pts from 23 global sites. Pts undergoing single stent implantation of a de novo lesion visually estimated to be 10 – 28 mm in length, with a reference vessel diameter of 2.2 – 2.5 mm, were enrolled to receive the 2.25 mm TL stent. The BMS control consists of a cohort of TAXUS V pts treated with either a 2.25 mm or 2.5 mm Express stent. The TE control consists of a cohort of TAXUS V patients treated with a 2.25 mm TE stent.
Results: Baseline demographics of the TL arm were well matched to both the 155 BMS and the 75 TE controls. Compared to BMS, TL demonstrated superiority based on 9m %DS, analysis segment; thus, the first primary endpoint was met. Compared to TE, TL demonstrated non-inferiority for 9m %DS, analysis segment (pre-specified non-inferiority margin = 10.0%, difference = −6.27%, upper 1-sided 95% Confidence Interval = −1.38%, p<0.0001), and, therefore, the second primary endpoint was met. In addition, TL showed clear superiority vs TE in reducing clinical and angiographic restenosis.
Conclusions: While the advantages of TE over BMS have been firmly established for a wide range of vessels, including small vessels, TAXUS ATLAS SV is the first pivotal trial evaluating the TAXUS Liberté 2.25 mm stent in very small vessels. The newly designed, thin-strut TAXUS Liberté stent demonstrated a robust reduction of restenosis and the need for revascularizations vs both BMS and TE in small vessels.