Clinical and angiographic outcomes with an everolimus-eluting stent in large coronary arteries: the SPIRIT III 4.0 mm registry.

Objective: This study evaluates the safety and efficacy of the XIENCE V (R) 4.0 mm stent for the treatment of de novo native coronary artery lesions. Background: In the SPIRIT III trial, the XIENCE V (R) everolimus-eluting stent (EES), compared with the TAXUS EXPRESS(2) paclitaxel-eluting stent (PES) in 2.5-3.75 mm diameter coronary arteries, resulted in reduced angiographic late loss (LL), noninferior rates of target vessel failure (TVF), and fewer major adverse cardiac events (MACE). Methods: The SPIRIT III 4.0 mm registry was a concurrent arm of the SPIRIT III trial consisting of 69 nonrandomized patients with lesions <= 28 mm in length and reference vessel diameter 3.75-4.25 mm treated with a 4.0 mm EES. The primary endpoint was 8-month in-segment LL compared with the randomized PES arm. Results: In-segment LL was 0.17 +/- 0.38 mm in the 4.0 mm EES registry compared with 0.28 +/- 0.48 mm in the PES arm (P < 0.0001 for noninferiority). The 1-year rates of ischemia-driven TVF (cardiac death, myocardial infarction [MI], or target vessel revascularization) and MACE (cardiac death, MI, or target lesion revascularization [TLR]) were numerically, but not statistically, lower in the 4.0 mm EES patients compared with the randomized PES patients (5.9 vs. 11.3%, P = 0.27 and 5.9 vs. 10.3%, P = 0.36, respectively). There was no difference in 8-month LL or 1-year TVF or MACE between the 4.0 mm EES and randomized EES patients. Conclusions: In large coronary arteries, the 4.0 mm EES results in low rates of LL at 8 months and adverse clinical events at 1 year. (C) 2009 Wiley-Liss, Inc.