Data Published From Abbott Vascular's
SPIRIT III 4-mm Registry

January 25, 2010—In Catheterization and Cardiovascular Interventions, Paul C. Gordon, MD, et al published findings from an evaluation of the safety and efficacy of Abbott Vascular’s (Santa Clara, CA) Xience V 4-mm stent for the treatment of de novo native coronary artery lesions (2010;75:179-186).

The background of the study is that in the SPIRIT III trial, the Xience V everolimus-eluting stent (EES) compared with the Taxus Express² paclitaxel-eluting stent (PES) (Boston Scientific Corporation, Natick, MA) in 2.5- to 3.75-mm diameter coronary arteries, resulted in reduced angiographic late loss, noninferior rates of target vessel failure (TVF), and fewer major adverse cardiac events (MACE). The SPIRIT III 4-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 diameters of 3.75 to 4.25 mm treated with a 4-mm EES. The primary endpoint was 8-month in-segment late loss compared with the randomized PES arm.

The investigators reported that in-segment late loss was 0.17 ± 0.38 mm in the 4-mm EES registry compared with 0.28 ± 0.48 mm in the PES arm (P < .0001 for noninferiority). The 1-year rates of ischemia-driven TVF (cardiac death, MI, or target vessel revascularization) and MACE (cardiac death, MI, or target lesion revascularization) were numerically, but not statistically, lower in the 4-mm EES patients compared with the randomized PES patients (5.9% vs 11.3%; P = .27; and 5.9% vs 10.3%; P = .36, respectively). There was no difference in 8-month late loss or 1-year TVF or MACE between the 4-mm EES and randomized EES patients.

The investigators concluded that in large coronary arteries, the 4-mm EES results in low rates of late loss at 8 months and adverse clinical events at 1 year.