One-Year Small Vessel Data Published From Abbott Vascular's XIENCE V USA Postmarket Study

July 14, 2014—One-year results of real-world patients with small versus nonsmall vessel lesions in the XIENCE V USA study were published by James B. Hermiller, MD, et al in Catheterization and Cardiovascular Interventions (2014;84:7–16).

XIENCE V USA is a prospective, multicenter, postapproval study required by the US Food and Drug Administration to examine the safety and effectiveness of Abbott Vascular’s Xience V everolimus-eluting coronary stent (EES) system in real-world settings. The FDA approved the Xience V EES in July 2008.

On June 20, 2012, the initial 1-year results from the overall XIENCE V USA study were published by Srihari S. Naidu, MD, et al in the Journal of the American College of Cardiology: Cardiovascular Interventions (2021;5:626–635).

As noted in Catheterization and Cardiovascular Interventions, the purpose of this study was to evaluate the 1-year clinical outcomes of more complex XIENCE V USA real-world patients with small versus nonsmall vessel lesions.

The investigators noted that patients with small vessel lesions undergoing coronary stent placement are at higher risk of major adverse cardiac events. Previous randomized clinical trials in selected low-risk small vessel populations have demonstrated improved safety and efficacy of the Xience V EES.

Conducted as a condition of FDA approval, the XIENCE V USA single-arm study in unselected real-world patients compared baseline and 1-year clinical outcomes between patients who received a single 2.5-mm stent (small vessel group; n = 838) and patients implanted with a single > 2.5-mm stent (nonsmall vessel group; n = 2,015). Mean reference vessel diameter was 2.55 ± 0.36 and 3.25 ± 0.46 mm in the small and nonsmall vessel groups, respectively (P  <  .001).

The small vessel group had more women, presented with a higher rate of diabetes, and had more complex lesion characteristics. The definite or probable stent thrombosis rates analyzed using the Kaplan–Meier method were low and not significantly different between the groups at 0.37% and 0.4% for the small and nonsmall vessel group (P  = 0.88), respectively. The composite rate of cardiac death or myocardial infarction was comparable at 4.5% for the small and 5.1% for the nonsmall vessel groups (P  = 0.57). The 1-year target lesion revascularization rate was also comparable in the small vessel group (3.8% vs 3%; P  = 0.35).

Despite gender difference, higher prevalence of diabetes, and more complex lesions in the small vessel groups, the 1-year clinical outcomes were similar in both small and nonsmall vessel groups. These results demonstrate the therapeutic benefit of Xience V EES in a real-world, all-inclusive patient population with small vessel disease, concluded the investigators in Catheterization and Cardiovascular Interventions.