XIENCE V USA Post-Approval Study 1-Year Data Published

June 20, 2012—One-year results from the XIENCE V USA post-approval study for the Xience V everolimus-eluting coronary stent system (Abbott Vascular, Santa Clara, CA) were published by Srihari S. Naidu, MD, et al in the Journal of the American College of Cardiology: Cardiovascular Interventions (2021;5:626–635). XIENCE V USA sought to identify predictors of clinical events after Xience V stenting.

The XIENCE V USA study is a prospective, multicenter, postapproval study required by the US Food and Drug Administration to examine safety and effectiveness in real-world settings. After an initial 5,062 patients, 2,999 more were included as part of the DAPT trial (total n = 8,061).

The investigators concluded that in this large, real-world population, Xience V demonstrated low event rates at 1 year, with several independent predictors. Early dual-antiplatelet therapy (DAPT) interruption (≤ 30 days) was the most potent predictor of stent thrombosis, whereas delayed interruption (> 30 days) was not predictive.

As summarized in the Journal of the American College of Cardiology: Cardiovascular Interventions, 1-year clinical events—including stent thrombosis, cardiac death/myocardial infarction (MI), target lesion failure, and target lesion revascularization—were adjudicated according to the Academic Research Consortium criteria, with stent thrombosis and cardiac death/MI as primary and co-primary endpoints. Demographic, clinical, and procedural variables were assessed by multivariable analysis.

A time-dependent covariate assessed the association between DAPT usage and stent thrombosis. The investigators found that approximately 61% were off-label; 85.6% remained on DAPT without interruption through 1 year. Incidences of definite/probable stent thrombosis, cardiac death/MI, target lesion failure, and target lesion revascularization were 0.8% (95% confidence interval [CI], 0.61% to 1.03%), 7.1% (95% CI, 6.51% to 7.68%), 8.9% (95% CI, 8.3% to 9.6%), and 4.3% (95% CI: 3.82% to 4.75%), respectively. Several independent clinical and angiographic predictors were identified for each outcome. Predictors of stent thrombosis included DAPT interruption ≤ 30 days (hazard ratio [HR]: 8.63, 95% CI, 2.69 to 27.73; P = .0003), renal insufficiency (HR: 3.72, 95% CI: 1.71 to 8.09; P = .0009), and total stent length (HR: 1.30, 95% CI: 1.16 to 1.47; P < .0001). A DAPT interruption > 30 days was not predictive of stent thrombosis, reported the investigators.