Contemporary Incidence and Predictors of Stent Thrombosis and Other Major Adverse Cardiac Events in the Year After XIENCE V Implantation

• Published in: JACC. Cardiovascular interventions Vol. 5; no. 6; pp. 626 - 635
• Main Authors: Naidu, Srihari S., MD, Krucoff, Mitchell W., MD, Rutledge, David R., PharmD, Mao, Vivian W., MD, MPH, Zhao, Weiying, MD, PhD, Zheng, Qing, MS, Wilburn, Olivia, MD, PhD, Sudhir, Krishnankutty, MD, PhD, Simonton, Charles, MD, Hermiller, James B., MD
• Format: Journal Article
• Language: English
• Published: Elsevier Inc 01.06.2012
• Subjects: Cardiovascular; drug-eluting stent (DES); dual-antiplatelet therapy; everolimus; percutaneous coronary intervention (PCI); predictors; real-world; stent thrombosis; predictors; FDA; myocardial infarction; HR; drug-eluting stent(s); TLF; dual antiplatelet therapy; real-world; everolimus; MACE; stent thrombosis; TLR; MI; DAPT; Food and Drug Administration; WHO; ST; target lesion revascularization; World Health Organization; CI; percutaneous coronary intervention (PCI); everolimus-eluting coronary stent system; dual-antiplatelet therapy; Academic Research Consortium; major adverse cardiac event(s); EECSS; drug-eluting stent (DES); ARC; DES; hazard ratio; confidence interval; target lesion failure
• ISSN: 1936-8798; 1876-7605
• DOI: 10.1016/j.jcin.2012.02.014

Objectives The aim of this study was to identify predictors of clinical events after XIENCE V (Abbott Vascular, Santa Clara, California) stenting. Background The XIENCE V USA (XIENCE V Everolimus Eluting Coronary Stent System [EECSS] USA Post-Approval) study is a prospective, multicenter, Food and Drug Administration-required post-approval study 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 (Dual Antiplatelet Therapy) trial (total n = 8,061). Methods One-year clinical events, including stent thrombosis (ST), cardiac death/myocardial infarction (MI), target lesion failure, and target lesion revascularization, were adjudicated according to Academic Research Consortium criteria, with ST 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 ST. Results Roughly 61% were off-label; 85.6% remained on DAPT without interruption through 1 year. Incidences of definite/probable ST, cardiac death/MI, target lesion failure, and target lesion revascularization were 0.80% (95% confidence interval [CI]: 0.61% to 1.03%), 7.1% (95% CI: 6.51% to 7.68%), 8.9% (95% CI: 8.30% to 9.60%), and 4.3% (95% CI: 3.82% to 4.75%), respectively. Several independent clinical and angiographic predictors were identified for each outcome. Predictors of ST included DAPT interruption ≤30 days (hazard ratio [HR]: 8.63, 95% CI: 2.69 to 27.73, p = 0.0003), renal insufficiency (HR: 3.72, 95% CI: 1.71 to 8.09, p = 0.0009), and total stent length (HR: 1.30, 95% CI: 1.16 to 1.47, p < 0.0001). A DAPT interruption >30 days was not predictive of ST. Conclusions In this large, real-world population, XIENCE V demonstrated low event rates at 1 year, with several independent predictors. Early DAPT interruption (≤30 days) was the most potent predictor of ST, whereas delayed interruption (>30 days) was not predictive. (XIENCE V Everolimus Eluting Coronary Stent System [EECSS] USA Post-Approval Study; NCT00676520 )