- 作者：Srihari S. Naidu ; MD?/sup> ; ssnaidu@winthrop.org ; Mitchell W. Krucoff ; MD&dagger ; ; David R. Rutledge ; PharmD&Dagger ; ; Vivian W. Mao ; MD ; MPH&Dagger ; ; Weiying Zhao ; MD ; PhD&Dagger ; ; Qing Zheng ; MS&Dagger ; ; Olivia Wilburn ; MD ; PhD&Dagger ; ; Krishnankutty Sudhir ; MD ; PhD&Dagger ; ; Charles Simonton ; MD&Dagger ; ; James B. Hermiller ; MD§ ;
- 关键词：drug-eluting stent (DES) ; dual-antiplatelet therapy ; everolimus ; percutaneous coronary intervention (PCI) ; predictors ; real-world ; stent thrombosis
- 刊名：JACC: Cardiovascular Interventions
- 出版年：2012
- 出版时间：June, 2012
- 年：2012
- 卷：5
- 期：6
- 页码：626-635
- 全文大小：806 K
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 ?0 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 (?0 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; )