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首页> 外文期刊>JACC. Cardiovascular interventions >Contemporary incidence and predictors of stent thrombosis and other major adverse cardiac events in the year after XIENCE V implantation: Results from the 8,061-patient XIENCE V United States study
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Contemporary incidence and predictors of stent thrombosis and other major adverse cardiac events in the year after XIENCE V implantation: Results from the 8,061-patient XIENCE V United States study

机译：XIENCE V植入后一年中支架血栓形成和其他主要不良心脏事件的当代发生率和预测指标：来自8,061名患者的XIENCE V美国研究的结果

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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).
机译：目的：本研究的目的是确定XIENCE V（加利福尼亚州圣克拉拉的Abbott Vascular，Abbott Vascular）支架置入术后临床事件的预测因素。背景：XIENCE V美国（XIENCE V依维莫司洗脱冠状动脉支架系统[EECSS]美国批准后）研究是一项前瞻性，多中心，食品和药物管理局要求的批准后研究，旨在检查现实环境中的安全性和有效性。在最初的5,062例患者中，有2,999例作为DAPT（双重抗血小板治疗）试验的一部分（总n = 8,061）。方法：根据学术研究协会的标准，对包括支架血栓形成（ST），心脏死亡/心肌梗死（MI），目标病变失败和目标病变血运重建在内的一年临床事件进行评估，以ST和心脏死亡/ MI为标准主要和共同主要终点。人口，临床和程序变量通过多变量分析进行评估。随时间变化的协变量评估了DAPT使用量与ST之间的关联。结果：约有61％的标签不合格;保持85.6％的DAPT连续1年没有中断。明确/可能的ST，心源性死亡/ MI，目标病变失败和目标病变血运重建的发生率分别为0.80％（95％置信区间[CI]：0.61％至1.03％），7.1％（95％CI：6.51％至7.68） ％），8.9％（95％CI：8.30％至9.60％）和4.3％（95％CI：3.82％至4.75％）。为每种结果确定了几种独立的临床和血管造影预测指标。 ST的预测因素包括≤30天的DAPT中断（危险比[HR]：8.63，95％CI：2.69至27.73，p = 0.0003），肾功能不全（HR：3.72，95％CI：1.71至8.09，p = 0.0009） ，以及支架总长度（HR：1.30，95％CI：1.16至1.47，p <0.0001）。 DAPT中断> 30天不能预测为ST。结论：在如此庞大的现实世界中，XIENCE V在1年内显示出较低的事件发生率，并具有多个独立的预测因子。早期DAPT中断（≤30天）是最有效的ST预测指标，而延迟中断（> 30天）则不能预测。 （XIENCE V Everolimus洗脱冠状动脉支架系统[EECSS]美国批准后研究; NCT00676520）。

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