Background:Stent thrombosis (ST) is a serious complication after drug-eluting stents (DES) implantation. To identify the risk factors of mortality following ST, we evaluated adverse event reports used for safety measures after approval.

Methods and Results:Between July 2004 and August 2019, 2,887 ST case reports were submitted to the Pharmaceutical and Medical Device Agency. Reports of probable or possible ST (n=604), with insufficient data regarding in-hospital outcome or duration between procedure and ST occurrence (n=37) or duplicate reports (n=191) were excluded. Accordingly, 2,045 reports with definite ST were analyzed. Among the subjects, there were 286 in-hospital deaths (14.0%). Multivariate logistic regression analysis revealed that left main trunk (LMT) (odds ratio [OR]: 4.76, 95% confidence interval [CI]: 3.26–6.96), chronic heart failure (CHF) (OR: 2.88, 95% CI: 1.61–5.14), hemodialysis (OR: 2.69, 95% CI: 1.66–4.36), prior stroke (OR: 2.28, 95% CI: 1.15–4.51), over 70 years old (OR: 1.62, 95% CI: 1.22–2.16), and right coronary artery (OR: 0.41, 95% CI: 0.27–0.63) were independent factors for in-hospital death after DES-ST.

Conclusions:LMT, CHF, hemodialysis, prior stroke, and older age were independently associated with higher risk of in-hospital death following DES-ST. If target patients have these factors, maximum preventive strategies against ST occurrence, including adequate dual-antiplatelet therapy duration and optimal DES deployment procedures, are required.

背景：支架血栓形成（ST）是药物洗脱支架（DES）植入后的严重并发症。为了确定 ST 后死亡的风险因素，我们评估了批准后用于安全措施的不良事件报告。

方法和结果：2004 年 7 月至 2019 年 8 月期间，向药品和医疗器械管理局提交了 2,887 份 ST 病例报告。排除了可能或可能 ST 的报告 (n=604)，关于住院结果或手术与 ST 发生之间持续时间的数据不足 (n=37) 或重复报告 (n=191) 被排除在外。因此，分析了 2,045 份具有明确 ST 的报告。在受试者中，有 286 例住院死亡（14.0%）。多变量逻辑回归分析显示左主干 (LMT)（优势比 [OR]：4.76，95% 置信区间 [CI]：3.26–6.96）、慢性心力衰竭 (CHF)（OR：2.88，95% CI：1.61 –5.14)、血液透析 (OR: 2.69, 95% CI: 1.66–4.36)、既往卒中 (OR: 2.28, 95% CI: 1.15–4.51)、70 岁以上 (OR: 1.62, 95% CI: 1.22– 2.16）和右冠状动脉（OR：0.41，95% CI：0.27-0。

结论： LMT、CHF、血液透析、既往卒中和高龄与 DES-ST 后院内死亡风险升高独立相关。如果目标患者具有这些因素，则需要针对 ST 发生的最大预防策略，包括足够的双重抗血小板治疗持续时间和最佳 DES 部署程序。