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504 例接受第一代或第二代药物洗脱支架治疗的患者中,一年血管镜检查结果对长期临床事件的影响:DESNOTE-X 研究。

Impact of the one-year angioscopic findings on long-term clinical events in 504 patients treated with first-generation or second-generation drug-eluting stents: the DESNOTE-X study.

机构信息

Department of Cardiology, Osaka Police Hospital, Osaka, Japan.

出版信息

EuroIntervention. 2019 Sep 20;15(7):631-639. doi: 10.4244/EIJ-D-18-00660.

Abstract

AIMS

We aimed to test the hypothesis that the presence of in-stent yellow plaque (YP) assessed by angioscopy would be a risk of very late stent failure (VLSF) of the cobalt-chromium everolimus-eluting stent (CoCr-EES) in comparison with first-generation drug-eluting stents (DES).

METHODS AND RESULTS

DESNOTE-X was a prospective cohort study, an extended study of the DESNOTE study (UMIN000013515). All patients who received successful angioscopic examination at planned one-year follow-up of DES were clinically followed. The primary endpoint was VLSF defined as a composite of cardiac death, target vessel myocardial infarction, and target lesion revascularisation. A total of 504 patients with 549 lesions were enrolled over a period of 12.5 years. At one-year follow-up, the incidence of YP was significantly higher in the first-generation DES than in the CoCr-EES (199/292 [68%] vs 80/257 [31%], p<0.001). Maximum yellow colour grade on coronary angioscopy at one-year follow-up was an independent predictor of future VLSF in the first-generation DES (HR 2.604 [95% CI: 1.265-5.361], p=0.009), whereas it was not in the CoCr-EES (p for interaction 0.022).

CONCLUSIONS

The incidence of in-stent atherosclerosis identified as YP on angioscopy was lower and its impact on late clinical events appeared smaller in the CoCr-EES than in the first-generation DES.

摘要

目的

我们旨在通过血管镜检查评估钴铬依维莫司洗脱支架(CoCr-EES)内的黄斑(YP)的存在,检验这一假说,即与第一代药物洗脱支架(DES)相比,YP 的存在将增加 CoCr-EES 发生晚期支架失败(VLSF)的风险。

方法和结果

DESNOTE-X 是一项前瞻性队列研究,是 DESNOTE 研究(UMIN000013515)的扩展研究。所有在 DES 计划一年随访时成功接受血管镜检查的患者均进行了临床随访。主要终点是 VLSF,定义为心脏死亡、靶血管心肌梗死和靶病变血运重建的复合终点。在 12.5 年的时间内,共纳入了 504 例患者的 549 处病变。在一年随访时,第一代 DES 中的 YP 发生率明显高于 CoCr-EES(199/292[68%]比 80/257[31%],p<0.001)。一年时血管镜下的最大黄色颜色分级是第一代 DES 未来 VLSF 的独立预测因子(HR 2.604[95%CI:1.265-5.361],p=0.009),但在 CoCr-EES 中并非如此(p 交互值为 0.022)。

结论

在血管镜下,CoCr-EES 支架内动脉粥样硬化的发生率低于第一代 DES,且作为黄斑识别的支架内动脉粥样硬化对晚期临床事件的影响似乎也较小。

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