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第二代钴铬西罗莫司洗脱支架植入糖尿病患者与非糖尿病患者后的长期临床结局比较:一项来自前瞻性FOCUS注册研究的亚组分析

Comparison of long-term clinical outcomes after the second-generation cobalt-chromium sirolimus-eluting stents implantation in diabetic versus non-diabetic patients: a subgroup analysis from the prospective FOCUS registry.

作者信息

Zhang Feng, Yang Ji'e, Qian Juying, Ge Lei, Zhou Jun, Ge Junbo

机构信息

a Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University , Shanghai , China.

出版信息

Ann Med. 2016;48(3):202-10. doi: 10.3109/07853890.2016.1162324. Epub 2016 Mar 16.

Abstract

BACKGROUND

Diabetes mellitus (DM) was broadly acknowledged as a risk factor for adverse events after coronary stent implantation. However, the role of DM in patients treated with second-generation cobalt-chromium sirolimus-eluting stents (CoCr-SES) was less known.

METHODS

A total of 4720 patients available for 3-year follow-up in the prospective FOCUS registry were subdivided into the DM group and the non-DM group to assess the effect of DM on the clinical outcomes after CoCr-SES implantation both before and after propensity score matching.

RESULTS

The rates of major adverse cardiovascular event was low (<10%) in both DM and non-DM groups but significantly greater in the DM group after matching (9.6% versus 6.1%; p = 0.005). Although the soft endpoints including target vessel revascularization (2.3% versus 2.3%; p = 0.938) and target lesion revascularization (1.2% versus 1.1%; p = 0.828) was not significantly different between two groups, the hard endpoints represented by cardiovascular death or myocardial infarction (7.3% versus 5.3%; p = 0.012) demonstrated a significant increase in the DM group.

CONCLUSIONS

This subgroup analysis demonstrated that DM significantly increased the risk of adverse events after implantation of CoCr-SES, but the general safety and efficacy performance of CoCr-SES in both diabetic and non-diabetic patients was satisfying and comparable with other types of new-generation drug-eluting stents.

摘要

背景

糖尿病(DM)被广泛认为是冠状动脉支架植入术后不良事件的危险因素。然而,DM在接受第二代钴铬西罗莫司洗脱支架(CoCr-SES)治疗的患者中的作用尚鲜为人知。

方法

前瞻性FOCUS注册研究中共有4720例可进行3年随访的患者被分为DM组和非DM组,以评估DM在倾向评分匹配前后对CoCr-SES植入术后临床结局的影响。

结果

DM组和非DM组的主要不良心血管事件发生率均较低(<10%),但匹配后DM组显著更高(9.6%对6.1%;p = 0.005)。尽管包括靶血管重建(2.3%对2.3%;p = 0.938)和靶病变重建(1.2%对1.1%;p = 0.828)在内的软性终点在两组之间无显著差异,但以心血管死亡或心肌梗死为代表的硬性终点(7.3%对5.3%;p = 0.012)在DM组中显著增加。

结论

该亚组分析表明,DM显著增加了CoCr-SES植入术后不良事件的风险,但CoCr-SES在糖尿病和非糖尿病患者中的总体安全性和有效性表现令人满意,与其他类型的新一代药物洗脱支架相当。

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