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糖尿病患者与非糖尿病患者使用可生物降解聚合物药物洗脱支架的长期心血管结局:荟萃分析。

Long-term cardiovascular outcomes of biodegradable polymer drug eluting stents in patients with diabetes versus non-diabetes mellitus: a meta-analysis.

机构信息

Department of Cardiology, The People's Hospital of Guangxi Zhuang Autonomous Region, 530021, Nanning, Guangxi, P. R. China.

College of Management and Economics, Tianjin University, 300072, Tianjin, P. R. China.

出版信息

Cardiovasc Diabetol. 2023 Aug 29;22(1):228. doi: 10.1186/s12933-023-01962-w.

DOI:10.1186/s12933-023-01962-w
PMID:37644465
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10466760/
Abstract

BACKGROUND

Today, diabetes mellitus (DM) has become a worldwide concern. DM is a major risk factor for the development of cardiovascular diseases (CVD). Eligible patients with CVD are treated invasively by percutaneous coronary intervention (PCI) whereby a stent is implanted inside the coronary vessel with the particular lesion to allow sufficient blood flow. Newer scientific research have shown that even though associated with a lower rate of re-stenosis, first-generation drug eluting stents (DES) were associated with a higher rate of late stent thrombosis. Recently, newer stents, namely biodegradable polymer DES (BP-DES) have been developed to overcome the safety issues of earlier generation DES. In this analysis we aimed to systematically compare the long term (≥ 12 months) adverse cardiovascular outcomes observed in DM versus non-DM patients who were implanted with BP-DES.

METHODS

Cochrane central, MEDLINE (Subset PubMed), EMBASE, Web of Science, http://www.

CLINICALTRIALS

gov and Google scholar were searched for relevant publications involving BP-DES in patients with DM versus non-DM and their associated adverse cardiovascular outcomes. The mean follow-up time period ranged from 12 to 120 months. Data analysis was carried out with the latest version of the RevMan software (version 5.4). Based on the Mantel-Haenszel test, risk ratios (RR) with 95% confidence intervals (CI) were calculated and used to represent the results following analysis.

RESULTS

Seven (7) studies with a total number of 10,246 participants were included in this analysis. Stents which were implanted during PCI were BP-DES. Participants were enrolled from the year 2006 to 2013. Our current results showed that in patients who were implanted with BP-DES, the risks of major adverse cardiac events (RR: 1.30, 95% CI: 1.18-1.43; P = 0.00001), myocardial infarction (RR: 1.48, 95% CI: 1.14-1.93; P = 0.003), all-cause mortality (RR: 1.70, 95% CI: 1.29-2.23; P = 0.0002), cardiac death (RR: 1.93, 95% CI: 1.28-2.93; P = 0.002), target vessel revascularization (RR: 1.35, 95% CI: 1.03-1.77; P = 0.03), target lesion revascularization (RR: 1.28, 95% CI: 1.07-1.54; P = 0.007) and target lesion failure (RR: 1.79, 95% CI: 1.52-2.12; P = 0.00001) were significantly higher in the DM group. Definite and probable stent thrombosis (RR: 1.80, 95% CI: 1.28-2.55; P = 0.0009) were also significantly higher in the DM group.

CONCLUSIONS

Diabetes mellitus was an independent risk factor associated with long term adverse cardiovascular outcomes following PCI with BP-DES.

摘要

背景

如今,糖尿病(DM)已成为全球性关注的问题。DM 是心血管疾病(CVD)发展的主要危险因素。有 CVD 适应证的患者通过经皮冠状动脉介入治疗(PCI)进行侵入性治疗,在冠状动脉内植入支架,以治疗特定病变,确保有足够的血流。新的科学研究表明,虽然第一代药物洗脱支架(DES)与较低的再狭窄率相关,但与晚期支架血栓形成的发生率较高有关。最近,开发了更新的支架,即生物可降解聚合物 DES(BP-DES),以克服早期代 DES 的安全性问题。在这项分析中,我们旨在系统比较 DM 与非 DM 患者植入 BP-DES 后观察到的长期(≥12 个月)不良心血管结局。

方法

Cochrane 中央、MEDLINE(PubMed 子集)、EMBASE、Web of Science、http://www.CLINICALTRIALS.gov 和 Google 学者搜索了涉及 DM 与非 DM 患者植入 BP-DES 及其相关不良心血管结局的相关出版物。平均随访时间范围为 12 至 120 个月。使用最新版本的 RevMan 软件(版本 5.4)进行数据分析。基于 Mantel-Haenszel 检验,计算风险比(RR)和 95%置信区间(CI),并用于表示分析后的结果。

结果

本分析纳入了 7 项研究,共纳入 10246 名参与者。在 PCI 期间植入的支架是 BP-DES。参与者于 2006 年至 2013 年期间入组。我们目前的结果表明,在植入 BP-DES 的患者中,主要不良心脏事件(RR:1.30,95%CI:1.18-1.43;P=0.00001)、心肌梗死(RR:1.48,95%CI:1.14-1.93;P=0.003)、全因死亡率(RR:1.70,95%CI:1.29-2.23;P=0.0002)、心源性死亡率(RR:1.93,95%CI:1.28-2.93;P=0.002)、靶血管血运重建(RR:1.35,95%CI:1.03-1.77;P=0.03)、靶病变血运重建(RR:1.28,95%CI:1.07-1.54;P=0.007)和靶病变失败(RR:1.79,95%CI:1.52-2.12;P=0.00001)在 DM 组中显著更高。确定和可能的支架血栓形成(RR:1.80,95%CI:1.28-2.55;P=0.0009)在 DM 组中也显著更高。

结论

糖尿病是与 PCI 后植入 BP-DES 相关的长期不良心血管结局的独立危险因素。

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