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药物洗脱支架对比裸金属支架治疗初发左主干冠状动脉疾病糖尿病患者的长期临床获益:一项真实世界多中心注册研究结果

Long-term clinical benefit of drug-eluting stents over bare-metal stents in diabetic patients with de novo left main coronary artery disease: results from a real-world multicenter registry.

作者信息

Capodanno Davide, Di Salvo Maria Elena, Palmerini Tullio, Sheiban Imad, Margheri Massimo, Vecchi Giuseppe, Sangiorgi Giuseppe, Piovaccari Giancarlo, Bartorelli Antonio, Briguori Carlo, Ardissino Diego, Di Pede Francesco, Ramondo Angelo, Inglese Luigi, Petronio Anna Sonia, Bolognese Leonardo, Benassi Alberto, Palmieri Cataldo, Filippone Vincenzo, De Servi Stefano, Tamburino Corrado

机构信息

Dipartimento di Cardiologia, Ospedale Ferrarotto, Università di Catania, Italy.

出版信息

Catheter Cardiovasc Interv. 2009 Feb 15;73(3):310-6. doi: 10.1002/ccd.21845.

DOI:10.1002/ccd.21845
PMID:19214964
Abstract

BACKGROUND

Few data are available on diabetic patients undergoing percutaneous coronary intervention (PCI) in the context of unprotected left main coronary artery (ULMCA) disease. The main goal of this study was to present the long-term relative benefits of using drug-eluting stent (DES) instead of bare-metal stent (BMS) for diabetic patients submitted to percutaneous ULMCA treatment in a large real world multicenter registry.

METHODS

The GISE-SICI registry is a retrospective, observational multicenter registry promoted by the Italian Society of Invasive Cardiology in which 19 high-volume participating centers enrolled 1,453 consecutive patients who underwent PCI on ULMCA between January 2002 and December 2006. From the registry, a total of 398 consecutive patients with diabetes mellitus who underwent DES (n = 321) or BMS (n = 77) implantation were analyzed, with extensive multivariable adjustments.

RESULTS

At 3-years, use of DES in diabetic patients resulted in no significant differences with respect to death (HR 0.56, 95% CIs 0.24-1.28), myocardial infarction (HR 0.82, 95% CIs 0.21-3.26), and the composite end-point of death or myocardial infarction (HR 0.56, 95% CIs 0.27-1.20). Conversely, DES were associated with significant reduction of target lesion revascularization (TLR, HR 0.33; 95% CIs 0.14-0.80, P = 0.001) rates.

CONCLUSIONS

Patients presenting with ULMCA disease in the context of diabetes mellitus who are treated with stent-supported PCI have a significant reduction in the rate of TLR with no increased risk of death or myocardial infarction.

摘要

背景

关于糖尿病患者在无保护左主干冠状动脉(ULMCA)疾病情况下接受经皮冠状动脉介入治疗(PCI)的数据很少。本研究的主要目的是在一个大型真实世界多中心注册研究中,呈现糖尿病患者接受经皮ULMCA治疗时使用药物洗脱支架(DES)而非裸金属支架(BMS)的长期相对益处。

方法

GISE-SICI注册研究是一项由意大利介入心脏病学会推动的回顾性、观察性多中心注册研究,19个高容量参与中心纳入了2002年1月至2006年12月期间连续1453例接受ULMCA PCI的患者。从该注册研究中,共分析了398例连续接受DES(n = 321)或BMS(n = 77)植入的糖尿病患者,并进行了广泛的多变量调整。

结果

在3年时,糖尿病患者使用DES在死亡(风险比[HR] 0.56,95%可信区间[CI] 0.24 - 1.28)、心肌梗死(HR 0.82,95% CI 0.21 - 3.26)以及死亡或心肌梗死的复合终点(HR 0.56,95% CI 0.27 - 1.20)方面无显著差异。相反,DES与靶病变血运重建(TLR)率的显著降低相关(HR 0.33;95% CI 0.14 - 0.80,P = 0.001)。

结论

在糖尿病背景下患有ULMCA疾病并接受支架置入PCI治疗的患者,TLR率显著降低,且死亡或心肌梗死风险未增加。

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