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药物洗脱支架时代冠状动脉分叉病变的真实世界结局:来自意大利介入心脏病学会(SICI-GISE)意大利分叉病变多中心注册研究(I-BIGIS)4314 例患者的结果。

Real-world outcome of coronary bifurcation lesions in the drug-eluting stent era: results from the 4,314-patient Italian Society of Invasive Cardiology (SICI-GISE) Italian Multicenter Registry on Bifurcations (I-BIGIS).

机构信息

San Raffaele Scientific Institute, Milan, Italy.

出版信息

Am Heart J. 2010 Sep;160(3):535-542.e1. doi: 10.1016/j.ahj.2010.06.028.

DOI:10.1016/j.ahj.2010.06.028
PMID:20826264
Abstract

BACKGROUND

Drug-eluting stents (DESs) introduction has somewhat renewed the issues of strategy and stenting technique for treatment of bifurcation lesions. In particular, concerns remain on extensive use of DESs, especially in the side branch, and on time of dual antiplatelet therapy (DAT) discontinuation, reflecting lack of pertinent long-term data. This study aimed to evaluate clinical safety and efficacy of different strategies for bifurcations treatment in a large observational real-world registry.

METHODS

A multicenter, retrospective Italian study of consecutive patients undergoing bifurcation percutaneous coronary intervention between January 2002 and December 2006 was performed. The primary end point was the long-term rate of major adverse cardiac events (MACEs). The role of DAT length on outcome was also analyzed.

RESULTS

A total of 4,314 patients (4,487 lesions) were enrolled at 22 independent centers. In-hospital procedural success rate was 98.7%. After median follow-up of 24 months, MACEs occurred in 17.7%, with cardiac death in 3.4%, myocardial infarction in 4.0%, target lesion revascularization in 13.2%, and stent thrombosis in 2.9%. Extensive multivariable analysis showed that MACEs were independently predicted by age, diabetes, renal failure, systolic dysfunction, multivessel disease, myocardial infarction at admission, restenotic lesion, bare-metal stent implantation, complex stenting strategy, and short duration of DAT.

CONCLUSIONS

This large study based on current clinical practice in an unselected patient population presenting with bifurcation disease and submitted to percutaneous coronary intervention demonstrated favorable long-term clinical results in this challenging patient setting, especially when DESs, simple stenting strategy, and DAT for at least 6 months are used.

摘要

背景

药物洗脱支架(DES)的引入在一定程度上重新引发了治疗分叉病变的策略和支架技术问题。特别是,人们对 DES 的广泛使用,尤其是在边支,以及双联抗血小板治疗(DAT)停药时间,仍存在担忧,这反映出缺乏相关的长期数据。本研究旨在评估在一个大型观察性真实世界注册研究中,不同策略治疗分叉病变的临床安全性和疗效。

方法

对 2002 年 1 月至 2006 年 12 月期间连续接受分叉经皮冠状动脉介入治疗的患者进行了一项多中心、回顾性意大利研究。主要终点是主要不良心脏事件(MACE)的长期发生率。还分析了 DAT 长度对结局的影响。

结果

共纳入 22 个独立中心的 4314 例(4487 处病变)患者。院内手术成功率为 98.7%。中位随访 24 个月后,MACE 发生率为 17.7%,其中心脏死亡 3.4%,心肌梗死 4.0%,靶病变血运重建 13.2%,支架血栓形成 2.9%。广泛的多变量分析显示,MACE 的独立预测因素包括年龄、糖尿病、肾衰竭、收缩功能障碍、多血管疾病、入院时心肌梗死、再狭窄病变、裸金属支架植入、复杂支架策略和 DAT 时间较短。

结论

这项基于当前临床实践的大型研究,纳入了未经选择的分叉病变患者,并接受了经皮冠状动脉介入治疗,在这一具有挑战性的患者群体中显示了良好的长期临床结果,尤其是在使用 DES、简单支架策略和 DAT 至少 6 个月时。

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