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无保护左主干支架置入术在真实世界中的应用:法国左主干 Taxus 注册研究的 5 年结果。

Unprotected left main stenting in the real world: five-year outcomes of the French Left Main Taxus registry.

机构信息

Institut Cardiovasculaire Paris Sud, Institut Hospitalier Jacques-Cartier, 6 Avenue du Noyer Lamber, Massy, France.

出版信息

EuroIntervention. 2012 Dec 20;8(8):970-81. doi: 10.4244/EIJV8I8A147.

Abstract

AIMS

Limited long-term data are available to support drug-eluting stent (DES) unprotected left main (LM) intervention. We sought to evaluate long-term outcomes of LM intervention with paclitaxel-eluting stents.

METHODS AND RESULTS

In this prospective multicentre registry, 291 patients with unprotected LM stenosis underwent percutaneous revascularisation with the TAXUS® Express® stent, using a consistent technical approach for both ostial/shaft and bifurcation lesions (provisional side branch stenting). At five years (n=263), the cumulative incidence of major adverse cardiac events (MACE) and cardiac death were 23.6% and 12.5%, respectively. Myocardial infarction (MI) occurred in 16 patients (6.1%), definite stent thrombosis in 0.4%, and target lesion revascularisation (TLR) was required in 10.3%. Patients with distal LM lesions requiring two-stent procedures had increased MACE compared with those with single-stent interventions (34.1% vs. 17.8%, p=0.009). This was primarily driven by an increased incidence of cardiac death (18.2% vs. 8.5%, p=0.05). Diabetes was associated with increased TLR and was an independent predictor of MACE at five years (odds ratio [OR] 2.10, 95% confidence interval [CI] 1.10-3.99, p=0.02).

CONCLUSIONS

This study confirms the long-term safety and efficacy of the TAXUS® DES in unprotected LM stenting. Diabetes and the need for a second stent in distal LM interventions were associated with an increased risk of adverse outcomes.

摘要

目的

目前仅有有限的长期数据支持药物洗脱支架(DES)未保护的左主干(LM)介入治疗。我们旨在评估紫杉醇洗脱支架治疗 LM 病变的长期疗效。

方法和结果

在这项前瞻性多中心注册研究中,291 例未保护的 LM 狭窄患者接受 TAXUS®Express®支架经皮血运重建,对于开口/主干和分叉病变(临时分支支架)采用一致的技术方法。在 5 年时(n=263),主要不良心脏事件(MACE)和心脏死亡的累积发生率分别为 23.6%和 12.5%。16 例患者发生心肌梗死(MI)(6.1%),明确支架血栓形成 0.4%,需要靶病变血运重建(TLR)10.3%。需要双支架治疗的远端 LM 病变患者与单支架干预患者相比,MACE 发生率更高(34.1% vs. 17.8%,p=0.009)。这主要是由于心脏死亡发生率增加(18.2% vs. 8.5%,p=0.05)。糖尿病与 TLR 增加相关,是 5 年时 MACE 的独立预测因素(比值比 [OR] 2.10,95%置信区间 [CI] 1.10-3.99,p=0.02)。

结论

本研究证实了 TAXUS®DES 在未保护的 LM 支架置入中的长期安全性和有效性。糖尿病和在远端 LM 介入治疗中需要第二个支架与不良结局风险增加相关。

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