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采用新一代药物洗脱支架与早期药物洗脱支架治疗无保护左主干远端分叉病变的双支架策略的临床结果:米兰和新东京(MITO)注册研究。

Clinical outcomes of double stent strategy for unprotected left main distal bifurcation lesions using current generation drug eluting stent comparing to early generation drug eluting stent; The Milan and New Tokyo (MITO) registry.

机构信息

Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy.

Interventional Cardiology Unit, New Tokyo Hospital, Chiba, Japan.

出版信息

Catheter Cardiovasc Interv. 2021 Feb 1;97(2):E198-E208. doi: 10.1002/ccd.28962. Epub 2020 May 8.

DOI:10.1002/ccd.28962
PMID:32384579
Abstract

BACKGROUND

There are only little data available on the comparison of clinical outcomes between a early generation drug eluting stent (eDES) and a current generation drug eluting stent (cDES) for percutaneous coronary intervention (PCI) with double stent strategy (DSS) for unprotected distal left main disease (ULMD).

METHODS

Between April 2005 and December 2015, we recruited 452 consecutive ULMD patients treated with DSS (eDES, 236 patients; cDES, 216 patients). In this study, eDES included Cipher, Taxus, and Endeavor and cDES included Ultimaster, Resolute family, Xience family, Promus family, Synergy, and Nobori. The primary endpoint was target lesion failure (TLF) defined as a composite of cardiac death, target lesion revascularization (TLR) and myocardial infarction (MI) during the median follow-up period of 1,809(IQR: 1,190-2,510) days.

RESULTS

In entire population, the rate of overall TLR was significantly lower in cDES group than that in eDES group (adjusted HR 0.62, 95% CI 0.40-0.96, p = .032). The rate of TLR for the ostium of LCX was significantly lower in cDES group than that in eDES group (adjusted HR 0.63, 95% CI 0.39-0.99, p = .047). Cardiac mortality, the rate of TLR for LM-LAD, MI and definite/probable ST did not significantly differ between both groups. The results were preserved in the propensity adjusted population.

CONCLUSIONS

cDES significantly improved the clinical outcomes in population treated with DSS mainly driven by the reduction of TLR for the ostium of LCX.

摘要

背景

对于经皮冠状动脉介入治疗(PCI)中采用双支架策略(DSS)治疗无保护左主干远端病变(ULMD),使用早期一代药物洗脱支架(eDES)和当前一代药物洗脱支架(cDES)的临床结果比较,仅有少量数据可用。

方法

在 2005 年 4 月至 2015 年 12 月期间,我们连续招募了 452 例接受 DSS 治疗的 ULMD 患者(eDES 组 236 例,cDES 组 216 例)。在本研究中,eDES 包括 Cipher、Taxus 和 Endeavor,cDES 包括 Ultimaster、Resolute 家族、Xience 家族、Promus 家族、Synergy 和 Nobori。主要终点是靶病变失败(TLF),定义为在中位数为 1809(IQR:1190-2510)天的随访期间发生心脏死亡、靶病变血运重建(TLR)和心肌梗死(MI)的复合终点。

结果

在整个人群中,cDES 组的总 TLR 发生率明显低于 eDES 组(调整后的 HR 为 0.62,95%CI 为 0.40-0.96,p = 0.032)。cDES 组 LCX 开口处的 TLR 发生率明显低于 eDES 组(调整后的 HR 为 0.63,95%CI 为 0.39-0.99,p = 0.047)。两组间心脏死亡率、LM-LAD 处的 TLR 发生率、MI 和明确/可能 ST 无显著差异。在倾向调整后的人群中,结果仍然成立。

结论

cDES 显著改善了采用 DSS 治疗的人群的临床结果,主要得益于 LCX 开口处 TLR 的减少。

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