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雷帕霉素洗脱支架和紫杉醇洗脱支架与裸金属支架治疗ST段抬高型心肌梗死患者的六年临床结局比较:RESEARCH(鹿特丹心脏病医院评估的雷帕霉素洗脱支架)和T-SEARCH(鹿特丹心脏病医院评估的紫杉醇洗脱支架)注册研究分析

Comparison of six-year clinical outcome of sirolimus- and paclitaxel-eluting stents to bare-metal stents in patients with ST-segment elevation myocardial infarction: an analysis of the RESEARCH (rapamycin-eluting stent evaluated at Rotterdam cardiology hospital) and T-SEARCH (taxus stent evaluated at Rotterdam cardiology hospital) registries.

作者信息

Simsek Cihan, Magro Michael, Boersma Eric, Onuma Yoshinobu, Nauta Sjoerd, Daemen Joost, Gaspersz Marcia, van Geuns Robert-Jan, van der Giessen Willem, van Domburg Ron, Serruys Patrick

机构信息

Department of Cardiology, Thoraxcenter, Room Ba 583, Erasmus Medical Center, Dr. Molewaterplein 40, 3015 RD, Rotterdam, the Netherlands.

出版信息

J Invasive Cardiol. 2011 Aug;23(8):336-41.

Abstract

BACKGROUND

Short- and long-term data showed that drug-eluting stents (DES) significantly decreased target vessel revascularization (TVR) and major adverse cardiac event (MACE) rates compared to bare-metal stents (BMS). However, conflicting long-term data remain for patients with ST-segment elevation myocardial infarction (STEMI).

OBJECTIVE

Our aim was to assess the 6-year clinical outcome of all patients undergoing primary percutaneous coronary intervention (PPCI) for a de novo lesion with exclusive use of BMS, sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES).

METHODS

Three PPCI cohorts (BMS = 80; SES = 92; PES = 162) were systematically followed for the occurrence of MACE.

RESULTS

Very late stent thrombosis was more common after the implantation of SES as compared to PES or BMS (7.6%, 0.6%, and 0.0%, respectively; p = 0.001). Kaplan-Meier estimates indicate no statistically significant difference for mortality between the three stent types at 6 years (BMS = 25%; SES = 15%; PES = 21%; Log-rank p = 0.2). After adjustment for differences in baseline characteristics, mortality, mortality/myocardial infarction (MI), and MACE rates were significantly lower for SES compared to BMS, but not for PES (aHR = 0.41, 95% CI: 0.17-0.98; aHR = 0.44, 95% CI: 0.21-0.96; aHR = 0.35, 95% CI: 0.17-0.72, respectively). No differences were observed between the three stent types for TVR rates.

CONCLUSION

Neither SES nor PES improved safety or efficacy as compared to BMS in a STEMI population at 6 years. After adjusting, the usage of SES resulted in a significant decrease in mortality, mortality/MI and MACE rates as compared to BMS, in contrast to the usage of PES. SES and PES have a similar effectiveness and safety profile, although very late stent thrombosis was more common with SES.

摘要

背景

短期和长期数据显示,与裸金属支架(BMS)相比,药物洗脱支架(DES)显著降低了靶血管重建(TVR)和主要不良心脏事件(MACE)发生率。然而,ST段抬高型心肌梗死(STEMI)患者的长期数据仍存在矛盾。

目的

我们的目的是评估所有因新发病变接受直接经皮冠状动脉介入治疗(PPCI)且仅使用BMS、西罗莫司洗脱支架(SES)和紫杉醇洗脱支架(PES)的患者的6年临床结局。

方法

对三个PPCI队列(BMS = 80;SES = 92;PES = 162)进行系统随访,观察MACE的发生情况。

结果

与PES或BMS相比,SES植入后极晚期支架血栓形成更为常见(分别为7.6%、0.6%和0.0%;p = 0.001)。Kaplan-Meier估计显示,6年时三种支架类型的死亡率无统计学显著差异(BMS = 25%;SES = 15%;PES = 21%;对数秩检验p = 0.2)。在对基线特征差异进行调整后,SES的死亡率、死亡率/心肌梗死(MI)和MACE发生率显著低于BMS,但PES并非如此(调整后风险比分别为0.41,95%置信区间:0.17 - 0.98;0.44,95%置信区间:0.21 - 0.96;0.35,95%置信区间:0.17 - 0.72)。三种支架类型的TVR发生率无差异。

结论

在STEMI人群中,6年时SES和PES与BMS相比均未改善安全性或有效性。调整后,与BMS相比,SES的使用导致死亡率、死亡率/MI和MACE发生率显著降低,而PES则不然。SES和PES具有相似的有效性和安全性,尽管SES的极晚期支架血栓形成更为常见。

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