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雷帕霉素洗脱钴基合金依维莫司洗脱支架治疗 ST 段抬高型心肌梗死(resolute-STEMI):来自 DAPT-STEMI 试验的预设前瞻性登记研究。

Resolute zotarolimus-eluting stent in ST-elevation myocardial infarction (resolute-STEMI): A prespecified prospective register from the DAPT-STEMI trial.

机构信息

Isala Hartcentrum, Zwolle, the Netherlands.

Cardiovascular Department, University of Trieste, Trieste, Italy.

出版信息

Catheter Cardiovasc Interv. 2020 Mar 1;95(4):706-710. doi: 10.1002/ccd.28376. Epub 2019 Jul 3.

Abstract

OBJECTIVES

To evaluate the safety and efficacy outcomes after primary percutaneous coronary intervention (pPCI) with second-generation Resolute™ zotarolimus-eluting stent (R-ZES) in patients enrolled in the DAPT-STEMI Trial (NCT01459627).

BACKGROUND

R-ZES is one of the most used drug eluting stents worldwide. To date, the safety and efficacy data of this stent in setting of STEMI is limited.

METHODS

The Resolute-STEMI is a prespecified prospective register that reports the safety and efficacy of R-ZES in setting of ST-Elevation Myocardial Infarction (STEMI) at 6 months for the following endpoints: a composite endpoint of all-cause mortality, any myocardial infarction (MI), any (unscheduled) revascularization, stroke and TIMI major bleeding, as well as target lesion failure and stent thrombosis (ST).

RESULTS

From a total of 1,100 STEMI patients enrolled in the trial, 998 received a R-ZES. At 6 months the PE occurred in 42 (4.2%) patients. All-cause death, MI, revascularization, stroke and TIMI major bleeding was respectively 8 (0.8%), 9 (0.8%), 34 (3.4%), 2 (0.2%), and 4 (0.4%). The rate of target lesion revascularizations involving the culprit lesion was 1.1%. Target lesion failure was 1.5%. The rate of definite ST was 0.5%. The rate of both definite or probable ST was 0.7%.

CONCLUSIONS

The present analysis is the largest to date reporting short-term and mid-term clinical outcomes with the R-ZES stent in setting of STEMI. At 30 days and 6-months R-ZES has an outstanding safety and efficacy even in this high-risk category of patients.

摘要

目的

评估在 DAPT-STEMI 试验(NCT01459627)中接受第二代 Resolute™佐他莫司洗脱支架(R-ZES)初次经皮冠状动脉介入治疗(pPCI)的患者的安全性和疗效结局。

背景

R-ZES 是全球应用最广泛的药物洗脱支架之一。迄今为止,该支架在 STEMI 中的安全性和疗效数据有限。

方法

Resolute-STEMI 是一个预先指定的前瞻性登记,报告了 R-ZES 在 ST 段抬高型心肌梗死(STEMI)中的安全性和疗效,6 个月时的主要终点包括全因死亡率、任何心肌梗死(MI)、任何(非计划)血运重建、卒中和 TIMI 大出血,以及靶病变失败和支架血栓形成(ST)。

结果

在该试验共纳入的 1100 例 STEMI 患者中,998 例接受了 R-ZES 治疗。6 个月时,42 例(4.2%)患者发生了 PE。全因死亡、MI、血运重建、卒中和 TIMI 大出血的发生率分别为 8 例(0.8%)、9 例(0.8%)、34 例(3.4%)、2 例(0.2%)和 4 例(0.4%)。罪犯病变的靶病变血运重建率为 1.1%。靶病变失败率为 1.5%。确定的 ST 发生率为 0.5%。明确或可能的 ST 发生率为 0.7%。

结论

目前的分析是迄今为止报告 R-ZES 支架在 STEMI 中的短期和中期临床结局的最大规模分析。在 30 天和 6 个月时,即使在这种高危患者人群中,R-ZES 也具有出色的安全性和疗效。

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