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替格瑞洛单药治疗与药物洗脱支架类型的关系:TWILIGHT-STENT 研究。

Safety and efficacy of ticagrelor monotherapy according to drug-eluting stent type: the TWILIGHT-STENT study.

机构信息

The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.

Department of Cardiology, The University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.

出版信息

EuroIntervention. 2022 Mar 18;17(16):1330-1339. doi: 10.4244/EIJ-D-21-00721.

Abstract

BACKGROUND

In the TWILIGHT trial, ticagrelor monotherapy after a short course of dual antiplatelet therapy (DAPT) was shown to be a safe bleeding avoidance strategy in high-risk patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES).

AIMS

The aim of this study was to evaluate the effects of ticagrelor monotherapy after three-month DAPT in patients undergoing PCI, according to DES type.

METHODS

In the current sub-analysis from TWILIGHT, patients were stratified into three groups based on DES type: durable polymer everolimus-eluting stents (DP-EES), durable polymer zotarolimus-eluting stents (DP-ZES), and biodegradable polymer DES (BP-DES). Bleeding and ischaemic outcomes were assessed at one year after randomisation.

RESULTS

Out of 5,769 patients, 3,014 (52.2%) had DP-EES, 1,350 (23.4%) had DP-ZES and 1,405 (24.4%) had BP-DES. Compared with ticagrelor plus aspirin, ticagrelor monotherapy had significantly lower BARC type 2, 3 or 5 bleeding compared with DAPT; DP-EES (3.8% vs 6.7%; HR 0.56, 95% CI: 0.41-0.78), DP-ZES (4.6% vs 6.9%; HR 0.66, 95% CI: 0.42-1.04) and BP-DES (4.2% vs 7.9%; HR 0.52, 95% CI: 0.33-0.81; p=0.76). Ticagrelor monotherapy resulted in similar rates of death, MI, or stroke: DP-EES (4.2% vs 4.3%; HR 0.97; 95% CI: 0.68-1.37); DP-ZES (4.1% vs 3.1%; HR 1.32; 95% CI: 0.75-2.33); BP-DES (3.9% vs 4.2%; HR 0.92; 95% CI: 0.54-1.55; p=0.60). In both unadjusted and covariate-adjusted analyses, DES type was not associated with any differences in ischaemic or bleeding complications.

CONCLUSIONS

As compared with ticagrelor plus aspirin, ticagrelor monotherapy after a short DAPT duration lowered bleeding complications without increasing the ischaemic risk, irrespective of DES type. We observed no significant differences among DES types.

摘要

背景

在 TWILIGHT 试验中,替格瑞洛单药治疗在接受药物洗脱支架(DES)经皮冠状动脉介入治疗(PCI)的高危患者中,在短期双联抗血小板治疗(DAPT)后显示出安全的避免出血策略。

目的

本研究旨在根据 DES 类型评估替格瑞洛单药治疗在接受 PCI 的患者中 DAPT 三个月后的效果。

方法

在 TWILIGHT 的当前亚分析中,根据 DES 类型将患者分为三组:耐用聚合物依维莫司洗脱支架(DP-EES)、耐用聚合物佐他莫司洗脱支架(DP-ZES)和生物可降解聚合物 DES(BP-DES)。随机分组后一年评估出血和缺血结局。

结果

在 5769 例患者中,3014 例(52.2%)为 DP-EES,1350 例(23.4%)为 DP-ZES,1405 例(24.4%)为 BP-DES。与替格瑞洛加阿司匹林相比,替格瑞洛单药治疗与 DAPT 相比,BARC 类型 2、3 或 5 出血显著降低;DP-EES(3.8% vs 6.7%;HR 0.56,95%CI:0.41-0.78)、DP-ZES(4.6% vs 6.9%;HR 0.66,95%CI:0.42-1.04)和 BP-DES(4.2% vs 7.9%;HR 0.52,95%CI:0.33-0.81;p=0.76)。替格瑞洛单药治疗导致死亡率、心肌梗死或卒中等缺血事件的发生率相似:DP-EES(4.2% vs 4.3%;HR 0.97;95%CI:0.68-1.37);DP-ZES(4.1% vs 3.1%;HR 1.32;95%CI:0.75-2.33);BP-DES(3.9% vs 4.2%;HR 0.92;95%CI:0.54-1.55;p=0.60)。在未调整和调整协变量的分析中,DES 类型与缺血或出血并发症均无差异。

结论

与替格瑞洛加阿司匹林相比,替格瑞洛单药治疗在较短的 DAPT 持续时间后可降低出血并发症,而不增加缺血风险,与 DES 类型无关。我们观察到不同 DES 类型之间没有显著差异。

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