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药物洗脱支架置入术后高血小板反应患者中添加西洛他唑的疗效:一项随机、开放标签、单中心、前瞻性研究(ADJUST-HPR)。

Adjunctive Cilostazol in Patients With High Residual Platelet Reactivity After Drug-Eluting Stent Implantation: A Randomized, Open-Label, Single-Center, Prospective Study (ADJUST-HPR).

机构信息

Department of Cardiology, Dong-A University Hospital, Busan, Republic of Korea.

Department of Cardiology, Affiliated Qiqihar Hospital, Southern Medical University, China.

出版信息

Am J Ther. 2024;31(3):e229-e236. doi: 10.1097/MJT.0000000000000244. Epub 2023 Apr 25.

DOI:10.1097/MJT.0000000000000244
PMID:37099013
Abstract

BACKGROUND

Cilostazol as an adjunct to dual antiplatelet therapy (DAPT) postcoronary stenting may further reduce vascular occlusion risks. The aim of this study was to assess the impact of cilostazol on high residual platelet reactivity (HRPR) in patients undergoing drug-eluting coronary stent implantation.

METHODS

In a randomized, open-label, single-center, prospective study, the degree of platelet inhibition by cilostazol 100 mg twice daily was assessed on top of conventional DAPT compared with standard clopidogrel and low-dose aspirin combination in poststent patients with HRPR. HRPR was defined as P2Y12 units (PRU) > 240 as measured by the VerifyNow P2Y12 assay. In addition, the platelet activity was assessed by light transmittance aggregometry (LTA) and Multiplate electrode analyzer (MEA).

RESULTS

The total of 148 patients were screened, and HRPR was observed in 64 (43.2%). Those were randomized for DAPT versus triple therapy (TAPT). After 30 days, TAPT group exhibited significantly lower rate of HRPR when assessed by all 3 devices (VerifyNow: 40.0 vs. 66.7% P = 0.04, LTA: 6.7 vs. 30.0% P = 0.02, MEA: 10.0 vs. 30.0% P = 0.05 L all vs. DAPT). Also, higher absolute mean difference in TAPT versus DAPT group after 30 days (VerifyNow: 71.3 ± 38.2 vs. 24.6 ± 40.2 P < 0.001, LTA: 23.9 ± 15.1 vs. 9.4 ± 11.8 P < 0.001, MEA: 9.3 ± 12.9 vs. 2.4 ± 17.3 P = 0.08) was observed.

CONCLUSIONS

Cilostazol in addition to standard DAPT reduces the incidence of HRPR and diminishes further platelet activity in poststent patients. Whether this favorable laboratory finding will affect clinical outcomes requires an adequately powered randomized trial.

摘要

背景

在冠状动脉支架置入术后,联合使用西洛他唑和双重抗血小板治疗(DAPT)可能进一步降低血管闭塞风险。本研究旨在评估西洛他唑对经皮冠状动脉支架置入术后存在高残余血小板反应性(HRPR)患者的影响。

方法

在一项随机、开放标签、单中心、前瞻性研究中,与标准氯吡格雷和低剂量阿司匹林联合治疗相比,评估了西洛他唑 100 mg 每日两次在 HRPR 患者中的血小板抑制程度。HRPR 定义为通过 VerifyNow P2Y12 检测到的血小板抑制单位(PRU)>240。此外,通过光透射聚集(LTA)和 Multiplate 电极分析仪(MEA)评估血小板活性。

结果

共筛选了 148 例患者,其中 64 例(43.2%)存在 HRPR。这些患者被随机分为 DAPT 组与三药治疗(TAPT)组。30 天后,TAPT 组的所有 3 种设备(VerifyNow:40.0%比 66.7%,P=0.04;LTA:6.7%比 30.0%,P=0.02;MEA:10.0%比 30.0%,P=0.05)检测到的 HRPR 发生率显著较低。此外,TAPT 组与 DAPT 组在 30 天后的平均绝对差异也更大(VerifyNow:71.3±38.2 比 24.6±40.2,P<0.001;LTA:23.9±15.1 比 9.4±11.8,P<0.001;MEA:9.3±12.9 比 2.4±17.3,P=0.08)。

结论

在标准 DAPT 的基础上加用西洛他唑可降低支架置入术后 HRPR 的发生率,并进一步降低血小板活性。这种有利的实验室发现是否会影响临床结局,需要进行充分的随机试验。

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