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比较替格瑞洛和氯吡格雷对急性冠状动脉综合征患者采用有创生理指标评估的微血管功能障碍的影响。

Comparison of the Effects of Ticagrelor and Clopidogrel on Microvascular Dysfunction in Patients With Acute Coronary Syndrome Using Invasive Physiologic Indices.

机构信息

Cardiology Department, Regional Cardiocerebrovascular Center, Dong-A University Hospital, Busan, Republic of Korea (K.P., Y.-R.C., J.-S.P., T.-H.P., M.-H.K., Y.-D.K.).

Division of Cardiology, Department of Internal Medicine, Dong-A University College of Medicine, Busan, Republic of Korea (K.P., Y.-R.C., J.-S.P., T.-H.P., M.-H.K., Y.-D.K.).

出版信息

Circ Cardiovasc Interv. 2019 Oct;12(10):e008105. doi: 10.1161/CIRCINTERVENTIONS.119.008105. Epub 2019 Sep 26.

Abstract

BACKGROUND

Ticagrelor reduced the rate of myocardial infarction and death compared with clopidogrel in patients with acute coronary syndrome. However, little is understood about chronic treatment of ticagrelor on microvascular dysfunction. The objective of this study was to assess the impact of ticagrelor maintenance treatment on microvascular system and coronary flow in comparison with clopidogrel.

METHODS

This study was a nonblinded, open-label, parallel-group, prospective, randomized controlled trial that enrolled 120 patients with acute coronary syndrome requiring stent implantation. Patients were randomized into the ticagrelor (180 mg loading dose, 90 mg twice daily thereafter) or clopidogrel (300 to 600 mg loading dose, 75 mg daily thereafter) group. The primary end point was coronary microvascular dysfunction as measured by an index of microcirculatory resistance (IMR) at 6 months after treatment.

RESULTS

The baseline clinical characteristics and physiological parameters, such as fractional flow reserve, coronary flow reserve, and IMR, did not differ between the ticagrelor and clopidogrel groups. Six-month follow-up physiological data showed that the IMR value was significantly lower in the ticagrelor group than the clopidogrel group (15.57±5.65 versus 21.15±8.39, <0.01), and coronary flow reserve was higher in the ticagrelor group than in the clopidogrel group (3.85±0.72 versus 3.37±0.76, <0.01). However, there was no difference in fractional flow reserve (0.87±0.08 versus 0.87±0.09, =0.94) between the 2 groups. The improvement in IMR after 6 months of treatment was higher in the ticagrelor group (<0.01). Analyses of 223 nonculprit vessels of registered patients based on physiological results showed no differences in baseline fractional flow reserve (0.93±0.13 versus 0.92±0.09, =0.58), coronary flow reserve (3.62±1.27 versus 3.51±1.24, =0.16), or IMR (21.37±12.37 versus 24.19±21.08, =0.22) or in follow-up fractional flow reserve (0.91±0.09 versus 0.91±0.08, =0.67), coronary flow reserve (3.91±1.22 versus 3.75±1.16, =0.36), or IMR (19.43±10.32 versus 21.52±18.90, =0.34) between the 2 groups.

CONCLUSIONS

Compared with clopidogrel, 6 months of ticagrelor therapy significantly improved microvascular dysfunction in acute coronary syndrome patients with stent implantation.

CLINICAL TRIAL REGISTRATION

URL: https://www.clinicaltrials.gov. Unique identifier: NCT02618733.

摘要

背景

替格瑞洛与氯吡格雷相比,可降低急性冠脉综合征患者的心肌梗死和死亡发生率。然而,对于替格瑞洛在微血管功能障碍方面的慢性治疗,我们知之甚少。本研究旨在评估与氯吡格雷相比,替格瑞洛维持治疗对微血管系统和冠状动脉血流的影响。

方法

这是一项非盲、开放标签、平行组、前瞻性、随机对照试验,纳入了 120 例需要支架植入的急性冠脉综合征患者。患者被随机分为替格瑞洛(180mg 负荷剂量,此后 90mg 每日 2 次)或氯吡格雷(300 至 600mg 负荷剂量,此后 75mg 每日 1 次)组。主要终点是治疗 6 个月后的微血管阻力指数(IMR)评估的冠状动脉微血管功能障碍。

结果

替格瑞洛组和氯吡格雷组的基线临床特征和生理参数(如血流储备分数、冠状动脉血流储备和 IMR)无差异。6 个月随访的生理数据显示,替格瑞洛组的 IMR 值明显低于氯吡格雷组(15.57±5.65 比 21.15±8.39,<0.01),替格瑞洛组的冠状动脉血流储备高于氯吡格雷组(3.85±0.72 比 3.37±0.76,<0.01)。然而,两组的血流储备分数(0.87±0.08 比 0.87±0.09,=0.94)无差异。替格瑞洛组治疗 6 个月后的 IMR 改善程度更高(<0.01)。根据生理结果对注册患者的 223 个非罪犯血管进行分析,基线血流储备分数(0.93±0.13 比 0.92±0.09,=0.58)、冠状动脉血流储备(3.62±1.27 比 3.51±1.24,=0.16)或 IMR(21.37±12.37 比 24.19±21.08,=0.22)或随访时的血流储备分数(0.91±0.09 比 0.91±0.08,=0.67)、冠状动脉血流储备(3.91±1.22 比 3.75±1.16,=0.36)或 IMR(19.43±10.32 比 21.52±18.90,=0.34)在两组之间无差异。

结论

与氯吡格雷相比,替格瑞洛治疗 6 个月可显著改善急性冠脉综合征支架植入患者的微血管功能障碍。

临床试验注册

网址:https://www.clinicaltrials.gov。唯一标识符:NCT02618733。

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