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SAMMPRIS 试验中症状性颅内狭窄患者超过 90 天的双联抗血小板治疗。

Dual Antiplatelet Therapy Beyond 90 days in Symptomatic Intracranial Stenosis in the SAMMPRIS Trial.

机构信息

Department of Neurology, 96 Jonathan Lucas Street, Clinical Science Building 301, MSC 606, Medical University of South Carolina, Charleston 29425-8050, SC, United States.

Department of Biostatistics and Bioinformatics, 1518 Clifton Rd, Emory University Rollins School of Public Health, Atlanta 30322, GA, United States.

出版信息

J Stroke Cerebrovasc Dis. 2020 Dec;29(12):105254. doi: 10.1016/j.jstrokecerebrovasdis.2020.105254. Epub 2020 Sep 10.

Abstract

BACKGROUND

The safety and efficacy of dual antiplatelet use for symptomatic intracranial atherosclerosis beyond 90 days is unknown. Data from SAMMPRIS was used to determine if dual antiplatelet therapy (DAPT) beyond 90 days impacted the risk of ischemic stroke and hemorrhage.

METHODS

This post hoc exploratory analysis from SAMMPRIS included patients who did not have a primary endpoint within 90 days after enrollment (n = 397). Patients in both the aggressive medical management (AMM) and percutaneous transluminal angioplasty and stenting (PTAS) arms were included. Baseline features and outcomes during follow-up were compared between patients who remained on DAPT beyond 90 days (on clopidogrel) and patients who discontinued clopidogrel and remained on aspirin alone at 90 days (off clopidogrel) using Fisher's exact tests.

RESULTS

The stroke rate was numerically lower in the group on clopidogrel vs off clopidogrel among both the AMM alone arm (6.0% versus 10.8%, p = 0.31) and the PTAS arm (8.7% versus 9.8%; p = 0.82), but the difference was not significant. The major hemorrhage rates were numerically higher in the group on clopidogrel vs. off clopidogrel group among both the AMM alone arm (4.0% versus 2.5%; p = 0.67) and the PTAS arm (10.9% versus 3.5%; p = 0.08), but were not significant.

CONCLUSION

This exploratory analysis suggests that prolonged DAPT use may lower the risk of stroke in medically treated patients with intracranial stenosis but may increase the risk of major hemorrhage.

摘要

背景

症状性颅内动脉粥样硬化患者双联抗血小板治疗(DAPT)超过 90 天的安全性和有效性尚不清楚。本研究使用 SAMMPRIS 数据,旨在明确 DAPT 超过 90 天是否会影响缺血性卒中和出血风险。

方法

本研究为 SAMMPRIS 的事后探索性分析,纳入在入组后 90 天内未发生主要终点事件的患者(n=397)。入组患者来自强化药物治疗(AMM)组和经皮腔内血管成形术和支架置入术(PTAS)组。采用 Fisher 确切概率法比较两组患者(DAPT 超过 90 天者继续使用氯吡格雷[clopidogrel]和 DAPT 超过 90 天者停用氯吡格雷而单独使用阿司匹林者[off clopidogrel])的基线特征和随访期间结局。

结果

在 AMM 组(6.0%比 10.8%,p=0.31)和 PTAS 组(8.7%比 9.8%,p=0.82)中,继续使用氯吡格雷者的卒中发生率低于停用氯吡格雷者,但差异无统计学意义。在 AMM 组(4.0%比 2.5%,p=0.67)和 PTAS 组(10.9%比 3.5%,p=0.08)中,继续使用氯吡格雷者的大出血发生率高于停用氯吡格雷者,但差异无统计学意义。

结论

本探索性分析表明,对于颅内狭窄的药物治疗患者,延长 DAPT 治疗可能会降低卒中风险,但可能会增加大出血风险。

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