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急性缺血性脑卒中患者血管内治疗成功后脑灌注血流动力学优化的随机试验(HOPE)

A Randomized Trial on Hemodynamic Optimization of Cerebral Perfusion after Successful Endovascular Therapy in Patients with Acute Ischemic Stroke (HOPE).

作者信息

Camps-Renom Pol, Guasch-Jiménez Marina, Martínez-Domeño Alejandro, Prats-Sánchez Luis, Ramos-Pachón Anna, Álvarez-Cienfuegos Juan, Silva Yolanda, Fortea-Cabo Gerardo, Morales-Caba Luis, Rodríguez-Campello Ana, Giralt-Steinhauer Eva, Flores Alan, Ustrell Xavier, López-Hernández Nicolás, Corona-García Diego José, Freijo-Guerrero Mari Mar, Luna Alain, Tejada-Meza Herbert, Marta-Moreno Javier, Moniche Francisco, Pardo-Galiana Blanca, Castellanos Mar, Albert-Lacal Laura, Sanz-Monllor Ainara, Aguilera-Simón Ana, Marín Rebeca, Ezcurra-Díaz Garbiñe, Lambea-Gil Álvaro, Martí-Fàbregas Joan

机构信息

Stroke Unit, Department of Neurology, Hospital de la Santa Creu i Sant Pau, Biomedical Research Institute Sant Pau (IIB-Sant Pau), Barcelona, Spain.

Stroke Unit, Department of Neurology, Hospital Dr. Josep Trueta, Girona, Spain.

出版信息

Cerebrovasc Dis. 2024 Aug 29:1-8. doi: 10.1159/000540606.

Abstract

INTRODUCTION

In patients with acute ischemic stroke (AIS) secondary to intracranial large vessel occlusion, optimal blood pressure (BP) management following endovascular treatment (EVT) has not yet been established. The randomized trial on Hemodynamic Optimization of Cerebral Perfusion after Successful Endovascular Therapy in Patients with Acute Ischemic Stroke (HOPE) (clinicaltrials.gov id: NCT04892511) aims to demonstrate whether hemodynamic optimization using different systolic BP targets following EVT according to the degree of final recanalization, is more effective than currently recommended BP management in improving functional outcomes of patients with AIS.

METHODS

HOPE is an investigator-initiated multicenter clinical trial with randomized allocation, open-label treatment, and blinded endpoint evaluation (PROBE). Patients with an anterior circulation AIS within 24 h of symptom onset, treated with EVT, and showing successful recanalization (mTICI ≥2b) at the end of the procedure, are equally allocated (1:1) to hemodynamic optimization according to the study protocol versus BP management according to current guidelines (≤180/105 mm Hg). The protocol includes two different targets of systolic BP depending on the recanalization status (mTICI = 2b: 140-160 mm Hg; mTICI = 2c/3: 100-140 mm Hg). The protocol is applied within the first 72 h and includes BP lowering as well as vasopressor therapies when needed. The primary outcome is the proportion of favorable outcome (modified Rankin Scale [mRS] 0-2) at 90 days. Secondary outcomes include the shift on the mRS score, neurological deterioration, symptomatic intracerebral hemorrhage, and mortality.

CONCLUSION

The HOPE trial will provide new information on the safety and efficacy of different BP targets following EVT according to the degree of final recanalization in patients with AIS.

摘要

引言

在颅内大血管闭塞继发急性缺血性卒中(AIS)的患者中,血管内治疗(EVT)后的最佳血压(BP)管理尚未确立。急性缺血性卒中患者血管内治疗成功后脑灌注血流动力学优化随机试验(HOPE)(临床试验.gov标识符:NCT04892511)旨在证明,根据最终再通程度在EVT后使用不同收缩压目标进行血流动力学优化,在改善AIS患者功能结局方面是否比目前推荐的BP管理更有效。

方法

HOPE是一项由研究者发起的多中心临床试验,采用随机分配、开放标签治疗和盲法终点评估(PROBE)。症状发作24小时内接受EVT治疗且在手术结束时显示成功再通(mTICI≥2b)的前循环AIS患者,根据研究方案与根据现行指南(收缩压≤180/105 mmHg)进行的BP管理按1:1比例平均分配。该方案根据再通状态包括两个不同的收缩压目标(mTICI = 2b:140 - 160 mmHg;mTICI = 2c/3:100 - 140 mmHg)。该方案在最初72小时内应用,包括降压以及必要时的血管升压治疗。主要结局是90天时良好结局(改良Rankin量表[mRS] 0 - 2)的比例。次要结局包括mRS评分的变化、神经功能恶化、症状性脑出血和死亡率。

结论

HOPE试验将提供关于AIS患者根据最终再通程度在EVT后不同BP目标的安全性和有效性的新信息。

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