Effectiveness of Revive SE in the RAPID registry : Revive Acute Ischemic Stroke Patients ImmeDiately (RAPID) Prospective Multicenter Trial.,Clinical Neuroradiology

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Effectiveness of Revive SE in the RAPID registry : Revive Acute Ischemic Stroke Patients ImmeDiately (RAPID) Prospective Multicenter Trial.
Clinical Neuroradiology ( IF 2.4 ) Pub Date : 2019-06-07 , DOI: 10.1007/s00062-019-00798-w
Yongxin Zhang ₁ , Wanling Wen ₂ , Changchun Chen ₃ , Zhilin Wu ₄ , Xin Xiang ₅ , Hongchao Shi ₆ , Sheng Guan ₇ , Guisheng Jiang ₈ , Ya Peng ₉ , Zhiqing Li ₁₀ , Zifu Li ₁ , Lei Zhang ₁ , Yongwei Zhang ₁₁ , Bo Hong ₁ , Pengfei Yang ₁ , Jianmin Liu ₁

Affiliation

Department of Neurosurgery, Shanghai Changhai Hospital, Naval Military Medical University, 168 Changhai Road, 200433, Shanghai, China.
Department of Neurology, the People's Liberation Army No. 306 Hospital, Beijing, China.
Department of Neurology, Anhui No. 2 Provincial People's Hospital, Hefei, China.
Department of Neurosurgery, Yunfu People's Hospital, Yunfu, China.
The Affiliated Hospital of Guizhou Medical University, Guiyang, China.
Nanjing First Hospital, Nanjing, China.
The First Affiliated Hospital, Zhengzhou University, Zhengzhou, China.
Liaocheng People's Hospital, Liaocheng, China.
The First People's Hospital of Changzhou, Changzhou, China.
Department of Neurosurgery, Shengjing Hospital, China Medical University, Shenyang, China.
Cerebrovascular Disease Center, Shanghai Changhai Hospital, Naval Military Medical University, Shanghai, China.

Purpose

The prospective, multicenter Revive Acute ischemic stroke Patients ImmeDiately (RAPID) trial was carried out to evaluate the real-world safety and efficacy of the Revive SE stent retriever.

Methods

From January 2017 the study planned to enroll 100 patients with acute ischemic stroke who were treated with the Revive SE as a first pass. The study primary outcomes were rates of favorable reperfusion using the modified thrombolysis in cerebral infarction score [mTICI] 2b/3 and rates of favorable outcome with the modified Rankin Scale (mRS) ≤2 at 3 months. The secondary outcomes were time interval from puncture to vascular reperfusion, number of passes by Revive SE stent-retriever, incidence of distal embolization and into new territories and rate of symptomatic intracranial hemorrhage (SICH) within 24 h post intervention.

Results

A total of 100 treated patients (mean age: 65.6 ± 11.3 years) were enrolled. The median National Institutes of Health Stroke Scale before the procedure was 16. Target vessel occlusions were as follows: middle cerebral artery (MCA) M1 in 48, M2 in 6, anterior cerebral artery (ACA) in 3, internal carotid artery (ICA) in 22, basilar artery (BA) in 17, and vertebral artery (VA) in 4. Reperfusion rate with Revive SE without rescue devices was 69%. Reperfusion rate with Revive SE only was 83.3% in MCA M2, followed by 82.4% in BA. Thromboembolic complications and SICH developed in 10% and 2% of patients, respectively. Overall, a satisfactory reperfusion was achieved in 92% and a favorable outcome at 90 days in 48%.

Conclusion

Use of the Revive SE for thrombectomy appeared to be effective and safe but these findings need be confirmed in larger clinical trials (RAPID ClinicalTrials.gov number, NCT03007082).

中文翻译：

Revive SE在RAPID注册表中的有效性：急性急性缺血性卒中患者立即（RAPID）前瞻性多中心试验。

目的

进行了一项前瞻性，多中心的Revive急性缺血性卒中患者ImmeDiately（RAPID）试验，以评估Revive SE支架取回器在现实世界中的安全性和有效性。

方法

从2017年1月开始，该研究计划招募100名接受Revive SE作为首过治疗的急性缺血性中风患者。研究的主要结果是在3个月时使用改良的溶栓治疗脑梗死评分[mTICI] 2b / 3的良好再灌注率和改良的Rankin量表（mRS）≤2的良好结果。次要结果是从穿刺到血管再灌注的时间间隔，Revive SE支架取回器的通过次数，远端栓塞和进入新区域的发生率以及干预后24小时内症状性颅内出血的发生率。

结果

总共纳入了100名接受治疗的患者（平均年龄：65.6±11.3岁）。手术前中位国家卫生研究院卒中量表的中位数为16。目标血管闭塞情况如下：大脑中动脉（MCA）M1在48个，M2在6个，前脑动脉（ACA）在3个，颈内动脉（ICA）在22例中，基底动脉（BA）在17例中，椎动脉（VA）在4例中。使用没有救援装置的Revive SE的再灌注率为69％。在MCA M2中，仅使用Revive SE的再灌注率为83.3％，其次是BA的82.4％。分别有10％和2％的患者发生了血栓栓塞并发症和SICH。总体而言，令人满意的再灌注率为92％，而90天的良好转归率为48％。