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REVASCAT试验(使用Solitaire FR装置进行血管再通与最佳药物治疗对比治疗症状发作8小时内出现的前循环大血管闭塞所致急性卒中的随机试验)中24小时时的血管通畅情况及其与临床结局和梗死体积的关系

Vessel Patency at 24 Hours and Its Relationship With Clinical Outcomes and Infarct Volume in REVASCAT Trial (Randomized Trial of Revascularization With Solitaire FR Device Versus Best Medical Therapy in the Treatment of Acute Stroke Due to Anterior Circulation Large Vessel Occlusion Presenting Within Eight Hours of Symptom Onset).

作者信息

Millán Mònica, Remollo Sebastià, Quesada Helena, Renú Arturo, Tomasello Alejandro, Minhas Priyanka, Pérez de la Ossa Natalia, Rubiera Marta, Llull Laura, Cardona Pedro, Al-Ajlan Fahad, Hernández María, Assis Zarina, Demchuk Andrew M, Jovin Tudor, Dávalos Antoni

机构信息

From the Stroke Unit and Interventional Neuroradiology Section, Department of Neurosciences, Hospital Germans Trias, Universitat Autònoma de Barcelona, Spain (M.M., S.R., N.P.d.l.O., M.H., A.D.); Stroke Unit, Neurology Department, Hospital de Bellvitge, L'Hospitalet de Llobregat (Barcelona), Spain (H.Q., P.C.); Stroke Unit, Neurology Department, Hospital Clínic, Barcelona, Spain (A.R., L.L.); Radiology Department (A.T.) and Stroke Unit, Neurology Department (M.R.), Hospital Vall d'Hebron, Barcelona, Spain; Calgary Stroke Program, Hotchkiss Brain Institute, Department of Clinical Neurosciences and Radiology, University of Calgary (P.M., F.A.-A., Z.A., A.M.D.); and Stroke Institute, Department of Neurology, University of Pittsburgh Medical Center, PA (T.J.).

出版信息

Stroke. 2017 Apr;48(4):983-989. doi: 10.1161/STROKEAHA.116.015455. Epub 2017 Mar 14.

Abstract

BACKGROUND AND PURPOSE

Higher rates of target vessel patency at 24 hours were noted in the thrombectomy group compared with control group in recent randomized trials. As a prespecified secondary end point, we aimed to assess 24-hour revascularization rates by treatment groups and occlusion site as they related to clinical outcome and 24-hour infarct volume in REVASCAT (Randomized Trial of Revascularization With Solitaire FR Device Versus Best Medical Therapy in the Treatment of Acute Stroke Due to Anterior Circulation Large Vessel Occlusion Presenting Within Eight Hours of Symptom Onset).

METHODS

Independent core laboratory adjudicated vessel status according to modified arterial occlusive lesion classification at 24 hours on computed tomographic/magnetic resonance (94.2%/5.8%) angiography and 24-hour infarct volume on computed tomography were studied (95/103 patients in the thrombectomy group versus 94/103 in the control group, respectively). Complete revascularization was defined as modified arterial occlusive lesion grade 3. Its effect on clinical outcome was analyzed by ordinal logistic regression.

RESULTS

Complete revascularization was achieved in 70.5% of the solitaire group and in 22.3% of the control group (<0.001). Significant differences in complete revascularization rates were found for terminus internal carotid artery, M1, and tandem occlusions (all <0.001) but not for M2 occlusions. In the thrombectomy group, 2 out of 63 patients (3.1%) with modified Thrombolysis in Cerebral Infarction 2b/3 after thrombectomy showed arterial reocclusion (modified arterial occlusive lesion grade 0/1) at 24 hours. Complete revascularization was associated with improved outcome in both thrombectomy (adjusted odds ratio, 4.5; 95% confidence interval, 1.9-10.9) and control groups (adjusted odds ratio, 2.7; 95% confidence interval, 1.0-6.7). Revascularization (modified arterial occlusive lesion grade 2/3) was associated with smaller infarct volumes in either treatment arm.

CONCLUSIONS

Complete revascularization at 24 hours is a powerful predictor of favorable clinical outcome, whereas revascularization of any type results in reduced infarct volume in both thrombectomy and control groups.

CLINICAL TRIAL REGISTRATION

URL: http://www.clinicaltrials.gov. Unique identifier: NCT01692379.

摘要

背景与目的

在近期的随机试验中,与对照组相比,血栓切除术组在24小时时的靶血管通畅率更高。作为一个预先设定的次要终点,我们旨在评估REVASCAT(使用Solitaire FR装置进行血管再通与最佳药物治疗对比治疗症状发作8小时内出现的急性前循环大血管闭塞性脑梗死的随机试验)中各治疗组和闭塞部位的24小时血管再通率,以及它们与临床结局和24小时梗死体积的关系。

方法

独立核心实验室根据计算机断层扫描/磁共振(94.2%/5.8%)血管造影在24小时时按照改良动脉闭塞病变分类判定血管状态,并研究计算机断层扫描上的24小时梗死体积(血栓切除术组分别为95/103例患者,对照组为94/103例患者)。完全再通定义为改良动脉闭塞病变3级。通过有序逻辑回归分析其对临床结局的影响。

结果

Solitaire组70.5%的患者实现了完全再通,对照组为22.3%(<0.001)。颈内动脉末端、M1段和串联闭塞的完全再通率存在显著差异(均<0.001),但M2段闭塞无差异。在血栓切除术组中,63例血栓切除术后脑梗死溶栓分级为2b/3级的患者中有2例(3.1%)在24小时时出现动脉再闭塞(改良动脉闭塞病变0/1级)。完全再通与血栓切除术组(调整比值比,4.5;95%置信区间,1.9 - 10.9)和对照组(调整比值比,2.7;95%置信区间,1.0 - 6.7)的预后改善相关。在任一治疗组中,血管再通(改良动脉闭塞病变2/3级)与较小的梗死体积相关。

结论

24小时时的完全再通是良好临床结局的有力预测指标,而任何类型的血管再通都会使血栓切除术组和对照组的梗死体积减小。

临床试验注册

网址:http://www.clinicaltrials.gov。唯一标识符:NCT 01692379。

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