Effect of Thrombectomy With Combined Contact Aspiration and Stent Retriever vs Stent Retriever Alone on Revascularization in Patients With Acute Ischemic Stroke and Large Vessel Occlusion The ASTER2 Randomized Clinical Trial

被引:151
作者
Lapergue, Bertrand [1 ]
Blanc, Raphael [2 ]
Costalat, Vincent [3 ]
Desal, Hubert [4 ]
Saleme, Susanna [5 ]
Spelle, Laurent [6 ]
Marnat, Gaultier [7 ]
Shotar, Eimad [8 ]
Eugene, Francois [9 ]
Mazighi, Mikael [2 ]
Houdart, Emmanuel [10 ]
Consoli, Arturo [1 ,11 ]
Rodesch, Georges [2 ,11 ]
Bourcier, Romain [4 ]
Bracard, Serge [12 ,13 ]
Duhamel, Alain [14 ]
Ben Maacha, Maalek [2 ]
Lopez, Delphine [1 ]
Renaud, Nicholas [1 ]
Labreuche, Julien [14 ]
Gory, Benjamin [12 ,13 ]
Piotin, Michel [2 ]
机构
[1] Univ Versailles & St Quentin en Yvelines, Stroke Ctr, Dept Neurol, Foch Hosp, 40 RueWorth, F-92150 Suresnes, France
[2] Rothschild Fdn, Dept Intervent Neuroradiol, Paris, France
[3] Hosp Ctr Univ Montpellier, Dept Neuroradiol, Univ Hosp Gui de Chauliac, Montpellier, France
[4] Univ Nantes, CNRS, Univ Hosp Nantes,INSERM 1087, Dept Diagnost & Therapeut Neuroradiol,Thorax Inst, Pays De La Loire, France
[5] Univ Hosp Limoges, Dept Diagnost & Intervent Neuroradiol, Limoges, France
[6] Bicetre Hosp, Dept Intervent Neuroradiol, Le Kremlin Bicetre, France
[7] Univ Hosp Bordeaux, Dept Diagnost & Intervent Neuroradiol, Bordeaux, France
[8] Hop La Pitie Salpetriere, Dept Neuroradiol, Paris, France
[9] Univ Hosp Rennes, Dept Diagnost & Intervent Neuroradiol, Rennes, France
[10] Lariboisiere Hosp, Dept Neuroradiol, Paris, France
[11] Univ Versailles & St Quentin en Yvelines, Foch Hosp, Dept Diagnost & Therapeut Neuroradiol, Suresnes, France
[12] Univ Lorraine, CHRU Nancy, Dept Diagnost & Therapeut Neuroradiol, F-54000 Nancy, France
[13] Univ Lorraine, INSERM, IADI, U1254, F-54000 Nancy, France
[14] Univ Lille, CHU Lille, ULR 2694 METRICS Assessment Hlth Technol & Med Pr, F-59000 Lille, France
来源
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION | 2021年 / 326卷 / 12期
关键词
GUIDELINES; MANAGEMENT; OUTCOMES; SCALE;
D O I
10.1001/jama.2021.13827
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
This randomized clinical trial compares the effect of thrombectomy with contact aspiration and stent retriever combined vs stent retriever alone on revascularization in patients with acute ischemic stroke and large vessel occlusion. Question Among patients with acute ischemic stroke and large vessel occlusion, does an initial thrombectomy technique consisting of contact aspiration and stent retriever combined improve the reperfusion rate compared with stent retriever alone? Findings In this randomized clinical trial that included 408 patients, the rate of near-total or total reperfusion on the extended Thrombolysis in Cerebral Infarction scale of 2c or 3 (eTICI 2c/3) at the end of the endovascular procedure was not significantly different in the combined contact aspiration and stent retriever group compared with the stent retriever alone group (64.5% vs 57.9%; adjusted odds ratio, 1.33). Meaning Among patients with acute ischemic stroke due to large vessel occlusion, an initial thrombectomy technique consisting of contact aspiration and stent retriever combined did not significantly improve the rate of near-total or total (eTICI 2c/3) reperfusion at the end of the endovascular procedure as compared with stent retriever alone. Importance Mechanical thrombectomy using a stent retriever or contact aspiration is widely used for treatment of patients with acute ischemic stroke due to anterior circulation large vessel occlusion, but the additional benefit of combining contact aspiration with stent retriever is uncertain. Objective To determine whether mechanical thrombectomy for treatment of anterior circulation large vessel occlusion stroke with initial contact aspiration and stent retriever combined results in better final angiographic outcome than with standard stent retriever alone. Design, Setting, and Participants This trial was a multicenter randomized, open-label, blinded end point evaluation that enrolled 408 patients from October 16, 2017, to May 29, 2018, in 11 French comprehensive stroke centers, with a 12-month outcome follow-up. Patients with a large vessel occlusion in the anterior circulation were included up to 8 hours after symptom onset. The final date of follow-up was June, 19, 2019. Interventions Patients were randomly assigned (1:1 allocation) to receive initial thrombectomy with contact aspiration and stent retriever combined (205) or stent retriever alone (203). Main Outcomes and Measures The primary outcome was the rate of expanded Thrombolysis In Cerebral Infarction score of 2c or 3 (eTICI 2c/3; ie, scores indicate near-total and total reperfusion grades) at the end of the procedure. Results Among the 408 patients who were randomized, 3 were excluded, and 405 (99.3%) patients (mean age, 73 years; 220 [54%] women and 185 [46%] men) were included in the primary analysis. The rate of eTICI 2c/3 at the end of the endovascular procedure was not significantly different between the 2 thrombectomy groups (64.5% [131 of 203 patients] for contact aspiration and stent retriever combined vs 57.9% [117 of 202 patients] for stent retriever alone; risk difference, 6.6% [95% CI, -3.0% to 16.2%]; adjusted odds ratio [OR], 1.33 [95% CI, 0.88 to 1.99]; P = .17). Of 14 prespecified secondary efficacy end points, 12 showed no significant difference. A higher rate of successful reperfusion was achieved in the contact aspiration combined with stent retriever group vs the stent retriever alone group (eTICI 2b50/2c/3, 86.2% vs 72.3%; adjusted OR, 2.54 [95% CI, 1.51 to 4.28]; P < .001) and of near-total or total reperfusion (eTICI 2c/3, 59.6% vs 49.5%; adjusted OR, 1.52 [95% CI, 1.02 to 2.27]; P = .04) after the assigned initial intervention alone. Conclusions and Relevance Among patients with acute ischemic stroke due to large vessel occlusion, an initial thrombectomy technique consisting of contact aspiration and stent retriever combined, compared with stent retriever alone, did not significantly improve the rate of near-total or total reperfusion (eTICI 2c/3) at the end of the endovascular procedure, although the trial may have been underpowered to detect smaller differences between groups.
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收藏
页码:1158 / 1169
页数:12
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