作者
B. Lapergue,Raphaël Blanc,Vincent Costalat,Hubert Desal,Susanna Saleme,Laurent Spelle,Gaultier Marnat,Eimad Shotar,François Eugène,Mikaël Mazighi,Emmanuel Houdart,Arturo Consoli,Georges Rodesch,Romain Bourcier,Serge Bracard,Alain Duhamel,Maalek Ben Maacha,Delphine Lopez,Nicholas Renaud,Julien Labreuche,Benjamin Gory,Michel Piotin,Michel Piotin,Raphaël Blanc,Hocine Redjem,Gabriele Cicciò,Stanislas Smajda,Mikaël Mazighi,Robert Fahed,Jean Philippe Desilles,Malek Ben Maacha,B. Lapergue,Georges Rodesch,Arturo Consoli,Oguzhan Coskun,Federico Di Maria,Frédéric Bourdain,Adrien Wang,Maya Tchikviladze,Serge Evrard,David Weisenburger‐Lile,Géraldine Buard,Lucas Gorza,Marthe Jiabe Chouakam,Charbel Mounayer,Suzanna Saleme,Aymeric Rouchaud,Francisco Macian Montoro,Vincent Costalat,Bonafé Alain,Grégory Gascou,Cyril Dargazanli,Caroline Arquizan,Serge Bracard,Romain Tonnelet,Anne Laure Derelle,René Anxionnat,Sébastien Richard,Benjamin Gory,Liang Liao,Lisa Humberjean,Gioia Mione,Hubert Desal,Romain Bourcier,Benjamin Daumas-Duport,Benoît Guillon,Jérôme Berge,Xavier Barreau,Gauthier Margnat,Igor Sibon,Lynda Djemmane,Julien Labreuche,Alain Duhamel,Frédéric Clarençon,Eimad Shotar,Charlotte Rosso,Nader Sourour,Stéphanie Lenck,Kévin Premat,Sonia Alamowitch,Laurent Spelle,Christian Denier,François Eugène,Stéphane Vannier
摘要
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. Trial Registration
ClinicalTrials.gov Identifier:NCT03290885