Bertrand Lapergue1, Raphaël Blanc2, Vincent Costalat3, Hubert Desal4, Susanna Saleme5, Laurent Spelle6, Gaultier Marnat7, Eimad Shotar8, Francois Eugene9, Mikael Mazighi2, Emmanuel Houdart10, Arturo Consoli1,11, Georges Rodesch2,11, Romain Bourcier4, Serge Bracard12, Alain Duhamel13, Maalek Ben Maacha2, Delphine Lopez1, Nicholas Renaud1, Julien Labreuche13, Benjamin Gory12, Michel Piotin2. 1. Department of Neurology, Stroke Center, University of Versailles and Saint Quentin en Yvelines, Foch Hospital, Suresnes, France. 2. Department of Interventional Neuroradiology, Rothschild Foundation, Paris, France. 3. Department of Neuroradiology, University Hospital Güi-de-Chauliac, Hospital Center University of Montpellier, Montpellier, France. 4. Department of Diagnostic and Therapeutic Neuroradiology, University Hospital of Nantes, Thorax Institute, INSERM 1087, CNRS, UNIV Nantes, Nantes, Pays de la Loire, France. 5. Department of Diagnostic and Interventional Neuroradiology, University Hospital of Limoges, Limoges, France. 6. Bicêtre Hospital, Department of Interventional Neuroradiology, Le Kremlin-Bicêtre, France. 7. Department of Diagnostic and Interventional Neuroradiology, University Hospital of Bordeaux, Bordeaux, France. 8. Department of Neuroradiology, Pitié-Salpêtrière Hospital, Paris, France. 9. Department of Diagnostic and Interventional Neuroradiology, University Hospital of Rennes, Rennes, France. 10. Department of Neuroradiology, Lariboisière Hospital, Paris, France. 11. Department of Diagnostic and Therapeutic Neuroradiology, University of Versailles and Saint Quentin en Yvelines, Foch Hospital, Suresnes, France. 12. University of Lorraine, CHRU-Nancy, Department of Diagnostic and Therapeutic Neuroradiology, F-54000 Nancy, France and University of Lorraine, IADI, INSERM U1254, F-54000 Nancy, France. 13. University of Lille, CHU Lille, ULR 2694 - METRICS: Assessment of Health Technologies and Medical Practices, F-59000 Lille, France.
Abstract
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.
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.
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