Randomized Study Comparing First-Line Dual Versus Single-Stent Retriever Technique: TWIN2WIN.

Autor:	Tomasello A; Interventional Neuroradiology, Vall d'Hebron University Hospital, Barcelona, Spain (A.T., M.J., F.D., D.H., M.d.D.).; Stroke Research Group, Vall d'Hebron Research Institute, Barcelona, Universitat Autonoma de Barcelona, Spain (A.T., M.J., J.C., F.D., D.H., M.d.D., M. Rubiera, A.G.-T., F.R., M.O., M.R.-G., C.M., M. Ribo)., Moreu M; Interventional Neuroradiology, Hospital Clínico San Carlos, Madrid, Spain (M.M., C.P.-G., C.T.G.)., Terceño M; Department of Neurology, Stroke Unit, Hospital Universitari Dr. Josep Trueta, Girona, Spain (M.T.)., Dinia L; Radiology, Hospital de la Santa Creu i Sant Pau, Interventional Neuroradiology Section, Barcelona, Spain (L.D.)., Barrena Caballo MR; Interventional Neuroradiology Unit, Hospital Universitario Miguel Servet, Grupo de Investigación en Neurociencias, Aragon Institute for Health Research (IIS Aragón), Zaragoza, Spain (M.R.B.C., M. Rubiera, A.G.-T., F.R., M.O., M.R.-G., C.M., M. Ribo)., Requena M; Neurology Department, Stroke Unit, Hospital Vall d'Hebron, Barcelona, Spain (M. Requena)., Jablonska M; Interventional Neuroradiology, Vall d'Hebron University Hospital, Barcelona, Spain (A.T., M.J., F.D., D.H., M.d.D.).; Stroke Research Group, Vall d'Hebron Research Institute, Barcelona, Universitat Autonoma de Barcelona, Spain (A.T., M.J., J.C., F.D., D.H., M.d.D., M. Rubiera, A.G.-T., F.R., M.O., M.R.-G., C.M., M. Ribo)., Cendrero J; Stroke Research Group, Vall d'Hebron Research Institute, Barcelona, Universitat Autonoma de Barcelona, Spain (A.T., M.J., J.C., F.D., D.H., M.d.D., M. Rubiera, A.G.-T., F.R., M.O., M.R.-G., C.M., M. Ribo).; Stroke Unit, Vall d'Hebron Institut de Recerca, Barcelona, Spain (J.C.)., Flores A; Neurology Department, Hospital Joan XXIII, Tarragona, Spain (A.F.)., Ortega S; Department of Neurology, Neurosurgery and Radiology, University of Iowa (S.O.)., Diana F; Interventional Neuroradiology, Vall d'Hebron University Hospital, Barcelona, Spain (A.T., M.J., F.D., D.H., M.d.D.).; Stroke Research Group, Vall d'Hebron Research Institute, Barcelona, Universitat Autonoma de Barcelona, Spain (A.T., M.J., J.C., F.D., D.H., M.d.D., M. Rubiera, A.G.-T., F.R., M.O., M.R.-G., C.M., M. Ribo).; Dipartimento di Scienze della Vita, della Salute e delle Professioni Sanitarie, Università degli Studi, Rome, Italy (F.D.)., Henandez D; Interventional Neuroradiology, Vall d'Hebron University Hospital, Barcelona, Spain (A.T., M.J., F.D., D.H., M.d.D.).; Stroke Research Group, Vall d'Hebron Research Institute, Barcelona, Universitat Autonoma de Barcelona, Spain (A.T., M.J., J.C., F.D., D.H., M.d.D., M. Rubiera, A.G.-T., F.R., M.O., M.R.-G., C.M., M. Ribo)., de Dios M; Interventional Neuroradiology, Vall d'Hebron University Hospital, Barcelona, Spain (A.T., M.J., F.D., D.H., M.d.D.).; Stroke Research Group, Vall d'Hebron Research Institute, Barcelona, Universitat Autonoma de Barcelona, Spain (A.T., M.J., J.C., F.D., D.H., M.d.D., M. Rubiera, A.G.-T., F.R., M.O., M.R.-G., C.M., M. Ribo)., Rubiera M; Stroke Research Group, Vall d'Hebron Research Institute, Barcelona, Universitat Autonoma de Barcelona, Spain (A.T., M.J., J.C., F.D., D.H., M.d.D., M. Rubiera, A.G.-T., F.R., M.O., M.R.-G., C.M., M. Ribo).; Interventional Neuroradiology Unit, Hospital Universitario Miguel Servet, Grupo de Investigación en Neurociencias, Aragon Institute for Health Research (IIS Aragón), Zaragoza, Spain (M.R.B.C., M. Rubiera, A.G.-T., F.R., M.O., M.R.-G., C.M., M. Ribo)., Garcia-Tornel A; Stroke Research Group, Vall d'Hebron Research Institute, Barcelona, Universitat Autonoma de Barcelona, Spain (A.T., M.J., J.C., F.D., D.H., M.d.D., M. Rubiera, A.G.-T., F.R., M.O., M.R.-G., C.M., M. Ribo).; Interventional Neuroradiology Unit, Hospital Universitario Miguel Servet, Grupo de Investigación en Neurociencias, Aragon Institute for Health Research (IIS Aragón), Zaragoza, Spain (M.R.B.C., M. Rubiera, A.G.-T., F.R., M.O., M.R.-G., C.M., M. Ribo)., Rizzo F; Stroke Research Group, Vall d'Hebron Research Institute, Barcelona, Universitat Autonoma de Barcelona, Spain (A.T., M.J., J.C., F.D., D.H., M.d.D., M. Rubiera, A.G.-T., F.R., M.O., M.R.-G., C.M., M. Ribo).; Interventional Neuroradiology Unit, Hospital Universitario Miguel Servet, Grupo de Investigación en Neurociencias, Aragon Institute for Health Research (IIS Aragón), Zaragoza, Spain (M.R.B.C., M. Rubiera, A.G.-T., F.R., M.O., M.R.-G., C.M., M. Ribo)., Olivé M; Stroke Research Group, Vall d'Hebron Research Institute, Barcelona, Universitat Autonoma de Barcelona, Spain (A.T., M.J., J.C., F.D., D.H., M.d.D., M. Rubiera, A.G.-T., F.R., M.O., M.R.-G., C.M., M. Ribo).; Interventional Neuroradiology Unit, Hospital Universitario Miguel Servet, Grupo de Investigación en Neurociencias, Aragon Institute for Health Research (IIS Aragón), Zaragoza, Spain (M.R.B.C., M. Rubiera, A.G.-T., F.R., M.O., M.R.-G., C.M., M. Ribo)., Pérez-García C; Interventional Neuroradiology, Hospital Clínico San Carlos, Madrid, Spain (M.M., C.P.-G., C.T.G.)., Trejo Gallego C; Interventional Neuroradiology, Hospital Clínico San Carlos, Madrid, Spain (M.M., C.P.-G., C.T.G.)., Carmona T; Neurosurgery Department, Hospital San Pablo, Coquimbo, Chile (T.C.)., Rodrigo-Gisbert M; Stroke Research Group, Vall d'Hebron Research Institute, Barcelona, Universitat Autonoma de Barcelona, Spain (A.T., M.J., J.C., F.D., D.H., M.d.D., M. Rubiera, A.G.-T., F.R., M.O., M.R.-G., C.M., M. Ribo).; Interventional Neuroradiology Unit, Hospital Universitario Miguel Servet, Grupo de Investigación en Neurociencias, Aragon Institute for Health Research (IIS Aragón), Zaragoza, Spain (M.R.B.C., M. Rubiera, A.G.-T., F.R., M.O., M.R.-G., C.M., M. Ribo)., Molina C; Stroke Research Group, Vall d'Hebron Research Institute, Barcelona, Universitat Autonoma de Barcelona, Spain (A.T., M.J., J.C., F.D., D.H., M.d.D., M. Rubiera, A.G.-T., F.R., M.O., M.R.-G., C.M., M. Ribo).; Interventional Neuroradiology Unit, Hospital Universitario Miguel Servet, Grupo de Investigación en Neurociencias, Aragon Institute for Health Research (IIS Aragón), Zaragoza, Spain (M.R.B.C., M. Rubiera, A.G.-T., F.R., M.O., M.R.-G., C.M., M. Ribo)., Ribo M; Stroke Research Group, Vall d'Hebron Research Institute, Barcelona, Universitat Autonoma de Barcelona, Spain (A.T., M.J., J.C., F.D., D.H., M.d.D., M. Rubiera, A.G.-T., F.R., M.O., M.R.-G., C.M., M. Ribo).; Interventional Neuroradiology Unit, Hospital Universitario Miguel Servet, Grupo de Investigación en Neurociencias, Aragon Institute for Health Research (IIS Aragón), Zaragoza, Spain (M.R.B.C., M. Rubiera, A.G.-T., F.R., M.O., M.R.-G., C.M., M. Ribo).
Jazyk:	angličtina
Zdroj:	Stroke [Stroke] 2024 Dec 20. Date of Electronic Publication: 2024 Dec 20.
DOI:	10.1161/STROKEAHA.124.048496
Abstrakt:	Background: The double-stent retriever (SR) technique has been described as an effective rescue technique when single-SR fails to induce recanalization. We aimed to assess the safety and efficacy of first-line double-SR in patients with stroke undergoing thrombectomy. Methods: This was a multicenter, randomized, controlled, blinded adjudicated primary outcome study. Patients with a large vessel occlusion stroke within 24 hours after onset and undergoing thrombectomy were included. Upon confirmation of large vessel occlusion on initial angiogram, patients were randomly allocated to receive a first-line strategy: single-SR versus double-SR technique. Investigators could use their technique of choice if further passes were needed. The primary objective was to evaluate the efficacy of double-SR defined as first-pass complete recanalization (expanded Treatment in Cerebral Infarction grade 2c-3) compared with single-SR. First-pass recanalization and final successful recanalization (expanded Treatment in Cerebral Infarction grade 2b50-3) were centrally assessed by a blinded investigator. The safety outcome was the occurrence of a symptomatic intracerebral hemorrhage. The data safety monitoring board stopped the recruitment after a preplanned interim analysis because a predefined efficacy boundary was reached. Results: From April 2022 to October 2023, 108 patients were included: 50 (46%) in the single-SR group and 58 (54%) in the double-SR group. First-pass recanalization was achieved in 12 of 50 patients (24%) allocated to single-SR and 27 of 58 patients (46%) allocated to double-SR (adjusted odds ratio, 2.72 [95% CI, 1.19-6.46]). Substantial reperfusion within 3 attempts was obtained in 42 patients (84%) allocated to single-SR and in 52 patients (89%) allocated to double-SR (adjusted odds ratio, 1.74 [95% CI, 0.5-5.76]). The mean number of passes was 2±1.3 with single-SR and 1.7±1 with double-SR (mean difference, -0.37 [95% CI, -0.9 to 0.06]). A symptomatic intracerebral hemorrhage occurred in 3 patients (6%) allocated to single-SR and in 6 patients (10%) allocated to double-SR (adjusted odds ratio, 1.66 [95% CI, 0.40-8.35]). Conclusions: In patients with stroke undergoing thrombectomy, first-line double-SR is safe and superior to single-SR in achieving first-pass recanalization but not final recanalization. Implications on clinical outcomes should be studied in specifically designed trials. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT05632458.
Databáze:	MEDLINE
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