Tomasello Alejandro, Moreu Manuel, Terceño Mikel, Dinia Lavinia, Barrena Caballo Maria Rosario, Requena Manuel, Jablonska Magda, Cendrero Judith, Flores Alan, Ortega-Gutierrez Santiago, Diana Francesco, Henandez David, de Dios Marta, Rubiera Marta, Garcia-Tornel Alvaro, Rizzo Federica, Olivé Marta, Pérez-García Carlos, Trejo Gallego Carmen, Carmona Tomas, Rodrigo-Gisbert Marc, Molina Carlos, Ribo Marc
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).
Stroke. 2025 Feb;56(2):326-334. doi: 10.1161/STROKEAHA.124.048496. Epub 2024 Dec 20.
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.
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.
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]).
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.
URL: https://www.clinicaltrials.gov; Unique identifier: NCT05632458.
当单支架取栓器（SR）未能实现再通时，双支架取栓器技术被描述为一种有效的补救技术。我们旨在评估一线双支架取栓器技术在接受血栓切除术的卒中患者中的安全性和有效性。
这是一项多中心、随机、对照、盲法判定主要结局的研究。纳入发病后24小时内接受血栓切除术的大血管闭塞性卒中患者。在初始血管造影证实大血管闭塞后，患者被随机分配接受一线策略：单支架取栓器技术与双支架取栓器技术。如果需要进一步操作，研究人员可使用他们选择的技术。主要目的是评估双支架取栓器技术与单支架取栓器技术相比，定义为首次通过完全再通（扩展脑梗死治疗分级2c - 3级）的有效性。首次通过再通和最终成功再通（扩展脑梗死治疗分级2b50 - 3级）由一名盲法研究者进行集中评估。安全性结局是有症状性脑出血的发生。在预先计划的中期分析后，数据安全监测委员会停止了招募，因为达到了预定的有效性边界。
2022年4月至2023年10月，共纳入了108例患者：单支架取栓器组50例（46%），双支架取栓器组58例（54%）。分配至单支架取栓器组的50例患者中有12例（24%）实现了首次通过再通，分配至双支架取栓器组的58例患者中有27例（46%）实现了首次通过再通（调整后的优势比为2.72 [95%置信区间，1.19 - 6.46]）。分配至单支架取栓器组的42例患者（84%）和分配至双支架取栓器组的52例患者（89%）在3次尝试内实现了显著再灌注（调整后的优势比为1.74 [95%置信区间，0.5 - 5.76]）。单支架取栓器组的平均操作次数为2±1.
