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

Abstract

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.