A Randomised Study Comparing First-line Dual Vs Single-Stentretriever Technique: TWIN2WIN

Abstract

ImportanceDouble stentretriever (double-SR) is used as a rescue technique when recanalization is not achieved in stroke patients undergoing thrombectomy. Double-SR, if applied as first-line technique could increase first-pass recanalization rates, known to be associated with better outcomes.ObjectiveTo assess the safety and efficacy of first-line double-SR in stroke patients undergoing thrombectomy.DesignRandomized, controlled, blinded adjudicated primary outcome study between 2022 and 2023.SettingMulticenter (5 sites), national (Spain).ParticipantsPatients with ischemic stroke due to large vessel occlusion within 24 hours after onset, undergoing thrombectomy.InterventionsUpon confirmation of large vessel occlusion on initial angiogram, patients were randomly allocated to receive a first-line strategy: single-SR Vs double-SR technique. Investigators could use their technique of choice if further passes were needed.Main Outcomes and MeasuresThe primary objective was to evaluate the efficacy of double-SR defined as first-pass complete recanalization (eTICI 2c-3) compared to single-SR. First/pass and final successful recanalization (eTICI2b50-3) were centrally assessed by a blinded investigator. The safety outcome was the occurrence of a symptomatic intracerebral hemorrhage (sICH). The data safety monitoring board stopped the recruitment after a pre-planned interim analysis because a predefined efficacy boundary was reached.ResultsFrom April 2022 to October 2023, 108 patients were included, 50 patients (46%) in the single-SR group and 58 (54%) in the double-SR group. FPR was achieved in 12/50 patients (24%) allocated to single-SR and 27/58 (46%) allocated to double-SR (aOR 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 (89%) allocated to double-SR (aOR 1.74; 95% CI, 0.55 - 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, −0.79 - 0.06). A sICH occurred in 3 patients (6%) allocated to single-SR and in 6 (10%) allocated to double-SR (aOR 1.66; 95% CI, 0.40-8.35).Conclusions and RelevanceIn stroke patients undergoing thrombectomy, first-line double-SR is safe and superior to single-SR in achieving first pass but not final recanalization. Implications on clinical outcomes should be studied in specifically designed trials.Trial IdentificationNCT05632458Key pointsQuestionWhat is the safety and efficacy of the double stentretriever (SR) technique as a first-line treatment in acute ischemic stroke patients undergoing endovascular treatment?FindingsIn this multicenter randomized, blinded primary endpoint adjudicated clinical trial that included 108 acute stroke patients, the rate of first-pass recanalization (TICI2c-3) was superior with double-SR as compared to single-SR technique.MeaningIn acute stroke patients with a large vessel occlusion, the first-line use of the double SR technique increases the chances of first-pass recanalization, which has been associated with improved clinical outcomes.