RESUMO
BACKGROUND: Acute basilar artery occlusion (BAO) is a severe disease that is associated with an 85% mortality rate if untreated. Several studies have analyzed the use of mechanical thrombectomy (MT) in the different scenarios of BAO. However, the results remain conflicting and the role of MT as standard of care for vertebrobasilar tandem occlusions (VBTO) has not been confirmed. Our goal was to assess technical feasibility, safety, and functional outcome of endovascular treatment of VBTO in comparison to isolated BAO (IBAO). METHODS: We retrospectively reviewed all prospectively collected patients with acute BAO from six tertiary centers between September 2016 and November 2021. Patients were subsequently divided into two groups: VBTO and IBAO. Baseline data, procedural details, and outcomes were compared between groups. RESULTS: A total of 190 patients were included, 55 presenting with a VBTO and 135 with IBAO. Successful recanalization was equally common in both groups (89.1% and 86.0%). Rates of favorable functional outcome (modified Rankin Scale: 0-2) were higher in patients with VBTO compared to IBAO (36.4% vs. 25.2%, p = 0.048) and mortality was lower (29.1% vs. 33.3%). However, these associations faded after adjustment for confounders (adjusted odds ratio [aOR] 0.86, 95% CI 0.35-2.05; aOR 0.93, 95% CI 0.35-2.45). Rates of symptomatic intracranial hemorrhage did not differ between the groups (VBTO: 7.3% vs. IBAO: 4.2%; p = 0.496). CONCLUSION: Endovascular treatment of VBTO is technically feasible and safe with similar rates of successful recanalization, favorable functional outcome, and mortality to those in patients with IBAO.
RESUMO
Importance: Stent retriever-based thrombectomy is highly beneficial in large vessel occlusion (LVO) strokes. Many stent retriever designs are currently available, but comparison of these technologies in well-conducted studies is lacking. Objective: To determine whether thrombectomy for LVO stroke with the pRESET stent retriever is noninferior to treatment with the Solitaire stent retriever. Design, Setting, and Participants: This study was a multicenter, prospective, randomized, controlled, open-label, adaptive, noninferiority trial with blinded primary end point evaluation. Between October 2019 and February 2022, multicenter participation occurred across 19 research hospitals and/or universities in the US and 5 in Germany. Patients with LVO stroke were enrolled and included up to 8 hours after symptom onset. Interventions: Patients underwent 1:1 randomization to thrombectomy with the pRESET or Solitaire stent retriever. Main Outcomes and Measures: The primary outcome was the difference in the rate of 90-day functional independence across the 2 devices, using a -12.5% noninferiority margin for the lower bound of the 1-sided 95% CI of the difference between pRESET and Solitaire retrievers. Results: Of 340 randomized patients, 170 (50.0%) were female, and the median (IQR) age was 73.0 (64.0-82.0) years. The study procedure was completed in 322 of the 340 randomized patients. The primary end point of 90-day functional independence was achieved by 95 patients (54.9%; 95% CI, 48.7-61.1) in the pRESET group and in 96 (57.5%; 95% CI, 51.2-63.8) in the Solitaire group (absolute difference, -2.57%; 95% CI, -11.42 to 6.28). As the lower bound of the 95% CI was greater than -12.5%, the pRESET retriever was deemed noninferior to the Solitaire retriever. The noninferiority of pRESET over Solitaire was also observed in the secondary clinical end point (90-day shift in modified Rankin Scale score) and in both angiographic end points (Expanded Treatment in Cerebral Infarction [eTICI] score of 2b50 or greater within 3 passes: 146 of 173 [84.4%] vs 149 of 167 [89.2%]; absolute difference, -4.83%; 95% CI, -10.84 to 1.19; eTICI of 2c or greater following the first pass: 76 of 173 [43.7%] vs 74 of 167 [44.3%]; absolute difference, -0.63%; 95% CI, -9.48 to 8.21). Symptomatic intracranial hemorrhage occurred in 0 patients in the pRESET group and 2 (1.2%) in the Solitaire group. Mortality occurred in 25 (14.5%) in the pRESET group and in 24 (14.4%) in the Solitaire group at 90 days. Findings of the per-protocol and as-treated analyses were in concordance with findings of the intention-to-treat analysis. Conclusions and Relevance: In this study, among patients with LVO stroke, thrombectomy with the pRESET stent retriever was noninferior to thrombectomy with the Solitaire stent retriever. Findings suggest that pRESET offers a safe and effective option for flow restoration and disability reduction in patients with LVO stroke.