Thrombectomy with the pRESET vs solitaire stent retrievers as first-line large vessel occlusion stroke treatment: a randomized clinical trial
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.To determine whether thrombectomy for LVO stroke with the pRESET stent retr...
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| Hauptverfasser: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
January 2, 2024
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| In: |
JAMA neurology
Year: 2024, Jahrgang: 81, Heft: 2, Pages: 170-178 |
| ISSN: | 2168-6157 |
| DOI: | 10.1001/jamaneurol.2023.5010 |
| Online-Zugang: | Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1001/jamaneurol.2023.5010
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| Verfasserangaben: | Raul G. Nogueira, MD; Donald Lobsien, MD; Joachim Klisch, MD; Daniel Pielenz, MD; Elmar Lobsien, MD; Eric Sauvageau, MD; Nima Aghaebrahim, MD; Markus Möhlenbruch, MD; Dominik Vollherbst, MD; Christian Ulfert, MD; Hormozd Bozorgchami, MD; Wayne Clark, MD; Ryan Priest, MD; Edgar A. Samaniego, MD; Santiago Ortega-Gutierrez, MD, MSc; Malik Ghannam, MD; Demetrius Lopes, MD; Joshua Billingsley, MD; Kiffon Keigher, DNP, ACNP; Diogo C. Haussen, MD; Alhamza R. Al-Bayati, MD; Adnan Siddiqui, MD, PhD; Elad Levy, MD, MBA; Michael Chen, MD; Stephan Munich, MD; Peter Schramm, MD; Tobias Boppel, MD; Sandra Narayanan, MD; Bradley A. Gross, MD; Christian Roth, MD; Tobias Boeckh-Behrens, MD; Ameer Hassan, DO; Johanna Fifi, MD; Ron F. Budzik, MD; Jason Tarpley, MD; Robert M. Starke, MD; Eytan Raz, MD; Gary Brogan, MSc, BSc; David S. Liebeskind, MD; Ricardo A. Hanel, MD, PhD |
| Zusammenfassung: | 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.To determine whether thrombectomy for LVO stroke with the pRESET stent retriever is noninferior to treatment with the Solitaire stent retriever.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.Patients underwent 1:1 randomization to thrombectomy with the pRESET or Solitaire stent retriever.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.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.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. |
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| Beschreibung: | Published online January 2, 2024. Corrected on February 12, 2024 Gesehen am 18.12.2024 |
| Beschreibung: | Online Resource |
| ISSN: | 2168-6157 |
| DOI: | 10.1001/jamaneurol.2023.5010 |