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WSC 2023 | PROOF trial results: high dose oxygen therapy for neuroprotective bridging in ischemic stroke

Sven Poli, MD, MSc, FESO, FWSO, FAHA, Eberhard-Karls University of Tübingen, Tübingen, Germany, shares the results of the Phase IIb PROOF trial (NCT03500939), assessing normobaric oxygen (NBO) administration for neuroprotective bridging in patients with ischemic stroke eligible for endovascular thrombectomy (EVT). Based on the consistent demonstration of protective effects in animal models, it was hypothesized that rapid application of high-dose oxygen therapy would stabilize the ischemic penumbra until restoration of blood flow. The trial randomized eligible patients to high-flow near 100% oxygen at ≥40 L/min via a non-rebreather mask or standard oxygen supplementation within six hours after stroke onset. The findings of a planned interim analysis led to termination of the trial due to futility, giving a final sample size of 223 patients. The study found no significant difference in infarct growth from baseline to 24 hours in the NBO versus standard treatment arm. There was also no difference in change in NIHSS from baseline to 24 hours or 90-day mRS. Dr Poli shares his thoughts on the how trial limitations may have impacted the findings, including the small sample size and use of an early imaging-based primary outcome. A similar trial, OPENS-2, recently reported a shift towards better outcomes on mRS at 90 days in NBO patients compared to controls. Dr Poli comments on how the PROOF data compare to the findings of OPENS-2 and future plans to generate a conclusive answer on the benefit of NBO in this setting. This interview took place at the World Stroke Congress (WSC) 2023 in Toronto, Canada.

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