1. Compared to placebo, edaravone dexborneol improved functional independence at 90 days in patients with acute ischaemic stroke who underwent endovascular thrombectomy.
Evidence Rating Level: 1 (Excellent)
Edaravone dexborneol is a novel multitarget brain cytoprotective agent that has shown efficacy in patients with acute ischaemic stroke without reperfusion therapy. It is unclear whether edaravone dexborneol provides additional benefits in patients undergoing reperfusion therapy. This study thus examined the efficacy and safety of edaravone dexborneol in improving functional outcomes among patients with acute ischaemic stroke undergoing endovascular thrombectomy. This multicentre, double blind, randomised controlled trial was conducted in China between March 2022 and May 2023. Patients aged 18-80 years were included if they had a clinically diagnosed acute ischaemic stroke and planned endovascular thrombectomy. Patients were randomly assigned 1:1 to receive edaravone dexborneol (37.5 mg) or placebo before endovascular thrombectomy, twice daily for a consecutive period of 10-14 days. The primary outcome was functional independence at 90 days, defined as a modified Rankin Scale score of 0-2 (range 0 [no symptoms] to 6 [death]), and serious adverse events. In total, 690 patients were included in the edaravone dexborneol group (median [IQR] age = 67.0 [57.0-73.0] years, male [%] = 435 [63.0]) and 672 in the placebo group (median [IQR] age = 67.0 [58.0-73.0]) years, male [%] = 436 [64.9]). Due to loss to follow-up, 1360 patients were included in the intent-to-treat analysis. At 90 days, 379 (55.0%) of 689 patients in the edaravone dexborneol group and 333 (49.6%) of 671 patients in the placebo group achieved functional independence. Patients who received edaravone dexborneol were 11% more likely to achieve functional dependence than those who received a placebo (risk ratio 1.11, 95% confidence interval (CI) 1.00 to 1.23; risk difference 5.4%, 95% CI 0.1% to 10.7%). Patients with mismatch at admission (NIHSS score ≥10 and ASPECTS ≥9 or NIHSS score ≥20 and ≥7) were more likely to achieve functional independence when treated with edaravone dexborneol compared to placebo (55.5% (178/321) versus 42.9% (134/312); risk ratio 1.29, 1.10 to 1.52; risk difference 13.0%, 5.6% to 20.3%; P for interaction=0.003). Overall, this study found that compared to placebo, edaravone dexborneol improved functional independence at 90 days in patients with acute ischaemic stroke who underwent endovascular thrombectomy, particularly for those with clinical imaging mismatch present at admission. These findings highlight the potential of edaravone dexborneol as an adjunctive therapy with reperfusion treatment. Future studies should validate these findings in other populations with larger sample sizes.
Click here to read this study in the BMJ
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