Design of the BEST‐II Randomized Clinical Trial

Eva A. Mistry, Kimberly Hart, Taylor Davis, Sharon Yeatts, Christopher J. Lindsell, Roger J. Lewis, Gregory Albers, Jonathan P. Wanderer, Charles Prestigiacomo, Gordon R. Bernard, Pooja Khatri
2022 Stroke: Vascular and Interventional Neurology  
Prior observational studies indicate that lower systolic blood pressure (SBP) after successful endovascular treatment (EVT) is associated with better functional outcomes in patients with acute ischemic stroke. However, whether targeting SBP to levels below the guideline‐recommended target of ≤180 mm Hg is safe and efficacious remains to be determined. Methods The BEST (Blood Pressure After Endovascular Stroke Therapy)‐II trial (NCT04116112) is a pragmatic, phase 2, multisite, prospective,
more » ... ized, open‐label trial with blinded end‐point assessment designed to (1) compare the safety of lower SBP targets with higher SBP targets in successfully EVT‐treated patients with stroke and (2) inform the design and estimate the probability of success of a future phase 3 trial. A total of 120 patients with acute ischemic stroke who undergo successful EVT (final modified Thrombolysis in Cerebral Infarction score ≥2b) for intracranial internal carotid artery or M1 or M2 segment of the middle cerebral artery will be randomized to the SBP targets of ≤180, <160, and <140 mm Hg, to be maintained for 24 hours using intravenous nicardipine as the first‐line agent. We will assess the harm of decreased post‐EVT SBP by quantifying its linear relationship with multiple primary outcomes of final infarct volume on magnetic resonance imaging (or computed tomography) at 36 hours and utility‐weighted modified Rankin scale score at 90 days. The study is approved by the Institutional Review Boards of both participating institutions and the Data and Safety Monitoring Board. Results Enrollment in the BEST‐II trial began in January 2020, with 90 patients enrolled as of October 13, 2021. The trial is progressing ahead of target, with an anticipated enrollment completion date before January 2023. Conclusions The BEST‐II trial results will inform the stroke community of the safety of lower SBP targets in patients with acute ischemic stroke who are successfully treated with EVT and will demonstrate the feasibility of both achieving lower blood pressure targets as well as conducting an efficacy trial. Trial enrollment is on target despite the COVID‐19 pandemic. Clinical Trial Registration Information NCT04116112 ( )
doi:10.1161/svin.121.000249 fatcat:xkibxprq5rhxzgq4762rds7vqu