Clevidipine infusion for blood pressure management after successful revascularisation in acute ischaemic stroke: the CLEVER study

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BACKGROUND: Limited studies have provided guidance on the optimal systolic blood pressure (SBP) after mechanical thrombectomy (MT) in acute ischemic stroke patients. In the Clevidipine Infusion for Blood Pressure Management After Successful Revascularization in Acute Ischemic Stroke (CLEVER) trial, our aim was to study the safety and efficacy of intensive SBP control with a Clevidipine infusion as the first-line agent. METHODS: The CLEVER trial was an investigator-initiated, single-center, open-label, randomized, controlled trial. Patients were randomized 1:1 to a SBP goal after successful MT (mTICI 2c or greater) of either 90-120mmHg (Intensive BP Management) or 90-160mmHg (Standard BP Management). The primary outcomes were time to target blood pressure and incidence of any hemorrhagic conversion at 24 hours. RESULTS: Between October 2021 and December 2023, 80 eligible patients were enrolled, 40 each into the intensive BP and the standard BP management cohorts. Overall, 72% of all BP measurements in the intensive BP management group were within the target range, compared to 93% in the standard BP management group (p<0.001). The median time from the initiation of Clevidipine infusion until reaching the target SBP was significantly shorter in the standard BP management group, 10 minutes [IQR 5.0-45.0] versus 20 IQR 12.5-42.5] (95%CI:5.0-20.0, p=0.002). The incidence of hemorrhagic transformation per core lab was not significantly different in the intensive BP management group (32.5%) and the standard BP management group (35.0%); adjusted OR (0.93 [95%CI, 0.30-2.85]; p=0.89). CONCLUSION: In the randomised CLEVER trial, intensive BP control using clevidipine after MT failed to reduce the rate of haemorrhagic conversion or sICH and resulted in a numerically lower rate of good clinical outcome compared to standard BP control. Clevidipine was well tolerated in both cohorts and demonstrated a similar safety profile. Larger studies are needed to understand the efficacy and safety of clevidipine for BP control and the optimal BP threshold after MT.

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