Early intensive blood pressure management after endovascular treatment in ischaemic stroke (IDENTIFY): a multicentre, open-label, blinded-endpoint, randomised controlled trial

Abstract

Background: The optimal blood pressure (BP) management following successful endovascular treatment (EVT) in acute ischaemic stroke (AIS) patients remains unclear. This study investigated the safety and efficacy of intensive BP control in AIS patients who had received EVT within 6 h.

Methods: This randomised, multicentre, open-label, blinded-endpoint clinical trial (ChiCTR2200057770) was conducted at 63 stroke centres in China. Eligible participants had AIS due to large vessel occlusion in anterior circulation, underwent EVT within 6 h, and achieved successful recanalisation. Patients were randomised to intensive (systolic BP target <130 mm Hg) or standard (systolic BP target <180 mm Hg) management, maintained until 24 h post-EVT. The primary outcome was unfavourable functional outcome (modified Rankin Scale score of 3-6) at 90 days. The trial was terminated following a neutral interim analysis results and publication of counterpart randomised trials.

Findings: Between October 14, 2022 and March 18, 2024, 383 patients were randomised. Unfavourable functional outcome occurred in 71.0% (130/183) of the intensive-management group and 67.5% (135/200) of the standard-management group (risk ratio, 1.05; 95% CI, 0.92-1.20; p = 0.45). There was no significant difference in symptomatic intracerebral haemorrhage, malignant brain oedema, or all-cause death at 90 days.

Interpretation: Intensive BP management to <130 mm Hg did not improve outcomes in AIS patients undergoing EVT within 6 h and achieved successful recanalisation. The optimal BP management strategies require further investigation.

Funding: Sichuan University West China Hospital, National Natural Science Foundation of China, National Key R&D Programme of China, and Science and Technology Department of Sichuan Province.

Keywords: Acute ischaemic stroke; Blood pressure; Endovascular therapy; Hypertension; Thrombectomy.

Fig. 1

Flow Chart. SBP, systolic blood pressure; ICH, intracerebral haemorrhage; mRS, modified Rankin Scale; EVT, endovascular treatment; IV, intravenous. ^aa patient could be excluded for multiple reasons. Detailed reasons were listed in eTable 3. ^bsevere stenosis: stenosis ≥70% or even occlusion. ^csevere heart failure: baseline New York Heart Association Functional Classification was class IV according to medical records ^dunsuccessful recanalisation: defined as modified Thrombolysis in Cerebral Infarction score 0,1a,1b or 2a. ^eend-stage cancers: assessed by an experienced physician based on the medical history. ^flarge infarct core: this patient had a baseline Alberta Stroke Program Early CT Score of 2.

Fig. 2

Mean blood pressure trajectories throughout the 24 Hours. This figure displays geometric mean blood pressure values (with geometric standard deviations) for the study cohort across sequential timepoints from emergency room admission to 24 h after endovascular treatment (admit: emergency room admission; 0: the timepoint of randomisation). The point measurements of both systolic blood pressure and diastolic blood pressure were maintained significantly lower in the intensive-management group compared to the standard-management group.

Fig. 3

Distribution of mRS at 90 Days (ITT population). The modified Rankin Scale ranges from 0 to 6, with 0 score indicates no symptom and 6 score indicates death. There was no significant difference in the distribution of mRS between the two groups (common odds ratio, 1.16 [95% CI, 0.81–1.65]; p = 0.42).