Intensive vs Conventional Blood Pressure Lowering After Endovascular Thrombectomy in Acute Ischemic Stroke: The OPTIMAL-BP Randomized Clinical Trial

Abstract

Importance: Optimal blood pressure (BP) control after successful reperfusion with endovascular thrombectomy (EVT) for patients with acute ischemic stroke is unclear.

Objective: To determine whether intensive BP management during the first 24 hours after successful reperfusion leads to better clinical outcomes than conventional BP management in patients who underwent EVT.

Design, setting, and participants: Multicenter, randomized, open-label trial with a blinded end-point evaluation, conducted across 19 stroke centers in South Korea from June 2020 to November 2022 (final follow-up, March 8, 2023). It included 306 patients with large vessel occlusion acute ischemic stroke treated with EVT and with a modified Thrombolysis in Cerebral Infarction score of 2b or greater (partial or complete reperfusion).

Interventions: Participants were randomly assigned to receive intensive BP management (systolic BP target <140 mm Hg; n = 155) or conventional management (systolic BP target 140-180 mm Hg; n = 150) for 24 hours after enrollment.

Main outcomes and measures: The primary outcome was functional independence at 3 months (modified Rankin Scale score of 0-2). The primary safety outcomes were symptomatic intracerebral hemorrhage within 36 hours and death related to the index stroke within 3 months.

Results: The trial was terminated early based on the recommendation of the data and safety monitoring board, which noted safety concerns. Among 306 randomized patients, 305 were confirmed eligible and 302 (99.0%) completed the trial (mean age, 73.0 years; 122 women [40.4%]). The intensive management group had a lower proportion achieving functional independence (39.4%) than the conventional management group (54.4%), with a significant risk difference (-15.1% [95% CI, -26.2% to -3.9%]) and adjusted odds ratio (0.56 [95% CI, 0.33-0.96]; P = .03). Rates of symptomatic intracerebral hemorrhage were 9.0% in the intensive group and 8.1% in the conventional group (risk difference, 1.0% [95% CI, -5.3% to 7.3%]; adjusted odds ratio, 1.10 [95% CI, 0.48-2.53]; P = .82). Death related to the index stroke within 3 months occurred in 7.7% of the intensive group and 5.4% of the conventional group (risk difference, 2.3% [95% CI, -3.3% to 7.9%]; adjusted odds ratio, 1.73 [95% CI, 0.61-4.92]; P = .31).

Conclusions and relevance: Among patients who achieved successful reperfusion with EVT for acute ischemic stroke with large vessel occlusion, intensive BP management for 24 hours led to a lower likelihood of functional independence at 3 months compared with conventional BP management. These results suggest that intensive BP management should be avoided after successful EVT in acute ischemic stroke.

Trial registration: ClinicalTrials.gov Identifier: NCT04205305.

Figure 1.. Participant Flow

mRS indicates modified Rankin Scale; mTICI, modified Thrombolysis in Cerebral Infarction score. ^aFifteen patients were excluded for terminal cancer, 14 with cardiac or aortic disease, 4 with severe anemia and hematologic disease, 4 with chronic kidney disease, 4 with pneumonia, 2 with sepsis, 1 with cholecystitis, 1 with hemothorax, and 1 with radius fracture. ^bEleven patients were excluded for COVID-19 infection, 5 due to investigator error, 2 due to non-Korean citizenship, 2 due to immediate transfer to other hospitals, 2 due to no guardian, 2 for advanced dementia, and 6 for unknown reasons. ^cOne patient had prestroke disability (mRS score of 3-5) and also was transferred within 24 hours, so numbers below do not add to 11. ^dOne patient had prestroke disability (mRS score of 3-5) and also was transferred within 24 hours.

Figure 2.. Distribution of mRS Score at 3 Months by Treatment Group

The modified Rankin Scale (mRS) score measures degree of disability (score range, 0 [symptom free] to 6 [death]). The proportion of patients who achieved functional independence at 3 months (mRS score of 0-2) was lower in the intensive management group (39.4%) than in the conventional management group (54.4%) (adjusted odds ratio, 0.56 [95% CI, 0.33-0.96]; P = .03). The mRS shift analysis also showed that the intensive management group had worse scores than the conventional management group (adjusted odds ratio, 0.65 [95% CI, 0.43-0.97]; P = .04).

Figure 3.. Changes in Mean Systolic and Diastolic Blood Pressure From Randomization to 24 Hours After Randomization

Compared with conventional management, intensive management significantly lowered mean systolic blood pressure (SBP; panel A) over 24 hours (129.2 mm Hg [SD, 7.7 mm Hg] vs 138.0 mm Hg [SD, 13.6 mm Hg]; P < .001) and mean diastolic blood pressure (DBP; panel B) over 24 hours (72.0 mm Hg [SD, 8.1 mm Hg] vs 77.0 mm Hg [SD, 9.9 mm Hg]; P < .001). The mean between-group difference in SBP over 24 hours was −9.6 mm Hg (95% CI, −12.2 to −6.9 mm Hg; P < .001), while the mean between-group difference in DBP over 24 hours was −5.5 mm Hg (95% CI, −7.6 to −3.3 mm Hg; P < .001). The black line within each box is the median blood pressure value at each respective time point; the upper and lower boundaries of the boxes represent the IQRs. Data points outside the boxes either surpass 1.5 times the value of the upper quartile or are less than 1.5 times the value of the lower quartile.