Summary Background The optimal systolic blood pressure after endovascular thrombectomy for acute ischemic stroke is uncertain. The objective was to compare the safety and efficacy of antihypertensive treatment according to more intensive versus less intensive treatment goals in patients with elevated blood pressure after reperfusion with endovascular treatment. Methods We conducted an open-label, endpoint-blinded, randomized controlled trial in 44 tertiary hospitals in China. Eligible patients (≥18 years of age) had persistently elevated systolic blood pressure (≥140 mm Hg for >10 min) after successful reperfusion with endovascular thrombectomy for acute ischemic stroke due to any intracranial large vessel occlusion. Patients were randomly assigned (1:1, using a web-based core program with a minimization algorithm) to more intensive (target systolic blood pressure <120 mm Hg) or less intensive (target 140–180 mm Hg) treatment. Hg) to be achieved within 1 h and sustained for 72 h. The primary efficacy outcome was functional recovery, assessed by the distribution of scores on the modified Rankin scale (range 0 [no symptoms] to 6 [death]) at 90 days. Analyzes were performed according to the modified intention-to-treat principle. Efficacy analyzes were performed with proportional odds logistic regression adjusting for treatment assignment as a fixed effect, site as a random effect, and baseline prognostic factors, and included all randomized patients who consented and had data available for the primary outcome. The safety analysis included all randomly assigned patients. Treatment effects were expressed as odds ratios (OR). This trial is registered with ClinicalTrials.gov, NCT04140110, and China Clinical Trials Registry, 1900027785; Recruitment has stopped at all participating centers. Results Between July 20, 2020 and March 7, 2022, 821 patients were randomly assigned . The trial was stopped after review of outcomes data on June 22, 2022, due to persistent efficacy and safety issues. 407 participants were assigned to the more intensive treatment group and 409 to the less intensive treatment group, of whom 404 patients in the more intensive treatment group and 406 patients in the less intensive treatment group had primary outcome data available. The likelihood of poor functional outcome was higher in the more intensive treatment group than in the less intensive treatment group (common OR 1.37 [95% CI 1.07–1.76]). Compared with the less intensive treatment group, the more intensive treatment group had more early neurological deterioration (common OR 1·53 [95% 1·18–1·97]) and major disability at 90 days (OR 2· 07 [95% CI 1·47–2·93]), but there were no significant differences in symptomatic intracerebral hemorrhage. There were no significant differences in serious adverse events or mortality between the groups. Interpretation Intensive control of systolic blood pressure below 120 mm Hg should be avoided to avoid compromising the functional recovery of patients who have received endovascular thrombectomy for acute ischemic stroke due to occlusion of large intracranial vessels. |
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The results of the trial, stopped early due to the importance of the findings, were presented in a late-breaking session at the World Stroke Congress and simultaneously published in The Lancet .
Professor Craig Anderson, director of Global Brain Health at the George Institute for Global Health, said the rapid onset of this effect suggests the more aggressive approach was compromising the return of blood flow to the affected area.
“Our study provides a strong indication that this increasingly common treatment strategy should now be avoided in clinical practice,” he said.
About 85 percent of strokes are ischemic strokes, caused by loss of blood flow to an area of the brain due to a blockage in a blood vessel, leading to a loss of neurological function.
Endovascular thrombectomy is an increasingly used non-surgical treatment for ischemic stroke, in which X-ray visible microcatheters are inserted into the blood clot to dissolve it.
“A potential disadvantage of this now widely used and effective treatment is that the rapid return of blood supply to an area that has been deprived of oxygen for some time can cause tissue damage known as reperfusion injury,” Professor Anderson said.
"This has resulted in a shift in medical practice toward more intense blood pressure lowering after clot removal to try to minimize this harm, but without evidence to support benefits versus potential harms."
To try to address the evidence gap, researchers recruited 816 adults with acute ischemic stroke who had elevated blood pressure after clot removal from 44 centers in China between July 2020 and March 2022. They had an average age of 67 years old and just over a third were women.
407 were assigned to more intensive systolic blood pressure control (target <120 mm Hg) and 409 to less intensive systolic blood pressure control (target 140-180 mm Hg), with the goal to be achieved within one hour of entering the study and keep for 72 hours.
The researchers looked at how well patients in both groups recovered according to a standard measure of disability, ranging from 0 to 1 for a good outcome without or with symptoms but no disability, scores of 2 to 5 indicating increasing levels of disability (and dependency), and a score of 6 is death.
Patients in the more intensively treated group obtained significantly worse scores on the scale compared to those assigned to the less intensely treated group.
Compared with the less intensive group, they had earlier deterioration of brain tissue and greater disability at 90 days, but there were no significant differences in brain hemorrhages, mortality or serious adverse events.
Patients who had their blood pressure monitored more intensively also rated their quality of life as significantly worse due to limitations in their physical abilities as a result of the stroke.
Professor Anderson said that after reviewing the medical literature, the research team could not find evidence strong enough to recommend the ideal target for blood pressure control after blood clot removal in ischemic stroke patients. sharp.
“While our study has now shown that intensive blood pressure control to a systolic target of less than 120 mm Hg is harmful, the optimal level of control has not yet been defined,” he said.
