Large Randomized Trials Investigating Concentrated Lowering of Blood Pressure in the Acute Phase ischemic stroke Patients undergoing mechanical thrombectomy were discontinued early due to safety concerns.
“To prevent compromising functional recovery in patients undergoing endovascular thrombectomy for acute ischemic stroke due to intracranial great vessel occlusion, intensive control of systolic blood pressure below 120 mmHg should be avoided. Yes,” conclude the researchers.
Results from the ENCHANTED2/MT trial were presented at the 14th World Stroke Congress (WSC) in Singapore on October 28 by Craig Anderson, MD, Professor of Neurology and Epidemiology, University of New South Wales, Sydney, Australia. Announced. .
the studies were conducted at the same time publish online of lancet.
“What shows our results quite convincingly is that acute stroke Patients undergoing mechanical thrombectomy are too low and too long to reduce blood pressure to 120 mmHg systolic in 3 days. You shouldn’t be so depressed,” Anderson said. theheart.org| Medscape Cardiology.
Anderson said the trial provided important messages for clinical practice.
“Although this result is not what we expected, it is a conclusive result and indicates a lower blood pressure safety margin in patients with acute ischemic stroke. This in itself is a significant step forward.”
He pointed out that the optimal blood pressure for these patients is unknown.
“More studies are needed to determine the optimal blood pressure for these acute patients, but we should probably aim for 140 mmHg,” he suggested.
“However, this study demonstrates the importance of careful blood pressure control to prevent blood pressure from becoming too low in patients with successful endovascular treatment of acute ischemic stroke, overshooting to 120 mm. should not be below Hg.”
Jeyaraj Pandian, MD, Chair of the WSC session where the trial was presented, Dean of Neurology, Christian Medical College, Ludhiana, India, and current Vice-President of the World Stroke Organization, said: increase. An important result. This has important practical implications. ”
For background, Anderson explained that elevated blood pressure is very common in patients with acute ischemic stroke, and that higher blood pressure is likely to lead to worse outcomes.
“Theoretically, controlling blood pressure could improve outcomes.
In 2019, First Enchanted Trial Anderson found that modest blood pressure control to about 140 mmHg, lower than currently recommended in guidelines, was associated with fewer bleeding complications from thrombolysis and appeared to be safe; reported that it did not improve recovery.
“This study was performed before the routine adoption of mechanical thrombectomy, which is now the standard of care for large vessel occlusive stroke, but what about blood pressure in these patients?” I don’t know what to do,” he added.
A smaller French trial suggested that lowering blood pressure to 130 mm Hg rather than the more lenient 130–180 mm Hg after successful mechanical thrombectomy was safe, although functional There was no effect on outcome.
“Blood pressure often rises to very high levels in stroke patients with great vessel occlusion. There are varying opinions about what to do about this. It’s also about how much to lower,” Anderson said. “To investigate this issue, he currently conducted an ENCHANTED2/MT trial.”
In this trial, patients who had successful mechanical thrombectomy and reperfusion but still had elevated blood pressure were randomly assigned to two groups. One group actively lowered blood pressure to less than 120 mm Hg within 1 hour after reperfusion, and blood pressure at this level he maintained for 3 days. The other group used a more lenient approach. Blood pressure was maintained between 140 and 180 mm Hg.
The primary endpoint was disability; Modified Rankine Scale (mRS) score 90 days.
This study was initiated in China with the intention of expanding recruitment internationally. Planned enrollment was over 2000 patients.
However, after 821 patients were enrolled in March of this year, the Data Safety and Monitoring Board (DSMB) recommended suspending participation in the trial, citing safety signals. All recruited patients were from China.
After following up these patients and obtaining 3 months of results, the DSMB recommended stopping the trial as safety was still an issue.
Mean systolic blood pressure was 125 mm Hg at 1 hour and 121 mm Hg at 24 hours in the more intensive treatment group. The low-intensity treatment group was 143 mm Hg at 1 hour and 139 mm Hg at 24 hours, with an adjusted mean difference of 18 mm Hg over 24 hours.
bad disability score
Results showed that patients who received more intensive blood pressure lowering had more disability at 3-month follow-up and scored worse on shift analysis of mRS than patients in the less intensive group. (common odds ratio) [OR]1.37; 95% CI, 1.07–1.76).
Unfavorable shifts in mRS scores in the more focused group were consistent in adjusted sensitivity analyses, with no significant heterogeneity in treatment effects on primary outcomes across all prespecified subgroups. There was not.
The incidence of death or neurological deterioration at 7 days was higher in the intensive care group than in the less intensive care group (common OR, 1.53), and differences between groups appeared at 24 hours .
The 90-day incidence of death or disability (mRS score, 3–6) was higher in patients in the more intensive treatment group than in the less intensive treatment group (53% vs. 39%; OR, 1.85; P. = .0001).
Among surviving patients, those in the more intensive treatment group had greater disability (mRS score, 3–5) at day 90 than those in the less intensive treatment group (43% vs. 28 %; OR, 2.07; P. = .0001).
No difference between ICH or severe hypotensive episodes
Symptomatic incidence intracranial hemorrhage, mortality, and serious adverse events were not significantly different between the two groups. There was no significant difference in ischemic stroke recurrence at 90 days, and no episodes of severe hypotension were reported as serious adverse events.
“Our results show that a significant decrease in blood pressure appears to be associated with worsening disability. There was no difference in mortality between the two groups, but lower blood pressure It appeared to compromise the ability to recover from stroke,” Anderson said.
As for the possible harm mechanism, he suggested that the focal drop in blood pressure may impede blood flow through the damaged part of the brain, impeding the ability to recover from the thrombectomy procedure.
What level should we aim for?
Anderson emphasized the importance of conducting this study.
“Current guidelines recommend a very conservative level of blood pressure in patients with acute ischemic stroke, less than 180 mm Hg, but no lower limit.
“Most clinicians aim for a mark of about 140 mm Hg, but there are wide differences of opinion on what to do,” he said. “Some physicians treat aggressively at lower pressures, believing that they are beneficial in preventing bleeding and swelling, while others prefer to maintain higher levels. Our results are a guideline in this regard. It helped me to give
When asked what the optimal target would be, Anderson said, “Right now, I think a systolic blood pressure target of about 140 mm Hg is reasonable. There’s no evidence to go below that.”
Yvo Roos, M.D., Ph.D., co-author of the ENCHANTED2/MT trial and Professor of Acute Neurology at the University Medical Center in Amsterdam, The Netherlands, also commented: theheart.org| Medscape Cardiology.
“The real significance of the results of these studies is that they show that lowering blood pressure too much is detrimental to outcomes. 140–150 mm Hg. This applies to patients who have undergone recanalization. It is recommended.
As to whether these results could be generalized to other populations given that the patients were Chinese, Anderson noted that Asians have a higher rate of intracranial hemorrhage. atherosclerosis Cardiac and renal blood pressure complications are more common than Caucasian patients. Stroke management patterns also differ.
“These points raise questions about generalizability. I think it’s an issue that should be considered, but I don’t think it should compromise the clarity of these results,” he commented.
This research was supported by grants from the Shanghai Hospital Development Centre, Australia’s National Health and Medical Research Council, and China. stroke prevention Project, Shanghai Changhai Hospital, Shanghai Municipal Commission of Science and Technology, Takeda China, Genesis Medtech, Penumbra. Anderson has received grants from Australia’s National Health and Medical Research Council and Medical Research Futures Fund, UK Medical Research Council, Penumbra and Takeda China.
World Stroke Conference: Presented on 28 October 2022.
lancet. Published online on October 28, 2022. Overview
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