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"Intensive blood pressure reduction" is not desirable, and the Lancet is a Chinese study that will quickly affect stroke treatment worldwide

 Last Update: 2022-11-05
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 Author: User

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Combined with various previous studies, it is clear that it is not advisable
to strengthen the antihypertensive scheme.

On October 28, the top medical journal "Lancet" released the results of the first phase of the "Research on Intensive Antihypertensive Treatment after Mechanical Thrombectomy for Acute Ischemic Stroke" (ENCHANTED-2/MT) online, which was announced to the world by co-principal investigator Professor Craig Anderson at the 14th World Stroke Congress on the same day, causing a sensation in the academic community at home and abroad
.

The study, co-led by a team of Chinese and Australian scholars, found that the clinical prognosis of patients in the intensive antihypertensive therapy (systolic blood pressure < 120mmHg) group was worse than that in the moderate antihypertensive therapy (140-180mmHg) group, and the lower limit of the target value was established for the management of blood pressure after embolectomy<b20> 。
Figure 1 Study
"At present, a considerable number of clinicians around the world tend to perform intensive blood pressure lowering on patients after thrombectomy and recanalization, and even reduce systolic blood pressure to less than
120mmHg.
Study co-first author Dr.
Lili Song, director of the stroke program at The George Institute for Global Health (China), said that as the largest randomized controlled clinical trial in this field to date, the ENCHANTED-2/MT study confirmed that "intensive blood pressure reduction (target value< 120mmHg)" is harmful to patients<b20>.
"This result will rapidly influence the clinical practice
of stroke treatment worldwide.
" Professor Liu Jianmin, co-principal investigator of the study, corresponding author and director of the Cerebrovascular Center of Changhai Hospital, told the medical community: "The study provides conclusive, high-quality evidence-based medical evidence, which is expected to rewrite the guidelines and allow patients to obtain better clinical outcomes
.
" ”

ENCHANTED-2/MT, or will rewrite global guidelines

ENCHANTED-2/MT is a prospective, multicenter, blinded endpoint assessment, randomized controlled study (RCT) initiated and implemented by the Stroke Prevention and Control Engineering Committee of the National Health Commission of China, Shanghai Changhai Hospital and
The George Institute for Global Health (China).

From July 20, 2020 to March 7, 2022, the research team recruited 816 patients
over the age of 18 with elevated systolic blood pressure (>140mmHg, > for 10min) after embolectomy and reperfusion in 44 hospitals across the country.

After screening, 407 of them were assigned to the intensive antihypertensive group, with an average systolic blood pressure of 121mmHg at 24 hours after antihypertensive treatment, and 409 people received moderate antihypertensive therapy with an average systolic blood pressure of 143mmHg
.

Fig.
2 The prognosis of patients in the two groups was evaluated by the modified Rankin scale, and the results showed that the prognostic score of the intensive antihypertensive treatment group was significantly worse than that of moderate antihypertensive therapy, and the odds ratio was 1.
37
.

Fig.
3 Prognosis score Seven days after surgery, the risk of early neurological deterioration or death in the intensive antihypertensive group was higher than that in the moderate antihypertensive treatment group, with an odds ratio of 1.
53
.
At 90 days, 212 (53%) patients in the intensive blood pressure group experienced moderate to severe disability or death, compared with 159 (39%)
in the moderate blood pressure group.

Among all patients who survived after 90 days, the functional prognosis and quality of life of the intensive antihypertensive group were also significantly worse than those in the moderately antihypertensive group, with the proportion of patients with moderate to severe disability being 43% and 28%,
respectively.
At the same time, in terms of quality of life related to mobility, the intensive antihypertensive group also scored lower than the moderate antihypertensive group
during follow-up.

Figure 4 Data sets of each group

At least 50,000 patients could be saved each year

The results of the ENCHANTED-2/MT study relate to the hundreds of thousands of stroke patients
worldwide who undergo thrombectomy each year.

Stroke, also known as "stroke", "stroke", etc.
, is an acute cerebrovascular disease
.
Among them, acute ischemic stroke due to cerebral thrombosis (commonly known as "cerebral infarction") is the most common type of stroke, accounting for about three-quarters
of strokes in China.
Thrombolysis or thrombectomy refers to the use of drugs or interventional surgery to "unblock blood vessels"
for patients.

Since 2015, for patients with acute large-vessel occlusive ischemic stroke with onset of less than 4.
5 hours, the standard treatment
of thrombolysis followed by thrombectomy (bridging thrombectomy) has been recommended.
In May 2020, the DIRECT-MT study led by the team of Professor Liu Jianmin of Changhai Hospital topped the New England Journal of Medicine, confirming for the first time in the world that for such patients, direct thrombectomy is no less effective than bridging thrombectomy
.

However, whether it is bridging therapy or direct thrombectomy, before the results of ENCHANTED-2/MT, the specific value of blood pressure management after vascular recanalization of patients has not been reached
worldwide.

"High blood pressure may lead to reperfusion injury and increase the risk of
intracerebral hemorrhage transformation.
" Professor Zhang Yongwei, co-first author of the study and chief physician of the Cerebrovascular Disease Center of Shanghai Changhai Hospital, told the "medical community" that if the blood pressure is too low, there may be insufficient reperfusion, and the "infarction" continues to worsen after thrombectomy, "especially for patients with
arterial stenosis.
"
"Under standard treatment, the current vascular recanalization rate of ischemic stroke patients can reach 90%, and even more than 95%
in first-tier urban advanced stroke centers.
" But the good prognosis for patients has not improved proportionately – only about
50%.

Professor Zhang Yongwei believes that "a key factor is that after thrombectomy, doctors do not know the optimal range to
manage the patient's blood pressure value.
" "
According to current global guidelines, systolic blood pressure after thrombectomy and reperfusion should be controlled below 180 mmHg
.
" The indicator is
too broad.
Professor Liu Jianmin explains, "This leads to different clinical treatment standards in each hospital, which is very confusing
.
"A survey data showed that for patients with good thrombectomy and reperfusion, 5%, 36%, 21%, and 28% of clinicians within 24 hours after surgery chose to reduce the patient's systolic blood pressure to less
than 120 mmHg, 120~139 mmHg, 140~159mmHg, and 180mmHg, respectively.

It is based on this situation that the ENCHANTED-2/MT study came into being
.
After nearly 4 years, the positive results published in the first phase, according to the research team, mean that at least 50,000 lives can be saved each year and their prognosis
can be improved.

"The study was terminated early
.
" Professor Yang Pengfei, the first author of the study and executive director of the Cerebrovascular Disease Center of Shanghai Changhai Hospital, told the "medical community" that as of March this year, more than 800 patients were enrolled, less than half of the original planned enrollment, but the Data Security Monitoring Committee (DSMB) stopped the trial on the grounds that significant positive results had been observed - patients with blood pressure down to less than 120mmHg had a poor
clinical prognosis.

The second phase of the study was launched simultaneously

"This result has strong guiding significance
for clinical practice and the formulation of future clinical guidelines.
" Professor Song Lili told the "medical community", "Our study provides a strong evidence that this increasingly common treatment strategy
should be avoided in clinical practice.
Before
ENCHANTED-2/MT, another relevant and famous study came from a team of
French scholars.
In April 2021, the BP-TARGET trial published in The Lancet Neurology showed that compared with the standard antihypertensive group (130~185 mmHg), intensive antihypertensive (100~129 mmHg) did not reduce the incidence of
cerebral hemorrhage on imaging at 24~36 hours after successful endovascular therapy.

"However, there is a difference between 'bleeding' and 'symptomatic bleeding' on imaging, and it may not accurately reflect the patient's real recovery
.
" Professor Yang Pengfei told the "medical community" that ENCHANTED-MT selected the clinical prognosis after 90 days as the main research endpoint, and clarified the safe lower limit
of blood pressure management in acute ischemic stroke through high-quality, high-standard, and large-sample studies.

Since its inception in 2018, the project has been designed, various research centers have been contacted, patients have been recruited, and data aggregation and analysis.
.
.
"The George Institute for Global Health has a deep accumulation in blood pressure management research, and more than 40 hospitals across the country share clinical data
with Changhai Hospital.
Both Lili Song and Professor Yang Pengfei believe that the key to the success of ENCHANTED-2/MT lies in the close collaboration
of many expert teams at home and abroad.

But this is still just the beginning
.
According to Professor Liu Jianmin, on the day of the release of the results of the first phase of ENCHANTED-2/MT, the second phase of the study will be launched
simultaneously.

Professor Anderson said the team had not been able to find strong enough evidence to recommend the ideal goal
of blood pressure control after clearing blood clots in patients with acute ischaemic stroke.
"While our study has shown that controlling systolic blood pressure to less than 120mmHg is harmful, the optimal level of control has yet to be determined
.
" He said
.

"Now we realize that systolic blood pressure after thrombectomy and reperfusion should be above 120 mmHg, but is it 130 mmHg, 140 mmHg, or 150mmHg?" Professor Liu Jianmin said, "In the second phase of the study, we hope to find a relatively clear upper limit of blood pressure, further revise or develop relevant guidelines around the world, and provide more conclusive high-quality evidence
.
" "
It is reported that ENCHANTED-2/MT will be carried out simultaneously in multiple centers in Australia and the United Kingdom in the future, including other patient groups of different ethnicities, and further explore whether relevant blood pressure management recommendations have global universality
.
"
Disease burden statistics show that as of 2019, there were 24.
18 million ischemic stroke patients in China, and 2.
87 million new cases
were added that year.
"In clinical treatment, if doctors only rely on personal experience to do what they think is 'the right thing', in the end the patient may not benefit, or even harm
.
" Professor Liu Jianmin emphasized, "We need to have a sufficiently rigorous trial design, a sufficient sample size, a sufficient scientific protocol and finally a compilation of evidence-based medical guideline recommendations, in order to truly improve patient outcomes
.
" "
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Source of this articleMedical communityLing JunResponsible editorMr.
Lu Li Xiang Yu

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