Use the labels in the right column to find what you want. Or you can go thru them one by one, there are only 33,724 posts. Searching is done in the search box in upper left corner. I blog on anything to do with stroke. DO NOT DO ANYTHING SUGGESTED HERE AS I AM NOT MEDICALLY TRAINED, YOUR DOCTOR IS, LISTEN TO THEM. BUT I BET THEY DON'T KNOW HOW TO GET YOU 100% RECOVERED. I DON'T EITHER BUT HAVE PLENTY OF QUESTIONS FOR YOUR DOCTOR TO ANSWER.
Changing stroke rehab and research worldwide now.Time is Brain!trillions and trillions of neuronsthatDIEeach day because there areNOeffective hyperacute therapies besides tPA(only 12% effective). I have 523 posts on hyperacute therapy, enough for researchers to spend decades proving them out. These are my personal ideas and blog on stroke rehabilitation and stroke research. Do not attempt any of these without checking with your medical provider. Unless you join me in agitating, when you need these therapies they won't be there.
What this blog is for:
My blog is not to help survivors recover, it is to have the 10 million yearly stroke survivors light fires underneath their doctors, stroke hospitals and stroke researchers to get stroke solved. 100% recovery. The stroke medical world is completely failing at that goal, they don't even have it as a goal. Shortly after getting out of the hospital and getting NO information on the process or protocols of stroke rehabilitation and recovery I started searching on the internet and found that no other survivor received useful information. This is an attempt to cover all stroke rehabilitation information that should be readily available to survivors so they can talk with informed knowledge to their medical staff. It lays out what needs to be done to get stroke survivors closer to 100% recovery. It's quite disgusting that this information is not available from every stroke association and doctors group.
Showing posts with label 'Better outcomes'. Show all posts
Showing posts with label 'Better outcomes'. Show all posts
Without 100% recovery protocols, 'awareness' barely does any good! Stroke is a total shitshow, known by everyone since medical school! Nothing that will allow your doctor to guarantee recovery!
That's cute you think survivors want 'better outcomes' rather than 100% recovery!
A stroke can happen to anyone at any age.
In fact, every 40 seconds someone in the United States has a stroke, with approximately 800,000 people experiencing a stroke annually, according to the American Heart Association, making it a leading cause of death and serious, long-term disability.
A stroke happens when normal blood flow in the brain is interrupted. When parts of the brain don’t get the oxygen-rich blood they need, those cells die.
However, many strokes may be prevented, treated and overcome by understanding the risk factors and taking steps toward managing them.
“When a stroke happens, every minute matters,” said Dr. Adrian Jaquin-Valdivia, a stroke neurologist at HCA Healthcare and American Stroke Association volunteer expert. “The faster someone gets treatment, the better the chance of saving brain function. On average, nearly 2 million brain cells die every minute a stroke goes untreated. Early treatment improves survival rates and reduces disability.”
Can you get tPA delivered in 3 minutes? In this research in mice the
needed time frame for tPA delivery is 3 minutes for full recovery.
Take control of your brain health with this information from the American Stroke Association.
Know the Warning Signs
Because strokes do not discriminate, knowing the signs is key. To help you recognize common warning signs and symptoms of stroke and take action in moments that matter, remember this simple acronym: B.E. F.A.S.T.
B: Balance loss – sudden difficulty with walking, dizziness or loss of balance or coordination.
E: Eye (or vision) changes – sudden vision loss or trouble seeing in one or both eyes.
F: Face drooping – one side of the face droops or feels numb; a smile may look uneven.
A: Arm weakness – one arm feels weak or numb or drifts downward when raised.
S: Speech difficulty – a telltale sign of a stroke is slurred speech or trouble speaking.
T: Time to call 911 – If someone is having any of these symptoms, even if the symptoms go away, call emergency services immediately to jumpstart care. Be sure to check the time so you’ll know when the first symptoms started.
Explore the signs by playing the interactive, web-based B.E. F.A.S.T. Experience to see what stroke symptoms may look, feel and sound like.
Take Steps to Protect Your Health
Approximately 80% of strokes are preventable, according to the American Stroke Association. Everyday choices – such as eating well, moving more, not smoking and keeping up with routine health screenings, along with managing risk factors with the support of a health care professional – can help lower stroke risk.
Manage Risk Factors
High blood pressure is the leading risk factor for stroke, according to the 2025 American Heart Association/ACC Guideline for the Management of High Blood Pressure in Adults. Controlling blood pressure through regular checkups, at-home monitoring, following your treatment plan and maintaining a healthy lifestyle can significantly reduce your risk of stroke and support overall brain health.
Additionally, having a stroke or mini stroke, known as a Transient Ischemic Attack (TIA), increases the chances of having a second one. That’s why identifying what caused your stroke and reducing your personal risk factors can help protect your health and reduce the risk of another stroke.
To learn more about stroke risk factors and better understand the warning signs, visit Stroke.org/StrokeMonth, where you can also access stroke support services and subscribe to the Stroke Connection e-newsletter for the latest resources.
'Better' and 'may' signify COMPLETE FUCKING FAILURE OF 100% RECOVERY! Don't you even know that is the only goal in stroke and you aren't even measuring that. With NO measurements, you'll never get there!
Here is your business101 requirements. Not measuring 100% recovery is the height of incompetence!
The best revascularization strategy for acute ischemic stroke from isolated vertebral artery occlusion remains unclear.
METHODS:
This retrospective, international, multicenter cohort study included patients from 30 comprehensive stroke centers across Europe (n=23), North America (n=5), and Asia (n=2) between 2016 and 2022. Eligible patients presented with acute ischemic stroke within 24 hours of last seen well and had imaging-confirmed isolated vertebral artery occlusion. Two treatment comparisons were analyzed: intravenous thrombolysis (IVT)-only versus conservative treatment (Cx), and endovascular treatment (EVT)±IVT versus medical management (Cx and IVT). The primary outcome was the shift in 3-month modified Rankin Scale (mRS) score; secondary outcomes included early neurological improvement (24-hour-delta National Institutes of Health Stroke Scale score), recanalization, early neurological deterioration of ischemic origin, symptomatic intracerebral hemorrhage, and 3-month mortality. Analyses were adjusted using inverse probability of treatment weighting (IPTW).
RESULTS:
Among 494 patients, 143 (29%) received Cx, 218 (44%) IVT-only, and 133 (27%) EVT±IVT. Compared with Cx, IVT-only showed similar 3-month mRS score (IPTW-adjusted odds ratio [aOR] mRS shift score, 1.32 [95% CI, 0.80–2.18]), greater early neurological improvement (IPTW-adjusted-β coefficient, −1 [95% CI, −2.05 to 0.05]), and higher recanalization rates (IPTW-aOR, 4.33 [95% CI, 1.36–13.78]). Compared with MM (=IVT+Cx), EVT±IVT was associated with an unfavorable mRS shift score (IPTW-aOR mRS shift score, 0.51 [95% CI, 0.35–0.74]), higher early neurological deterioration of ischemic origin (IPTW-aOR, 9.06 [95% CI, 2.86–28.67]), and symptomatic intracerebral hemorrhage (IPTW-aOR, 6.05 [95% CI, 1.14–32.1]) though recanalization was over 4-fold higher (OR, 4.64 [95% CI, 1.90–11.33]). Patients with National Institutes of Health Stroke Scale score ≥10 showed point estimates favoring EVT+IVT (Pinteraction=0.025).
CONCLUSIONS:
IVT-only appeared safe and was associated with better early recovery and recanalization. EVT±IVT showed overall worse outcomes, potentially due to increased early neurological deterioration of ischemic origin and symptomatic intracerebral hemorrhage rates, but may confer benefit in moderate-to-severe strokes, warranting prospective trials in symptomatic isolated vertebral artery occlusion.
Graphical Abstract
Despite robust evidence demonstrating the benefits of revascularization treatments for large vessel occlusions in anterior circulation strokes, the optimal acute management of occlusive posterior circulation (PC) acute ischemic strokes (AISs) other than basilar artery occlusion (BAO) remains less clear.
At the very bottom, they tell you this: does not have FDA approval for this purpose, so future action may involve seeking this approval.
So your competent? doctor would have to know of this research and buck the system to use it on you as a stroke patient! Do you really think your doctor is up to that challenge? I bet they don't even know of this research.
A
new study has found that between tenecteplase and alteplase treatment,
the former leads to slightly better stroke recovery. Image credit:
Mihajlo Ckovric/Stocksy.
Ischemic strokes occur when there is blocked blood flow to the brain, something that can result in permanent disability.
Doctors can use certain medications to dissolve blood clots when they are the cause of blockage in an ischemic stroke.
A
recent paper reports that the use of the drug tenecteplase may lead to
slightly better functional and disability outcomes than alteplase for
people who experience acute ischemic stroke. (Slightly better IS NOT GOOD ENOUGH YOU BLITHERING IDIOTS! 100% recovery is good enough. GET THERE!)
Strokes are a common cause of death and disability in the United States. Ischemic strokes are the most common stroke type, which have to do with the obstruction of blood flow to the brain.
Doctors are interested in what medications can best assist people who experience ischemic strokes to improve overall outcomes.
A systematic review and meta-analysis recently published in Neurology, the American Academy of Neurology’s medical journal, compared the effectiveness of two clot-dissolving medications doctors use to treat ischemic stroke: tenecteplase and alteplase.
Researchers
found that tenecteplase had a higher association with excellent
functional outcome and decreased disability 3 months after a stroke than
alteplase.
The results of this review support increasing the use of tenecteplase in clinical practice.
Tenecteplase vs alteplase: How do they compare?
Taking action to dissolve clots can be part of ischemic stroke treatment. Alteplase has to be administered within hours of when stroke symptoms start.
The
authors of the current review noted that “alteplase is the only
approved systemic reperfusion treatment of acute ischemic stroke.”
However, they also noted that some groups, like the European Stroke
Organisation, have recommended using tenecteplase as an alternative for
ischemic stroke treatment.
Researchers sought to compare the use
of tenecteplase and alteplase within four and a half hours of stroke
symptom onset. They also examined tenecteplase’s efficacy and safety.
This
review and meta-analysis included 11 randomized controlled trials. The
authors identified these trials through a systematic literature search.
From
all the trials, researchers were able to examine data from 3,788
participants who received tenecteplase, and 3,757 participants who
received alteplase. These participants had similar baseline
characteristics, stroke symptoms, and time of treatment intervention.
The main outcome researchers looked for was excellent function outcome at 3 months after a stroke occurred.
Excellent function was described as a score of 0 to 1 on the modified Rankin Scale, which corresponds to either no symptoms post-stroke or some symptoms but no significant disability.
Researchers
also looked at several secondary outcomes, like good functional
outcome, which indicates a stroke recovery level range of no symptoms to
slight disability.
Based on their analyses, participants
who received tenecteplase were more likely to experience an excellent
functional outcome compared to participants who received alteplase.
Tenecteplase-treated participants also had a lower risk for disability 3
months post-stroke compared to alteplase-treated participants.
Researchers
observed similar rates of good functional outcome, safety, all-cause
mortality, and symptomatic intracranial hemorrhage between the treatment
groups.
Are there different types of tenecteplase?
In a subgroup analysis, the researchers distinguished between two types of tenecteplase: original and biocopy.
Advertisement
Based
on the findings from two studies, the review authors did not find a
significant difference in excellent functional outcome rates in
participants who received biocopy tenecteplase and participants who
received alteplase.
However, the authors noted that these two studies likely “do not have enough statistical power to demonstrate superiority.”
They
further conducted a trial sequential analysis to see if they could
firmly conclude teneteplase’s effectiveness. This analysis suggested
that tenecteplase is effective.
José Morales, MD,
a vascular neurologist and neurointerventional surgeon at Providence
Saint John’s Health Center in Santa Monica, CA, who was not involved in
this review, explained to Medical News Today that:
“When
tenecteplase (TNK) was first released and trialed for clinical use in
acute stroke, there were a lot of mixed signals. Some initial reports
indicated TNK achieved better recanalization rates, had less bleeding
complications, and possibly could provide a longer therapeutic window
([over] 4.5 hours). None of these have been borne out in randomized
trials, but there was a clear signal of TNK’s non-inferiority both in
terms of safety and efficacy compared to tPA [alteplase]. Meta analyses
such as these are helpful to consolidate data and achieve the sample
size necessary to draw meaningful statistical comparisons where
individual trials might have fallen short.”
What are the implications for people who had a stroke?
This
research suggests that tenecteplase may lead to slightly better
outcomes for people who experience ischemic stroke. Thus, the study
authors advocate for transitioning to tenecteplase in clinical practice.
Morales
noted that: “The capacity to administer clot-busting medications is the
first step for any hospital hoping to serve patients at need. The ease
of use of TNK continues to be backed by valid clinical data and has
implications for systems of care.”
“For instance,” he
added, “since tPA administration required an infusion, this impacted
timely transfer between stroke centers for escalation of care. TNK
offers the advantage of not only being easier to use, but also now has
growing validated clinical data supporting its safety and efficacy.”
Christopher Yi, MD,
a board-certified vascular surgeon at Memorial Orange Coast Medical
Center in Fountain Valley, CA, also not involved in the study, further
emphasized the clinical benefits of using tenecteplase:
“The
clinical implications include a shift in standard practice towards
using TNK as the preferred thrombolytic agent for AIS [acute ischemic
stroke] within the early 4.5-hour window. Given its ease of
administration, TNK could streamline the thrombolysis process, reduce
treatment times, and facilitate faster transfers between hospitals.
Additionally, adopting TNK widely may improve patient outcomes and
reduce healthcare costs due to its effectiveness.”
“However,”
Yi cautioned, “challenges such as regulatory barriers, availability,
and medicolegal considerations must be addressed to implement this
transition effectively. The findings advocate for TNK’s broader
implementation, potentially leading to modifications in treatment
protocols and guidelines across various healthcare systems.”
Is tenecteplase approved for stroke treatment in the US?
The
limitations of this review are also worth acknowledging. First, its
authors pointed out, that at the time they conducted the meta-analysis,
three of the trials had not had detailed study results published.
Second,
the meta-analysis was a study-level analysis, which does not allow for
certain actions like subgroup analyses and confounding adjustments.
There
were also different types of tenecteplase under review, so more
research may be required to examine the difference between original
tenecteplase and biocopy tenecteplase.
Researchers were also
limited by trials available for analysis, which came from a limited
number of countries. Finally, all included trials had their own
limitations that could have affected any of the results of the analyzed
trials.
The researchers were able to identify certain concerns of
the trials that could have affected the results, such as certain
participants not receiving randomized treatment and one trial where they
could not guarantee masking. The trial sequential analyses also made
certain assumptions.
Despite these limitations, if future research
continues to confirm tenecteplase’s superiority, it may become more
widely used in clinical practice.
Alteplase
has been a first-line treatment for ischemic stroke for decades and has
approval from the Food and Drug Administration (FDA) for this purpose.
Currently, tenecteplase, while approved as a treatment for heart attacks, does not have FDA approval for this purpose, so future action may involve seeking this approval.
WOW, and you're promoting this tyranny of
low expectations('better' outcomes) as a good thing. I'd fire everyone who isn't working
towards 100% recovery!
Prior data from the TENSION study established safety and efficacy of endovascular thrombectomy at 90 days.
At 12 months, ET bested medical treatment alone in several metrics.
In those with acute ischemic stroke, endovascular thrombectomy was
associated with better overall outcomes at 12 months compared with
standard medical treatment alone, according to research from The Lancet Neurology.
“Available long-term data from endovascular thrombectomy trials,
which mostly included patients with small or medium-sized infarcts,
suggest that the beneficial effect of treatment on functional outcome at
90 days — the usual timepoint for primary endpoints in stroke
reperfusion trials — persists in long-term follow up,” Gotz Thomalla, MD, professor in the department of neurology at the University Medical Center, Hamburg-Eppendorf in Germany, and colleagues wrote.
New research found that individuals given endovascular
thrombectomy for acute ischemic stroke fared better at 12 months
compared with those who received standard medical care alone.Image: Adobe Stock
Thomalla and colleagues sought to evaluate the safety and efficacy of endovascular thrombectomy at 12 months in the TENSION study, which previously established such for ischemic stroke and ischemic infarct at 90 days.
TENSION was an open-label, blinded endpoint, randomized clinical
trial conducted at 41 hospitals across Europe and Canada. The study
included 253 individuals with acute ischemic stroke due to large vessel
occlusion in the anterior circulation and who had a large infarct.
Participants, who underwent standard CT and MRI, were randomly assigned
1:1 to receive either endovascular thrombectomy as adjunct to standard
medical treatment or standard care alone. Clinical assessments were
performed at baseline, 24 hours, at 7 days or upon hospital discharge;
then at 90 days and 12 months.
The primary outcome was functional outcome across the entire range of
the modified Rankin Scale (mRS) at 90 days, with 12-month follow-up
analyses for functional outcome measured by the simplified mRS
questionnaire, quality of life measured by the Patient-Reported Outcomes
Measurement Information System 10-item (PROMIS-100) and EuroQol 5
Dimension (EQ-5D) questionnaires, post-stroke anxiety and depression
gauged via the Patient Health Questionnaire-4 (PHQ-4), as well as
overall survival.
Due to dropouts between the 90-day and 12-month follow-up intervals,
data on long-term effects were available for 244 participants
(thrombectomy, n = 125; medical treatment, n = 121).
According to the results, endovascular thrombectomy was associated with
a shift in mRS scores towards better functional outcome at 12 months
(adjusted common OR = 2.39; 95% CI, 1.47–3.9), better quality of life
compared with medical treatment only on the EQ-5D (0.7 vs. 0.4) and
median overall health scores as reflected by the PROMIS-10 (T-score 39.8
vs. 37.4).
The researchers found insufficient evidence to suggest a difference
between groups in global mental health scores on PROMIS-10, or among
those with anxiety and depression on the PHQ-4.
Data additionally showed scores for overall survival were slightly
better for those given endovascular thrombectomy group compared with
medical treatment only (adjusted HR = 0.7; 95% CI, 0.5–0.99).
“This finding is of particular interest because the course of
recovery from stroke symptoms is dynamic and might include improvements
as well as complications and secondary deterioration even months after
stroke,” Thomalla and colleagues wrote.
Disclosures:
Thomalla reports receiving funding from the European Commission;
receiving personal consulting fees from Acandis, AstraZeneca, Bayer,
Boehringer Ingelheim and Stryker; receiving either personal payment or
honoraria for lectures, presentations, speakers bureaus, manuscript
writing, or educational events from Acandis, Alexion, Amarin, Bayer,
Boehringer Ingelheim, Bristol Myers Squibb/Pfizer, Daiichi Sankyo and
Stryker outside the submitted work; participating as a Data Safety
Monitoring Board member for the TEA Stroke Trial and ReSCInD trial;
serving as speaker of the Commission for Cerebrovascular Diseases of the
German Society of Neurology and member of the Board of Directors of the
European Stroke Organization. Please see the study for all other
authors’ relevant financial disclosures. The study was funded by the
European Union Horizon 2020 Research and Innovation Program.
Prior data from the TENSION study established safety and efficacy of endovascular thrombectomy at 90 days.
At 12 months, ET bested medical treatment alone in several metrics.
In those with acute ischemic stroke, endovascular thrombectomy was
associated with better overall outcomes at 12 months compared with
standard medical treatment alone, according to research from The Lancet Neurology.
“Available long-term data from endovascular thrombectomy trials,
which mostly included patients with small or medium-sized infarcts,
suggest that the beneficial effect of treatment on functional outcome at
90 days — the usual timepoint for primary endpoints in stroke
reperfusion trials — persists in long-term follow up,” Gotz Thomalla, MD, professor in the department of neurology at the University Medical Center, Hamburg-Eppendorf in Germany, and colleagues wrote.
New research found that individuals given endovascular thrombectomy for
acute ischemic stroke fared better at 12 months compared with those who
received standard medical care alone.Image: Adobe Stock
Thomalla and colleagues sought to evaluate the safety and efficacy of endovascular thrombectomy at 12 months in the TENSION study, which previously established such for ischemic stroke and ischemic infarct at 90 days.
TENSION was an open-label, blinded endpoint, randomized clinical
trial conducted at 41 hospitals across Europe and Canada. The study
included 253 individuals with acute ischemic stroke due to large vessel
occlusion in the anterior circulation and who had a large infarct.
Participants, who underwent standard CT and MRI, were randomly assigned
1:1 to receive either endovascular thrombectomy as adjunct to standard
medical treatment or standard care alone. Clinical assessments were
performed at baseline, 24 hours, at 7 days or upon hospital discharge;
then at 90 days and 12 months.
The primary outcome was functional outcome across the entire range of
the modified Rankin Scale (mRS) at 90 days, with 12-month follow-up
analyses for functional outcome measured by the simplified mRS
questionnaire, quality of life measured by the Patient-Reported Outcomes
Measurement Information System 10-item (PROMIS-100) and EuroQol 5
Dimension (EQ-5D) questionnaires, post-stroke anxiety and depression
gauged via the Patient Health Questionnaire-4 (PHQ-4), as well as
overall survival.
Due to dropouts between the 90-day and 12-month follow-up intervals,
data on long-term effects were available for 244 participants
(thrombectomy, n = 125; medical treatment, n = 121).
According to the results, endovascular thrombectomy was associated with
a shift in mRS scores towards better functional outcome at 12 months
(adjusted common OR = 2.39; 95% CI, 1.47–3.9), better quality of life
compared with medical treatment only on the EQ-5D (0.7 vs. 0.4) and
median overall health scores as reflected by the PROMIS-10 (T-score 39.8
vs. 37.4).
The researchers found insufficient evidence to suggest a difference
between groups in global mental health scores on PROMIS-10, or among
those with anxiety and depression on the PHQ-4.
Data additionally showed scores for overall survival were slightly
better for those given endovascular thrombectomy group compared with
medical treatment only (adjusted HR = 0.7; 95% CI, 0.5–0.99).
“This finding is of particular interest because the course of
recovery from stroke symptoms is dynamic and might include improvements
as well as complications and secondary deterioration even months after
stroke,” Thomalla and colleagues wrote.
Disclosures:
Thomalla reports receiving funding from the European Commission;
receiving personal consulting fees from Acandis, AstraZeneca, Bayer,
Boehringer Ingelheim and Stryker; receiving either personal payment or
honoraria for lectures, presentations, speakers bureaus, manuscript
writing, or educational events from Acandis, Alexion, Amarin, Bayer,
Boehringer Ingelheim, Bristol Myers Squibb/Pfizer, Daiichi Sankyo and
Stryker outside the submitted work; participating as a Data Safety
Monitoring Board member for the TEA Stroke Trial and ReSCInD trial;
serving as speaker of the Commission for Cerebrovascular Diseases of the
German Society of Neurology and member of the Board of Directors of the
European Stroke Organization. Please see the study for all other
authors’ relevant financial disclosures. The study was funded by the
European Union Horizon 2020 Research and Innovation Program.
SELECT2 trial's 1-year results show continued benefits for patients with slower recovery
by
Crystal Phend, Contributing Editor, MedPage Today
February 13, 2024
PHOENIX -- Endovascular thrombectomy for
large-core acute ischemic stroke improved long-term outcomes, the
SELECT2 trial affirmed.
The intervention shifted the 1-year modified Rankin Scale (mRS) score
distribution toward less disability compared with medical care alone
(probability of superiority 0.59, 95% CI 0.53-0.64, generalized OR 1.43,
95% CI 1.14-1.78), Amrou Sarraj, MD, of University Hospital Cleveland
Medical Center, reported at the American Stroke Association International Stroke Conferenceopens in a new tab or window.
The number needed to treat was just six to improve mRS by 1 point for one patient.
"Our
study, evaluating 1-year clinical outcomes from the SELECT2 trial, is
the first to show that thrombectomy treatment effect was preserved in
patients with large [ischemic] stroke up to 24 h from when they were
last known to be well," the group noted in a paper released in The Lancetopens in a new tab or window.
"Taken together with previous evidence, this analysis shows that
endovascular thrombectomy improves clinical outcomes and quality-of-life
scores in patients with large [ischemic] stroke not only in the short
term but also in the long term (at 1 year), and provides strong evidence
to support the use of endovascular thrombectomy in patients with
extensive [ischemic] changes on CT or perfusion imaging," Sarraj and
colleagues wrote.
An accompanying editorial agreedopens in a new tab or window.
"The endovascular thrombectomy of acute [ischemic] stroke is
experiencing another new beginning, which will probably lead to broader
indications for treatment, including patients with large [ischemic]
lesions," wrote Arturo Consoli, MD, PhD, of Foch Hospital in Suresnes,
France, and Benjamin Gory, MD, PhD, of the Université de Lorraine in
Nancy, France.
The trial had been stopped early for superior efficacy of thrombectomy at the 90-day analysisopens in a new tab or window.
It and other previous trials have established the benefit of
thrombectomy for large-core ischemic strokes in 90-day functional
outcomes, but long-term impact had been uncertain, with a "considerably
lower" proportion of patients independent in function and ambulation
compared with the prior trialsopens in a new tab or window in populations with favorable imaging profiles and small to moderate ischemic core strokes.
"The timeline of recovery in patients with extensive stroke also
differed, with a significantly lower proportion of patients showing
marked neurological recovery within the first 24 h after stroke
(compared with those with small core stroke)," Sarraj's group pointed
out.
Indeed, they added: "In our study, more than a quarter of the
patients with continued follow-up beyond 3 months showed at least a
1-point improvement in functional status on the mRS at 1 year. These
findings provide evidence of continued improvement beyond the 3-month
window."
SELECT2
was designed with the primary aim of looking beyond the first 6 months
when most small core stroke recovery occurs, since complete recovery
could take longer for patients with more severe brain injury.
The phase III trial randomized 352 patients at 31 hospitals in the
United States, Canada, Spain, Switzerland, Australia, and New Zealand to
open-label treatment with supportive medical care with or without
endovascular thrombectomy within 24 hours of stroke onset. Participants
were ages 18 to 85 years and were eligible if their ischemic stroke was
due to proximal occlusion of the internal carotid artery or of the first
segment of the middle cerebral artery and had a large ischemic core on
non-contrast CT (Alberta Stroke Program Early CT Score [ASPECTS] 3-5) or
at least 50 mL on CT perfusion and MRI.
For key secondary endpoints, thrombectomy made functional
independence (mRS 0-2) 3.17-fold more likely at 1 year (24% vs 6%) and
independent ambulation (mRS 0-3) 85% more likely (37% vs 18%), both
statistically significant differences from medical care alone.
Notably,
"the proportion of patients requiring continuous nursing care (mRS 5)
remained lower in patients receiving thrombectomy (8%) than in those
receiving medical care only (14%), and of similar magnitude to the
proportion of mRS 5 outcomes after endovascular thrombectomy at 90 days
(8%)," Sarraj's group wrote.
Patients in the thrombectomy group also showed higher quality of life
scores at 1-year follow-up. All-cause mortality trended the same
direction without reaching statistical significance (45% vs 52% at 1
year, RR 0.89, 95% 0.71-1.11).
"We did not find any evidence of significant difference in
thrombectomy treatment effect based on age, stroke severity, time from
last known to have been well to [randomization], ASPECTS score, core
volume estimates, and mismatch status, although patients enrolled at
non-U.S. sites had lower point estimates of treatment effect than those
enrolled at U.S. sites," the researchers noted.
As far as limitations, there was 6.5% loss to follow-up at 1 year
that "could still be considered acceptable compared with other trials"
and some "potentially relevant" adverse event data not collected beyond
90 days, the editorial pointed out. "Furthermore, the absence of data on
the duration and type of rehabilitation protocol could limit the
interpretation of the results, since these aspects could have a major
role in the extended follow-up windows after the [ischemic] event;
however, data for patients with large volume strokes are poorly
available," they added.
"Therefore, to provide an appropriate clinical assessment for
patients with large volume strokes, a long-term follow-up beyond the
standard 3-month evaluation should be carefully considered in the design
of new studies and trials that will have an impact on future
guidelines," they wrote.
Sarraj
disclosed having received grant support from Stryker Neurovascular for
the trial. Co-authors disclosed numerous relationships with industry.
Consoli and Gory disclosed no relevant relationships with industry.
Primary Source
The Lancet
Source Reference: opens in a new tab or windowSarraj
A, et al "Endovascular thrombectomy plus medical care versus medical
care alone for large ischaemic stroke: 1-year outcomes of the SELECT2
trial" Lancet 2024; DOI: 10.1016/S0140-6736(24)00050-3.
Secondary Source
The Lancet
Source Reference: opens in a new tab or windowConsoli
A, Gory B "Long-term results of mechanical thrombectomy for large
ischaemic stroke" Lancet 2024; DOI: 10.1016/S0140-6736(24)00158-2.
'Better' IS NOT WHAT SURVIVORS WANT! THEY WANT 100% RECOVERY! WHY THE HELL AREN'T YOU WORKING TOWARDS THAT? Are you that fucking lazy? That's a serious question, what's your answer?
SELECT2 trial's 1-year results show continued benefits for patients with slower recovery
by
Crystal Phend, Contributing Editor, MedPage Today
February 13, 2024
PHOENIX -- Endovascular thrombectomy for
large-core acute ischemic stroke improved long-term outcomes, the
SELECT2 trial affirmed.
The intervention shifted the 1-year modified Rankin Scale (mRS) score
distribution toward less disability compared with medical care alone
(probability of superiority 0.59, 95% CI 0.53-0.64, generalized OR 1.43,
95% CI 1.14-1.78), Amrou Sarraj, MD, of University Hospital Cleveland
Medical Center, reported at the American Stroke Association International Stroke Conferenceopens in a new tab or window.
The number needed to treat was just six to improve mRS by 1 point for one patient.
"Our
study, evaluating 1-year clinical outcomes from the SELECT2 trial, is
the first to show that thrombectomy treatment effect was preserved in
patients with large [ischemic] stroke up to 24 h from when they were
last known to be well," the group noted in a paper released in The Lancetopens in a new tab or window.
"Taken together with previous evidence, this analysis shows that
endovascular thrombectomy improves clinical outcomes and quality-of-life
scores in patients with large [ischemic] stroke not only in the short
term but also in the long term (at 1 year), and provides strong evidence
to support the use of endovascular thrombectomy in patients with
extensive [ischemic] changes on CT or perfusion imaging," Sarraj and
colleagues wrote.
An accompanying editorial agreedopens in a new tab or window.
"The endovascular thrombectomy of acute [ischemic] stroke is
experiencing another new beginning, which will probably lead to broader
indications for treatment, including patients with large [ischemic]
lesions," wrote Arturo Consoli, MD, PhD, of Foch Hospital in Suresnes,
France, and Benjamin Gory, MD, PhD, of the Université de Lorraine in
Nancy, France.
The trial had been stopped early for superior efficacy of thrombectomy at the 90-day analysisopens in a new tab or window.
It and other previous trials have established the benefit of
thrombectomy for large-core ischemic strokes in 90-day functional
outcomes, but long-term impact had been uncertain, with a "considerably
lower" proportion of patients independent in function and ambulation
compared with the prior trialsopens in a new tab or window in populations with favorable imaging profiles and small to moderate ischemic core strokes.
"The timeline of recovery in patients with extensive stroke also
differed, with a significantly lower proportion of patients showing
marked neurological recovery within the first 24 h after stroke
(compared with those with small core stroke)," Sarraj's group pointed
out.
Indeed, they added: "In our study, more than a quarter of the
patients with continued follow-up beyond 3 months showed at least a
1-point improvement in functional status on the mRS at 1 year. These
findings provide evidence of continued improvement beyond the 3-month
window."
SELECT2
was designed with the primary aim of looking beyond the first 6 months
when most small core stroke recovery occurs, since complete recovery
could take longer for patients with more severe brain injury.
The phase III trial randomized 352 patients at 31 hospitals in the
United States, Canada, Spain, Switzerland, Australia, and New Zealand to
open-label treatment with supportive medical care with or without
endovascular thrombectomy within 24 hours of stroke onset. Participants
were ages 18 to 85 years and were eligible if their ischemic stroke was
due to proximal occlusion of the internal carotid artery or of the first
segment of the middle cerebral artery and had a large ischemic core on
non-contrast CT (Alberta Stroke Program Early CT Score [ASPECTS] 3-5) or
at least 50 mL on CT perfusion and MRI.
For key secondary endpoints, thrombectomy made functional
independence (mRS 0-2) 3.17-fold more likely at 1 year (24% vs 6%) and
independent ambulation (mRS 0-3) 85% more likely (37% vs 18%), both
statistically significant differences from medical care alone.
Notably,
"the proportion of patients requiring continuous nursing care (mRS 5)
remained lower in patients receiving thrombectomy (8%) than in those
receiving medical care only (14%), and of similar magnitude to the
proportion of mRS 5 outcomes after endovascular thrombectomy at 90 days
(8%)," Sarraj's group wrote.
Patients in the thrombectomy group also showed higher quality of life
scores at 1-year follow-up. All-cause mortality trended the same
direction without reaching statistical significance (45% vs 52% at 1
year, RR 0.89, 95% 0.71-1.11).
"We did not find any evidence of significant difference in
thrombectomy treatment effect based on age, stroke severity, time from
last known to have been well to [randomization], ASPECTS score, core
volume estimates, and mismatch status, although patients enrolled at
non-U.S. sites had lower point estimates of treatment effect than those
enrolled at U.S. sites," the researchers noted.
As far as limitations, there was 6.5% loss to follow-up at 1 year
that "could still be considered acceptable compared with other trials"
and some "potentially relevant" adverse event data not collected beyond
90 days, the editorial pointed out. "Furthermore, the absence of data on
the duration and type of rehabilitation protocol could limit the
interpretation of the results, since these aspects could have a major
role in the extended follow-up windows after the [ischemic] event;
however, data for patients with large volume strokes are poorly
available," they added.
"Therefore, to provide an appropriate clinical assessment for
patients with large volume strokes, a long-term follow-up beyond the
standard 3-month evaluation should be carefully considered in the design
of new studies and trials that will have an impact on future
guidelines," they wrote.
Sarraj
disclosed having received grant support from Stryker Neurovascular for
the trial. Co-authors disclosed numerous relationships with industry.
Consoli and Gory disclosed no relevant relationships with industry.
Primary Source
The Lancet
Source Reference: opens in a new tab or windowSarraj
A, et al "Endovascular thrombectomy plus medical care versus medical
care alone for large ischaemic stroke: 1-year outcomes of the SELECT2
trial" Lancet 2024; DOI: 10.1016/S0140-6736(24)00050-3.
Secondary Source
The Lancet
Source Reference: opens in a new tab or windowConsoli
A, Gory B "Long-term results of mechanical thrombectomy for large
ischaemic stroke" Lancet 2024; DOI: 10.1016/S0140-6736(24)00158-2.
When comparing outcomes for acute ischaemic stroke patients treated at various levels of stroke centres, patients who received care at comprehensive stroke centres (CSC)
or thrombectomy-capable stroke centres (TSC) were more likely to
receive rapid treatment with clot-busting medication and/or mechanical
clot removal—and be discharged home or to rehabilitation centres—
compared to those treated at primary stroke centres (PSC) in the USA.
“Certification status of the centre where a stroke patient receives
care matters, and it is important to know that the specific requirements
to become a CSC or TSC are validated by these data. The quality of care
is higher in these centres, as also confirmed by our findings,” said
lead author of the study Radoslav Raychev (University of California, Los
Angeles [UCLA], Los Angeles, USA).
PSCs are hospitals with the necessary
resources to manage patients with acute ischaemic stroke—the most common
type of stroke that is caused by a clot blocking an artery supplying
blood to areas of the brain. CSCs are hospitals that meet specific
standards for managing more severe ischaemic and haemorrhagic
strokes that require advanced endovascular and surgical interventions
including mechanical thrombectomy. TSCs meet all the rigorous standards
for performing a thrombectomy and are essentially the same as CSCs in
treating acute ischaemic strokes, according to an American Heart
Association (AHA) press release. However, unlike CSCs, TSCs may not have
the necessary resources to treat the less common and more complex
haemorrhagic strokes.
“TSC is a relatively new designation, introduced in 2018 by the
accreditation agencies in cooperation with the American Heart
Association/American Stroke Association,” Raychev added. “This is the
first study to include the new thrombectomy-capable designation when
comparing outcomes in the treatment of ischaemic stroke at the different
levels of stroke centres.”
Researchers compared outcomes and quality of care indicators for
84,903 patients (median age=70, 49.2% female) with ischaemic stroke
treated between 2018 and 2020 at stroke centres participating in the Get
With The Guidelines (GWTG) Stroke Registry. The study analysed 185
CSCs, 29 TSCs and 169 PSCs in the registry. As part of their treatment,
each patient had received either intravenous clot-busting medication or
thrombectomy to restore blood flow in a blocked artery.
Among their findings on quality of care measures, the study found
more patients treated at a CSC or TSC had intravenous clot-busting
treatment started within the target time period set by GWTG than those
treated at a PSC, and that the thrombectomy procedure started within the
target time period set by GWTG compared to patients treated at a
PSC—although the difference between TSC and PSC timing was not
statistically significant.
“Our data indicate that nearly one quarter of all endovascular
thrombectomies in the USA are being performed in primary stroke
centres,” Raychev said. “This is unfortunate because PSCs are not
required to have close oversight and implementation of
thrombectomy-specific American Stroke Association standards. We hope
that clinicians recognise the importance of the certification status and
its impact on the quality of acute stroke care, and we hope they
advocate for appropriate changes within their institutions.”
Patients also had better outcomes if they were treated at a CSC or TSC, the AHA release states, with the analysis finding:
CSC and TSC patients were more likely to have their blood flow
successfully restored after endovascular thrombectomy than PSC patients.
Fewer patients treated at CSC and TSC died or were discharged to hospice than PSC patients.
More CSC and TSC patients were discharged to their homes or to
rehabilitation facilities than PSC patients (however, the difference
between TSC and PSC rates was not statistically significant).
Overall, there was no significant difference in outcomes between CSC and TSC patients.
The data identified differences in the baseline characteristics of
the stroke patients at each centre status. The patients treated at TSCs
and CSCs tended to have more severe strokes. They were also more likely
to have been transferred from another hospital because they required a
higher level of care, and they arrived at the centres after a longer
time since the onset of their stroke symptoms. The study’s results
underscore the value of participating in the certification process to
improve stroke care, the release adds.
“Our findings demonstrate that patients with acute ischaemic stroke
receive a better quality of care and have a higher chance of improved
outcome when treated at a Comprehensive or Thrombectomy-capable stroke
centre,” Raychev said. “Patients should keep this in mind when
researching the level of stroke care available in their area. The good
news is that, in most parts of the country, the emergency medical
systems of acute stroke care are designed to triage and expedite
patients to appropriate centres based on the severity of their stroke
symptoms. Patients and their loved ones should always remember to call
911 when there is a suspected stroke.”
“Everyone involved in the acute stroke chain of survival should be
aware of the importance of certification status. One of the biggest
challenges in achieving TSC-level status is that a PSC must perform 15
or more endovascular thrombectomies per year. In our study, the median
volume at PSCs was 32—therefore, most PSCs far exceed the minimum
thrombectomy volume requirements. Advancing certification for PSCs that
meet the volume requirement is very feasible, yet it does require
coordinated efforts and additional resources. Our data should serve as
strong evidence for initiating such important changes and ultimately
elevate the standard of acute ischaemic stroke care nationwide,” Raychev
said.
The analysis is limited, the researchers state, by the relatively
small number of TSCs included in the registry. Another limitation was
that the sample only included centres certified by two accreditation
agencies, The Joint Commission and DNV (Det Norske Veritas) Healthcare.
Centres that have received state-specific designations or were certified
by other national accreditation agencies were not part of the study.
Endovascular
thrombectomy for large vessel occlusion stroke is a time-sensitive
intervention. The use of a Mobile Interventional Stroke Team (MIST)
traveling to Thrombectomy Capable Stroke Centers to perform endovascular
thrombectomy has been shown to be significantly faster with improved
discharge outcomes, as compared with the drip-and-ship (DS) model. The
effect of the MIST model stratified by time of presentation has yet to
be studied. We hypothesize that patients who present in the early window
(last known well of ≤6 hours) will have better clinical outcomes in the
MIST model.
Methods:
The
NYC MIST Trial and a prospectively collected stroke database were
assessed for patients undergoing endovascular thrombectomy from January
2017 to February 2020. Patients presenting in early and late time
windows were analyzed separately. The primary end point was the
proportion with a good outcome (modified Rankin Scale score of 0–2) at
90 days. Secondary end points included discharge National Institutes of
Health Stroke Scale and modified Rankin Scale.
Results:
Among
561 cases, 226 patients fit inclusion criteria and were categorized
into MIST and DS cohorts. Exclusion criteria included a baseline
modified Rankin Scale score of >2, inpatient status, or fluctuating
exams. In the early window, 54% (40/74) had a good 90-day outcome in the
MIST model, as compared with 28% (24/86) in the DS model (P<0.01). In the late window, outcomes were similar (35% versus 41%; P=0.77). The median National Institutes of Health Stroke Scale at discharge was 5.0 and 12.0 in the early window (P<0.01) and 5.0 and 11.0 in the late window (P=0.11)
in the MIST and DS models, respectively. The early window discharge
modified Rankin Scale was significantly better in the MIST model (P<0.01) and similar in the late window (P=0.41).
Conclusions:
The
MIST model in the early time window results in better 90-day outcomes
compared with the DS model. This may be due to the MIST capturing
high-risk fast progressors at an earlier time point.
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