One-Year Outcome After Endovascular Thrombectomy for Basilar Artery Occlusion With Mild Deficits

 Your favorable functional outcome (a modified Rankin Scale score of 0–3) is still a COMPLETE FUCKING FAILURE! Survivors expect 100% recovery and you're not measuring that! GET THERE! YOU need to rid the stroke medical world of all these incompetent persons!

Well, since no one is measuring 100% recovery, you'll never get there.

“What's measured, improves.” So said management legend and author Peter F. Drucker 

The latest useless shit here:

One-Year Outcome After Endovascular Thrombectomy for Basilar Artery Occlusion With Mild Deficits

Yingjie Xu, MD https://orcid.org/0000-0002-4181-7450, Lulu Xiao, PhD https://orcid.org/0000-0002-5942-0902, Pan Zhang, MD https://orcid.org/0000-0001-6320-6987, Weiliang Shi, PhD, Shidong Tan, PhD, Miaomiao Hu, MD https://orcid.org/0009-0006-1821-0534, Zhanglin Li, MD https://orcid.org/0009-0001-6813-8589, … Show All … , and Wen Sun, PhD https://orcid.org/0000-0002-7268-2085 sunwen_medneuro@163.comAuthor Info & Affiliations

Stroke

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https://doi.org/10.1161/STROKEAHA.124.050389

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Abstract

BACKGROUND:

The long-term benefits of endovascular thrombectomy (EVT) for basilar artery occlusion (BAO) in patients with low National Institutes of Health Stroke Scale scores upon admission remain unclear. This study aimed to compare the 1-year clinical follow-up outcomes of best medical management (BMM) alone versus BMM plus EVT.

METHODS:

Patients with BAO and admission National Institutes of Health Stroke Scale score of ≤10 at 65 stroke centers in China from December 2015 to June 2022 were retrospectively enrolled. The primary outcome was favorable functional outcome (a modified Rankin Scale score of 0–3 at 1 year). Early (door-to-puncture time ≤120 minutes) and late EVT (door-to-puncture time >120 minutes) classifications were defined as surrogates for comparing initial treatment with EVT versus late (potentially rescue) EVT after initially being treated with BMM only. Multivariable logistic regression and propensity score matching analyses were used to assess the association between treatment and outcomes.

RESULTS:

Among 1232 patients who had 1-year follow-up data, 856 (69.5%) were male, and the mean (SD) age was 65 (12) years. After adjustment for confounders, there were no significant differences between EVT and BMM in favorable functional outcome (odds ratio, 0.96 [95% CI, 0.71–1.29]; P=0.778). The cumulative 1-year mortality rate was 16.4% in the EVT group versus 13.7% in the BMM group (odds ratio, 1.23 [95% CI, 0.86–1.77]; P=0.262). Predefined subgroup analyses revealed that late EVT was inferior to early EVT (odds ratio, 0.47 [95% CI, 0.28–0.79]; P=0.005), while no significant difference was observed between BMM and early EVT in 1-year outcomes (odds ratio, 0.87 [95% CI, 0.63–1.21]; P=0.421).

CONCLUSIONS:

In this long-term follow-up study among patients with BAO admitted with a National Institutes of Health Stroke Scale score of ≤10, there were no significant differences in functional outcomes and mortality at 1 year between BMM plus EVT and BMM alone.

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Revalesio announces new analyses from Phase 2 RESCUE study assessing RNS60 in acute ischaemic stroke

 You'll have to ask your competent? doctor which of the 5 causes of the neuronal cascade of death in the first week is being addressed! 

I wish they had used the proper term; penumbra, and specified exactly how many millions of neurons were saved.

I consider the Rankin scale useless, not objective except for #6, dead?

NIHSS and the Berthel Index ARE NOT DAMAGE DIAGNOSES, they do not give you the 3d location of your dead and damaged neurons. In my opinion, they are FUCKING WORTHLESS to getting you recovered! 

The latest here:

Revalesio announces new analyses from Phase 2 RESCUE study assessing RNS60 in acute ischaemic stroke

Revalesio has announced new analyses of the completed Phase 2 RESCUE clinical trial evaluating its drug candidate RNS60 in acute ischaemic stroke that demonstrate a nominally significant lowering of infarct growth in patients treated less than 12 hours from last known well. The lowering of infarct growth correlated with clinically meaningful improvements in several functional stroke measures for assessing a patient’s recovery(None of which are worth a damn, about helping you get recovered!), including the modified Rankin scale (mRS), Barthel index (BI), and National Institutes of Health stroke scale (NIHSS), the company claims in a recent press release.

These results were delivered during an oral presentation at the ongoing International Stroke Conference (ISC; 5–7 February, Los Angeles, USA).

“This analysis of the RESCUE trial adds further information regarding the beneficial effects of RNS60, confirming that it has favourable effects on MRI [magnetic resonance imaging]-confirmed ischaemic lesion growth that translated into improved clinical outcomes,” said former World Stroke Organization (WSO) president Marc Fisher (Beth Israel Deaconess Medical Center, Boston, USA). “These are exciting results that suggest that RNS60 should be evaluated in a large Phase 3 clinical trial that will hopefully confirm its benefits and lead to approval as the first therapeutic agent in decades to demonstrate significant efficacy in improving outcomes for acute ischaemic stroke patients.”

In RESCUE—a multicentre, double-blinded, placebo-controlled, randomised Phase 2 clinical trial—Revalesio evaluated the safety and initial efficacy of RNS60. Eighty-two participants with acute ischaemic stroke eligible for endovascular therapy (EVT) were enrolled and received either intravenous RNS60 0.5mL/kg/h (low dose), RNS60 1mL/kg/h (high dose), or placebo, starting before completion of EVT and continuing for 48 hours.

The trial had two primary endpoints: safety and mortality. Secondary endpoints for the study assessed disability based on mRS scores, changes in the size of the stroke measured via MRI at 48 hours, and additional standard stroke scales like BI and NIHSS.

Highlights from the oral presentation—given by Revalesio’s acting chief medical officer Jordan Dubow on 5 February at ISC 2025—are as follows:

• The high dose of RNS60 significantly lowered infarct growth by 50% (nominal p<0.05) when compared to placebo, based on imaging performed at approximately 48 hours compared to immediately post-EVT, both in patients treated within 12 hours and 24 hours of last known well
• The high dose of RNS60 was also numerically better than placebo for each prespecified functional endpoint at day 90 (mRS, with 72% of subjects on high-dose RNS60 being independent [mRS 0–2] at day 90 compared to 37% on placebo; BI, with 72% of subjects on high-dose RNS60 returning to normal activities of daily living [BI³ 95] compared to 37% on placebo; and patient health status as measured by the EQ-5D-5L index, with 1 being ideal, which was 0.79 for RNS60 subjects and 0.57 for placebo)
• RNS60 was safe and well tolerated

“As the number-one cause of disability worldwide, the impact of stroke is staggering, accounting for US$721 billion annually to the global healthcare system,” said Bert van den Bergh, Revalesio’s executive chairman of the board of directors. “Additionally, more than 80% of patients in the USA have no treatment options following a stroke, underscoring the significant need for new and effective treatment options. These highly encouraging results further demonstrate the potential of RNS60 to greatly reduce the likelihood of disability in patients following a stroke, and we plan to advance RNS60 into a Phase 3 clinical trial in order to bring this promising therapy to patients.”

Initial topline results from the RESCUE Phase 2 study—which evaluated patients who were 24 hours from last known well, and saw RNS60 meet its safety- and mortality-related endpoints—were presented as a late-breaking oral presentation at last year’s ISC (7–9 February 2024, Phoenix, USA).

Clinician perceptions of a novel wearable robotic hand orthosis for post-stroke hemiparesis

 I happen to think it is vastly more important to have stroke survivors evaluate the efficacy and protocols used with these interventions. Any clinician evaluations using the Rankin scale can't discriminate any useful improvements.

I consider the Rankin scale useless, not objective except for #6, dead?

Clinician perceptions of a novel wearable robotic hand orthosis for post-stroke hemiparesis

Lauren Winterbottom

,

Ava Chen

,

Rochelle Mendonca

,

Dawn M. Nilsen

,

Matei Ciocarlie

&

Joel Stein

Received 19 Oct 2023, Accepted 27 Jun 2024, Published online: 08 Jul 2024

• Cite this article
• https://doi.org/10.1080/09638288.2024.2375056
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Abstract

Purpose

Wearable robotic devices are currently being developed to improve upper limb function for individuals with hemiparesis after stroke. Incorporating the views of clinicians during the development of new technologies can help ensure that end products meet clinical needs and can be adopted for patient care.

Methods

In this cross-sectional mixed-methods study, an anonymous online survey was used to gather clinicians’ perceptions of a wearable robotic hand orthosis for post-stroke hemiparesis. Participants were asked about their clinical experience and provided feedback on the prototype device after viewing a video.

Results

154 participants completed the survey. Only 18.8% had previous experience with robotic technology. The majority of participants (64.9%) reported that they would use the device for both rehabilitative and assistive purposes. Participants perceived that the device could be used in supervised clinical settings with all phases of stroke. Participants also indicated a need for insurance coverage and quick setup time.

Conclusions

Engaging clinicians early in the design process can help guide the development of wearable robotic devices. Both rehabilitative and assistive functions are valued by clinicians and should be considered during device development. Future research is needed to understand a broader set of stakeholders’ perspectives on utility and design.

IMPLICATIONS FOR REHABILITATION

• Clinicians valued both assistive and rehabilitative uses of a wearable robotic hand orthosis designed for individuals with hemiparesis after stroke.

• Wearable robotic hand devices should have the capacity to engage in functional, real-world activities for both assistive and rehabilitative purposes.

• Pragmatic factors, such as set-up and training time, must be balanced with device complexity to enable implementation in clinical settings.

• Stakeholders, such as clinicians, play an important role in identifying design priorities for wearable robotic devices to ensure these devices can meet the needs of end-users.

An automated flowchart for the Modified Rankin Scale assessment: A multicenter inter-rater agreement analysis

 Why standardize the Rankin scale since it is useless, not objective except for #6, dead? You can't use it to objectively point to the EXACT STROKE PROTOCOLS  needed.  The exact same deficit could have 9 causes.

See this example of nine reasons for a movement disability:

 

You can't tell me these all have the same solution, I'm not that stupid.
1. Penumbra damage to the motor cortex.
2. Dead brain in the motor cortex.
3. Penumbra damage in the pre-motor cortex.
4. Dead brain in the pre-motor cortex.
5. Penumbra damage in the executive control area.
6. Dead brain in the executive control area.
7. Penumbra damage in the white matter underlying any of these three.
8. Dead brain in the white matter underlying any of these three.
9. Spasticity preventing movement from occurring.

The latest here:

An automated flowchart for the Modified Rankin Scale assessment: A multicenter inter-rater agreement analysis

Joao Brainer C de Andrade https://orcid.org/0000-0001-8768-7164 joao.brainer@unifesp.br, Terence J Quinn https://orcid.org/0000-0003-1401-0181, […], and Gisele Sampaio Silva+5View all authors and affiliations

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https://doi.org/10.1177/17474930241246157

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Abstract

Background and objective:

The Modified Rankin Scale (mRS) is a widely adopted scale for assessing stroke recovery. Despite limitations, the mRS has been adopted as primary outcome in most recent clinical acute stroke trials. Designed to be used by multidisciplinary clinical staff, the congruency of this scale is not consistent, which may lead to mistakes in clinical or research application. We aimed to develop and validate an interactive and automated digital tool for assessing the mRS—the iRankin.

Methods:

A panel of five board-certified and mRS-trained vascular neurologists developed an automated flowchart based on current mRS literature. Two international experts were consulted on content and provided feedback on the prototype platform. The platform contained five vignettes and five real video cases, representing mRS grades 0–5. For validation, we invited neurological staff from six comprehensive stroke centers to complete an online assessment. Participants were randomized into two equal groups usual practice versus iRankin. The participants were randomly allocated in pairs for the congruency analysis. Weighted kappa (kw) and proportions were used to describe agreement.

Results:

A total of 59 professionals completed the assessment. The kw was dramatically improved among nurses, 0.76 (95% confidence interval (CI) = 0.55–0.97) × 0.30 (0.07–0.67), and among vascular neurologists, 0.87 (0.72–1) × 0.82 (0.66–0.98). In the accuracy analysis, after the standard mRS values for the vignettes and videos were determined by a panel of experts, and considering each correct answer as equivalent to 1 point on a scale of 0–15, it revealed a higher mean of 10.6 (±2.2) in the iRankin group and 8.2 (±2.3) points in the control group (p = 0.02). In an adjusted analysis, the iRankin adoption was independently associated with the score of congruencies between reported and standard scores (beta coefficient = 2.22, 95% CI = 0.64–3.81, p = 0.007).

Conclusion:

The iRankin adoption led to a substantial or near-perfect agreement in all analyzed professional categories. More trials are needed to generalize our findings. Our user-friendly and free platform is available at https://www.irankinscale.com/.

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Remote ischemic conditioning for acute stroke

Ask your doctor if this definitively refutes all the earlier research suggesting that it worked? Your doctor needs to know the answer prior to treating you. Does s/he?

But the modified Rankin score has no objectivity and can't tell slight increases in functionality. So I consider anyone using it to not know what they are doing.

mRS scale:

0  The patient has no residual symptoms.

1  The patient has no significant disability; able to carry out all pre-stroke activities.

2  The patient has slight disability; unable to carry out all pre-stroke activities but able to look after self without daily help.

3  The patient has moderate disability; requiring some external help but able to walk without the assistance of another individual.

4  The patient has moderately severe disability; unable to walk or attend to bodily functions without assistance of another individual.

5  The patient has severe disability; bedridden, incontinent, requires continuous care.

6  The patient has expired (during the hospital stay or after discharge from the hospital).

• leg compressions (25 posts to September 2015)

  Remote ischemic conditioning (17 posts to July 2018)

  • remote ischemic postconditioning (3 posts to March 2021)

   

   

• leg wraps (14 posts to May 2013)

Remote ischemic conditioning for acute stroke

In a randomized, sham-controlled study published in the Journal of the American Medical Association (JAMA), researchers investigated the effect of remote ischemic conditioning (RIC) on functional outcomes in patients with acute stroke in a combined prehospital and in-hospital setting.

They found that at 90 days, RIC treatment did not significantly improve functional outcomes in patients with acute stroke compared to the control group.

Study: Remote Ischemic Conditioning for Acute Stroke. Image Credit: SewCreamStudio/Shutterstock.com

Background

RIC with transient cycles of limb ischemia and reperfusion is a simple, noninvasive intervention to minimize the risk of ischemic injury to the affected organs. In preclinical studies on intracerebral hemorrhage models, RIC enhances collateral blood flow in the ischemic area and reduces poststroke inflammation.

In clinical trials, RIC was found to be safe, feasible, and effective after 48 hours of stroke. RIC is also shown to be associated with increased hematoma resorption.

However, evidence remains inconclusive on the effectiveness of RIC as a treatment option for acute stroke. Therefore, the present clinical trial aimed to determine whether RIC started in the prehospital setting and repeated in the hospital could improve functional outcomes in patients diagnosed with acute ischemic or hemorrhagic stroke.

About the study

The “remote ischemic conditioning in patients with acute stroke trial” (RESIST) was a randomized, double-blinded, sham-controlled trial conducted at four different centers in Denmark between March 2018 and November 2022, and a follow-up was conducted in February 2023.

The study included 1,500 adult patients who presented to the hospital within four hours of stroke symptoms, as indicated by a prehospital stroke score (PreSS) of one or greater.

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The exclusion criteria were a history of intracranial aneurysm, cerebral neoplasm, arteriovenous malformation, brain abscess, progressive neurodegenerative disease, severe peripheral arterial disease in the upper extremities, or the presence of an arteriovenous shunt in the arm selected for RIC.

The “target population” was patients receiving an in-hospital diagnosis of acute ischemic stroke or intracerebral hemorrhage.

The patients were randomized 1:1 to receive either RIC (n= 749) or sham (n= 751) on one upper extremity using an inflatable cuff. The procedure involved five cycles: cuff inflation (five minutes) followed by deflation (five minutes).

The cuff pressure in the RIC was 200 mmHg, while that in the sham was 20 mmHg. The treatment was initiated in the ambulance and performed again in the hospital at least once. Patients with a target diagnosis were treated twice daily for seven days.

The improvement in functional outcome at 90 days was the primary efficacy endpoint in the target population, measured as a favorable shift in the modified Rankin scale (mRS) score, where 0 implies no symptoms and a score of 6 implies death.

The secondary endpoints were a change in PreSS at 24 hours, severe adverse cardiac or cerebral events at 90 days, recurrent ischemic events, early neurological improvement, length of hospital stay, and all-cause mortality at 90 days.

The statistical analysis involved using Kaplan-Meier curves, Aalen-Johansen curves, and the estimation of odds ratio, relative risks, and difference in means.

Results and discussion

Out of the 1,500 included patients, 1,433 could complete the trial. The mean age of the patients was 71 years, and 41% of them were females. The target population consisted of 902 patients, with 436 in the RIC group and 466 in the sham group.

About 82% of the target population had acute ischemic stroke, while 18% had intracerebral hemorrhage. The two groups were similar regarding the baseline demographic, reperfusion rates, and clinical characteristics. About 90% of patients adhered to the treatment in the target population.

At 90 days, the median mRS score was estimated to be 2 in the RIC group, while that of the sham group was 1 (odds ratio = 0.95). Thus, as per the study, the RIC treatment did not significantly improve functional outcomes in the target population.

The secondary efficacy outcomes, mortality, and serious adverse events did not significantly differ among the two groups.

In a per-protocol analysis conducted on adherent patients, the results obtained were similar to the primary research in the target population. While the study has several limitations, the findings do not demonstrate significant benefits from RIC when applied in patients with acute stroke.

Conclusion

As per the study findings, RIC initiated in prehospital settings and continued in the hospital did not improve functional outcomes significantly at 90 days in patients with a confirmed diagnosis of acute ischemic stroke or intracerebral hemorrhage.

These results suggest that RIC may not be an effective standalone treatment for acute stroke. However, its role as an adjunctive therapy needs to be evaluated through further research.

Journal reference:

• Blauenfeldt RA et al., Remote Ischemic Conditioning for Acute Stroke: The RESIST Randomized Clinical Trial., JAMA. doi: 10.1001/jama.2023.16893. https://jamanetwork.com/journals/jama/article-abstract/2810034

Ordinal Prediction Model of 90-Day Modified Rankin Scale in Ischemic Stroke

 Just what the fuck does predictions of failure to recover do for survivors?

 

Ordinal Prediction Model of 90-Day Modified Rankin Scale in Ischemic Stroke

Michelle Y. Zhang¹, Michael Mlynash², Kristin L. Sainani³, Gregory W. Albers² and Maarten G. Lansberg^2*

• ¹Stanford University School of Medicine, Stanford, CA, United States
• ²Department of Neurology and Neurological Sciences and the Stanford Stroke Center, Stanford University Medical Center, Stanford, CA, United States
• ³Department of Epidemiology and Population Health, Stanford University, Stanford, CA, United States

Background and Purpose: Prediction models for functional outcomes after ischemic stroke are useful for statistical analyses in clinical trials and guiding patient expectations. While there are models predicting dichotomous functional outcomes after ischemic stroke, there are no models that predict ordinal mRS outcomes. We aimed to create a model that predicts, at the time of hospital discharge, a patient's modified Rankin Scale (mRS) score on day 90 after ischemic stroke.

Methods: We used data from three multi-center prospective studies: CRISP, DEFUSE 2, and DEFUSE 3 to derive and validate an ordinal logistic regression model that predicts the 90-day mRS score based on variables available during the stroke hospitalization. Forward selection was used to retain independent significant variables in the multivariable model.

Results: The prediction model was derived using data on 297 stroke patients from the CRISP and DEFUSE 2 studies. National Institutes of Health Stroke Scale (NIHSS) at discharge and age were retained as significant (p < 0.001) independent predictors of the 90-day mRS score. When applied to the external validation set (DEFUSE 3, n = 160), the model accurately predicted the 90-day mRS score within one point for 78% of the patients in the validation cohort.

Conclusions: A simple model using age and NIHSS score at time of discharge can predict 90-day mRS scores in patients with ischemic stroke. This model can be useful for prognostication in routine clinical care and to impute missing data in clinical trials.

Introduction

Prediction models of functional outcome after ischemic stroke can aid clinical decision making for providers, patients, and families by guiding rehabilitation goals, discharge planning, and patient expectations (1–3). They can also be useful for imputing missing data in clinical trials. These models stroke have generally focused on predicting a dichotomization of the modified Rankin Scale (mRS) such as functional independence (mRS 0–2) vs. functional dependency or death (mRS 3–6), or alive (mRS 0–5) vs. dead (mRS 6) (4–6). While these dichotomizations are meaningful, a model that could predict outcome across the entire spectrum of the mRS would be more informative. For example, for patients who have less severe strokes, a model predicting mortality may be less useful than a model that predicts the exact score on the mRS (7). Such a model could also be used to impute missing data in clinical trials when patients are lost to follow-up or when outcome data is not yet available.

More at link. 

 

Stroke Patients With Faster Core Growth Have Greater Benefit From Endovascular Therapy

 Wrong goal: mRS of 2 is not a good outcome.

Unless failure is acknowledged it will NEVER BE FIXED. This just normalizes failure.

THIS IS WHY SURVIVORS NEED TO BE IN CHARGE. We would never approve such crapola. 

mRS scale:

0  The patient has no residual symptoms.

1  The patient has no significant disability; able to carry out all pre-stroke activities.

2  The patient has slight disability; unable to carry out all pre-stroke activities but able to look after self without daily help.

3  The patient has moderate disability; requiring some external help but able to walk without the assistance of another individual.

4  The patient has moderately severe disability; unable to walk or attend to bodily functions without assistance of another individual.

5  The patient has severe disability; bedridden, incontinent, requires continuous care.

6  The patient has expired (during the hospital stay or after discharge from the hospital).

Stroke Patients With Faster Core Growth Have Greater Benefit From Endovascular Therapy

Longting Lin

,

Hao Zhang

,

Chushuang Chen

,

Andrew Bivard

,

Kenneth Butcher

,

Carlos Garcia-Esperon

,

Neil J. Spratt

,

Christopher R. Levi

,

Mark W. Parsons

,

Gang Li

,

and on behalf of INSPIRE Study Group‡

Originally published29 Sep 2021https://doi.org/10.1161/STROKEAHA.121.034205Stroke. 2021;52:3998–4006

• This article is commented on by the following:

Abstract

Background and Purpose:

This study aimed to explore whether the therapeutic benefit of endovascular thrombectomy (EVT) was mediated by core growth rate.

Methods:

This retrospective cohort study identified acute ischemic stroke patients with large vessel occlusion and receiving reperfusion treatment, either EVT or intravenous thrombolysis (IVT), within 4.5 hours of stroke onset. Patients were divided into 2 groups: EVT versus IVT only patients (who had no access to EVT). Core growth rate was estimated by the acute core volume on perfusion computed tomography divided by the time from stroke onset to perfusion computed tomography. The primary clinical outcome was good outcome defined by 3-month modified Rankin Scale score of 0–2. Tissue outcome was the final infarction volume.

Results:

A total of 806 patients were included, 429 in the EVT group (recanalization rate of 61.6%) and 377 in the IVT only group (recanalization rate of 44.7%). The treatment effect of EVT versus IVT only was mediated by core growth rate, showing a significant interaction between EVT treatment and core growth rate in predicting good clinical outcome (interaction odds ratio=1.03 [1.01–1.05], P=0.007) and final infarct volume (interaction odds ratio=−0.44 [−0.87 to −0.01], P=0.047). For patients with fast core growth of >25 mL/h, EVT treatment (compared with IVT only) increased the odds of good clinical outcome (adjusted odds ratio=3.62 [1.21–10.76], P=0.021) and resulted in smaller final infarction volume (37.5 versus 73.9 mL, P=0.012). For patients with slow core growth of <15 mL/h, there were no significant differences between the EVT and the IVT only group in either good clinical outcome (adjusted odds ratio=1.44 [0.97–2.14], P=0.070) or final infarction volume (22.6 versus 21.9 mL, P=0.551).

Conclusions:

Fast core growth was associated with greater benefit from EVT compared with IVT in the early <4.5-hour time window.

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A randomized controlled trial to optimize patient’s selection for endovascular treatment in acute ischemic stroke (SELECT2): Study protocol

You can see from the start of this research they have the wrong outcome measurements, mRS 0 or 1 should be the only measures needed, anything else should be considered failure. Unless failure is acknowledged it will NEVER BE FIXED. This just normalizes failure.

0  The patient has no residual symptoms.

1  The patient has no significant disability; able to carry out all pre-stroke activities.

2  The patient has slight disability; unable to carry out all pre-stroke activities but able to look after self without daily help.

3  The patient has moderate disability; requiring some external help but able to walk without the assistance of another individual.

4  The patient has moderately severe disability; unable to walk or attend to bodily functions without assistance of another individual.

5  The patient has severe disability; bedridden, incontinent, requires continuous care.

6  The patient has expired (during the hospital stay or after discharge from the hospital).

A randomized controlled trial to optimize patient’s selection for endovascular treatment in acute ischemic stroke (SELECT2): Study protocol

Amrou Sarrajhttps://orcid.org/0000-0001-5726-44781, Ameer E Hassanhttps://orcid.org/0000-0002-7148-76162, Michael Abraham3, Marc Ribo4, Spiros Blackburn5, Michael Chen6, Muhammad Shazam Hussain7, Vitor Mendes Pereira8, Santiago Ortega-Gutierrez9, Clark Sitton10, Phillip W Lavori11, Chunyan Cai12, Mohammed Rahbar12, Deep Pujarahttps://orcid.org/0000-0001-6187-894X1, Faris Shakerhttps://orcid.org/0000-0003-4462-52321, Maarten G Lansberghttps://orcid.org/0000-0002-3545-692713, Bruce Campbellhttps://orcid.org/0000-0003-3632-943314, James C Grotta15, Gregory W Albers13, and on behalf of the SELECT2 Investigators
Rationale

Randomized evidence for endovascular thrombectomy safety and efficacy in patients with large core strokes is lacking.
Aims

To demonstrate endovascular thrombectomy efficacy and safety in patients with large core on non-contrast CT or perfusion imaging (CT/MR) and determine if there is heterogeneity of treatment effect in large cores based on the imaging modality.
Design

SELECT2 is a prospective, randomized, multi-center, assessor-blinded controlled trial with adaptive enrichment design, enrolling up to 560 patients.
Procedure

Patients who meet the clinical criteria and have anterior circulation large vessel occlusions with large core on either NCCT (ASPECTS 3–5) or perfusion imaging (CTP [rCBF < 30%] and/or MRI [ADC < 620] ≥ 50 cc) will be randomized in a 1:1 ratio to undergo endovascular thrombectomy or medical management (MM) only up to 24 h of last known well.
Study outcomes

The distribution of 90-day mRS scores is the primary outcome. Functional independence (mRS = 0–2) rate is a secondary outcome. Other secondary outcomes include safety (symptomatic ICH, neurological worsening, mortality) and imaging outcomes.
Analysis

A normal approximation of the Wilcoxon-Mann-Whitney test (the generalized likelihood ratio test) to assess the primary outcome. Functional independence rates, safety and imaging outcomes will also be compared.
Discussion

The SELECT2 trial will evaluate endovascular thrombectomy safety and efficacy in large cores on either CT or perfusion imaging and may provide randomized evidence to extend endovascular thrombectomy eligibility to larger population.
Registration: ClinicalTrials.gov–NCT03876457
Keywords
Acute stroke therapy, thrombectomy, clinical trial, large vessel occlusion, ischemic stroke, protocols
1Department of Neurology, UT McGovern Medical School, Houston, USA
2Department of Neurology, Valley Baptist Medical Center, Harlingen, USA
3Department of Neurology, University of Kansas Medical Center, Kansas City, USA
4Department of Neurology, Vall d'Hebron Hospital Universitari, Barcelona, Spain
5Department of Neurosurgery, UT McGovern Medical School, Houston, USA
6Department of Neurosurgery, Rush University, Chicago, USA
7Department of Neurology, Cleveland Clinic, Cleveland, USA
8Department of Neurology, Toronto Western Hospital, Toronto, Canada
9Department of Neurology, University of Iowa Hospitals, Iowa City, USA
10Department of Neuroradiology, UT McGovern Medical School, Houston, USA
11Biomedical Data Science, Stanford University, Stanford, USA
12CCTS, UT McGovern Medical School, Houston, USA
13Department of Neurology, Stanford University, Stanford, USA
14Department of Neurology, Royal Melbourne Hospital, Parkville, Australia
15Department of Neurology, Memorial Hermann–Texas Medical Center, Houston, USA
*Investigators listed in eTable 3.
Corresponding author(s):
Amrou Sarraj, UT McGovern Medical School, 6431 Fannin St #7.044; Houston, TX 77030, USA. Email: Amrou.Sarraj@uth.tmc.edu

Non-contrast head CT alone for thrombectomy in acute ischemic stroke: analysis of the ANGEL-ACT registry

Rankin scores have very little discrimination and are way too gross in subjective measures to have any meaning at all. So I don't see much meaning in here at all.

Non-contrast head CT alone for thrombectomy in acute ischemic stroke: analysis of the ANGEL-ACT registry

 

1. Zeguang Ren1,
2. http://orcid.org/0000-0002-9374-7589Gaoting Ma2,
3. Maxim Mokin1,
4. Ashutosh P Jadhav3,
5. Baixue Jia2,
6. http://orcid.org/0000-0002-3277-6941Xu Tong2,
7. Clayton Bauer1,
8. Raynald Liu2,
9. Anxin Wang4,
10. Xuelei Zhang5,
11. Dapeng Mo2,
12. http://orcid.org/0000-0002-4909-7048Ning Ma2,
13. Feng Gao2,
14. Ligang Song2,
15. Xuan Sun2,
16. Xiaochuan Huo2,
17. Yiming Deng2,
18. Lian Liu2,
19. Gang Luo2,
20. Xiang Luo6,
21. Ya Peng7,
22. Liqiang Gui8,
23. Cunfeng Song9,
24. Jin Wu10,
25. Leyuan Wang11,
26. Chunlei Li12,
27. Tudor G Jovin13,
28. Yilong Wang4,14,
29. Yongjun Wang4,14,
30. Zhongrong Miao2
31. on behalf of ANGEL-ACT Study Group

1. Correspondence to Dr Zhongrong Miao, Department of Interventional Neuroradiology, Beijing Tiantan Hospital, Beijing 100070, China; zhongrongm@163.com

Abstract

Backgroud The goal of this study was to determine if the choice of imaging paradigm performed in the emergency department influences the procedural or clinical outcomes after mechanical thrombectomy (MT).

Methods This is a retrospective comparative outcome study which was conducted from the ANGEL-ACT registry. Comparisons were made between baseline characteristics and clinical outcomes of patients with acute ischemic stroke undergoing MT with non-contrast head computed tomography (NCHCT) alone versus patients undergoing NCHCT plus non-invasive vessel imaging (NVI) (including CT angiography (with or without CT perfusion) and magnetic resonance angiography). The primary outcome was the modified Rankin Scale (mRS) score at 90 days. Secondary outcomes included change in mRS score from baseline to 90 days, the proportions of mRS 0–1, 0–2, and 0–3, and dramatic clinical improvement at 24 hours. The safety outcomes were any intracranial hemorrhage (ICH), symptomatic ICH, and mortality within 90 days.

Results A total of 894 patients met the inclusion criteria; 476 (53%) underwent NCHCT alone and 418 (47%) underwent NCHCT + NVI. In the NCHCT alone group, the door-to-reperfusion time was shorter by 47 min compared with the NCHCT + NVI group (219 vs 266 min, P<0.001). Patients in the NCHCT alone group showed a smaller increase in baseline mRS score at 90 days (median 3 vs 2 points; P=0.004) after adjustment. There were no significant differences between groups in the remaining clinical outcomes.

Conclusions In patients selected for MT using NCHCT alone versus NCHCT + NVI, there were improved procedural outcomes and smaller increases in baseline mRS scores at 90 days.

Data availability statement

Data are available upon reasonable request. All data relevant to the study are included in the article or uploaded as supplementary information. All data relevant to the study are included in the article or uploaded as supplementary information. Data are available to researchers on request for purposes of reproducing the results or replicating the procedure by directly contacting the corresponding author.

http://dx.doi.org/10.1136/neurintsurg-2021-017940

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Data are available upon reasonable request. All data relevant to the study are included in the article or uploaded as supplementary information. All data relevant to the study are included in the article or uploaded as supplementary information. Data are available to researchers on request for purposes of reproducing the results or replicating the procedure by directly contacting the corresponding author.

Assessment of Optimal Patient Selection for Endovascular Thrombectomy Beyond 6 Hours After Symptom Onset: A Pooled Analysis of the AURORA Database

IT IS YOUR RESPONSIBILITY  to have the proper stroke and time it to get to the hospital on time.  All because your doctors and stroke hospital have not taken the proper steps to create 100% recovery protocols for ANY situation. 

 Any amount of cherry picking like this means your doctors haven't been proactive is solving for any stroke situation. I would have them fired.

It is obviously not your doctors or hospitals responsibility to be able to successfully treat all stroke patients. 100% recovery is success, NOTHING LESS!

 

Assessment of Optimal Patient Selection for Endovascular Thrombectomy Beyond 6 Hours After Symptom Onset: A Pooled Analysis of the AURORA Database

Gregory W Albers  ^{1   2} , Maarten G Lansberg  ^{1   2} , Scott Brown  ³ , Ashutosh P Jadhav  ⁴ , Diogo C Haussen  ⁵ , Sheila O Martins  ⁶ , Leticia C Rebello  ⁵ , Andrew M Demchuk  ^{7   8} , Mayank Goyal  ^{7   8} , Marc Ribo  ⁹ , Aquilla S Turk  ¹⁰ , David S Liebeskind  ^{11   12} , Jeremy J Heit  ¹³ , Michael P Marks  ¹³ , Tudor G Jovin  ¹⁴ , Raul G Nogueira  ⁵ , AURORA Investigators

Collaborators, Affiliations

• PMID: 34309619
• DOI: 10.1001/jamaneurol.2021.2319

Abstract

Importance: The optimal imaging approach for identifying patients who may benefit from endovascular thrombectomy (EVT) beyond 6 hours after they were last known well is unclear. Six randomized clinical trials (RCTs) have evaluated the efficacy of EVT vs standard medical care among patients with ischemic stroke.

Objective: To assess the benefits of EVT among patients with 3 baseline imaging profiles using a pooled analysis of RCTs.

Data sources: The AURORA (Analysis of Pooled Data from Randomized Studies of Thrombectomy More Than 6 Hours After Last Known Well) Collaboration pooled patient-level data from the included clinical trials.

Study selection: An online database search identified RCTs of endovascular stroke therapy published between January 1, 2010, and March 1, 2021, that recruited patients with ischemic stroke who were randomized between 6 and 24 hours after they were last known well.

Data extraction/synthesis: Data from the final locked database of each study were provided. Data were pooled, and analyses were performed using mixed-effects modeling with fixed effects for parameters of interest.

Main outcomes and measures: The primary outcome was reduction in disability(Look at that fucking tyranny of low expectations! NOT 100% RECOVERY!) measured by the modified Rankin Scale at 90 days. An evaluation was also performed to examine whether the therapeutic response differed based on imaging profile among patients who received treatment based on the time they were last known well. Treatment benefits were assessed among a clinical mismatch subgroup, a target perfusion mismatch subgroup, and an undetermined profile subgroup. The primary end point was assessed among these subgroups and during 3 treatment intervals (tercile 1, 360-574 minutes [6.0-9.5 hours]; tercile 2, 575-762 minutes [9.6-12.7 hours]; and tercile 3, 763-1440 minutes [12.8-24.0 hours]).

Results: Among 505 eligible patients, 266 (mean [SD] age, 68.4 [13.8] years; 146 women [54.9%]) were assigned to the EVT group and 239 (mean [SD] age, 68.7 [13.7] years; 126 men [52.7%]) were assigned to the control group. Among 295 patients in the clinical mismatch subgroup and 359 patients in the target perfusion mismatch subgroup, EVT was associated with reductions in disability at 90 days vs no EVT (clinical mismatch subgroup, odds ratio [OR], 3.57; 95% CI, 2.29-5.57; P < .001; target perfusion mismatch subgroup, OR, 3.13; 95% CI, 2.10-4.66; P = .001). Statistically significant benefits were observed in all 3 terciles for both subgroups, with the highest OR observed for tercile 3 (clinical mismatch subgroup, OR, 4.95; 95% CI, 2.20-11.16; P < .001; target perfusion mismatch subgroup, OR, 5.01; 95% CI, 2.37-10.60; P < .001). A total of 132 patients (26.1%) had an undetermined imaging profile and no significant treatment benefit (OR, 1.59; 95% CI, 0.82-3.06; P = .17). The interaction between treatment effects for the clinical and target perfusion mismatch subgroups vs the undetermined profile subgroup was significant (OR, 2.28; 95% CI, 1.11-4.70; P = .03).

Conclusions and relevance: In this study, EVT was associated with similar benefit among patients in the clinical mismatch and target perfusion mismatch subgroups during the 6- to 24-hour treatment interval. These findings support EVT as a treatment for patients meeting the criteria for either of the imaging mismatch profiles within the 6- to 24-hour interval.