Treatment of Acute Ischemic Stroke (ReMEDy2 Trial)

 FYI. You'll have to contact them to see if they are even measuring 100% recovery.

Here is your business101 requirements. Not measuring 100% recovery is the height of incompetence!

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

Ask your competent? doctor to explain the previous FDA hold on this research and notify you of the results when research is completed. No knowledge of this at all is fucking complete incompetence! I expect my doctors and therapists to be completely up to date on all research in the stroke field. You should be getting this information from your doctor, not me.

DM199 (3 posts to August 2022)

Treatment of Acute Ischemic Stroke (ReMEDy2 Trial)

ClinicalTrials.gov IDNCT05065216

SponsorDiaMedica Therapeutics Inc

Information Provided byJay Volpi, M.D.

Study Start (Actual)2021-11-07

Primary Completion (Estimated) 2026-12

Study Completion (Estimated)2026-12

Enrollment (Estimated)728

Study TypeInterventional

Last Update Posted2026-08-21

Study Overview

Brief Summary

This is a Phase 2/3 study evaluating the safety and efficacy of DM199 (rinvecalinase alfa) in treating participants with moderate stroke severity, who present within 24 hours of Acute Ischemic Stroke (AIS) onset due to small and medium vessel occlusions. This study focuses on participants with limited treatment options. Participants who have or will receive mechanical thrombectomy (MT) are not eligible for participation. Additionally, participants who have received fibrinolytics are excluded unless they experience a persistent neurological deficit of moderate severity six or more hours after fibrinolytic treatment. Participants considered for this trial should not be denied the use of standard of care (SoC) AIS therapies, such as fibrinolytics or MT, when appropriate. The double-blinded study will be randomized and placebo-controlled at up to approximately 100 sites.

To learn more, visitClinicalTrials.gov

International Classification of Functioning, Disability and Health-based rehabilitation program promotes activity and participation of post-stroke patients

Survivors don't just want perceived improvements, they want actual improvements. Did you measure actual?

International Classification of Functioning, Disability and Health-based rehabilitation program promotes activity and participation of post-stroke patients

Ngai-Kiu Mabel Wong^{1, 2} Mike Kwun-Ting Cheung³ Yuk-Mun Ng³ Huan-Ling Yuan¹ Bess Yin-Hung Lam⁴ Siu Ngor Fu¹ Chetwyn Che Hin Chan^5*

• ¹Department of Rehabilitation Sciences, Faculty of Health and Social Sciences, Hong Kong Polytechnic University, Hong Kong, SAR China
• ²Department of Psychology, The Education University of Hong Kong, Hong Kong, SAR China
• ³The Hong Kong Society for Rehabilitation (HKSR), Hong Kong, SAR China
• ⁴Department of Counselling and Psychology, Faculty of Social Sciences, Hong Kong Shue Yan University, Hong Kong, SAR China
• ⁵The Education University of Hong Kong, Hong Kong, SAR China

The final, formatted version of the article will be published soon.

The International Classification of Functioning, Disability, and Health (ICF) model has been applied in post-stroke rehabilitation, yet limited studies explored its clinical application on enhancing patients' Activity and Participation (ICF-A&P) level.Purpose: This study gathered evidence of the effects of an ICF-based post-stroke rehabilitation program (ICF-PSRP) in enhancing community reintegration in terms of ICF-A&P of post-stroke patients.Methods: Fifty-two post-stroke patients completed an 8-to-12-week multidisciplinary ICF-PSRP after setting personal treatment goals in an outpatient community rehabilitation center. Intake and pre-discharge assessments were administered for primary outcomes of Body function (ICF-BF; e.g., muscle strength) and ICF-A&P (e.g., mobility), and secondary outcomes of perceived improvements in ability (e.g., goal attainment and quality of life).

Results: There were significantly higher levels in the ICF-BF and ICF-A&P domains, except cognitive function under the ICF-BF. Improvements in the primary outcomes predicted corresponding secondary outcomes. Firstly, expressive and receptive functions (ICP-BF) were mediated by the everyday language (ICF-A&P) which predicted patients' satisfaction with the language-related quality of life. Secondly, upper extremity function (ICP-BF) was mediated by the lower extremity mobility (ICF-A&P) predicting work and productivity-related quality of life. Content analyses showed that combined ICF-BF and ICF-A&P contents throughout the ICF-PSRP contributed to the positive treatment effects.The ICF-PSRP was effective in promoting body function, and activity and participation levels of post-stroke patients. Positive treatment effects are characterized by goal-setting process, cross-domain content design, and community-setting delivery.

Keywords: Goal-setting process1, multidisciplinary approach2, community reintegration3, resuming life roles4, stroke rehabilitation5

Received: 16 Jun 2023; Accepted: 12 Oct 2023.

Copyright: © 2023 Wong, Cheung, Ng, Yuan, Lam, Fu and Chan. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence: Prof. Chetwyn Che Hin Chan, The Education University of Hong Kong, Tai Po, Hong Kong, SAR China

Shorter Intensive Care Unit Stay (12 Hours) Post Thrombolysis Is Safe and Reduces Length of Stay for Minor Stroke Patients

 Do you really think survivors care about safety? Safety is a given when they get to 100% recovery. They want full recovery. Where is your research providing that? This lazy crapola research needs to stop and that will only occur after survivors are in charge.

Shorter Intensive Care Unit Stay (12 Hours) Post Thrombolysis Is Safe and Reduces Length of Stay for Minor Stroke Patients

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Samantha Cencer, DO, Tricia Tubergen, Laurel Packard, ...

First Published February 23, 2022 Brief Report 

https://doi.org/10.1177/19418744211048014

Article information

Abstract

The current standard of practice for patients with acute ischemic stroke treated with intravenous tissue-type plasminogen activator (tPA) requires critical monitoring for 24-hours post-treatment due to the risk of symptomatic intracranial hemorrhage (sICH). This is a costly and resource intensive practice. In this study, we evaluated the safety and efficacy of this standard 24-hour ICU monitoring period compared with a shorter 12-hour ICU monitoring period for minor stroke patients (NIHSS 0-5) treated with tPA only. Stroke mimics and those who underwent thrombectomy were excluded. The primary outcome was length of hospital stay.( Totally the wrong outcome to measure. 100% recovery is the needed measurement!) Secondary outcome measures included sICH, deep venous thrombosis (DVT), pulmonary embolism (PE), pneumonia, favorable discharge to home or acute rehabilitation, readmission within 30 days, and favorable functional outcome defined as modified Rankin scale (mRS) of 0-2 at 90 days. Of the 122 patients identified, 77 were in the 24-hour protocol and 45 were in 12-hour protocol. There was significant difference in length of hospital stay for the 24-hour ICU protocol (2.8 days) compared with the 12-hour ICU protocol (1.8 days) (P < 0.001). Although not statistically significant, the 12-hour group had favorable rates of sICH, 30-day readmission rates, favorable discharge disposition and favorable functional outcome. Rates of DVT, PE and aspiration pneumonia were identical between the groups. Compared with 24-hour ICU monitoring, 12-hour ICU monitoring after thrombolysis for minor acute ischemic stroke was not associated with any increase in adverse outcomes. A randomized trial is needed to verify these findings.

Keywords

stroke, thrombolysis, intensive care

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Step Number and Aerobic Minute Exercise Prescription and Progression in Stroke: A Roadmap

Yeah, higher functioning survivors can walk longer and faster. Duh. Measurement does nothing for getting survivors recovered. You need to create a protocol and distribute it to all 10 million yearly stroke survivors.

Step Number and Aerobic Minute Exercise Prescription and Progression in Stroke: A Roadmap

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Sue Peters, PhD, Tara Klassen, PhD, Amy Schneeberg, PhD, ...

First Published December 23, 2021 Research Article Find in PubMed 

https://doi.org/10.1177/15459683211062894

Article information

Abstract

Background

While higher therapeutic intensity improves motor recovery after stroke, translating findings from successful studies is challenging without clear exercise intensity targets. We show in the DOSE trial¹ more than double the steps and aerobic minutes within a session can be achieved compared with usual care and translates to improved long-term walking outcomes.

Objective

We modeled data from this successful higher intensity multi-site RCT to develop targets for prescribing and progressing exercise for varying levels of walking impairment after stroke.

Methods

In twenty-five individuals in inpatient rehabilitation, twenty sessions were monitored for a total of 500 one-hour physical therapy sessions. For the 500 sessions, step number and aerobic minute progression were modeled using linear mixed effects regression. Using formulas from the linear mixed effects regression, targets were calculated.

Results

The model for step number included session number and baseline walking speed, and for aerobic minutes, session number and age. For steps, there was an increase of 73 steps per session. With baseline walking speed, for every 0.1 m/s increase, a corresponding increase of 302 steps was predicted. For aerobic minutes, there was an increase of .56 minutes of aerobic activity (ie, 34 seconds) per session. For every year increase in age, a decrease of .39 minutes (ie, 23 seconds) was predicted.

Conclusions

Using data associated with better walking outcomes, we provide step number and aerobic minute targets that future studies can cross-validate. As walking speed and age are collected at admission, these models allow for uptake of routine measurement of therapeutic intensity.

Registration: www.clinicaltrials.gov; NCT01915368.

Keywords

Rehabilitation, gait, outcomes, stroke, exercise

Introduction

Frequency, intensity, time, and type, or the FITT principle, is a way to outline the components of exercise prescription. While interpretation of clinical trials require the components of FITT to be depicted to allow for successful implementation, Billinger et al (2015) report that exercise intensity is only described adequately in 59% of clinical trials.² Further, no studies outline data-driven prescription and progression of therapeutic exercise intensity after stroke. In the absence of specific exercise prescription guidelines, rehabilitation therapists provide low exercise doses, despite evidence that higher intensity exercise improves neural and functional recovery.^1,3

When general targets are given to research therapists, our recent study shows more than double the steps and aerobic minutes can be achieved vs usual care and translates to improved long-term walking outcomes.¹ Yet, safety concerns keep some therapists from delivering higher exercise intensity⁴ since the subacute stroke period is a time of higher risk for cardiac complications.⁵ A roadmap highlighting key parameters that impact safe prescription and progression targets based on these parameters would be a useful clinical tool. To address this gap, we modeled data from a successful higher intensity multi-site randomized clinical trial to develop formulas for prescribing and progressing exercise for varying walking impairment levels after stroke.¹

More at link.

 

Thrombectomy With and Without Computed Tomography Perfusion Imaging in the Early Time Window: A Pooled Analysis of Patient-Level Data

 The tyranny of low expectations front and center. 'Good functional outcome' instead of 100% RECOVERY. 

What the fuck good does this do if you are not even measuring 100% recovery? You do realize the only goal in stroke is 100% recovery? If not get the hell out of stroke.

 With no measurements of 100% recovery they obviously have no intention of solving stroke at all.

Business 101: If you don't measure it, it is not important, so obviously 100% recovery is not important. 

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

The latest here:

Thrombectomy With and Without Computed Tomography Perfusion Imaging in the Early Time Window: A Pooled Analysis of Patient-Level Data

Ashutosh P. Jadhav

,

Mayank Goyal

,

Johanna Ospel

,

Bruce C. Campbell

,

Charles B.L.M. Majoie

,

Diederik W. Dippel

,

Phil White

,

Serge Bracard

,

Francis Guillemin

,

Antoni Davalos

,

Michael D. Hill

, … See all authors

Originally published30 Nov 2021https://doi.org/10.1161/STROKEAHA.121.034331Stroke. 2021;0:STROKEAHA.121.034331

Abstract

Background and Purpose:

The optimal imaging paradigm for endovascular thrombectomy (EVT) patient selection in early time window (0–6 hours) treated acute ischemic stroke patients remains uncertain. We aimed to compare post-EVT outcomes between patients who underwent prerandomization basic (noncontrast computed tomography [CT], CT angiography only) versus additional advanced imaging (computed tomography perfusion [CTP] imaging) and to determine the association of performance of prerandomization CTP imaging with clinical outcomes.

Methods:

The HERMES collaboration (Highly Effective Reperfusion Evaluated in Multiple Endovascular Stroke Trials) pooled patient-level data from randomized controlled trials comparing EVT with usual care for acute ischemic stroke due to anterior circulation large vessel occlusion. Good functional outcome, defined as modified Rankin Scale score 0 to 2 at 90 days, was compared between randomized patients with and without CTP baseline imaging. Univariable and multivariable binary logistic regression analysis was performed to determine the association of baseline CTP imaging and good functional outcome.

Results:

We analyzed 1348 patients 610 (45.3%) of whom underwent CTP prerandomization. The benefit of EVT compared with best medical management was maintained irrespective of the baseline imaging paradigm (90-day modified Rankin Scale score 0–2 in EVT versus control patients: with CTP: 46.0% (137/298) versus 28.9% (88/305), without CTP: 44.1% (162/367) versus 27.3% (100/366). Performance of CTP baseline imaging compared with baseline noncontrast CT and CT angiography only yielded similar rates of good outcome (odds ratio, 1.05 [95% CI, 0.82–1.33], adjusted odds ratio, 1.04, [95% CI, 0.80–1.35]).

Conclusions:

Rates of good functional outcome were similar among patients in whom CTP was or was not performed, and EVT treatment effect in the 0- to 6-hour time window was similar in patients with and without baseline CTP imaging.

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Implementation of dynamic Lycra® orthoses for arm rehabilitation in the context of a randomized controlled feasibility trial in stroke: A qualitative study using normalisation process theory

 So you measured NOTHING about recovery? Useless.

 Implementation of dynamic Lycra® orthoses for arm rehabilitation in the context of a randomized controlled feasibility trial in stroke: A qualitative study using normalisation process theory

Rehabilitation Process and Outcome , Volume 9

NARIC Accession Number: J85746.  What's this?
ISSN: 1179-5727.
Author(s): Delvaux, Joke ; John, Alexandra ; Wedderburn, Lucy ; Morris, Jacqui.
Publication Year: 2020.
Number of Pages: 10.

Abstract: 

Study explored how rehabilitation practitioners implemented dynamic Lycra® orthoses for arm recovery after stroke into rehabilitation practice as part of a feasibility randomized controlled trial. Semi-structured interviews were conducted at the end of the trial with 15 healthcare practitioners involved in delivery of dynamic Lycra® orthoses at 2 inpatient stroke units and their associated rehabilitation hospitals in Scotland. The interviews examined their experiences of orthosis implementation. Normalization Process Theory structured the interview guide and informed data analysis. NVivo software supported data analysis. Practitioners intuitively made sense of the intervention in the face of uncertainty about its precise mechanisms of action (Normalization Process Theory construct: coherence) and espoused commitment to the research, despite uncertainty about orthosis effectiveness (cognitive participation). They did however adapt the intervention based on perceived therapeutic need, their own skillsets and stroke survivor preference (collective action). They were uncertain about benefits (reflexive monitoring). Across the 4 theoretical constructs, ambivalence about the intervention was detected. Ambivalence interfered with implementation – but only to an extent. ‘Good-enough’ coherence, cognitive participation, collective action and reflexive monitoring were sufficient to initiate normalization – as long as implementation did not undermine the relationship between practitioner and stroke survivor. Ambivalence stemmed from practitioners’ uncertainty about the intervention theory and mechanisms of action. Making intervention mechanisms of action more explicit to practitioners may influence how they implement and adapt a research intervention and may determine whether those processes undermine or enhance outcomes.
Descriptor Terms: ASSISTIVE TECHNOLOGY, CLINICAL MANAGEMENT, HEALTH PERSONNEL, INTERNATIONAL REHABILITATION, LIMBS, MOTOR SKILLS, NURSING, OCCUPATIONAL THERAPY, ORTHOTICS, PHYSICAL THERAPY, STROKE.


Can this document be ordered through NARIC's document delivery service*?: Y.

Citation: Delvaux, Joke , John, Alexandra , Wedderburn, Lucy , Morris, Jacqui. (2020). Implementation of dynamic Lycra® orthoses for arm rehabilitation in the context of a randomized controlled feasibility trial in stroke: A qualitative study using normalisation process theory.  Rehabilitation Process and Outcome , 9 Retrieved 4/23/2021, from REHABDATA database.

Effect of Mechanical Thrombectomy Without vs With Intravenous Thrombolysis on Functional Outcome Among Patients With Acute Ischemic Stroke

Oh God, more noninferiority measurement rather than measuring it against 100% recovery. YOU DO KNOW THE ONLY GOAL IN STROKE IS 100% RECOVERY? Was the previous goal 100% recovery? If not then it had the wrong goal. Which means the stroke leadership doesn't know what it is doing.

Effect of Mechanical Thrombectomy Without vs With Intravenous Thrombolysis on Functional Outcome Among Patients With Acute Ischemic Stroke2++

The SKIP Randomized Clinical Trial

Kentaro Suzuki, MD, PhD¹; Yuji Matsumaru, MD, PhD²; Masataka Takeuchi, MD³; et al Masafumi Morimoto, MD, PhD⁴; Ryuzaburo Kanazawa, MD, PhD⁵; Yohei Takayama, MD⁶; Yuki Kamiya, MD, PhD⁷; Keigo Shigeta, MD, PhD⁸; Seiji Okubo, MD, PhD⁹; Mikito Hayakawa, MD²; Norihiro Ishii, MD, PhD¹⁰; Yorio Koguchi, MD, PhD¹¹; Tomoji Takigawa, MD, PhD¹²; Masato Inoue, MD, PhD¹³; Hiromichi Naito, MD¹⁴; Takahiro Ota, MD, PhD¹⁵; Teruyuki Hirano, MD, PhD¹⁶; Noriyuki Kato, MD, PhD¹⁷; Toshihiro Ueda, MD, PhD¹⁸; Yasuyuki Iguchi, MD, PhD¹⁹; Kazunori Akaji, MD, PhD²⁰; Wataro Tsuruta, MD, PhD²¹; Kazunori Miki, MD, PhD²²; Shigeru Fujimoto, MD, PhD²³; Tetsuhiro Higashida, MD, PhD⁵; Mitsuhiro Iwasaki, MD⁴; Junya Aoki, MD, PhD¹; Yasuhiro Nishiyama, MD, PhD¹; Toshiaki Otsuka, MD, PhD²⁴; Kazumi Kimura, MD, PhD¹; for the SKIP Study Investigators

Author Affiliations

JAMA. 2021;325(3):244-253. doi:10.1001/jama.2020.23522

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• Editorial
  Intravenous Thrombolysis Before Endovascular Thrombectomy for Acute Ischemic Stroke
  Jeffrey L. Saver, MD; Opeolu Adeoye, MD, MS

• Original Investigation
  Thrombolysis and Thrombectomy vs Thrombectomy Alone for Ischemic Stroke
  Jonathan M. Coutinho, MD; David S. Liebeskind, MD; Lee-Anne Slater, MD; Raul G. Nogueira, MD; Wayne Clark, MD; Antoni Dávalos, MD; Alain Bonafé, MD; Reza Jahan, MD; Urs Fischer, MD; Jan Gralla, MD; Jeffrey L. Saver, MD; Vitor M. Pereira, MD
• Original Investigation
  Effect of Intravenous Tenecteplase Dose on Cerebral Reperfusion Before Thrombectomy in Patients With Ischemic Stroke
  Bruce C. V. Campbell, PhD; Peter J. Mitchell, MMed; Leonid Churilov, PhD; Nawaf Yassi, PhD; Timothy J. Kleinig, PhD; Richard J. Dowling, MBBS; Bernard Yan, DMedSci; Steven J. Bush, MBBS; Vincent Thijs, PhD; Rebecca Scroop, MBBS; Marion Simpson, MBBS; Mark Brooks, MBBS; Hamed Asadi, MBBS; Teddy Y. Wu, PhD; Darshan G. Shah, MBBS; Tissa Wijeratne, MD; Henry Zhao, MBBS; Fana Alemseged, MD; Felix Ng, MBBS; Peter Bailey, MD; Henry Rice, MBBS; Laetitia de Villiers, MBBS; Helen M. Dewey, PhD; Philip M. C. Choi, MBChB; Helen Brown, MB BCh BAO; Kendal Redmond, MBBS; David Leggett, MBBS; John N. Fink, MBChB; Wayne Collecutt, MBBS; Thomas Kraemer, MD; Martin Krause, MD; Dennis Cordato, PhD; Deborah Field, MBBS; Henry Ma, PhD; Bill O’Brien, MBBS; Benjamin Clissold, MBBS; Ferdinand Miteff, MBBS; Anna Clissold, MBBS; Geoffrey C. Cloud, MBBS; Leslie E. Bolitho, MBBS; Luke Bonavia, MBBS; Arup Bhattacharya, MBBS; Alistair Wright, MBBS; Abul Mamun, MBBS; Fintan O’Rourke, MBBS; John Worthington, MBBS; Andrew A. Wong, PhD; Christopher R. Levi, MBBS; Christopher F. Bladin, MD; Gagan Sharma, MCA; Patricia M. Desmond, MD; Mark W. Parsons, PhD; Geoffrey A. Donnan, MD; Stephen M. Davis, MD; for the EXTEND-IA TNK Part 2 investigators
• Original Investigation
  Effect of Endovascular Treatment With vs Without IV Alteplase on Functional Independence After Acute Ischemic Stroke
  Wenjie Zi, MD; Zhongming Qiu, MD; Fengli Li, MD; Hongfei Sang, MD; Deping Wu, MD; Weidong Luo, MD; Shuai Liu, MD; Junjie Yuan, MD; Jiaxing Song, MD; Zhonghua Shi, MD; Wenguo Huang, MD; Min Zhang, MS; Wenhua Liu, MD; Zhangbao Guo, MS; Tao Qiu, MD; Qiang Shi, MS; Peiyang Zhou, MD; Li Wang, MD; Xinmin Fu, MD; Shudong Liu, MD; Shiquan Yang, MD; Shuai Zhang, MD; Zhiming Zhou, MD; Xianjun Huang, MD; Yan Wang, MD; Jun Luo, MS; Yongjie Bai, MD; Min Zhang, MS; Youlin Wu, MS; Guoyong Zeng, MD; Yue Wan, MD; Changming Wen, MD; Hongbin Wen, MD; Wentong Ling, MS; Zhuo Chen, MS; Miao Peng, MS; Zhibing Ai, MD; Fuqiang Guo, MD; Huagang Li, MD; Jing Guo, MS; Haitao Guan, MD; Zhiyi Wang, MS; Yong Liu, MS; Jie Pu, MD; Zhen Wang, MD; Hansheng Liu, MD; Luming Chen, MD; Jiacheng Huang, MD; Guoqiang Yang, MD; Zili Gong, MD; Jie Shuai, MD; Raul G. Nogueira, MD; Qingwu Yang, MD, PhD; DEVT Trial Investigators

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Thrombolysis Before Thrombectomy for Stroke

   

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Thrombolysis Before Thrombectomy for Stroke

Key Points

Question  In patients with acute large vessel occlusion stroke, is mechanical thrombectomy alone noninferior to combined intravenous thrombolysis using 0.6-mg/kg alteplase plus mechanical thrombectomy regarding functional outcomes?

Findings  In this randomized clinical trial of 204 patients, a favorable functional outcome occurred in 59.4% of those randomized to mechanical thrombectomy alone and in 57.3% of those randomized to combined intravenous thrombolysis plus mechanical thrombectomy (odds ratio, 1.09 [95% confidence limit below the noninferiority margin of 0.74]).

Meaning  The findings failed to demonstrate noninferiority of mechanical thrombectomy alone, compared with combined intravenous thrombolysis plus mechanical thrombectomy, for favorable functional outcome following acute large vessel occlusive ischemic stroke, although the wide confidence intervals around the effect estimate also did not allow a conclusion of inferiority.

Abstract

Importance  Whether intravenous thrombolysis is needed in combination with mechanical thrombectomy in patients with acute large vessel occlusion stroke is unclear.

Objective  To examine whether mechanical thrombectomy alone is noninferior to combined intravenous thrombolysis plus mechanical thrombectomy for favorable poststroke outcome.

Design, Setting, and Participants  Investigator-initiated, multicenter, randomized, open-label, noninferiority clinical trial in 204 patients with acute ischemic stroke due to large vessel occlusion enrolled at 23 hospital networks in Japan from January 1, 2017, to July 31, 2019, with final follow-up on October 31, 2019.

Interventions  Patients were randomly assigned to mechanical thrombectomy alone (n = 101) or combined intravenous thrombolysis (alteplase at a 0.6-mg/kg dose) plus mechanical thrombectomy (n = 103).

Main Outcomes and Measures  The primary efficacy end point was a favorable outcome defined as a modified Rankin Scale score (range, 0 [no symptoms] to 6 [death]) of 0 to 2 at 90 days, with a noninferiority margin odds ratio of 0.74, assessed using a 1-sided significance threshold of .025 (97.5% CI). There were 7 prespecified secondary efficacy end points, including mortality by day 90. There were 4 prespecified safety end points, including any intracerebral hemorrhage and symptomatic intracerebral hemorrhage within 36 hours.

Results  Among 204 patients (median age, 74 years; 62.7% men; median National Institutes of Health Stroke Scale score, 18), all patients completed the trial. Favorable outcome occurred in 60 patients (59.4%) in the mechanical thrombectomy alone group and 59 patients (57.3%) in the combined intravenous thrombolysis plus mechanical thrombectomy group, with no significant between-group difference (difference, 2.1% [1-sided 97.5% CI, −11.4% to ∞]; odds ratio, 1.09 [1-sided 97.5% CI, 0.63 to ∞]; P = .18 for noninferiority). Among the 7 secondary efficacy end points and 4 safety end points, 10 were not significantly different, including mortality at 90 days (8 [7.9%] vs 9 [8.7%]; difference, –0.8% [95% CI, –9.5% to 7.8%]; odds ratio, 0.90 [95% CI, 0.33 to 2.43]; P > .99). Any intracerebral hemorrhage was observed less frequently in the mechanical thrombectomy alone group than in the combined group (34 [33.7%] vs 52 [50.5%]; difference, –16.8% [95% CI, –32.1% to –1.6%]; odds ratio, 0.50 [95% CI, 0.28 to 0.88]; P = .02). Symptomatic intracerebral hemorrhage was not significantly different between groups (6 [5.9%] vs 8 [7.7%]; difference, –1.8% [95% CI, –9.7% to 6.1%]; odds ratio, 0.75 [95% CI, 0.25 to 2.24]; P = .78).

Conclusions and Relevance  Among patients with acute large vessel occlusion stroke, mechanical thrombectomy alone, compared with combined intravenous thrombolysis plus mechanical thrombectomy, failed to demonstrate noninferiority regarding favorable functional outcome. However, the wide confidence intervals around the effect estimate also did not allow a conclusion of inferiority.

Trial Registration  umin.ac.jp/ctr Identifier: UMIN000021488

• Editorial
  Intravenous Thrombolysis Before Endovascular Thrombectomy for Acute Ischemic Stroke

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Effect of Endovascular Treatment Alone vs Intravenous Alteplase Plus Endovascular Treatment on Functional Independence in Patients With Acute Ischemic Stroke

Oh God, more noninferiority measurement rather than measuring it against 100% recovery. YOU DO KNOW THE ONLY GOAL IN STROKE IS 100% RECOVERY? Was the previous goal 100% recovery? If not then it had the wrong goal. Which means the stroke leadership doesn't know what it is doing.

Effect of Endovascular Treatment Alone vs Intravenous Alteplase Plus Endovascular Treatment on Functional Independence in Patients With Acute Ischemic Stroke

The DEVT Randomized Clinical Trial

Wenjie Zi, MD¹; Zhongming Qiu, MD^1,2; Fengli Li, MD¹; et al Hongfei Sang, MD^1,3; Deping Wu, MD^1,4; Weidong Luo, MD¹; Shuai Liu, MD¹; Junjie Yuan, MD¹; Jiaxing Song, MD¹; Zhonghua Shi, MD⁵; Wenguo Huang, MD⁶; Min Zhang, MS⁶; Wenhua Liu, MD⁷; Zhangbao Guo, MS⁷; Tao Qiu, MD⁸; Qiang Shi, MS⁸; Peiyang Zhou, MD⁹; Li Wang, MD¹⁰; Xinmin Fu, MD¹¹; Shudong Liu, MD¹²; Shiquan Yang, MD¹³; Shuai Zhang, MD¹⁴; Zhiming Zhou, MD¹⁵; Xianjun Huang, MD¹⁵; Yan Wang, MD¹⁶; Jun Luo, MS¹⁷; Yongjie Bai, MD¹⁸; Min Zhang, MS¹⁹; Youlin Wu, MS²⁰; Guoyong Zeng, MD²¹; Yue Wan, MD²²; Changming Wen, MD²³; Hongbin Wen, MD²⁴; Wentong Ling, MS²⁵; Zhuo Chen, MS²⁶; Miao Peng, MS²⁷; Zhibing Ai, MD²⁸; Fuqiang Guo, MD²⁹; Huagang Li, MD³⁰; Jing Guo, MS³¹; Haitao Guan, MD³²; Zhiyi Wang, MS³³; Yong Liu, MS³⁴; Jie Pu, MD³⁵; Zhen Wang, MD³⁶; Hansheng Liu, MD¹; Luming Chen, MD¹; Jiacheng Huang, MD¹; Guoqiang Yang, MD¹; Zili Gong, MD¹; Jie Shuai, MD¹; Raul G. Nogueira, MD³⁷; Qingwu Yang, MD, PhD¹; for the DEVT Trial Investigators

Author Affiliations

JAMA. 2021;325(3):234-243. doi:10.1001/jama.2020.23523

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• Editorial
  Intravenous Thrombolysis Before Endovascular Thrombectomy for Acute Ischemic Stroke
  Jeffrey L. Saver, MD; Opeolu Adeoye, MD, MS

• Original Investigation
  Effect of Mechanical Thrombectomy Without vs With Intravenous Thrombolysis in Acute Ischemic Stroke
  Kentaro Suzuki, MD, PhD; Yuji Matsumaru, MD, PhD; Masataka Takeuchi, MD; Masafumi Morimoto, MD, PhD; Ryuzaburo Kanazawa, MD, PhD; Yohei Takayama, MD; Yuki Kamiya, MD, PhD; Keigo Shigeta, MD, PhD; Seiji Okubo, MD, PhD; Mikito Hayakawa, MD; Norihiro Ishii, MD, PhD; Yorio Koguchi, MD, PhD; Tomoji Takigawa, MD, PhD; Masato Inoue, MD, PhD; Hiromichi Naito, MD; Takahiro Ota, MD, PhD; Teruyuki Hirano, MD, PhD; Noriyuki Kato, MD, PhD; Toshihiro Ueda, MD, PhD; Yasuyuki Iguchi, MD, PhD; Kazunori Akaji, MD, PhD; Wataro Tsuruta, MD, PhD; Kazunori Miki, MD, PhD; Shigeru Fujimoto, MD, PhD; Tetsuhiro Higashida, MD, PhD; Mitsuhiro Iwasaki, MD; Junya Aoki, MD, PhD; Yasuhiro Nishiyama, MD, PhD; Toshiaki Otsuka, MD, PhD; Kazumi Kimura, MD, PhD; SKIP Study Investigators

Conversations with Dr Bauchner (21:48)

Thrombolysis Before Thrombectomy for Stroke

   

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Thrombolysis Before Thrombectomy for Stroke

Key Points

Question  Among patients with ischemic stroke secondary to large vessel occlusion and eligible for thrombolysis, is endovascular treatment alone noninferior to intravenous alteplase plus endovascular treatment with regard to functional independence?

Findings  In this randomized clinical trial that included 234 patients with acute ischemic stroke, the proportion who achieved functional independence at 90 days was 54.3% in the endovascular treatment alone group vs 46.6% in the intravenous alteplase plus endovascular treatment group, a difference that met the prespecified noninferiority margin of 10%.

Meaning  Among patients with acute ischemic stroke due to large vessel occlusion and eligible for thrombolysis, endovascular treatment alone, compared with intravenous alteplase plus endovascular treatment, met the prespecified statistical threshold for noninferiority for the outcome of 90-day functional independence, although the clinical acceptability of the threshold for noninferiority should be considered when interpreting the results.

Abstract

Importance  For patients with large vessel occlusion strokes, it is unknown whether endovascular treatment alone compared with intravenous thrombolysis plus endovascular treatment (standard treatment) can achieve similar functional outcomes.

Objective  To investigate whether endovascular thrombectomy alone is noninferior to intravenous alteplase followed by endovascular thrombectomy for achieving functional independence at 90 days among patients with large vessel occlusion stroke.

Design, Setting, and Participants  Multicenter, randomized, noninferiority trial conducted at 33 stroke centers in China. Patients (n = 234) were 18 years or older with proximal anterior circulation intracranial occlusion strokes within 4.5 hours from symptoms onset and eligible for intravenous thrombolysis. Enrollment took place from May 20, 2018, to May 2, 2020. Patients were enrolled and followed up for 90 days (final follow-up was July 22, 2020).

Interventions  A total of 116 patients were randomized to the endovascular thrombectomy alone group and 118 patients to combined intravenous thrombolysis and endovascular thrombectomy group.

Main Outcomes and Measures  The primary end point was the proportion of patients achieving functional independence at 90 days (defined as score 0-2 on the modified Rankin Scale; range, 0 [no symptoms] to 6 [death]). The noninferiority margin was −10%. Safety outcomes included the incidence of symptomatic intracerebral hemorrhage within 48 hours and 90-day mortality.

Results  The trial was stopped early because of efficacy when 234 of a planned 970 patients had undergone randomization. All 234 patients who were randomized (mean age, 68 years; 102 women [43.6%]) completed the trial. At the 90-day follow-up, 63 patients (54.3%) in the endovascular thrombectomy alone group vs 55 (46.6%) in the combined treatment group achieved functional independence at the 90-day follow-up (difference, 7.7%, 1-sided 97.5% CI, −5.1% to ∞)P for noninferiority = .003). No significant between-group differences were detected in symptomatic intracerebral hemorrhage (6.1% vs 6.8%; difference, −0.8%; 95% CI, −7.1% to 5.6%) and 90-day mortality (17.2% vs 17.8%; difference, −0.5%; 95% CI, −10.3% to 9.2%).

Conclusions and Relevance  Among patients with ischemic stroke due to proximal anterior circulation occlusion within 4.5 hours from onset, endovascular treatment alone, compared with intravenous alteplase plus endovascular treatment, met the prespecified statistical threshold for noninferiority for the outcome of 90-day functional independence. These findings should be interpreted in the context of the clinical acceptability of the selected noninferiority threshold.

Trial Registration  Chinese Clinical Trial Registry: ChiCTR-IOR-17013568

• Editorial
  Intravenous Thrombolysis Before Endovascular Thrombectomy for Acute Ischemic Stroke

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