scholarly journals EXPRESS: Clinical Effectiveness of Endovascular Stroke Treatment in the Early and Extended Time Windows

2021 ◽  
pp. 174749302110057
Author(s):  
Raul Nogueira ◽  
Diogo C. Haussen ◽  
David S. Liebeskind ◽  
Tudor G Jovin ◽  
Rishi Gupta ◽  
...  
Keyword(s):  
Randomized Clinical Trials ◽  
Mechanical Thrombectomy ◽  
Time Windows ◽  
Clinical Effectiveness ◽  
Inclusion Criteria ◽  
Open Label ◽  
Stroke Treatment ◽  
Clinical Criteria ◽  
Lower Baseline ◽  
Iv Tpa

Background The clinical efficacy of mechanical thrombectomy (MT) has been unequivocally demonstrated in multiple randomized clinical trials (RCTs). However, these studies were performed in carefully selected centers and utilized strict inclusion criteria. Aim We aimed to assess the clinical effectiveness of MT in a prospective registry. Methods A total of 2008 patients from 76 sites across 12 countries were enrolled in a prospective open-label MT registry. Patients were categorized into the corresponding cohorts of the SWIFT-Prime, DAWN, and DEFUSE 3 trials according to the basic demographic and clinical criteria without considering specific parenchymal imaging findings. Baseline and outcome variables were compared across the corresponding groups. Results As compared to the treated patients in the actual trials, registry-derived patients tended to be younger and had lower baseline ASPECTS. In addition, time to treatment was earlier and the use of IV-tPA and general anesthesia were higher in DAWN- and DEFUSE 3-registry derived patients versus their corresponding trials. Reperfusion rates were higher in the registry patients. The rates of 90-day good outcome (mRS0-2) in registry-derived patients were comparable to those of the patients treated in the corresponding RCTs (SWIFT-Prime,64.5% vs 60.2%; DAWN,50.4% vs 48.6%; Beyond-DAWN:52.4% vs 48.6%; DEFUSE 3, 52% vs 44.6%, respectively; all P>0.05). Registry-derived patients had significant less disability than the corresponding RCT controls (ordinal mRS shift OR, P<0.05 for all). Conclusion Our study provides favorable generalizability data for the safety and efficacy of thrombectomy in the “real-world” setting and supports that patients may be safely treated outside the constraints of RCTs.

Abstract P467: Clinical Effectiveness of Endovascular Stroke Treatment in the Early and Extended Time Windows

Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
Raul Nogueira ◽  
Diogo C Haussen ◽  
David S Liebeskind ◽  
Tudor G Jovin ◽  
Rishi Gupta ◽  
...  
Keyword(s):  
Randomized Clinical Trials ◽  
Time Windows ◽  
Clinical Effectiveness ◽  
Inclusion Criteria ◽  
Open Label ◽  
Time To Treatment ◽  
Stroke Treatment ◽  
Real World Setting ◽  
Lower Baseline ◽  
Iv Tpa

Background and Purpose: The clinical efficacy of mechanical thrombectomy (MT) has been unequivocally demonstrated in multiple randomized clinical trials (RCTs). However, these studies were performed in carefully selected centers and utilized strict inclusion criteria. We aim to assess the clinical effectiveness of MT by comparing the specific RCT populations with corresponding patient cohorts derived from a prospective registry. Methods: A total of 2008 patients from 76 sites across 12 countries were enrolled in a prospective open-label MT registry. Patients were categorized into the corresponding cohorts of the SWIFT-Prime, DAWN, and DEFUSE 3 trials based on the age, baseline NIHSS, occlusion site, IV tPA use, pre-morbid mRS and time to treatment criteria used in the RCTs without considering specific parenchymal imaging findings. Baseline and outcome variables were compared across the corresponding groups. Results: As compared to the treated patients in the actual trials, registry-derived patients tended to be younger and had lower baseline ASPECTS. In addition, time to treatment was earlier and the use of IV tPA and general anesthesia were higher in DAWN- and DEFUSE 3-registry derived patients versus their corresponding trials. Reperfusion rates were higher in the registry patients. The rates of 90-day good outcome (mRS 0-2) in registry-derived patients were comparable to those of the patients treated in the corresponding RCTs (SWIFT-Prime, 64.5% vs 60.2%; DAWN, 50.4% vs 48.6%; Beyond-DAWN: 52.4% vs 48.6%; DEFUSE 3, 52% vs 44.6%, respectively; all P>0.05). Registry-derived patients had significant less disability than the corresponding RCT controls (ordinal mRS shift OR, P <0.05 for all). Conclusion: Our study provides favorable generalizability data for the safety and efficacy of thrombectomy in the “real-world” setting and supports that patients may be safely treated outside the constraints of RCTs and strict guidelines.

scholarly journals Extended Window for Stroke Thrombectomy

2019 ◽  
Vol 10 (02) ◽  
pp. 294-300 ◽  
Author(s):  
Brian Snelling ◽  
David J. Mccarthy ◽  
Stephanie Chen ◽  
Samir Sur ◽  
Omar Elwardany ◽  
...  
Keyword(s):  
Perfusion Imaging ◽  
Randomized Clinical Trials ◽  
Standard Treatment ◽  
Mechanical Thrombectomy ◽  
Meta Analysis ◽  
Functional Independence ◽  
Endovascular Management ◽  
Vessel Occlusion ◽  
Stroke Treatment ◽  
Symptomatic Intracranial Hemorrhage

ABSTRACT Objective: Mechanical thrombectomy is the standard treatment for large vessel occlusion (LVO) in acute ischemic stroke (AIS) up to 6 h after onset. Recent trials have demonstrated a benefit for wake-up strokes and patients beyond 6 h. Methods: A systematic literature review was conducted for multicenter randomized clinical trials (RCTs) investigating endovascular stroke treatment using perfusion imaging to identify patients that may benefit from mechanical thrombectomy for AIS beyond 6 h of onset. Random effects meta-analysis was used to analyze the following outcomes: 90-day functional independence rates with modified Rankin Scale (mRS ≤2), 90-day mortality, and symptomatic intracranial hemorrhage (sICH) rates. Further stratification was carried out by age and presentation. Results: Two multicenter RCT’s were included as follows: DAWN and DEFUSE-3. Pooled 90-day functional independence rates favored endovascular management (odds ratio [OR] 5.01; P < 0.00001). Subgroup analysis demonstrated continued 90-day functional independence benefit for endovascular management regardless of age (≥80 years, OR 5.65, P = 0.01; ≤80 years, OR 4.92, P < 0.00001). When stratified for the manner of stroke discovery, 90-day functional independence rates favored endovascular management for wake-up strokes (OR 8.74, P < 0.00001) and known-time onset strokes (OR 5.08, 95% confidence interval [CI] 2.04–12.65, P = 0.0005), although no benefit was observed for unwitnessed strokes (OR 1.64, 95% CI 0.17–16.04, P = 0.67). No difference observed in 90-day mortality rates (OR 0.71; P = 0.14) or in SICH rates (OR 1.67; P = 0.29). Conclusions: This meta-analysis reinforces that endovascular management is superior to standard medical management alone for the treatment of AIS due to LVO beyond 6 h of onset in patients with perfusion-imaging selection.

Mechanical thrombectomy in ischemic stroke: Parameters affecting the TICI outcome

2021 ◽  
Vol 79 (1) ◽  
pp. 19-26
Author(s):  
Carolina Rio Bartulos ◽  
Dennis Lier ◽  
Harald Sahl ◽  
Mazen Abu-Mugheisib ◽  
Annette Spreer ◽  
...  
Keyword(s):  
Randomized Clinical Trials ◽  
Mechanical Thrombectomy ◽  
Clinical Trial Data ◽  
Successful Outcome ◽  
Data Sets ◽  
Stroke Management ◽  
Stroke Treatment ◽  
Treatment Objective ◽  
Time Periods ◽  
Timely Treatment

BACKGROUND: Mechanical thrombectomy (MT) is a standard stroke treatment for patients with large vessel occlusions (LVOs). A decisive factor for a successful outcome is, among other things, timely treatment. OBJECTIVE: The objective was to analyze several time points in relation to outcomes and/or surrogate parameters. Furthermore, our data was placed in the context of other clinical trial data. METHODS: We retrospectively evaluated 133 data sets from patients who underwent MT. The correlation of various time periods with parameters, such as the ASPECTS, NIHSS, mRS, and, particularly, the TICI score, was investigated. RESULTS: A correlation was found for both the NIHSS score at discharge and the TICI score with the time periods of arrival and/or start to groin puncture as well as with arrival to the end of the intervention and the duration of the intervention. CONCLUSIONS: This retrospective study is consistent with large randomized clinical trials investigating stroke management and provides data from daily clinical practice.

scholarly journals Assessing Durability of Vaccine Effect Following Blinded Crossover in COVID-19 Vaccine Efficacy Trials

2020 ◽  
Author(s):  
Dean Follmann ◽  
Jonathan Fintzi ◽  
Michael P. Fay ◽  
Holly E. Janes ◽  
Lindsey Baden ◽  
...  
Keyword(s):  
Vaccine Efficacy ◽  
Large Scale ◽  
Randomized Clinical Trials ◽  
Clinical Effectiveness ◽  
Late Enhancement ◽  
Open Label ◽  
Term Efficacy ◽  
Efficacy Trials ◽  
Timely Access ◽  
Over Time

ABSTRACTBackgroundSeveral candidate vaccines to prevent COVID-19 disease have entered large-scale phase 3 placebo-controlled randomized clinical trials and some have demonstrated substantial short-term efficacy. Efficacious vaccines should, at some point, be offered to placebo participants, which will occur before long-term efficacy and safety are known.MethodsFollowing vaccination of the placebo group, we show that placebo-controlled vaccine efficacy can be derived by assuming the benefit of vaccination over time has the same profile for the original vaccine recipients and the placebo crossovers. This reconstruction allows estimation of both vaccine durability and potential vaccine-associated enhanced disease.ResultsPost-crossover estimates of vaccine efficacy can provide insights about durability, identify waning efficacy, and identify late enhancement of disease, but are less reliable estimates than those obtained by a standard trial where the placebo cohort is maintained. As vaccine efficacy estimates for post-crossover periods depend on prior vaccine efficacy estimates, longer pre-crossover periods with higher case counts provide better estimates of late vaccine efficacy. Further, open-label crossover may lead to riskier behavior in the immediate crossover period for the unblinded vaccine arm, confounding vaccine efficacy estimates for all post-crossover periods.ConclusionsWe advocate blinded crossover and continued follow-up of trial participants to best assess vaccine durability and potential delayed enhancement of disease. This approach allows placebo recipients timely access to the vaccine when it would no longer be proper to maintain participants on placebo, yet still allows important insights about immunological and clinical effectiveness over time.

scholarly journals Acute reperfusion therapies for acute ischemic stroke patients with unknown time of symptom onset or in extended time windows: an individualized approach

2021 ◽  
Vol 14 ◽  
pp. 175628642110211
Author(s):  
Georgios Magoufis ◽  
Apostolos Safouris ◽  
Guy Raphaeli ◽  
Odysseas Kargiotis ◽  
Klearchos Psychogios ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Endovascular Treatment ◽  
Acute Ischemic Stroke ◽  
Symptom Onset ◽  
Time Windows ◽  
Intravenous Thrombolysis ◽  
Inclusion Criteria ◽  
Stroke Patients ◽  
Treatment Algorithms ◽  
Late Presenters

Recent randomized controlled clinical trials (RCTs) have revolutionized acute ischemic stroke care by extending the use of intravenous thrombolysis and endovascular reperfusion therapies in time windows that have been originally considered futile or even unsafe. Both systemic and endovascular reperfusion therapies have been shown to improve outcome in patients with wake-up strokes or symptom onset beyond 4.5 h for intravenous thrombolysis and beyond 6 h for endovascular treatment; however, they require advanced neuroimaging to select stroke patients safely. Experts have proposed simpler imaging algorithms but high-quality data on safety and efficacy are currently missing. RCTs used diverse imaging and clinical inclusion criteria for patient selection during the dawn of this novel stroke treatment paradigm. After taking into consideration the dismal prognosis of nonrecanalized ischemic stroke patients and the substantial clinical benefit of reperfusion therapies in selected late presenters, we propose rescue reperfusion therapies for acute ischemic stroke patients not fulfilling all clinical and imaging inclusion criteria as an option in a subgroup of patients with clinical and radiological profiles suggesting low risk for complications, notably hemorrhagic transformation as well as local or remote parenchymal hemorrhage. Incorporating new data to treatment algorithms may seem perplexing to stroke physicians, since treatment and imaging capabilities of each stroke center may dictate diverse treatment pathways. This narrative review will summarize current data that will assist clinicians in the selection of those late presenters that will most likely benefit from acute reperfusion therapies. Different treatment algorithms are provided according to available neuroimaging and endovascular treatment capabilities.

scholarly journals How to objectively assess and observe maladaptive pain behaviors in clinical rehabilitation: a systematic search and review

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Florian Naye ◽  
Chloé Cachinho ◽  
Annie-Pier Tremblay ◽  
Maude Saint-Germain Lavoie ◽  
Gabriel Lepage ◽  
...  
Keyword(s):  
Back Pain ◽  
Clinical Practice ◽  
Critical Appraisal ◽  
Inclusion Criteria ◽  
Clinical Criteria ◽  
Affective Factors ◽  
Pain Behaviors ◽  
Observation Methods ◽  
Critical Appraisal Tool ◽  
Secondary Objective

Abstract Background Cognitive-affective factors influence the perception of pain and disability. These factors can lead to pain behaviors (PB) that can persist and become maladaptive. These maladaptive PB will further increase the risk of chronicity or persistence of symptoms and disability. Thus, clinicians must be prepared to recognize maladaptive PB in a clinical context. To date, in the context of assessment in a rehabilitation setting, PB in clinical settings are poorly documented. The main objective of this study was to identify direct observation methods and critically appraise them in order to propose recommendations for practice. As a secondary objective, we explored and extracted the different observable PB that patients could exhibit and that clinicians could observe. Methods We conducted a comprehensive review on four databases with a generic search strategy in order to obtain the largest range of PB. For the first objective, a two-step critical appraisal used clinical criteria (from qualitative studies on barriers to implement routine measures) and psychometric criteria (from Brink and Louw critical appraisal tool) to determine which observation methods could be recommended for clinical practice. For the second objective, we extracted PB found in the literature to list potential PB that patients could exhibit, and clinicians could observe. Results From the 3362 retrieved studies, 47 met the inclusion criteria for the first objective. The clinical criteria allowed us to select three observation methods. After the psychometric step, two observation methods were retained and recommended for clinical practice: the Behavioral Avoidance Test-Back Pain (BAT-Back) and the Pain Behaviour Scale (PaBS). For the second objective, 107 studies met the inclusion criteria. The extraction of the PB allowed us to list a large range of PB and classify the data in 7 categories of PB. Conclusion Our results allowed us to recommend two observation methods for clinical practice. However, these methods have limitations and are validated only in chronic low back pain populations. With the extraction of PB presented in the literature, we contribute to better prepare clinicians to recognize PB in all patients who are experiencing pain.

scholarly journals Factors associated with early reperfusion improvement after intra-arterial fibrinolytics as rescue for mechanical thrombectomy

2021 ◽  
Vol 5 (1) ◽  
pp. 2514183X2110173
Author(s):  
Johannes Kaesmacher ◽  
Giovanni Peschi ◽  
Nuran Abdullayev ◽  
Basel Maamari ◽  
Tomas Dobrocky ◽  
...  
Keyword(s):  
Odds Ratio ◽  
Clinical Effect ◽  
Mechanical Thrombectomy ◽  
Functional Independence ◽  
Cardioembolic Stroke ◽  
Inclusion Criteria ◽  
Early Reperfusion ◽  
Factors Associated ◽  
Randomized Controlled ◽  
Interaction Terms

Objective: To identify factors associated with early angiographic reperfusion improvement (EARI) following intra-arterial fibrinolytics (IAF) after failed or incomplete mechanical thrombectomy (MT). Methods: A subset of patients treated with MT and IAF rescue after incomplete reperfusion included in the INFINITY (INtra-arterial FIbriNolytics In ThrombectomY) multicenter observational registry was analyzed. Multivariable logistic regression was used to identify factors associated with EARI. Heterogeneity of the clinical effect of EARI on functional independence (defined as modified Rankin Score ≤2) was tested with interaction terms. Results: A total of 228 patients (median age: 72 years, 44.1% female) received IAF as rescue for failed or incomplete MT and had a post-fibrinolytic angiographic control run available (50.9% EARI). A cardioembolic stroke origin (adjusted odds ratio (aOR) 3.72, 95% confidence interval (CI) 1.39–10.0) and shorter groin puncture to IAF intervals (aOR 0.82, 95% CI 0.71–0.95 per 15-min delay) were associated with EARI, while pre-interventional thrombolysis showed no association (aOR 1.15, 95% CI 0.59–2.26). The clinical benefit of EARI after IAF seemed more pronounced in patients without or only minor early ischemic changes (Alberta Stroke Program Early Computed Tomography Score (ASPECTS) ≥9, aOR 4.00, 95% CI 1.37–11.61) and was absent in patients with moderate to severe ischemic changes (ASPECTS ≤8, aOR 0.94, 95% CI 0.27–3.27, p for interaction: 0.095). Conclusion: Early rescue and a cardioembolic stroke origin were associated with more frequent EARI after IAF. The clinical effect of EARI seemed reduced in patients with already established infarcts. If confirmed, these findings can help to inform patient selection and inclusion criteria for randomized-controlled trials evaluating IAF as rescue after MT.

scholarly journals Non-operative orthobiologic use for rotator cuff disorders and glenohumeral osteoarthritis: A systematic review

2020 ◽  
pp. 1-16
Author(s):  
David M. Robinson ◽  
Christine Eng ◽  
Steven Makovitch ◽  
Joshua B. Rothenberg ◽  
Stephanie DeLuca ◽  
...  
Keyword(s):  
Systematic Review ◽  
Rotator Cuff ◽  
Cohort Studies ◽  
Randomized Clinical Trials ◽  
Platelet Rich Plasma ◽  
Inclusion Criteria ◽  
Serious Adverse Events ◽  
Bias Risk ◽  
Glenohumeral Osteoarthritis ◽  
Functional Outcome Measures

BACKGROUND: Shoulder pain from rotator cuff pathology and glenohumeral osteoarthritis is a common entity encountered in musculoskeletal practices. Orthobiologic agents are being increasingly used as a treatment option and understanding their safety and efficacy is necessary. OBJECTIVE: To systematically evaluate the available evidence for orthobiologic use in rotator cuff and glenohumeral pathology. METHODS: A systematic review was undertaken following PRISMA guidelines. Randomized clinical trials (RCTs) and prospective cohort studies evaluating non-operative treatment with prolotherapy, platelet-rich plasma (PRP), or medicinal signaling cells (MSCs) for rotator cuff pathology and glenohumeral osteoarthritis were included. Bias risk assessments used were the Cochrane tool and Newcastle-Ottawa score. RESULTS: The search yielded 852 potential articles, of which 20 met the inclusion criteria with a breakdown of 5 prolotherapy, 13 PRP, and 2 MSC. Sixteen studies were RCTs and 4 were cohort studies. Six studies were deemed “low risk of bias or good quality”. Efficacy results were mixed, and no serious adverse events were reported from orthobiologic treatment. CONCLUSIONS: Orthobiologics offer a relatively safe management option with inconclusive evidence for or against its use for rotator cuff pathology. No studies on glenohumeral osteoarthritis met the inclusion criteria. Adoption of standardized preparation reporting and consistent use of functional outcome measures is imperative for future studies to consider.

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