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  • 1
    Online Resource
    Online Resource
    Sonothrombolysis in Patients With Acute Ischemic Stroke With Large Vessel Occlusion: An Individual Patient Data Meta-Analysis
    Ovid Technologies (Wolters Kluwer Health) ; 2021
    In:  Stroke Vol. 52, No. 12 ( 2021-12), p. 3786-3795
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 52, No. 12 ( 2021-12), p. 3786-3795
    Abstract: Evidence about the utility of ultrasound-enhanced thrombolysis (sonothrombolysis) in patients with acute ischemic stroke (AIS) is conflicting. We aimed to evaluate the safety and efficacy of sonothrombolysis in patients with AIS with large vessel occlusion, by analyzing individual patient data of available randomized-controlled clinical trials. Methods: We included all available randomized-controlled clinical trials comparing sonothrombolysis with or without addition of microspheres (treatment group) to intravenous thrombolysis alone (control group) in patients with AIS with large vessel occlusion. The primary outcome measure was the rate of complete recanalization at 1 to 36 hours following intravenous thrombolysis initiation. We present crude odds ratios (ORs) and ORs adjusted for the predefined variables of age, sex, baseline stroke severity, systolic blood pressure, and onset-to-treatment time. Results: We included 7 randomized controlled clinical trials that enrolled 1102 patients with AIS. A total of 138 and 134 confirmed large vessel occlusion patients were randomized to treatment and control groups respectively. Patients randomized to sonothrombolysis had increased odds of complete recanalization compared with patients receiving intravenous thrombolysis alone (40.3% versus 22.4%; OR, 2.17 [95% CI, 1.03–4.54]; adjusted OR, 2.33 [95% CI, 1.02–5.34] ). The likelihood of symptomatic intracranial hemorrhage was not significantly different between the 2 groups (7.3% versus 3.7%; OR, 2.03 [95% CI, 0.68–6.11]; adjusted OR, 2.55 [95% CI, 0.76–8.52] ). No differences in the likelihood of asymptomatic intracranial hemorrhage, 3-month favorable functional and 3-month functional independence were documented. Conclusions: Sonothrombolysis was associated with a nearly 2-fold increase in the odds of complete recanalization compared with intravenous thrombolysis alone in patients with AIS with large vessel occlusions. Further study of the safety and efficacy of sonothrombolysis is warranted.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/STROKEAHA.120.030960
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2021
    detail.hit.zdb_id: 1467823-8
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  • 2
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    Blood pressure excursions in acute ischemic stroke patients treated with intravenous thrombolysis
    Ovid Technologies (Wolters Kluwer Health) ; 2021
    In:  Journal of Hypertension Vol. 39, No. 2 ( 2021-02), p. 266-272
    Details
    In: Journal of Hypertension, Ovid Technologies (Wolters Kluwer Health), Vol. 39, No. 2 ( 2021-02), p. 266-272
    Abstract: To investigate the association of blood pressure BP excursions, defined as greater than 185 SBP or greater than 105 DBP, with the probability of intracranial hemorrhage (ICH) and worse functional outcomes in patients with acute ischemic stroke (AIS) treated with tissue plasminogen activator (tPA). Methods: We performed a post hoc analysis of the CLOTBUST-ER trial. Serial BP measurements were conducted using automated cuff recording according to the recommended BP protocol guidelines for tPA administration. The outcomes were prespecified efficacy and safety endpoints of CLOTBUST-ER. Results: The mean number of serial BP recordings per patient was 37. Of the 674 patients, 227 (34%) had at least one BP excursion ( 〉 185/105 mmHg) during the first 24 h following tPA-bolus. The majority of BP excursions (46%) occurred within the first 75 min from tPA-bolus. Patients with at least one BP excursion in the first 24 h following tPA bolus had significantly lower rates of independent functional outcome at 90 days (31 vs. 40.1%, P  = 0.028). The total number of BP excursions was associated with decreased odds of 24-h clinical recovery (OR = 0.88, 95% CI:0.80–0.96), 24-h neurological improvement (OR = 0.87, 95% CI: 0.81–0.94), 7-day functional improvement (common OR = 0.92, 95% CI: 0.87–0.97), 90-day functional improvement (common OR = 0.94, 95% CI: 0.88–0.98) and 90-day independent functional outcome (OR = 0.90, 95% CI: 0.82–0.98) in analyses adjusted for potential confounders. DBP excursions were independently associated with increased odds of any intracranial hemorrhage (OR = 1.26, 95% CI: 1.04–1.53). Conclusion: BP excursions above guideline thresholds during the first 24 h following tPA administration for AIS are common and are independently associated with adverse clinical outcomes.
    Type of Medium: Online Resource
    ISSN: 0263-6352 , 1473-5598
    URL: Article
    DOI: 10.1097/HJH.0000000000002628
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2021
    detail.hit.zdb_id: 2017684-3
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  • 3
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    Outcomes following Sonothrombolysis in Severe Acute Ischemic Stroke: Subgroup Analysis of the CLOTBUST Trial
    SAGE Publications ; 2014
    In:  International Journal of Stroke Vol. 9, No. 8 ( 2014-12), p. 1006-1010
    Details
    In: International Journal of Stroke, SAGE Publications, Vol. 9, No. 8 ( 2014-12), p. 1006-1010
    Abstract: Sonothrombolysis is safe and may increase the likelihood of early recanalization in acute ischemic stroke patients. Aims In preparation of a phase III clinical trial, we contrast the likelihood of achieving a sustained recanalization and functional independence in a post hoc subgroup analysis of patients randomized to transcranial Doppler monitoring plus intravenous tissue plasminogen activator (sonothrombolysis) compared with intravenous tissue plasminogen activator alone in the CLOTBUST trial. Methods We analyzed the data from all randomized acute ischemic stroke patients with pretreatment National Institutes of Health Stroke Scale scores ≥ 10 points and proximal intracranial occlusions in the CLOTBUST trial. We compared sustained complete recanalization rate (Thrombolysis in Brain Ischemia flow grades 4–5) and functional independence (modified Rankin Scale 0–1) at 90 days. Safety was evaluated by the rate of symptomatic intracranial hemorrhage within 72 h of stroke onset. Results Of 126 patients, a total of 85 acute ischemic stroke patients met our inclusion criteria: mean age 71 ± 11years, 56% men, median National Institutes of Health Stroke Scale 17 (interquartile range 14–20). Of these patients, 41 (48%) and 44 (52%) were randomized to intravenous tissue plasminogen activator alone and sonothrombolysis, respectively. More patients achieved sustained complete recanalization in the sonothrombolysis than in the intravenous tissue plasminogen activator alone group (38·6% vs. 17·1%; P = 0·032). Functional independence at 90 days was more frequently achieved in the sonothrombolysis than in the intravenous tissue plasminogen activator alone group (37·2% vs. 15·8%; P = 0·045). Symptomatic intracranial hemorrhage rate was similar in both groups (4·9% vs. 4·6%; P = 1·00). Conclusions Our results point to a signal of efficacy and provide information to guide the subsequent phase III randomized trial of sonothrombolysis in patients with severe ischemic strokes.
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    URL: Article
    DOI: 10.1111/ijs.12340
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2014
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  • 4
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    Endovascular equipoise shift in a phase III randomized clinical trial of sonothrombolysis for acute ischemic stroke
    SAGE Publications ; 2019
    In:  Therapeutic Advances in Neurological Disorders Vol. 12 ( 2019-01), p. 175628641986065-
    Details
    In: Therapeutic Advances in Neurological Disorders, SAGE Publications, Vol. 12 ( 2019-01), p. 175628641986065-
    Abstract: Results of our recently published phase III randomized clinical trial of ultrasound-enhanced thrombolysis (sonothrombolysis) using an operator-independent, high frequency ultrasound device revealed heterogeneity of patient recruitment among centers. Methods: We performed a post hoc analysis after excluding subjects that were recruited at centers reporting a decline in the balance of randomization between sonothrombolysis and concurrent endovascular trials. Results: From a total of 676 participants randomized in the CLOTBUST-ER trial we identified 52 patients from 7 centers with perceived equipoise shift in favor of endovascular treatment. Post hoc sensitivity analysis in the intention-to-treat population adjusted for age, National Institutes of Health Scale score at baseline, time from stroke onset to tPA bolus and baseline serum glucose showed a significant (p  〈  0.01) interaction of perceived endovascular equipoise shift on the association between sonothrombolysis and 3 month functional outcome [adjusted common odds ratio (cOR) in centers with perceived endovascular equipoise shift: 0.22, 95% CI 0.06–0.75; p = 0.02; adjusted cOR for centers without endovascular equipoise shift: 1.20, 95% CI 0.89–1.62; p = 0.24)]. After excluding centers with perceived endovascular equipoise shift, patients randomized to sonothrombolysis had higher odds of 3 month functional independence (mRS scores 0–2) compared with patients treated with tPA only (adjusted OR: 1.53; 95% CI 1.01–2.31; p = 0.04). Conclusion: Our experience in CLOTBUST-ER indicates that increasing implementation of endovascular therapies across major academic stroke centers raises significant challenges for clinical trials aiming to test noninterventional or adjuvant reperfusion strategies.
    Type of Medium: Online Resource
    ISSN: 1756-2864 , 1756-2864
    URL: Article
    DOI: 10.1177/1756286419860652
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2019
    detail.hit.zdb_id: 2442245-9
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  • 5
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    Transcranial ultrasound in clinical sonothrombolysis (TUCSON) trial
    Wiley ; 2009
    In:  Annals of Neurology Vol. 66, No. 1 ( 2009-07), p. 28-38
    Details
    In: Annals of Neurology, Wiley, Vol. 66, No. 1 ( 2009-07), p. 28-38
    Type of Medium: Online Resource
    ISSN: 0364-5134 , 1531-8249
    URL: Issue
    URL: Article
    DOI: 10.1002/ana.v66:1
    DOI: 10.1002/ana.21723
    Language: English
    Publisher: Wiley
    Publication Date: 2009
    detail.hit.zdb_id: 2037912-2
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  • 6
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    Partial Aortic Occlusion for Cerebral Perfusion Augmentation : Safety and Efficacy of NeuroFlo in Acute Ischemic Stroke Trial
    Ovid Technologies (Wolters Kluwer Health) ; 2011
    In:  Stroke Vol. 42, No. 6 ( 2011-06), p. 1680-1690
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 42, No. 6 ( 2011-06), p. 1680-1690
    Abstract: Fewer than 5% of patients with acute ischemic stroke are currently treated, and there is need for additional treatment options. A novel catheter treatment (NeuroFlo) that increases cerebral blood flow was tested to 14 hours. Methods— The Safety and Efficacy of NeuroFlo in Acute Ischemic Stroke trial is a randomized trial of the safety and efficacy of NeuroFlo treatment in improving neurological outcome versus standard medical management. The primary safety end point was the incidence of serious adverse events through 90 days. The primary efficacy end point on a modified intent-to-treat population was a global disability end point at 90 days. Secondary end points included mortality, intracranial hemorrhage, modified Rankin scale score outcome of 0 to 2, and modified Rankin scale shift analysis. Results— Between October 2005 and January 2010, 515 patients were enrolled at 68 centers in 9 countries. The primary efficacy end point did not reach statistical significance (OR, 1.17; CI, 0.81–1.67; P =0.407). The primary safety end point did not show a difference in serious adverse events ( P =0.923). Ninety-day mortality was 11.3% (26/230) in treatment and 16.3% (42/257) in control ( P =0.087). Post hoc analyses showed that patients presenting within 5 hours (OR, 3.33; CI, 1.31–8.48), with NIHSS score 8 to 14 (OR, 1.80; CI, 0.99–3.30), or older than age 70 years (OR, 2.02; CI, 1.02–4.03) had better modified Rankin scale score outcomes of 0 to 2; additionally, there were fewer stroke-related deaths in treatment compared to control groups (7.4%=17/230; 14.4%=37/257). Conclusions— The trial met its primary safety end point but not its primary efficacy end point. Signals of treatment effect were suggested on all-cause mortality, in patients presenting early, older than age 70 years, or with moderate strokes, but these require confirmation. Clinical Trial Registration Information— URL: http://clinicaltrials.gov . Unique identifier: NCT00119717.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/STROKEAHA.110.609933
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2011
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  • 7
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    Combined Lysis of Thrombus with Ultrasound and Systemic Tissue Plasminogen Activator for Emergent Revascularization in Acute Ischemic Stroke (Clotbust-ER): Design and Methodology of a Multinational Phase 3 Trial
    SAGE Publications ; 2015
    In:  International Journal of Stroke Vol. 10, No. 7 ( 2015-10), p. 1141-1148
    Details
    In: International Journal of Stroke, SAGE Publications, Vol. 10, No. 7 ( 2015-10), p. 1141-1148
    Abstract: We designed a Phase 3 clinical trial to determine the safety and efficacy of adding transcranial ultrasound using an operator-independent headframe to recombinant tissue-plasminogen-activator for the treatment of acute ischemic stroke. Methods Combined lysis of thrombus with ultrasound and systemic tissue-plasminogen-activator for emergent revascularization in acute ischemic stroke is a randomized, double-blind, placebo-controlled clinical trial that will enroll subjects with the following main inclusion criteria: less than 4·5 hours from symptom onset (three-hours in US and Canada), age 18–80 years, baseline National Institutes of Health Stroke Scale score ≥ 10, and premorbid modified-Rankin-score of 0–1, eligibility for full dose recombinant tissue-plasminogen-activator. Subjects will receive two-hours of 2-MHz pulsed wave transcranial ultrasound (target group) or sham ultrasound (control group). The projected sample size is approximately 824 subjects. Results The primary endpoint, based on intention-to-treat criteria of patients enrolled within three-hours of symptom onset is the comparison between target and control groups of modified-Rankin-score scores at day 90 poststroke assessed using the proportional odds method. The study will have two planned interim analyses after approximately one-third and two-thirds of subjects have reached the 90-day modified-Rankin-score evaluation. Safety outcomes are symptomatic intracranial hemorrhage within 24 h and an overall analysis of adverse events. Conclusions Since intravenous recombinant tissue-plasminogen-activator remains the only medical therapy to reverse ischemic stroke applicable in the emergency department, our trial will determine if the additional use of transcranial ultrasound improves functional outcomes in patients with severe acute ischemic stroke (NCT#01098981).
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    URL: Article
    DOI: 10.1111/ijs.12536
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2015
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  • 8
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    Safety and Dose-Escalation Study Design of Transcranial Ultrasound in Clinical Sonolysis for Acute Ischemic Stroke: The TUCSON Trial
    SAGE Publications ; 2009
    In:  International Journal of Stroke Vol. 4, No. 1 ( 2009-02), p. 42-48
    Details
    In: International Journal of Stroke, SAGE Publications, Vol. 4, No. 1 ( 2009-02), p. 42-48
    Abstract: Transcranial Doppler (TCD) monitoring during intravenous tissue plasminogen activator (i.v.-tPA) infusion increases recanalization rates in acute ischemic stroke. Addition of perflutren-lipid microspheres MRX-801 (μS) may further enhance the process of recanalization. This article describes the design of the Transcranial Ultrasound in Clinical SONolysis (TUCSON) trial. Aims and Design TUCSON is a phase I-II, randomized, placebo-controlled, open-label, safety, dose-escalation clinical trial of μS+TCD ultrasound (sonolysis). Patients with acute ischemic stroke and arterial intracranial occlusions are enrolled within 3 h of symptom onset. All patients receive standard i.v.-tPA and will be randomized to 90 min of continuous 2-MHz TCD+μS or 90 min of saline+brief TCD vessel assessments. The safety profile of four escalating dose tiers will be assessed. Arterial occlusions and recanalization are defined with the Thrombolysis in Brain Ischemia flow grades. Study Outcomes Safety is determined by the rates of symptomatic intracerebral hemorrhage within 36 h. Neurological deficits and outcomes are measured with the National Institute of Health Stroke Scale and modified Rankin Scale (mRS). The signal-of-efficacy is determined by rates of recanalization, dramatic or early clinical recovery within 2 h, clinical recovery at 24–36 h and independent outcome (mRS 0–2) at 90 days.
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    URL: Article
    DOI: 10.1111/j.1747-4949.2009.00252.x
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2009
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  • 9
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    Validity of HAT Score for Predicting Symptomatic Intracranial Hemorrhage in Acute Stroke Patients with Proximal Occlusions: Data from Randomized Trials of Sonothrombolysis
    S. Karger AG ; 2011
    In:  Cerebrovascular Diseases Vol. 31, No. 5 ( 2011), p. 471-476
    Details
    In: Cerebrovascular Diseases, S. Karger AG, Vol. 31, No. 5 ( 2011), p. 471-476
    Abstract: 〈 i 〉 Background: 〈 /i 〉 The Hemorrhage after Thrombolysis (HAT) score has recently been introduced as a practical scale for risk stratification of intracranial hemorrhage (ICH) in patients receiving intravenous tissue plasminogen activator (tPA). We aimed to externally validate and evaluate the predictive ability of the HAT score in patients with proximal arterial occlusions (PAO) enrolled into randomized clinical trials of sonothrombolysis. 〈 i 〉 Methods: 〈 /i 〉 The HAT score (range 0, minimum risk, to 5, maximum risk) was retrospectively calculated for each patient using clinical trial data (baseline NIHSS, extent of hypodensity on CT, history of diabetes mellitus and serum glucose). Symptomatic ICH (sICH) was defined as imaging evidence of ICH with clinical worsening (NIHSS ≧4) within 72 h from stroke onset. The predictive ability of the HAT score for sICH and any ICH (both asymptomatic and symptomatic) was calculated using c statistics. 〈 i 〉 Results: 〈 /i 〉 A total of 161 tPA-treated patients (mean age 68 ± 13 years, 58% men, median NIHSS 16, interquartile range 9) with PAO were randomized in TUCSON (n = 35) and CLOTBUST (n = 126). sICH occurred in 9 (5.6%) cases, and 6 had asymptomatic ICH. The rates of sICH for the corresponding HAT scores were: HAT 0–1: 3%; 2: 9%; 3: 14%; 4–5: 14%. The risk of sICH (c statistic 0.72, 95% CI: 0.58–0.86; p = 0.027) and any ICH (c statistic 0.70, 95% CI: 0.58–0.82; p = 0.011) increased with higher HAT scores. Higher HAT scores were also associated with higher likelihood of persisting occlusion (c statistic 0.63, 95% CI: 0.54–0.72; p = 0.004). 〈 i 〉 Conclusions: 〈 /i 〉 The HAT score has reasonable external validity for predicting the risk of sICH following intravenous thrombolysis in patients with PAO. Moreover, higher HAT scores appear to be associated with higher likelihood of persisting occlusion in tPA-treated patients.
    Type of Medium: Online Resource
    ISSN: 1015-9770 , 1421-9786
    URL: Article
    DOI: 10.1159/000324387
    Language: English
    Publisher: S. Karger AG
    Publication Date: 2011
    detail.hit.zdb_id: 1482069-9
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  • 10
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    Reperfusion and Outcomes in Penumbra Vs. Systemic Tissue Plasminogen Activator Clinical Trials
    SAGE Publications ; 2011
    In:  International Journal of Stroke Vol. 6, No. 2 ( 2011-04), p. 118-122
    Details
    In: International Journal of Stroke, SAGE Publications, Vol. 6, No. 2 ( 2011-04), p. 118-122
    Abstract: An uncontrolled clinical study of the Penumbra ™ system showed high rates of recanalisation and relatively poor functional outcomes that were inadequately compared with historic controls. We aimed to compare the findings in Penumbra with intravenous tissue plasminogen activator trials that determined recanalisation (Combined Lysis Of Thrombus in Brain ischaemia using transcranial Ultrasound and Systemic tissue plasminogen activator and Transcranial Ultrasound in Clinical Sonothrombolysis). Methods Control patients treated with intravenous tissue plasminogen activator and intermittent ultrasound surveillance had National Institutes of Health Stroke Scale scores 〉 7. The Penumbra trial definition of symptomatic intracranial haemorrhage was used. Revascularisation was defined using thrombolysis in brain ischaemia scores predictive of thrombolysis in myocardial infarction flow grades and compared with thrombolysis in myocardial infarction data from Penumbra. Favourable functional outcomes was defined as a modified Rankin Scale of 0–2. Results Pretreatment stroke severity (National Institutes of Health Stroke Scale score) was 17·6 ± 5·2 points in Penumbra patients ( n=125) and 16·3 ± 5·3 in controls ( n=68; P=0·101). The control group was older compared with Penumbra (68·8 ± 13·4 vs. 63·5 ± 13·5-years; P=0·010). Time-to-treatment initiation was on average 2 h later (2·3 ± 0·6 vs. 4·3 ± 1·5 h; P 〈 0·001) in Penumbra. The rate of any revascularisation after treatment with Penumbra was higher than that following intravenous thrombolysis: 82% (54% thrombolysis in myocardial infarction II and 27% thrombolysis in myocardial infarction III) vs. 40% (25% partial, 15% complete revascularisation), P 〈 0·001. Symptomatic intracranial haemorrhage tended to be higher with Penumbra (11·2% vs. 4·4%; P=0·182, Fisher's exact test). At three-months, mortality with Penumbra was higher (32·8%) than controls (14·1%; P=0·006). Favourable functional outcomes were higher in historic controls (39% vs. 25%; P=0·046). Conclusions Despite lower revascularisation rates, patients treated with systemic thrombolysis achieved better functional outcomes likely due to earlier treatment initiation. These data indicate that it is unrealistic to expect primary intraarterial revascularisation to be any better than systemic plasminogen activator within the 3-h time window. Improvements in the speed of delivery and performance of intraarterial reperfusion are needed.
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    URL: Article
    DOI: 10.1111/j.1747-4949.2010.00559.x
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2011
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