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  • 1
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    Addition of Brain Infarction to the ABCD 2 Score (ABCD 2 I) : A Collaborative Analysis of Unpublished Data on 4574 Patients
    Ovid Technologies (Wolters Kluwer Health) ; 2010
    In:  Stroke Vol. 41, No. 9 ( 2010-09), p. 1907-1913
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 41, No. 9 ( 2010-09), p. 1907-1913
    Abstract: Background and Purpose— The ABCD system was developed to predict early stroke risk after transient ischemic attack. Incorporation of brain imaging findings has been suggested, but reports have used inconsistent methods and been underpowered. We therefore performed an international, multicenter collaborative study of the prognostic performance of the ABCD 2 score and brain infarction on imaging to determine the optimal weighting of infarction in the score (ABCD 2 I). Methods— Twelve centers provided unpublished data on ABCD 2 scores, presence of brain infarction on either diffusion-weighted imaging or CT, and follow-up in cohorts of patients with transient ischemic attack diagnosed by World Health Organization criteria. Optimal weighting of infarction in the ABCD 2 I score was determined using area under the receiver operating characteristic curve analyses and random effects meta-analysis. Results— Among 4574 patients with TIA, acute infarction was present in 884 (27.6%) of 3206 imaged with diffusion-weighted imaging and new or old infarction was present in 327 (23.9%) of 1368 imaged with CT. ABCD 2 score and presence of infarction on diffusion-weighted imaging or CT were both independently predictive of stroke (n=145) at 7 days (after adjustment for ABCD 2 score, OR for infarction=6.2, 95% CI=4.2 to 9.0, overall; 14.9, 7.4 to 30.2, for diffusion-weighted imaging; 4.2, 2.6 to 6.9, for CT; all P 〈 0.001). Incorporation of infarction in the ABCD 2 I score improved predictive power with an optimal weighting of 3 points for infarction on CT or diffusion-weighted imaging. Pooled areas under the curve increased from 0.66 (0.53 to 0.78) for the ABCD 2 score to 0.78 (0.72 to 0.85) for the ABCD 2 I score. Conclusions— In secondary care, incorporation of brain infarction into the ABCD system (ABCD 2 I score) improves prediction of stroke in the acute phase after transient ischemic attack.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/STROKEAHA.110.578971
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2010
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  • 2
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    The Argatroban and Tissue-Type Plasminogen Activator Stroke Study : Final Results of a Pilot Safety Study
    Ovid Technologies (Wolters Kluwer Health) ; 2012
    In:  Stroke Vol. 43, No. 3 ( 2012-03), p. 770-775
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 43, No. 3 ( 2012-03), p. 770-775
    Abstract: Argatroban is a direct thrombin inhibitor that safely augments recanalization achieved by tissue-type plasminogen activator (tPA) in animal stroke models. The Argatroban tPA Stroke Study was an open-label, pilot safety study of tPA plus Argatroban in patients with ischemic stroke due to proximal intracranial occlusion. Methods— During standard-dose intravenous tPA, a 100-μg/kg bolus of Argatroban and infusion for 48 hours was adjusted to a target partial thromboplastin time of 1.75× baseline. The primary outcome was incidence of significant intracerebral hemorrhage defined as either symptomatic intracerebral hemorrhage or Parenchymal Hematoma Type 2. Recanalization was measured at 2 and 24 hours by transcranial Doppler or CT angiography. Results— Sixty-five patients were enrolled (45% men, mean age 63±14 years, median National Institutes of Health Stroke Scale=13). The median (interquartile range) time tPA to Argatroban bolus was 51 (38–60) minutes. Target anticoagulation was reached at a median (interquartile range) of 3 (2–7) hours. Significant intracerebral hemorrhage occurred in 4 patients (6.2%; 95% CI, 1.7–15.0). Of these, 3 were symptomatic (4.6%; 95% CI, 0.9–12.9). Seven patients (10%) died in the first 7 days. Within the 2-hour monitoring period, transcranial Doppler recanalization (n=47) occurred in 29 (61%) patients: complete in 19 (40%) and partial in another 10 (21%). Conclusions— The combination of Argatroban and intravenous tPA is potentially safe in patients with moderate neurological deficits due to proximal intracranial arterial occlusions and may produce more complete recanalization than tPA alone. Continued evaluation of this treatment combination is warranted. Clinical Trial Registration— URL: www.clinicaltrials.gov . Unique identifier: NCT00268762.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/STROKEAHA.111.625574
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2012
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  • 3
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    Abstract 60: Outcomes Following Sonothrombolysis in Severe Acute Ischemic Stroke
    Ovid Technologies (Wolters Kluwer Health) ; 2012
    In:  Stroke Vol. 43, No. suppl_1 ( 2012-02)
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 43, No. suppl_1 ( 2012-02)
    Abstract: Background & Purpose: A recent meta-analysis showed that sonothrombolysis is safe and can double the rate of early recanalization in acute ischemic stroke (AIS). We sought to explore whether patients with severe strokes could clinically benefit from ultrasound amplification of tPA-induced recanalization. Subjects & Methods: We compared functional outcomes at 3 months among randomized AIS patients with pre-treatment NIHSS scores 〉 =10 in the Combined Lysis of Thrombus in Brain Ischemia (CLOTBUST), Transcranial Ultrasound in Clinical Sonothrombolysis (TUCSON) and pilot randomized clinical safety study of sonothrombolysis with microspheres (Definity study). Patients had proximal arterial occlusions identified by baseline TCD and received intravenous (IV) tPA or IV tPA plus continuous 2-hour TCD ultrasound monitoring (=sonothrombolysis). Favorable outcome was defined as modified Rankin Scale (mRS) 0-1 at 3 months. Sustained complete recanalization was defined as Thrombolysis in Brain Ischemia (TIBI) flow grades 4-5 assessed by TCD at 2 hours after tPA bolus. Symptomatic intracranial hemorrhage (sICH) was defined using ECASS-2 definition as imaging evidence of ICH with clinical worsening (NIHSS 〉 =4) within 72 hours from stroke onset. Results: A total of 139 AIS patients with severe stroke due to proximal arterial occlusions (mean age 69±13years, 56% men, median NIHSS 17, interquartile range 14-21, range 10-34) were randomized in CLOTBUST (n=105), TUCSON (n=21) and Definity (n=13). A total of 60 (43%) and 79 (57%) patients were randomized to IV tPA and sonothrombolysis, respectively. Patients treated with IV tPA and sonothrombolysis did not differ in terms of age, baseline stroke severity, baseline TIBI grades and onset-to-treatment time. Symptomatic ICH rates were similar in patients treated with IV tPA and sonothrombolysis (5.0% vs. 5.1%; p=0.987). More patients achieved sustained complete recanalization in the sonothrombolysis than in the IV tPA group (38.0% vs. 18.3%; p=0.012). Favorable outcome (mRS 0-1) tended to be more prevalent in the sonothrombolysis than in the IV tPA group (36.6% vs. 23.2%; p=0.104). Conclusions: Our data point to a signal-of-efficacy and provide basis to determine the sample size of a phase 3 randomized trial of sonothrombolysis in patients with severe strokes ( NCT01098981 ).
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/str.43.suppl_1.A60
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2012
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  • 4
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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
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  • 5
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    Abstract WP71: Recanalization Leads To Early Clinical Improvement In Patients Treated With Argatroban And Intravenous TPA A Subanalysis Of The Argatroban Tpa Stroke Study
    Ovid Technologies (Wolters Kluwer Health) ; 2013
    In:  Stroke Vol. 44, No. suppl_1 ( 2013-02)
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 44, No. suppl_1 ( 2013-02)
    Abstract: Background and Objectives: Early neurological improvement (ENI) at 2-hours post thrombolysis has recently been proposed to most accurately predict recanalization when repeat vascular imaging is not available. However, these studies analyzed recanalization at a delayed time point (≥24 hours). The Argatroban tPA Stroke Study (ARTSS-1), is a recently completed NIH sponsored, Phase IIa, prospective, open-label, safety and activity study of Argatroban and rtPA in patients with ischemic stroke ( NCT00268762 ). We hypothesized 2-hour recanalization correlates with ENI (NIHSS improvement of 20% or greater from baseline). Methods: A total of 65 patients with intracranial large vessel occlusive disease were given standard dose (0.9mg/kg) tPA and a 100 μg/kg bolus of argatroban followed by infusion of 1 μg/kg per minute for 48 hours adjusted to a PTT of 1.75 times baseline. Pre-tPA vessel imaging using TCD or CTA confirmed intracranial occlusions. A multivariate logistic regression tested whether recanalization at 2 hours was associated with ENI after controlling for age, NIHSS, clot location (ICA, MCA or vertebrobasilar). We analyzed whether patients with ENI had statistically significant greater odds of an excellent mRS (0 or 1) at day 7. Results: Recanalization data was available for 47 patients at 2-hours. ENI occurred at 2-hours in 46% patients. Patients with any recanalization (complete or partial) at 2-hours were more likely to experience ENI (OR 3.4; 95% CI 0.71-16.6, p=0.124). This association strengthened when 2-hour complete recanalization was analyzed (OR 5.4; 95% CI 0.98-29.2, p=0.053). In an unadjusted analysis, patients with ENI at 2-hours were five times more likely to have excellent mRS outcomes at day 7 (OR 4.7; 95% CI 1.4-15.6, p=0.01). In the adjusted model, the association remained significant (OR 3.8; 95%CI 1.1-13.4, p=0.041). Conclusion: Two-hour recanalization is predictive of early neurological improvement and better early clinical outcomes in patients treated with combination Argatroban and tPA. A randomized, controlled clinical trial of this promising adjunctive therapy is warranted and ongoing (ARTSS-2 trial, NCT01464788 ).
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/str.44.suppl_1.AWP71
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2013
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  • 6
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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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  • 7
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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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  • 8
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    Initial experience with a self-expanding retrievable stent for recanalization of large vessel occlusions in acute ischemic stroke
    Springer Science and Business Media LLC ; 2012
    In:  Neuroradiology Vol. 54, No. 2 ( 2012-2), p. 147-154
    Details
    In: Neuroradiology, Springer Science and Business Media LLC, Vol. 54, No. 2 ( 2012-2), p. 147-154
    Type of Medium: Online Resource
    ISSN: 0028-3940 , 1432-1920
    URL: Article
    DOI: 10.1007/s00234-010-0835-x
    RVK:
    XA 10000
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2012
    detail.hit.zdb_id: 1462953-7
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  • 9
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    Assessment of Leptomeningeal Collaterals Using Dynamic CT Angiography in Patients with Acute Ischemic Stroke
    SAGE Publications ; 2013
    In:  Journal of Cerebral Blood Flow & Metabolism Vol. 33, No. 3 ( 2013-03), p. 365-371
    Details
    In: Journal of Cerebral Blood Flow & Metabolism, SAGE Publications, Vol. 33, No. 3 ( 2013-03), p. 365-371
    Abstract: Whole-brain dynamic time-resolved computed tomography angiography (CTA) is a technique developed on the new 320-detector row CT scanner capable of generating time-resolved cerebral angiograms from skull base to vertex. Unlike a conventional cerebral angiogram, this technique visualizes pial arterial filling in all vascular territories, thereby providing additional hemodynamic information. Ours was a retrospective study of consecutive patients with ischemic stroke and M1 middle cerebral artery +/– intracranial internal carotid artery occlusions presenting to our center from June 2010 and undergoing dynamic time-resolved CTA and perfusion CT within 6 hours of symptom onset. Leptomeningeal collateral status was assessed by determining relative prominence of pial arteries in the ischemic region, rate and extent of retrograde flow, and various topographical patterns of pial arterial filling. Twenty-five patients were included in the study. We demonstrate the existence of the following novel properties of leptomeningeal collaterals in humans: (a) posterior (posterior cerebral artery (PCA)–MCA) dominant collateralization, (b) intra-territorial ‘within MCA region’ leptomeningeal collaterals, and (c) significant variability in size, extent, and retrograde filling time in pial arteries. We also describe a simple and reliable collateral grading template that, for the first time on dynamic CTA, incorporates back-filling time as well as size and extent of collateral filling.
    Type of Medium: Online Resource
    ISSN: 0271-678X , 1559-7016
    URL: Article
    DOI: 10.1038/jcbfm.2012.171
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2013
    detail.hit.zdb_id: 2039456-1
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  • 10
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    Abstract WP58: Early Recanalization Rates Do Not Differ among Stroke Subtypes when treated with Argatroban and intravenous tPA: a Subanalysis of the Argatroban TPA Stroke Study
    Ovid Technologies (Wolters Kluwer Health) ; 2013
    In:  Stroke Vol. 44, No. suppl_1 ( 2013-02)
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 44, No. suppl_1 ( 2013-02)
    Abstract: Background and Objectives: Argatroban is a direct thrombin inhibitor that safely augments the benefit of tPA in animal stroke models. The Argatroban tPA Stroke Study (ARTSS-1), was a recently completed NIH sponsored, Phase IIa, prospective, open-label, safety and activity study of Argatroban and tPA in patients with ischemic stroke ( NCT00268762 ). Symptomatic hemorrhage occurred in 4.6% and rates of complete recanalization were 30% and 63% at 2 and 24 hours, respectively. We hypothesized that stroke subtypes might respond differently to the treatment combination. Methods: A total of 65 patients with intracranial large vessel occlusive disease were given standard dose (0.9mg/kg) tPA and a 100 μg/kg bolus of argatroban followed by infusion of 1 μg/kg per minute for 48 hours adjusted to a PTT of 1.75 times baseline. Pre-tPA vessel imaging using TCD or CTA confirmed intracranial occlusions. A multivariate logistic regression was performed to test whether stroke subtype independently influenced recanalization after controlling for: NIHSS, antithrombotic use, diabetes, age and clot location (ICA, MCA, Vertebrobasilar). Results: Recanalization data was available for 47 patients at 2-hours. Baseline characteristics are displayed in the table. After adjusting for age, NIHSS, diabetes, clot location and previous antithrombotic use, there was no difference between any recanalization at 2-hours in the different stroke etiologies. Interestingly, M1 clots were more likely to recanalize compared with M2 (OR 6.2; 95% CI 1.3-25, p=0.019). Results were similar when only analyzing 2-hours complete recanalization. Conclusion: Although all large vessel stroke subtypes recanalize at similar rates when treated with combination Argatroban and rtPA, larger thrombi may benefit to a greater degree. A randomized, controlled clinical trial of this promising adjunctive therapy is warranted and ongoing (ARTSS-2 trial, NCT01464788 ).
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/str.44.suppl_1.AWP58
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2013
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