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  • 1
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    Online Resource
    Intravenous alteplase for stroke with unknown time of onset guided by advanced imaging: systematic review and meta-analysis of individual patient data
    Elsevier BV ; 2020
    In:  The Lancet Vol. 396, No. 10262 ( 2020-11), p. 1574-1584
    Details
    In: The Lancet, Elsevier BV, Vol. 396, No. 10262 ( 2020-11), p. 1574-1584
    Type of Medium: Online Resource
    ISSN: 0140-6736
    URL: Article
    DOI: 10.1016/S0140-6736(20)32163-2
    RVK:
    XA 10000
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2020
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    SSG: 5,21
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  • 2
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    Intravenous nicardipine for Japanese patients with acute intracerebral hemorrhage: an individual participant data analysis
    Springer Science and Business Media LLC ; 2023
    In:  Hypertension Research Vol. 46, No. 1 ( 2023-01), p. 75-83
    Details
    In: Hypertension Research, Springer Science and Business Media LLC, Vol. 46, No. 1 ( 2023-01), p. 75-83
    Abstract: The effects of acute systolic blood pressure levels achieved with continuous intravenous administration of nicardipine for Japanese patients with acute intracerebral hemorrhage on clinical outcomes were determined. A systematic review and individual participant data analysis of articles were performed based on prospective studies involving adults developing hyperacute intracerebral hemorrhage who were treated with intravenous nicardipine. Outcomes included death or disability at 90 days, defined as the modified Rankin Scale score of 4–6, and hematoma expansion, defined as an increase 6 mL or more from baseline to 24 h computed tomography. Of the total 499 Japanese patients (age 64.9 ± 11.8 years, 183 women, initial BP 203.5 ± 18.3/109.1 ± 17.2 mmHg) studied, death or disability occurred in 35.6%, and hematoma expansion occurred in 15.6%. Mean hourly systolic blood pressure during the initial 24 h was positively associated with death or disability (adjusted odds ratio 1.25, 95% confidence interval 1.03–1.52 per 10 mmHg) and hematoma expansion (1.49, 1.18–1.87). These odds ratios were relatively high as compared to the reported ones for overall global patients of this individual participant data analysis [1.12 (95% confidence interval 1.00–1.26) and 1.16 (1.02–1.32), respectively]. In conclusion, lower levels of systolic blood pressure by continuous intravenous nicardipine were associated with lower risks of hematoma expansion and 90-day death or disability in Japanese patients with hyperacute intracerebral hemorrhage. The impact of systolic blood pressure lowering on better outcome seemed to be stronger in Japanese patients than the global ones.
    Type of Medium: Online Resource
    ISSN: 0916-9636 , 1348-4214
    URL: Article
    DOI: 10.1038/s41440-022-01046-4
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2023
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  • 3
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    Impact of Renal Impairment on Intensive Blood-Pressure–Lowering Therapy and Outcomes in Intracerebral Hemorrhage : Results From ATACH-2
    Ovid Technologies (Wolters Kluwer Health) ; 2021
    In:  Neurology Vol. 97, No. 9 ( 2021-08-31), p. e913-e921
    Details
    In: Neurology, Ovid Technologies (Wolters Kluwer Health), Vol. 97, No. 9 ( 2021-08-31), p. e913-e921
    Abstract: The clinical effect of renal impairment on intracerebral hemorrhage (ICH) is unknown. This study sought to assess whether estimated glomerular filtration rate (eGFR) affects clinical outcomes or modifies the efficacy of intensive systolic blood pressure (BP) control (target, 110–139 mm Hg) against the standard (target, 140–179 mm Hg) among patients with ICH. Methods We conducted post hoc analyses of ATACH-2, a randomized, 2-group, open-label trial. The baseline eGFR of each eligible patient was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation. The outcome of interest was death or disability at 90 days. Multivariate logistic regression models were used for analysis. Results Among the 1,000 patients randomized, 974 were analyzed. The median baseline eGFR was 88 (interquartile range, 68, 99) mL/min/1.73 m 2 ; 451 (46.3%), 363 (37.3%), and 160 (16.4%) patients had baseline eGFR values of ≥90, 60–89, and 〈 60 mL/min/1.73 m 2 , respectively. Compared with normal eGFR (≥90 mL/min/1.73 m 2 ), higher odds of death or disability were noted among those with eGFR values of 〈 60 mL/min/1.73 m 2 (adjusted odds ratio [OR], 2.02; 95% confidence interval [CI] , 1.25–3.26) but not among those with eGFR values of 60–89 mL/min/1.73 m 2 (OR, 1.01; 95% CI, 0.70–1.46). The odds of death or disability were significantly higher in the intensive arm among patients with decreased eGFR; the ORs were 0.89 (95% CI, 0.55–1.44), 1.13 (0.68–1.89), and 3.60 (1.47–8.80) in patients with eGFR values of ≥90, 60–89, and 〈 60 mL/min/1.73 m 2 , respectively ( p for interaction = 0.02). Discussion Decreased eGFR is associated with unfavorable outcomes following ICH. The statistically significant interaction between the eGFR group and treatment assignment raised safety concerns for the intensive BP-lowering therapy among patients with renal impairment. Trial Registration Information Clinicaltrials.gov identifier: NCT01176565. Classification of Evidence This study provides Class II evidence that in spontaneous ICH, decreased eGFR identifies patients at risk of death or disability following intensive BP control.
    Type of Medium: Online Resource
    ISSN: 0028-3878 , 1526-632X
    URL: Article
    DOI: 10.1212/WNL.0000000000012442
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2021
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  • 4
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    Magnetic Resonance Imaging–Guided Thrombolysis (0.6 mg/kg) Was Beneficial for Unknown Onset Stroke Above a Certain Core Size : THAWS RCT Substudy
    Ovid Technologies (Wolters Kluwer Health) ; 2021
    In:  Stroke Vol. 52, No. 1 ( 2021-01), p. 12-19
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 52, No. 1 ( 2021-01), p. 12-19
    Abstract: We determined to identify patients with unknown onset stroke who could have favorable 90-day outcomes after low-dose thrombolysis from the THAWS (Thrombolysis for Acute Wake-Up and Unclear-Onset Strokes With Alteplase at 0.6 mg/kg) database. Methods: This was a subanalysis of an investigator-initiated, multicenter, randomized, open-label, blinded–end point trial. Patients with stroke with a time last-known-well 〉 4.5 hours who showed a mismatch between diffusion-weighted imaging (DWI) and fluid-attenuated inversion recovery were randomly assigned (1:1) to receive alteplase at 0.6 mg/kg intravenously or standard medical treatment. The patients were dichotomized by ischemic core size or National Institutes of Health Stroke Scale score, and the effects of assigned treatments were compared in each group. The efficacy outcome was favorable outcome at 90 days, defined as a modified Rankin Scale score of 0 to 1. Results: The median DWI-Alberta Stroke Program Early CT Score (ASPECTS) was 9, and the median ischemic core volume was 2.5 mL. Both favorable outcome (47.1% versus 48.3%) and any intracranial hemorrhage (26% versus 14%) at 22 to 36 hours were comparable between the 68 thrombolyzed patients and the 58 control patients. There was a significant treatment-by-cohort interaction for favorable outcome between dichotomized patients by ASPECTS on DWI ( P =0.026) and core volume ( P =0.035). Favorable outcome was more common in the alteplase group than in the control group in patients with DWI-ASPECTS 5 to 8 (RR, 4.75 [95% CI, 1.33–30.2]), although not in patients with DWI-ASPECTS 9 to 10. Favorable outcome tended to be more common in the alteplase group than in the control group in patients with core volume 〉 6.4 mL (RR, 6.15 [95% CI, 0.87–43.64]), although not in patients with volume ≤6.4 mL. The frequency of any intracranial hemorrhage did not differ significantly between the 2 treatment groups in any dichotomized patients. Conclusions: Patients developing unknown onset stroke with DWI-ASPECTS 5 to 8 showed favorable outcomes more commonly after low-dose thrombolysis than after standard treatment. Registration: URL: https://www.clinicaltrials.gov ; Unique Identifier: NCT02002325. URL: https://www.umin.ac.jp/ctr ; Unique Identifier: UMIN000011630.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/STROKEAHA.120.030848
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2021
    detail.hit.zdb_id: 1467823-8
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  • 5
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    Effect of Heart Rate Variabilities on Outcome After Acute Intracerebral Hemorrhage: A Post Hoc Analysis of ATACH‐2
    Ovid Technologies (Wolters Kluwer Health) ; 2021
    In:  Journal of the American Heart Association Vol. 10, No. 16 ( 2021-08-17)
    Details
    In: Journal of the American Heart Association, Ovid Technologies (Wolters Kluwer Health), Vol. 10, No. 16 ( 2021-08-17)
    Abstract: To explore how the clinical impact of heart rate (HR) and heart rate variabilities (HRV) during the initial 24 hours after acute intracerebral hemorrhage (ICH) contribute to worse clinical outcomes. Methods and Results In the ATACH‐2 (Antihypertensive Treatment in Intracerebral Hemorrhage 2) trial, the HR was recorded for every 15 minutes from baseline to 1 hour and hourly during the initial 24 hours post‐randomization. We calculated the following: mean, standard deviation, coefficient of variation, successive variation, and average real variability (ARV). Outcomes were hematoma expansion at 24 hours and unfavorable functional outcome, defined as modified Rankin Scale score 4 to 6 at 90 days. Of the 1000 subjects in ATACH‐2, 994 with available HR data were included in the analyses. Overall, 262 experienced hematoma expansion, and 362 had unfavorable outcomes. Increased mean HR was linearly associated with unfavorable outcome (per 10 bpm increase adjusted odds ratio [aOR], 1.31, 95% CI, 1.14–1.50) but not with hematoma expansion, while HR‐ARV was associated with hematoma expansion (aOR, 1.06, 95% CI, 1.01–1.12) and unfavorable outcome (aOR, 1.07, 95% CI, 1.01–1.3). Every 10‐bpm increase in mean HR increased the probability of unfavorable outcome by 4.3%, while every 1 increase in HR‐ARV increased the probability of hematoma expansion by 1.1% and unfavorable outcome by 1.3%. Conclusions Increased mean HR and HR‐ARV within the initial 24 hours were independently associated with unfavorable outcome in acute ICH. Moreover, HR‐ARV was associated with hematoma expansion at 24 hours. This may have future therapeutic implications to accommodate HR and HRV in acute ICH. Registration URL: https://www.clinicaltrials.gov ; Unique Identifier: NCT01176565.
    Type of Medium: Online Resource
    ISSN: 2047-9980
    URL: Article
    DOI: 10.1161/JAHA.120.020364
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2021
    detail.hit.zdb_id: 2653953-6
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  • 6
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    Cerebral microbleeds development after stroke thrombolysis: A secondary analysis of the THAWS randomized clinical trial
    SAGE Publications ; 2022
    In:  International Journal of Stroke Vol. 17, No. 6 ( 2022-07), p. 628-636
    Details
    In: International Journal of Stroke, SAGE Publications, Vol. 17, No. 6 ( 2022-07), p. 628-636
    Abstract: We determined to investigate the incidence and clinical impact of new cerebral microbleeds after intravenous thrombolysis in patients with acute stroke. Methods The THAWS was a multicenter, randomized trial to study the efficacy and safety of intravenous thrombolysis with alteplase in patients with wake-up stroke or unknown onset stroke. Prescheduled T2*-weighted imaging assessed cerebral microbleeds at three time points: baseline, 22–36 h, and 7–14 days. Outcomes included new cerebral microbleeds development, modified Rankin Scale (mRS) ≥3 at 90 days, and change in the National Institutes of Health Stroke Scale (NIHSS) score from 24 h to 7 days. Results Of all 131 patients randomized in the THAWS trial, 113 patients (mean 74.3 ± 12.6 years, 50 female, 62 allocated to intravenous thrombolysis) were available for analysis. Overall, 46 (41%) had baseline cerebral microbleeds (15 strictly lobar cerebral microbleeds, 14 mixed cerebral microbleeds, and 17 deep cerebral microbleeds). New cerebral microbleeds only emerged in the intravenous thrombolysis group (seven patients, 11%) within a median of 28.3 h, and did not additionally increase within a median of 7.35 days. In adjusted models, number of cerebral microbleeds (relative risk (RR) 1.30, 95% confidence interval (CI): 1.17–1.44), mixed distribution (RR 19.2, 95% CI: 3.94–93.7), and cerebral microbleeds burden ≥5 (RR 44.9, 95% CI: 5.78–349.8) were associated with new cerebral microbleeds. New cerebral microbleeds were associated with an increase in NIHSS score ( p = 0.023). Treatment with alteplase in patients with baseline ≥5 cerebral microbleeds resulted in a numerical shift toward worse outcomes on ordinal mRS (median [IQR]; 4 [3–4] vs. 0 [0–3]), compared with those with 〈 5 cerebral microbleeds (common odds ratio 17.1, 95% CI: 0.76–382.8). The association of baseline ≥5 cerebral microbleeds with ordinal mRS score differed according to the treatment group ( p interaction = 0.042). Conclusion New cerebral microbleeds developed within 36 h in 11% of the patients after intravenous thrombolysis, and they were significantly associated with mixed-distribution and ≥5 cerebral microbleeds. New cerebral microbleeds development might impede neurological improvement. Furthermore, cerebral microbleeds burden might affect the effect of alteplase.
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    URL: Article
    DOI: 10.1177/17474930211035023
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2022
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  • 7
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    Intravenous Alteplase at 0.6 mg/kg for Unknown Onset Stroke with Prior Antithrombotic Medication: THAWS Randomized Clinical Trial
    Japan Atherosclerosis Society ; 2023
    In:  Journal of Atherosclerosis and Thrombosis Vol. 30, No. 1 ( 2023-1-1), p. 15-22
    Details
    In: Journal of Atherosclerosis and Thrombosis, Japan Atherosclerosis Society, Vol. 30, No. 1 ( 2023-1-1), p. 15-22
    Type of Medium: Online Resource
    ISSN: 1340-3478 , 1880-3873
    URL: Article
    DOI: 10.5551/jat.63337
    Language: English
    Publisher: Japan Atherosclerosis Society
    Publication Date: 2023
    detail.hit.zdb_id: 2185870-6
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  • 8
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    Abstract WMP10: Sex Difference In Imaging-based Intravenous Thrombolysisfor Ischemic Stroke With Unknown Onset Time: A Pooled Analysis Of Clinical Trials
    Ovid Technologies (Wolters Kluwer Health) ; 2022
    In:  Stroke Vol. 53, No. Suppl_1 ( 2022-02)
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 53, No. Suppl_1 ( 2022-02)
    Abstract: Introduction: Our prior meta-analysis reported that imaging-based intravenous thrombolysis (IVT) was safe and effective for patients who have had a stroke with an unknown onset time. The aim of this study is to investigate whether sex differences exist in clinical outcomes among this population. Methods: This is a pooled analysis of individual patient-level data acquired from the EOS project, a meta-analysis of clinical trials (PROSPERO, CRD42020166903). Patients treated with imaging-based IVT for stroke with an unknown time of onset were included. The primary outcome was a favorable functional outcome (mRS 0-1) at 90 days. Secondary outcomes were mRS shift towards a better functional outcome and death within 90 days. Sex differences were investigated using mixed-effect logistic or ordinal regression models adjusted for covariates, considering potential heterogeneity across trials. Results: Among 509 patients treated with imaging-based IVT, 204 (40.1%) were women. Compared to men, women were older (70 ± 12 vs. 67 ± 13, p=0.003), more frequently had atrial fibrillation (27.6% vs. 17.2%, p=0.005), and were taking antiplatelets prior to the onset (45.5% vs. 36.4%, p=0.045). Baseline NIHSS score was higher (8.0 (IQR 5-15) vs.6 (4-11), p 〈 0.001), and hours from last-known-well to treatment were longer (11.2 (9.3-12.9) vs. 10.3 (8.1-11.9), p 〈 0.001) in women than men. Favorable outcomes occurred in 80 (40.6%) women and in 150 (49.7%) men (p=0.047). Among women, 19 (9.6%) patients died, compared with 15 (5.0%) patients in men (p=0.042). After multivariate adjustment, female sex was not significantly associated with favorable functional outcome (adjusted odds ratio (OR) 1.01[95% confidential intervals (CI) 0.66-1.54]; p=0.97) nor death (adjusted OR 1.28 [95%CI 0.59-2.76] ; p=0.59). Female sex was not associated with a significant shift towards the better functional outcome (common OR 1.07 [95%CI 0.77-1.49]; p=0.70). Conclusions: Pooled data from clinical trials show that in univariate analysis, women had numerically less good functional outcomes following imaging-based IVT among ischemic stroke patients with unknown onset time. However, this sex difference can be explained by higher age and more severe clinical status in women at stroke onset.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/str.53.suppl_1.WMP10
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2022
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  • 9
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    Abstract P7: Prior Antithrombotic Medication May Affect Outcomes Following Alteplase at 0.6mg for Unknown Onset Stroke: THAWS Randomized Clinical Trial
    Ovid Technologies (Wolters Kluwer Health) ; 2021
    In:  Stroke Vol. 52, No. Suppl_1 ( 2021-03)
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 52, No. Suppl_1 ( 2021-03)
    Abstract: Background and purpose: To assess the potential effect of prior antithrombotic medication for thrombolysis using alteplase at 0.6mg/kg in unknown onset stroke. Methods: This was a prespecified sub-analysis of a THAWS trial (an investigator-initiated, multicenter, randomized, open, blinded-endpoint trial). Stroke patients with a time last-known-well 〉 4.5 h who had a mismatch between diffusion-weighted imaging (DWI) and fluid-attenuated inversion recovery were randomly assigned (1:1) to receive alteplase at 0.6mg/kg or standard medical treatment (SMT). Patients were dichotomized by taking prior antithrombotic medication. The favorable outcome defined as a modified Rankin Scale score of 0-1 at 90 days and any intracranial hemorrhage within 22-36 h were compared in each group. Results: Of 126 patients (intention-to-treat population), 68 received alteplase and 58 had SMT. Seventeen in the alteplase group and 23 in the SMT group took antithrombotic medication (10 with antiplatelet alone, 5 with anticoagulant alone and 2 with both in the IVT group, and 14, 8 and 1, respectively, in the SMT group) before stroke onset. Antithrombotic therapy was more frequently initiated within 24 hours after randomization in the SMT group than in the alteplase group (86% vs. 12%, p 〈 0.0001). Both any intracranial hemorrhage (26% in the alteplase group vs. 14% in the SMT group) and favorable outcome (47% vs. 48%) were comparable between the two treatment groups. There was a significant treatment-by-cohort interaction for favorable outcome between patients with prior antithrombotic medication and those without (p=0.006). Favorable outcome was more common in the alteplase group than in the SMT group in patients with prior antithrombotic medication (59% vs. 26%; RR 2.25, 95% CI 1.02 to 4.99), but it tended to be less common in the alteplase group than in the SMT group in those without prior antithrombotic medication (43% vs. 63%; RR 0.69, 95% CI 0.46 to 1.03). The frequency of any intracranial hemorrhage did not differ significantly between the two treatment groups in any dichotomized patients. Conclusions: Alteplase at 0.6mg/kg appears more beneficial in patients with prior antithrombotic medication.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/str.52.suppl_1.P7
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2021
    detail.hit.zdb_id: 1467823-8
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  • 10
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    Sex Differences in Blood Pressure–Lowering Therapy and Outcomes Following Intracerebral Hemorrhage : Results From ATACH-2
    Ovid Technologies (Wolters Kluwer Health) ; 2020
    In:  Stroke Vol. 51, No. 8 ( 2020-08), p. 2282-2286
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 51, No. 8 ( 2020-08), p. 2282-2286
    Abstract: Evidence regarding sex differences in clinical outcomes and treatment effect following intracerebral hemorrhage is limited. Using the ATACH-2 trial (Antihypertensive Treatment in Intracerebral Hemorrhage-2) data, we explored whether sex disparities exist in outcomes and response to intensive blood pressure (BP)–lowering therapy. Methods: Eligible intracerebral hemorrhage subjects were randomly assigned to intensive (target systolic BP, 110–139 mm Hg) or standard (140–179 mm Hg) BP-lowering therapy within 4.5 hours after onset. Relative risk of death or disability corresponding to the modified Rankin Scale score of 4 to 6 was calculated, and interaction between sex and treatment was explored. Results: In total, 380 women and 620 men were included. Women were older, more prescribed antihypertensive drugs before onset, and had more lobar intracerebral hemorrhage than men. Hematoma expansion was observed less in women. After multivariable adjustment, the relative risk of death or disability in women was 1.19 (95% CI, 1.02–1.37, P =0.023). The relative risk of death or disability between intensive versus standard BP-lowering therapy was 0.91 (95% CI, 0.74–1.13) in women versus 1.13 (95% CI, 0.92–1.39) in men ( P for interaction=0.11), with inconclusive Gail-Simmon test ( P =0.16). Conclusions: Women had a higher risk of death or disability following intracerebral hemorrhage. The benefit of intensive BP-lowering therapy in women is inconclusive, consistent with the overall results of ATACH-2. Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01176565.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/STROKEAHA.120.029770
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2020
    detail.hit.zdb_id: 1467823-8
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