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  • 1
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 53, No. 5 ( 2022-05), p. 1540-1549
    Abstract: The “1-3-6-12-day rule” for starting direct oral anticoagulants (DOACs) in patients with nonvalvular atrial fibrillation after acute ischemic stroke or transient ischemic attack recommends timings that may be later than used in clinical practice. We investigated more practical optimal timing of DOAC initiation according to stroke severity. Methods: The combined data of prospective registries in Japan, Stroke Acute Management with Urgent Risk-factor Assessment and Improvement-nonvalvular atrial fibrillation (September 2011 to March 2014) and RELAXED (February 2014 to April 2016) were used. Patients were divided into transient ischemic attack and 3 stroke subgroups by the National Institutes of Health Stroke Scale score: mild (0–7), moderate (8–15), and severe (≥16). The early treatment group was defined as patients starting DOACs earlier than the median initiation day in each subgroup. Outcomes included a composite of recurrent stroke or systemic embolism, ischemic stroke, and severe bleeding within 90 days. Six European prospective registries were used for validation. Results: In the 1797 derivation cohort patients, DOACs were started at median 2 days after transient ischemic attack and 3, 4, and 5 days after mild, moderate, and severe strokes, respectively. Stroke or systemic embolism was less common in Early Group (n=785)—initiating DOACS within 1, 2, 3, and 4 days, respectively—than Late Group (n=1012) (1.9% versus 3.9%; adjusted hazard ratio, 0.50 [95% CI, 0.27–0.89]), as was ischemic stroke (1.7% versus 3.2%, 0.54 [0.27–0.999] ). Major bleeding was similarly common in the 2 groups (0.8% versus 1.0%). On validation, both ischemic stroke (2.4% versus 2.2%) and intracranial hemorrhage (0.2% versus 0.6%) were similarly common in Early (n=547) and Late (n=1483) Groups defined using derivation data. Conclusions: In Japanese and European populations, early DOAC initiation within 1, 2, 3, or 4 days according to stroke severity seemed to be feasible to decrease the risk of recurrent stroke or systemic embolism and no increase in major bleeding. These findings support ongoing randomized trials to better establish the optimal timing of DOAC initiation.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    RVK:
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2022
    detail.hit.zdb_id: 1467823-8
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  • 2
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 44, No. suppl_1 ( 2013-02)
    Abstract: Background and Purpose: The association between chronic kidney disease and clinical outcomes in acute intracerebral hemorrhage (ICH) remains uncertain. We aimed to assess associations of renal dysfunction and outcomes in acute ICH patients treated with intensive BP lowering. Methods: The SAMURAI-ICH study was a prospective, multicenter, observational study. A total of 211 patients with acute supratentorial ICH were recruited. BP was targeted between 120 mmHg and 160 mmHg during initial 24 h using intravenous nicardipine. Glomerular filtration rate (eGFR) was calculated using admission serum creatinine. After 23 patients on maintenance hemodialysis were excluded, the remaining 188 were divided into 3 groups as follows: Group 1, eGFR of 〈 60; Group 2, 60 to 75; and Group 3, ≥75 mL/min/1.73m 2 . Clinical outcomes were hematoma expansion of ≥33% at 24 h, neurological deterioration within 72 h (GCS decrement ≥2 points or NIHSS increment ≥4 points), and favorable (modified Rankin Scale [mRS] ≤2) and unfavorable (mRS ≥5) outcomes at 3 months. Results: Of 188 patients, 35 (18 women) were allocated to Group 1, 58 (20) to Group 2, and 95 (33) to Group 3. Significant differences among 3 groups were found in age (73.1±13.6, 63.3±13.2, 63.8±9.8 yo; p 〈 0.001) and initial systolic BP (208.9±18.1, 201.2±15.6, 200.2±14.8 mmHg; p=0.018). Initial hematoma volume (14.9±11.9, 15.5±14.9, 14.3±12.3 mL) and initial median NIHSS score (14, 11, 13) were similar among 3 groups. For outcomes, significant differences among 3 groups were found in favorable outcome (17.7%, 51.7%, 41.3%; p=0.004) and unfavorable outcome (22.9%, 10.3%, 5.3%; p=0.021), but not in hematoma expansion (17.1%, 10.3%, 22.1%) and neurological deterioration (11.4%, 8.6%, 7.4%). After adjustment with initial hematoma volume, initial systolic BP and initial NIHSS score, eGFR 〈 60 ml/min/1.73m 2 was inversely associated with favorable outcome (OR 0.20, 95% CI 0.07-0.54) and positively associated with unfavorable outcome (4.27, 1.36-13.53). Conclusions: Although decreased eGFR on admission was not associated with initial hematoma volume or initial NIHSS score, it was associated with poor outcomes at 3 months of ICH onset.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    RVK:
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2013
    detail.hit.zdb_id: 1467823-8
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  • 3
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 44, No. 7 ( 2013-07), p. 1846-1851
    Abstract: Blood pressure (BP) lowering is often conducted as part of general acute management in patients with acute intracerebral hemorrhage. However, the relationship between BP after antihypertensive therapy and clinical outcomes is not fully known. Methods— Hyperacute ( 〈 3 hours from onset) intracerebral hemorrhage patients with initial systolic BP (SBP) 〉 180 mm Hg were included. All patients received intravenous antihypertensive treatment, based on predefined protocol to lower and maintain SBP between 120 and 160 mm Hg. BPs were measured every 15 minutes during the initial 2 hours and every 60 minutes in the next 22 hours (a total of 30 measurements). The mean achieved SBP was defined as the mean of 30 SBPs, and associations between the mean achieved SBP and neurological deterioration (≥2 points’ decrease in Glasgow Coma Score or ≥4 points’ increase in National Institutes of Health Stroke Scale score), hematoma expansion ( 〉 33% increase), and unfavorable outcome (modified Rankin Scale score 4–6 at 3 months) were assessed with multivariate logistic regression analyses. Results— Of the 211 patients (81 women, median age 65 [interquartile range, 58–74] years, and median initial National Institutes of Health Stroke Scale score 13 [8–17] ) enrolled, 17 (8%) showed neurological deterioration, 36 (17%) showed hematoma expansion, and 87 (41%) had an unfavorable outcome. On multivariate regression analyses, mean achieved SBP was independently associated with neurological deterioration (odds ratio, 4.45; 95% confidence interval, 2.03–9.74 per 10 mm Hg increment), hematoma expansion (1.86; 1.09–3.16), and unfavorable outcome (2.03; 1.24–3.33) after adjusting for known predictive factors. Conclusions— High achieved SBP after standardized antihypertensive therapy in hyperacute intracerebral hemorrhage was independently associated with poor clinical outcomes. Aggressive antihypertensive treatment may ameliorate clinical outcomes.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    RVK:
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2013
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  • 4
    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
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2023
    detail.hit.zdb_id: 2110941-2
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  • 5
    In: Journal of Stroke and Cerebrovascular Diseases, Elsevier BV, Vol. 24, No. 1 ( 2015-01), p. 176-182
    Type of Medium: Online Resource
    ISSN: 1052-3057
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2015
    detail.hit.zdb_id: 2052957-0
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  • 6
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 46, No. suppl_1 ( 2015-02)
    Abstract: Backgound and Purpose: Recently, three non-vitamin K antagonist oral anticoagulants (NOACs) became available for patients with nonvalvular atrial fibrillation (NVAF) in Japan. We aimed to determine 3-month outcomes in ischemic stroke/TIA patients receiving NOACs or warfarin from a multicenter prospective registry (SAMURAI-NVAF registry, NCT01581502). Methods: Among 1,191 acute ischemic stroke /TIA patients enrolled between September 2011 and March 2014, we studied 916 patients (389 women, 77±10 y) who took oral anticoagulants (OACs) after index stroke and completed 3-month follow-up survey. Primary outcome measures were ischemic events, including recurrent stroke/TIA and thromboembolism, and major bleedings events, such as fatal bleeding and/or symptomatic bleeding in a critical area or organ according to the International Society on Thrombosis and Haemostasis statement. We assessed the incidence and clinical factors associated with primary outcomes within 90 days after initiating OACs. Results: NOACs were given for 370 patients (126 women, 74±9 y; dabigatran 168, rivaroxaban 183 and apixaban 19) and warfarin for 546 (263 women, 79±10 y). NOAC users had lower scores of CHADS2 (median 3 in NOAC, 4 in warfarin, p 〈 0.001) and HAS-BLED (3, 3, p 〈 0.001) than warfarin users. Ischemic events occurred in 14 NOAC users (3.8%; 2 women, 76±6 y, including 8 lower dose users between two approved dose for each NOAC) and 25 warfarin users (4.6%; 13 women, 81±9 y). Of these, 13 NOAC users (3.5%) and 16 warfarin users (2.9%) developed ischemic stroke/TIA. Among NOAC users, patients with ischemic events had lower body weights (53±11 vs 60±11kg, p= 0.017), more frequently had congestive heart failure (36 vs 10%, p = 0.003) and intracardiac thrombus (27 vs 4%, p 〈 0.001) than those without. Major bleeding events occurred in 5 NOAC users (1.4%, all using lower dose), and 14 warfarin users (2.6%). Of these, one NOAC user (0.3%) and 4 warfarin users (0.7%) developed intracranial hemorrhage. Conclusion: The 3-month incidence of ischemic events in stroke/TIA patients with NVAF was approximately 4% in both NOAC and warfarin users. Intracranial hemorrhage was relatively infrequent in NOAC users.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    RVK:
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2015
    detail.hit.zdb_id: 1467823-8
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  • 7
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 45, No. suppl_1 ( 2014-02)
    Abstract: Objective: Early anticoagulant therapy is commonly used for acute cardioembolic stroke in Japan, although its usefulness remains undetected. The purpose of this study was to estimate the efficacy and safety of early anticoagulation for the treatment of acute stroke/TIA patients with nonvalvular atrial fibrillation (NVAF). Methods: From September 2011 through June 2013, 697 acute ischemic stroke/TIA patients with NVAF were registered from a multicenter prospective registry (the SAMURAI-NVAF study including 18 Japanese stroke centers, NCT01581502). Of those, the patients who started anticoagulant therapy within 48 hours after the onset were assessed for the incidence of ischemic and hemorrhagic events during the first 30 days. Results: A total of 438 patients (62.8%; 247 men, 77.4±9.8 years old) was evaluated. Of these, 292 patients (66.7%) started anticoagulation with intravenous unfractionated heparin (UFH) mono-therapy, 87 patients (19.9%) with UFH and warfarin, and 2 patients (0.5%) with UFH switched to novel oral anticoagulants (NOACs). As oral anticoagulants mono-therapy, 34 patients (7.8%) started with warfarin, and 23 (5.3%) with NOAC. Ischemic events were developed in 11 patients (2.5%: 11 recurrent ischemic strokes), and hemorrhagic events in 11 patients (2.5%: 6 symptomatic intracranial hemorrhages during the first 7days and 5 extracranial hemorrhages). Patients with major artery occlusion had higher incidence of hemorrhagic events than those without (4.0% versus 0.6%, p=0.02), whereas ischemic events were similar in both groups (2.4% versus 2.7%, p=0.82). In multivariable analysis, major artery occlusion was independently associated with higher rate of major hemorrhagic events (OR 6.19; 95% CI 1.01-119.75) adjusted for age, sex, BMI, HAS-BLED score before index TIA/stroke, and NIHSS on admission. Conclusion: In our cohort, early initiation of anticoagulant therapy is often performed in patients with acute stroke/TIA with NVAF patient, and the frequency of ischemic and hemorrhagic events seems to be low compared with previous reports. Early anticoagulant therapy can be safe for patients without major artery occlusion.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    RVK:
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2014
    detail.hit.zdb_id: 1467823-8
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  • 8
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 46, No. suppl_1 ( 2015-02)
    Abstract: Background and purpose: The impact of albuminuria on clinical outcomes in acute cardioembolic stroke is not fully investigated. We assessed whether high spot urine albumin/creatinine ratio (ACR) was associated with clinical outcomes in acute stroke with non-valvular atrial fibrillation (NVAF). Methods: From 2011 to 2014, we enrolled acute ischemic stroke/TIA patients with NVAF in the SAMURAI-NVAF study, which is a multicenter, observational study. Patients with complete ACR values were included in the analysis. They were divided into the N (normal, ACR 〈 30mg/g) and the H (high, ACR ≥ 30mg/g) groups. Clinical outcomes were neurological deterioration (an increase of NIHSS ≥1 point during the initial 7 days) and poor outcome (mRS of 4-6 at 3 months). Results: Of 558 patients (328 men, 77±10 y) who were included, 271 and 287 were assigned to the H group and the N group, respectively. As compared with patients in the N group, those in the H group were more frequently female (52 vs 31%, p 〈 0.001) and older (80±10 vs 75±10 y, p 〈 0.001). On admission, patients in the H group more frequently had diabetes (28 vs 17%, p = 0.003), less frequently had paroxysmal AF (68 vs 57%, p = 0.009), had higher levels of SBP (157±28 vs 151±24 mmHg, p = 0.003), NIHSS score (11 vs 5, p 〈 0.001), CHA2DS2-VASc score (6 vs 5, p 〈 0.001), plasma glucose (141±62 vs 132±41 mg/dL, p = 0.04), and brain natriuretic peptide (348±331 vs 259±309 pg/mL, p = 0.002), and had lower levels of hemoglobin (13±2 vs 14±2 g/dL, p = 0.02), and estimated glomerular filtration ratio (eGFR) (60±24 vs 66±20 mL/min/1.73m2 p = 0.002). On imaging studies, patients in the H group more frequently had large infarct (29 vs 20 %, p = 0.02) and culprit artery occlusion (64 vs 48%, p 〈 0.001). Neurological deterioration (14 vs 4%, p 〈 0.001) and poor outcome (49 vs 24%, p 〈 0.001) were more frequently observed in the H group. On multivariate regression analysis adjusted for significant confounders and reperfusion therapy, the H group was associated with neurological deterioration (OR 2.43; 95% CI 1.14-5.5; p = 0.02) and poor outcome (OR 2.75; 95% CI 1.45-5.2; p = 0.002), although eGFR was not significantly related to either. Conclusion: High ACR, a marker of albuminuria, was independently associated with unfavorable outcomes in acute stroke patients with NVAF.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    RVK:
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2015
    detail.hit.zdb_id: 1467823-8
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  • 9
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 45, No. suppl_1 ( 2014-02)
    Abstract: Purpose: Intravenous nicardipine is commonly used to reduce elevated blood pressure (BP) in acute intracerebral hemorrhage (ICH). We determined factors associated with nicardipine dose and the association of the dose with clinical outcomes in hyperacute ICH. Methods: Hyperacute ( 〈 3 h from onset) ICH patients with initial systolic BP (SBP) 〉 180 mmHg were registered in a multicenter observational study (the SAMURAI-ICH study). All patients initially received 5mg/h of intravenous nicardipine to lower BP. The dose was adjusted to maintain SBP between 120 and 160 mmHg based on BPs measured every 15 min during the initial 2 h and every 60 min in the following 22 h. Maximum hourly and total doses during the initial 24 h were calculated. Associations of the doses with neurological deterioration (a decrease of ≥2 in GCS or an increase of ≥4 in NIHSS score at 72 h after treatment initiation), hematoma expansion ( 〉 33% from baseline to 24 h), and unfavorable outcome (modified Rankin Scale score 4-6 at 3 months) were assessed. Results: Of 211 patients in the registry, 206 patients (81 women, 65.8±11.8 years old) whose nicardipine data were available throughout 24-h observation were studied. Initial BP was 201.9±15.9/107.9±15.1 mmHg. Median time to reach target SBP range was 30 min (IQR 15-45). Maximum and total doses were 9.1±4.2mg/h and 123.7±100.2mg/day, respectively. Multivariate analyses revealed that male sex [standardized regression coefficient (β)=0.20, p=0.0030 for maximum dose; β=0.25, p=0.0002 for total dose], age (β= -0.28, p=0.0002; β= -0.25, p=0.0005) and initial SBP (β=0.19, p=0.0018; β=0.18, p=0.0021) were independently associated with both maximum and total doses. Body weight (β=0.20, p=0.0084) was independently associated with total dose. After multivariate adjustment, maximum dose (per 1mg/h; OR 1.25, 95% CI 1.09-1.45; p=0.0022) was independently and total dose (per 10mg/day; OR 1.06, 95% CI 0.998-1.132; p=0.0555) tended to be associated with neurological deterioration. Nicardipine dose was not associated with hematoma expansion and unfavorable outcome. Conclusions: Nicardipine dosage is roughly predictable with sex, age, body weight and initial SBP in acute ICH. Maximum hourly nicardipine dose was associated with neurological deterioration.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    RVK:
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2014
    detail.hit.zdb_id: 1467823-8
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  • 10
    In: International Journal of Stroke, SAGE Publications, Vol. 10, No. 6 ( 2015-08), p. 836-842
    Abstract: Large clinical trials are lack of data on non-vitamin K antagonist oral anticoagulants for acute stroke patients. Aim To evaluate the choice of oral anticoagulants at acute hospital discharge in stroke patients with nonvalvular atrial fibrillation and clarify the underlying characteristics potentially affecting that choice using the multicenter Stroke Acute Management with Urgent Risk-factor Assessment and Improvement-NVAF registry (ClinicalTrials.gov NCT01581502). Method The study included 1192 acute ischemic stroke/transient ischemic attack patients with nonvalvular atrial fibrillation (527 women, 77·7 ± 9·9 years old) between September 2011 and March 2014, during which three nonvitamin K antagonist oral anticoagulant oral anticoagulants were approved for clinical use. Oral anticoagulant choice at hospital discharge (median 23-day stay) was assessed. Results Warfarin was chosen for 650 patients, dabigatran for 203, rivaroxaban for 238, and apixaban for 25. Over the three 10-month observation periods, patients taking warfarin gradually decreased to 46·5% and those taking nonvitamin K antagonist oral anticoagulants increased to 48·0%. As compared with warfarin users, patients taking nonvitamin K antagonist oral anticoagulants included more men, were younger, more frequently had small infarcts, and had lower scores for poststroke CHADS 2 , CHA 2 DS 2 -VASc, and HAS-BLED, admission National Institutes of Health stroke scale, and discharge modified Rankin Scale. Nonvitamin K antagonist oral anticoagulants were started at a median of four-days after stroke onset without early intracranial hemorrhage. Patients starting nonvitamin K antagonist oral anticoagulants earlier had smaller infarcts and lower scores for the admission National Institutes of Health stroke scale and the discharge modified Rankin Scale than those starting later. Choice of nonvitamin K antagonist oral anticoagulants was independently associated with 20-day or shorter hospitalization (OR 2·46, 95% CI 1·87–3·24). Conclusions Warfarin use at acute hospital discharge was still common in the initial years after approval of nonvitamin K antagonist oral anticoagulants, although nonvitamin K antagonist oral anticoagulant users increased gradually. The index stroke was milder and ischemia-risk indices were lower in nonvitamin K antagonist oral anticoagulant users than in warfarin users. Early initiation of nonvitamin K antagonist oral anticoagulants seemed safe.
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2015
    detail.hit.zdb_id: 2211666-7
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