Abstract WP418: Characteristic of Intracerebral Hemorrhage Related to Direct Oral Anticoagulant versus Warfarin: Results From the PASTA Registry

Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Satoshi Suda ◽  
Yasuyuki Iguchi ◽  
Shigeru Fujimoto ◽  
Yoshiki Yagita ◽  
Takayuki Mizunari ◽  
...  

Background and Purpose: The characteristics of direct oral anticoagulant (DOAC)-related intracerebral hemorrhage (ICH) have not been fully clarified. We planned to recruit patients prospectively and to investigate the characteristics and outcomes in patients with ICH receiving direct oral anticoagulant (DOAC) and warfarin treatment. Methods: The prospective analysis of stroke patients taking anticoagulants (PASTA) registry study is an observational, multicenter, prospective registry of stroke patients receiving OAC. Patient enrollment started in April 2016 at 25 tertiary centers across Japan. We compared imaging, clinical characteristics, and discharge modified Rankin Scale (mRS) between DOAC- and warfarin-related ICH patients with atrial fibrillation (AF). Results: A total of 154 patients (51 women; median age 77 [quartiles 69-87] years) were analyzed. Of these, 111 patients (72%) received prior DOAC treatment and the remaining 43 (28%) received prior warfarin treatment (Fig. A, B and C). There were no relevant differences in clinical and hematoma characteristics between DOAC- and warfarin-related ICH regarding baseline hematoma volume (median [quartiles]: DOAC, 11 [5-23] mL vs. warfarin, 12 [5-30] mL; P =0.95), rate of hematoma expansion (DOAC, 12/111 [11%] vs. warfarin, 4/43 [9%]; P =0.80), rate of subcortical hemorrhage (DOAC, 15/111 [11%] vs. warfarin, 10/43 [9%]; P =0.80) and the proportion of patients with unfavorable outcome (mRS, 4-6: DOAC 76/108 [70%] vs. warfarin 23/38 [61%]; P =0.26). Cerebral microbleeds (CMBs) were detected more frequently in DOAC group than in warfarin (47/76 [62%] vs. 11/32 [34%]; P <0.01). Subgroup analyses showed that type of DOAC agent did not result in relevant differences in imaging characteristics or outcome (Fig. D and E). Conclusions: Our results showed that there were no significant differences in hematoma characteristics and functional outcome among AF patients with DOAC- or warfarin-related ICH.

Stroke ◽  
2016 ◽  
Vol 47 (suppl_1) ◽  
Author(s):  
Daniel Vela-Duarte ◽  
Ramnath Santosh Ramanathan ◽  
Atif Zafar ◽  
Ather Taqui ◽  
Stacey Winners ◽  
...  

Introduction: The mobile stroke unit (MSTU) is an on-site pre-hospital treatment team that incorporates laboratory and CT scanner and reduces times to treatment for ischemic stroke thrombolysis. The impact of MSTU on treatment and outcomes of intracerebral hemorrhage (ICH) remains unknown. We report our initial experience with ICH encountered on MSTU. Hypothesis: ICH can be quickly identified using MSTU. Hypertension and coagulopathy are common in ICH evaluated on MSTU. Methods: We identified ICH cases from the prospectively collected database encounters. Demographics, clinical features, MSTU imaging and repeat imaging characteristics were reviewed. Initial and follow-up hematoma volume was calculated by the ABC/2 method. Results: Of 295 encounters on MSTU from July 2014 to July 2015, 20 (6.7%) had intracranial hemorrhage, which comprised of 17 intracerebral, 1 subarachnoid and 2 subdural hemorrhages. Median time to CT diagnosis of ICH from emergency medical dispatch was 31 minutes (interquartile range (IQR) 28-36) and that from last known well was 118 minutes (IQR 39-301). Of the 17 ICH patients, 15 (88%) were hypertensive, with a mean systolic blood pressure of 178.1 and diastolic 91.0 mm Hg. Five (29.4%) individuals were found with INR>1.4, 1 of whom received 4-factor prothrombin complex concentrate. Median NIH Stroke Scale was 11 (IQR 7.5-14.5), and median hematoma volume was 10.7 cc (IQR 4.3-30.8). One patient had significant hematoma expansion as defined by >6 cc or 33% relative volume increase. Conclusions: Over 5% of the cases evaluated in the unit presented with ICH, most of whom were hypertensive and had small hematoma volume. MSTU enables early diagnosis of ICH after activation of emergency system, can provide early treatment, and appropriate triage.


Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Satoshi Suda ◽  
Yasuyuki Iguchi ◽  
Shigeru Fujimoto ◽  
Yoshiki Yagita ◽  
Takayuki Mizunari ◽  
...  

Background and Purpose: The characteristics of patients with stroke prior receiving direct oral anticoagulant (DOAC) have not been fully clarified. We planned to recruit patients prospectively and to investigate the characteristics and outcomes in stroke patients taking DOAC and warfarin treatment prior to the event. Methods: The prospective analysis of stroke patients taking anticoagulants (PASTA) registry study is an observational, multicenter, prospective registry of stroke patients receiving OAC. Patient enrollment started in April 2016 at 25 tertiary centers across Japan. We compared clinical characteristics and discharge modified Rankin Scale (mRS) between DOAC-and warfarin-treatment in patients with atrial fibrillation (AF). Results: A total of 580 patients (231 women; median age 80 [quartiles 73-84] years) were analyzed (Fig. A). Of these, 365 patients (63%) received prior DOAC treatment and the remaining 215 (37%) received prior warfarin treatment (Fig. B and C). There were significant differences in clinical characteristics and outcome between DOAC-and warfarin-treatment prior to the event regarding initial NIHSS score (median [quartiles]: DOAC, 4 [2-16] vs. warfarin, 9 [3-21]; P =0.0001), rate of medium-large size of infarct (DOAC, 202/340 [59%] versus warfarin, 152/203 [75%]; P =0.0003) and the proportion of patients with favorable outcome (mRS, 0-3: DOAC 218/354 [62%] vs. warfarin 108/212 [49%]; P =0.0036). Subclassification according to DOAC dosing revealed patients with low-dose (259/365; 71%) to be older and to have a higher NIHSS score compared with regular dose (low-dose, 5 [2-17] vs. regular-dose, 3 [1-11]; P =0.0023) (Fig. D). Type of DOAC agent did not result in relevant differences in clinical characteristics or outcome (Fig. E). Conclusions: Our results showed that patients with DOAC treatment before the event showed smaller infarct size, milder initial stroke severity, and favorable outcome compared to patients with warfarin.


Stroke ◽  
2012 ◽  
Vol 43 (suppl_1) ◽  
Author(s):  
Nerses Sanossian ◽  
Adrian M Burgos ◽  
David S Liebeskind ◽  
Sidney Starkman ◽  
Pablo Villablanca ◽  
...  

Background: Early neurologic deterioration (END) occurs commonly in intracerebral hemorrhage (ICH) patients being transported by EMS ambulances, but the imaging correlates of END have not been previously delineated. Methods: We analyzed consecutive ICH patients in the Field Administration of Stroke Therapy - Magnesium (FAST-MAG) Trial, a phase 3, multicenter of paramedic-initiated magnesium sulfate vs. placebo for stroke patients presenting within 2 hours of symptom onset. END was defined as a 2-point or greater decrease in the Glasgow Coma Scale (GCS) from paramedic evaluation to ED evaluation. Baseline imaging studies were independently analyzed by 2 neurologists for ICH location, volume, presence of intraventricular hemorrhage (IVH), heterogeneity (defined as >20 point difference in Hounsfield units), irregular hematoma borders, multilobulated appearance, and substantial edema (defined as >0.5cm thickness). Leukoaraiosis was graded using the Fazekas scale for periventricular and deep white matter changes (0-3 for each). Results: Among 127 patients, mean age was 66 (SD 14) years, 34% were women, 35% were Hispanic ethnicity, 83% white, and 84% had a history of HTN. Patients were evaluated by paramedics a median of 23 (IQR 16, 39) minutes after last known well time (LKWT). At that time, the median GCS was 15 (IQR 15-15) and mean SBP/DBP was 177/95 (SD 34/22). Initial post-arrival brain imaging was performed a median of 94 (IQR 77, 117) min after LKWT. Post-arrival study GCS scores were obtained at a median of 108 (IQR 70, 144) min after LWKT. Early neurologic deterioration occurred in 37 (29%) patients. Among these patients, median first ED GCS was 3 (IQR 3-10). On first imaging, compared with neurologically stable patients, END patients had larger hematoma volume (33 cc v 16 cc, p<0.0001), and more frequent presence of intraventricular extension (45% v 20%, p=0.003), midline shift (58% v 22%), substantial edema (54% v 26%, p=0.038), heterogeneous density (50% v 22%, p=0.006), multilobulated appearance (44% v 18%, p=0.002), and irregular border (39% v 14%, p=0.010). Leukoaraiosis and cortical v subcortical location did not affect rates of END. In multivariate analysis, hematoma volume and presence of IVH were imaging findings independently associated with early neurologic deterioration. Conclusions: About 3 in 10 patients with hyperacute ICH neurologically deteriorate during the prehospital and early emergency department course, often before neuroimaging is obtained. Patients with early neurologic deterioration have larger hematoma volume and occurrence of IVH on initial imaging. These findings suggest hematoma expansion prior to ED arrival drives early neurologic deterioration in ICH and emphasize the need for prehospital interventions.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Yong Soo Kim ◽  
Han-Gil Jeong ◽  
Hee-Yun Chae ◽  
Beom Joon Kim ◽  
Jihoon Kang ◽  
...  

AbstractLow hemoglobin levels are known to be associated with hematoma expansion (HE) and poor functional outcome in patients with intracerebral hemorrhage (ICH). However, it is not yet known whether low hemoglobin itself causes HE directly or is merely a confounder. Thus, we investigated the mediation effect of the mean Hounsfield unit (HU) of hematoma on the relationship between low hemoglobin and expansion of ICH. Overall, 232 consecutive patients with ICH who underwent non-contrast computed tomography (NCCT) within 12 h since onset were included. The mean HU and hematoma volume on NCCT were investigated using semi-automated planimetry. HE was defined as an increase in hematoma volume > 33% or 6 mL. The respective associations among the hemoglobin level, mean HU, and HE were analyzed using multivariable regression analysis, adjusting for age, sex, and known HE predictors. Mediation analysis was performed to examine the potential causal association among the three. HE occurred in 34.5% of patients; hemoglobin levels were inversely associated with HE occurrence (adjusted odds ratio, 0.90; p = 0.03). The mean HU of the hematoma was lower in patients with HE than in patients without HE (58.5 ± 3.3 vs. 56.8 ± 3.0; p < 0.01). Hemoglobin levels on admission were linearly related to the mean HU (adjusted β, 0.33; p < 0.01) after adjusting for known HE predictors (time from onset to CT, antithrombotic use, hematoma volume). Causal mediation analysis showed a significant mediation effect of the mean HU on the association between hemoglobin levels and HE (p = 0.04). The proportion of indirect effect through the mean HU among the total effect was 19% (p = 0.05). The mediation effect became nonsignificant in the when the multivariable model was adjusted with additional covariates (baseline systolic blood pressure and hematoma location). The mean HU of the hematoma mediated the association between hemoglobin levels and HE occurrence. Therefore, the mean HU of the hematoma may be a potential marker of impaired hemostasis in patients with ICH.


Stroke ◽  
2013 ◽  
Vol 44 (suppl_1) ◽  
Author(s):  
TETSUYA MIYAGI ◽  
Masatoshi Koga ◽  
Hiroshi Yamagami ◽  
Satoshi Okuda ◽  
Yasushi Okada ◽  
...  

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.


2020 ◽  
Vol 5 (4) ◽  
pp. 384-393
Author(s):  
Manuel Cappellari ◽  
David J Seiffge ◽  
Masatoshi Koga ◽  
Maurizio Paciaroni ◽  
Stefano Forlivesi ◽  
...  

Introduction It is unknown whether the type of treatment (direct oral anticoagulant versus vitamin K antagonist) and the time of treatment introduction (early versus late) may affect the functional outcome in stroke patients with atrial fibrillation. We aimed to develop and validate a nomogram model including direct oral anticoagulant/vitamin K antagonist and early/late oral anticoagulant introduction for predicting the probability of unfavourable outcome after stroke in atrial fibrillation-patients. Patients and Methods We conducted an individual patient data analysis of four prospective studies. Unfavourable functional outcome was defined as three-month modified Rankin Scale score 3 -6. To generate the nomogram, five independent predictors including age (<65 years, reference; 65--79; or 80), National Institutes of Health Stroke Scale score (0--5 points, reference; 6--15; 16--25; or >25), acute revascularisation treatments (yes, reference, or no), direct oral anticoagulant (reference) or vitamin K antagonist, and early (7 days, reference) or late (8--30) anticoagulant introduction entered into a final logistic regression model. The discriminative performance of the model was assessed by using the area under the receiver operating characteristic curve. Results A total of 2102 patients with complete data for generating the nomogram was randomly dichotomised into training ( n = 1553) and test ( n = 549) sets. The area under the receiver operating characteristic curve was 0.822 (95% confidence interval, CI: 0.800--0.844) in the training set and 0.803 (95% CI: 0.764--0.842) in the test set. The model was adequately calibrated (9.852; p = 0.276 for the Hosmer--Lemeshow test). Discussion and Conclusion Our nomogram is the first model including type of oral anticoagulant and time of treatment introduction to predict the probability of three-month unfavourable outcome in a large multicentre cohort of stroke patients with atrial fibrillation.


2016 ◽  
Vol 42 (5-6) ◽  
pp. 485-492 ◽  
Author(s):  
Paola Forti ◽  
Fabiola Maioli ◽  
Michele Domenico Spampinato ◽  
Carlotta Barbara ◽  
Valeria Nativio ◽  
...  

Background: Incidence of acute intracerebral hemorrhage (ICH) increases with age, but there is a lack of information about ICH characteristics in the oldest-old (age ≥85 years). In particular, there is a need for information about hematoma volume, which is included in most clinical scales for prediction of mortality in ICH patients. Many of these scales also assume that, independent of ICH characteristics, the oldest-old have a higher mortality than younger elderly patients (age 65-74 years). However, supporting evidence from cohort studies is limited. We investigated ICH characteristics of oldest-old subjects compared to young (<65 years), young-old (65-74 years) and old-old (75-84 years) subjects. We also investigated whether age is an independent mortality predictor in elderly (age ≥65 years) subjects with acute ICH. Methods: We retrospectively collected clinical and neuroimaging data of 383 subjects (age 34-104 years) with acute supratentorial primary ICH who were admitted to an Italian Stroke Unit (SU) between October 2007 and December 2014. Measured ICH characteristics included hematoma location, volume and intraventricular extension of hemorrhage on admission CT scan; admission Glasgow Coma Scale ≤8 and hematoma expansion (HE) measured on follow-up CT-scans obtained after 24 h. General linear models and logistic models were used to investigate the association of age with ICH characteristics. These models were adjusted for pre-admission characteristics, hematoma location and time from symptom onset to admission CT scan. Limited to elderly subjects, Cox models were used to investigate the association of age with in-SU and 1-year mortality: the model for in-SU mortality adjusted for pre-admission and ICH admission characteristics and the model for 1-year mortality additionally adjusted for functional status and disposition at SU discharge. Results: Independent of pre-admission characteristics, hematoma location and time from symptom onset to admission CT-scan, oldest-old subjects had the highest admission hematoma volume (p < 0.01). Age was unrelated to all other ICH characteristics including HE. In elderly patients, multivariable adjusted risk of in-SU and 1-year mortality did not vary across age categories. Conclusions: Oldest-old subjects with acute supratentorial ICH have higher admission hematoma volume than young and young-old subjects but do not differ for other ICH characteristics. When taking into account confounding from ICH characteristics, risk of in-SU and 1-year mortality in elderly subjects with acute supratentorial ICH does not differ across age categories. Our findings question use of age as an independent criterion for stratification of mortality risk in elderly subjects with acute ICH.


Stroke ◽  
2021 ◽  
Author(s):  
Hagen B. Huttner ◽  
Stefan T. Gerner ◽  
Joji B. Kuramatsu ◽  
Stuart J. Connolly ◽  
Jan Beyer-Westendorf ◽  
...  

Background and Purpose: It is unestablished whether andexanet alfa, compared with guideline-based usual care including prothrombin complex concentrates, is associated with reduced hematoma expansion (HE) and mortality in patients with factor-Xa inhibitor–related intracerebral hemorrhage (ICH). We compared the occurrence of HE and clinical outcomes in patients treated either with andexanet alfa or with usual care during the acute phase of factor-Xa inhibitor–related ICH. Methods: Data were extracted from the multicenter, prospective, single-arm ANNEXA-4 trial (Andexanet Alfa, a Novel Antidote to the Anticoagulation Effects of Factor Xa Inhibitors) and a multicenter observational cohort study, RETRACE-II (German-Wide Multicenter Analysis of Oral Anticoagulant-Associated Intracerebral Hemorrhage - Part Two). HE was based on computed tomography scans performed within 36 hours from baseline imaging. Inverse probability of treatment weighting was performed to adjust for baseline comorbidities and ICH severity. Patients presenting with atraumatic ICH while receiving apixaban or rivaroxaban within 18 hours of admission were included. Patients with secondary ICH or not fulfilling the inclusion criteria for the ANNEXA-4 trial were excluded. We compared ANNEXA-4 patients, who received andexanet alfa for hemostatic treatment, with RETRACE-II patients who were treated with usual care, primarily administration of prothrombin complex concentrates. Primary outcome was rate of HE defined as relative increase of ≥35%. Secondary outcomes comprised mean absolute change in hematoma volume, as well as in-hospital mortality and functional outcome. Results: Overall, 182 patients with factor-Xa inhibitor–related ICH (85 receiving andexanet alfa versus 97 receiving usual care) were selected for analysis. There were no relevant differences regarding demographic or clinical characteristics between both groups. HE occurred in 11 of 80 (14%) andexanet alfa patients compared with 21 of 67 (36%) usual care patients (adjusted relative risk, 0.40 [95% CI, 0.20–0.78]; P =0.005), with a reduction in mean overall hematoma volume change of 7 mL. There were no statistically significant differences among in-hospital mortality or functional outcomes. Sensitivity analysis including only usual care patients receiving prothrombin complex concentrates demonstrated consistent results. Conclusions: As compared with usual care, andexanet alfa was associated with a lower rate of HE in atraumatic factor-Xa inhibitor–related ICH, however, without translating into significantly improved clinical outcomes. A comparative trial is needed to confirm the benefit on limiting HE and to explore clinical outcomes across patient subgroups and by time to treatment.


Stroke ◽  
2012 ◽  
Vol 43 (suppl_1) ◽  
Author(s):  
Tanzila Shams ◽  
Prachi Mehndiratta ◽  
Pichet Termsarasab ◽  
Hesham Masoud ◽  
Siddharth Sehgal ◽  
...  

Introduction: The availability of sophisticated neuroimaging has led to increased utilization of imaging studies, particularly at comprehensive stroke centers. This increase in advanced imaging contributes to healthcare costs and has been questioned in this era of reducing reimbursement. Hypothesis: Multiple neuroimaging studies have limited impact in determining the plan of care for most patients with intracerebral hemorrhage. Methods: An IRB-approved retrospective chart review of all patients with Intracerebral Hemorrhage (ICH, ICD 431) treated at UH-CMC in 2010 collected data on demographics, number of neuroimaging studies and imaging characteristics, and the impact of testing on determining a medical or surgical plan of care. Hemorrhage location dictated one of two groups: basal ganglia and thalamus (BG) versus IVH alone, infratentorial and lobar (NBG). Results: Data was available on 120 (86%) of patients; 74 (62%) were male. Mean volume of ICH on initial CT was significantly smaller at 8.5±11.7cc in 41 BG patients vs 63±27cc in 79 NBG patients (p=0.01). The decision to pursue surgical treatment (extraventricular drainage in 14, craniotomy in 9, or both in 4) was determined prior to a third neuroimaging study. Three or more neuroimaging studies were obtained in 56% of BG and 59% of NBG patients. Hematoma expansion was less likely to occur in BG vs NBG patients, both for significant hematoma expansion (>33% or +12.5cc increase, 5% vs 22%, p=0.05) and nonsignificant hematoma expansion (10-33% increase, 2.4% vs 8.9%, p=0.27). Hematoma expansion was exclusively within the first 2 imaging studies for BG patients but occurred in a delayed fashion in 3 (4%) of NBG patients. MRI was obtained in 17% of BG and 44% of NBG patients; only in 3 of the NBG patients did it identify a vascular malformation which led to surgery in 1 patient. Conclusion: Although more than half of patients with intracerebral hemorrhage underwent three or more neuroimaging studies, 95% of patients’ care plan decisions were determined by the first, and to a lesser extent, the second neuroimaging study. Serial neuroimaging after the second study was of no value in patients with small basal ganglia hemorrhages and impacted the care plan in less than 10% of patients with hemorrhages in alternate locations. Our data suggests many neuroimaging studies can be safely omitted.


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