Abstract 61: Safety and Feasibility of Acute Dabigatran Therapy in Minor Ischemic Stroke Patients Without Atrial Fibrillation.

Stroke ◽  
2014 ◽  
Vol 45 (suppl_1) ◽  
Author(s):  
Ken Butcher ◽  
Mahesh Kate ◽  
Laura Gioia ◽  
Tom Jeerakathil ◽  
Brian Buck ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Ischemic Stroke ◽  
Recurrent Events ◽  
Dabigatran Etexilate ◽  
Hemorrhagic Transformation ◽  
Open Label ◽  
Minor Ischemic Stroke ◽  
Novel Oral Anticoagulant ◽  
Symptomatic Intracranial Hemorrhage ◽  
Ischemic Attack

Introduction: Transient Ischemic Attack (TIA) and Minor ischemic stroke (MIS) patients are at high risk for recurrent events. Older anticoagulants are associated with a reduction in recurrent events, but also an increase in hemorrhagic transformation (HT). Dabigatran etexilate (DE), a novel oral anticoagulant that is associated with reduced risk of intracranial bleeding in atrial fibrillation (AF) patients, may be an effective therapy in this population. DE is not indicated within 14 days of ischemic stroke, due to an absence of data. We tested the feasibility and safety of initiating DE therapy within 24 h of TIA/MIS. Methods: We designed a 50 patient single arm open label treatment trial. The primary endpoint was symptomatic HT within 30 days of enrolment. All patients underwent MRI prior to treatment. TIA/MIS patients (NIHSS score ≤3) with a DWI lesion were prospectively treated with DE 150 mg BID (110 mg BID in patients ≥ 80 or if CrCl <40 ml/min). Treatment began within 24 h of onset and continued for 30 days. Patients with known atrial fibrillation (AF) were excluded. Patients were re-imaged at day 7 and 30, with clinical assessment to 90 days. Results: Forty-three of 50 patients have been enrolled to date (March 2012-August 2013). The mean age was 66±12 years and median (IQR) NIHSS was 1 (2). Median baseline DWI volume was 0.89(1.9) ml. The median time from onset to initial DE dose was 18.5 (12.2) h. Therapy was completed in 41 patients and discontinued in two (withdrawal of consent (1) and dysphagia (1)). Two patients died within the 90 day study period, both after completion of DE therapy. No patients experienced systemic bleeding or symptomatic intracranial hemorrhage. One patient had asymptomatic HT (ECASS grade, HI1) on day 7, which resolved by day 30 despite continuing DE. No patients experienced recurrent clinical stroke. New asymptomatic DWI lesions developed in 7 (16%) patients by day 30. Conclusion: These preliminary data suggest DE may be used safely in acute TIA/MIS patients and larger randomized trials are warranted. The low HT rate may make DE an ideal antithrombotic for use immediately after TIA/ischemic stroke.

Hemostatic Activity in Patients with a Transient Ischemic Attack or Minor Ischemic Stroke with or without Chronic Non-Valvular Atrial Fibrillation

1993 ◽  
Vol 3 (6) ◽  
pp. 350-356
Author(s):  
Gheorghe A. Pop ◽  
Han J. Meeder ◽  
Wynsen van Oudenaarden ◽  
Jeannette C. van Latum ◽  
Wim Verweij ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Ischemic Stroke ◽  
Transient Ischemic Attack ◽  
Minor Ischemic Stroke ◽  
Hemostatic Activity ◽  
Ischemic Attack

Abstract P713: Early Apixaban Therapy After Ischemic Stroke in Patients With Atrial Fibrillation

Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
Anas Alrohimi ◽  
Brian H Buck ◽  
Glen Jickling ◽  
Ashfaq Shuaib ◽  
Sibi Thirunavukkarasu ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Ischemic Stroke ◽  
Infarct Volume ◽  
Hemorrhagic Transformation ◽  
Performance Criteria ◽  
Optimal Timing ◽  
Open Label ◽  
Stroke Study ◽  
Ischemic Events

Background: The optimal timing of anticoagulation after stroke in patients with atrial fibrillation (AF) is unknown. Patients and methods: A prospective, open label study (NCT04435418) of patients with AF treated with apixaban within 14 days of ischemic stroke/TIA onset was conducted. Baseline and follow-up CT scans were assessed for hemorrhagic transformation (HT) and graded using European Cooperative Acute Stroke Study (ECASS) criteria. The primary endpoint was symptomatic HT. Incident HT rates were assessed as Objective Performance Criteria. Results: One-hundred AF stroke patients, with a mean age of 79±11 years were enrolled. Median infarct volume was 4 (0.5-10.75) ml. Median time from index event onset to apixaban initiation was 2 (1-6) days, and median baseline NIHSS was 4 (1-9). Asymptomatic HT on baseline imaging was present in 15 patients. Infarct volume (OR= 1.1, [1.02-1.12], P <0.0001) and NIHSS (OR= 1.11, [1.03-1.20], P =0.007) were both associated with baseline HT. No patients developed symptomatic HT or systemic hemorrhage. Incident asymptomatic HT was seen on follow-up CT scan in 3 patients. Patients with incident HT were functionally independent (mRS=0-2) at 90 days. Recurrent ischemic events occurred within 90 days in 13 patients, 4 of which were associated with severe disability (mRS 3-5) and 4 with death. Discussion: Early apixaban treatment did not precipitate symptomatic HT after stroke. All HT was asymptomatic identified on imaging. Recurrent ischemic events were common and clinically symptomatic. Conclusions: Symptomatic HT rates are likely to be low in randomized trials of DOAC initiation post-stroke. Recurrent ischemic stroke may be the major clinical outcome.

scholarly journals Early Dabigatran Treatment After Transient Ischemic Attack and Minor Ischemic Stroke Does Not Result in Hemorrhagic Transformation

2020 ◽  
Vol 47 (5) ◽  
pp. 604-611
Author(s):  
Anas Alrohimi ◽  
Kelvin Ng ◽  
Dar Dowlatshahi ◽  
Brian Buck ◽  
Grant Stotts ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Transient Ischemic Attack ◽  
Infarct Volume ◽  
Hemorrhagic Transformation ◽  
Minor Stroke ◽  
Optimal Timing ◽  
Minor Ischemic Stroke ◽  
Pre Treatment ◽  
Ischemic Attack ◽  
Ischemic Events

ABSTRACT:Objectives:The optimal timing of anticoagulation after ischemic stroke in atrial fibrillation (AF) patients is unknown. Our aim was to demonstrate the feasibility and safety of initiating dabigatran therapy within 14 days of transient ischemic attack (TIA) or minor stroke in AF patients.Patients and Methods:A prospective, multi-center registry (NCT02415855) in patients with AF treated with dabigatran within 14 days of acute ischemic stroke/TIA (National Institutes of Health Stroke Scale (NIHSS) ≤ 3) onset. Baseline and follow-up computed tomography (CT) scans were assessed for hemorrhagic transformation (HT) and graded by using European Cooperative Acute Stroke Study criteria.Results:One hundred and one patients, with a mean age of 72.4 ± 11.5 years, were enrolled. Median infarct volume was 0 ml. Median time from index event onset to dabigatran initiation was 2 days, and median baseline NIHSS was 1. Pre-treatment HT was present in seven patients. No patients developed symptomatic HT. On the day 7 CT scan, HT was present in six patients (one progressing from baseline hemorrhagic infarction type 1). Infarct volume was a predictor of incident HT (odds ratio = 1.063 [1.020–1.107], p < 0.003). All six (100%) patients with new/progressive HT were functionally independent (modified Rankin Scale (mRS) = 0–2) at 30 days, which was similar to those without HT (90%, p = 0.422). Recurrent ischemic events occurred within 30 days in four patients, two of which were associated with severe disability and death (mRS 5 and 6, respectively).Conclusion:Early dabigatran treatment did not precipitate symptomatic HT after minor stroke. Asymptomatic HT was associated with larger baseline infarct volumes. Early recurrent ischemic events may be clinically more important.

scholarly journals Newly Diagnosed Atrial Fibrillation After Transient Ischemic Attack Versus Minor Ischemic Stroke in the POINT Trial

2021 ◽  
Vol 10 (6) ◽  
Author(s):  
Hooman Kamel ◽  
Mary Farrant ◽  
J. Donald Easton ◽  
Luciano A. Sposato ◽  
Jordan J. Elm ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Ischemic Stroke ◽  
Transient Ischemic Attack ◽  
Minor Stroke ◽  
Newly Diagnosed ◽  
Event Type ◽  
Primary Analysis ◽  
Index Event ◽  
Minor Ischemic Stroke ◽  
Ischemic Attack

Background Atrial fibrillation/flutter (AF) after transient ischemic attack (TIA) has not been well studied. We compared the likelihood of new AF diagnosis after ischemic stroke versus TIA. Methods and Results The POINT (Platelet‐Oriented Inhibition in New TIA and Minor Ischemic Stroke) trial enrolled adults within 12 hours of minor ischemic stroke or high‐risk TIA. Our exposure was index event type (ischemic stroke versus TIA). The primary analysis used the original trial definition of TIA (resolution of symptoms/signs). In secondary analyses, TIA cases with infarction on neuroimaging were reclassified as strokes. Our primary outcome was a new AF diagnosis, ascertained from adverse event and treatment interruption/discontinuation reports. We calculated C‐statistics for variables associated with newly diagnosed AF. We used Kaplan‐Meier survival statistics and Cox models adjusted for demographics and vascular risk factors. Excluding 49 subjects with baseline AF, 2746 patients had index stroke and 2086 patients had index TIA. During the 90‐day follow‐up, 106 patients had newly diagnosed AF. Cumulative risks of AF were 2.7% (95% CI, 2.1%–3.4%) after stroke and 2.0% (95% CI, 1.5%–2.7%) after TIA ( P =0.15). After reclassifying index events by neuroimaging, cumulative AF risk was higher after stroke (2.7%; 95% CI, 2.2%–3.4%) than TIA (1.8%; 95% CI, 1.3%–2.5%) ( P =0.04). Index event type had negligible predictive utility (C‐statistic, 0.54). Conclusions Among patients with cerebral ischemia, the distinction between TIA versus minor stroke did not stratify the risk of subsequent AF diagnosis, implying that patients with TIA should undergo similar heart‐rhythm monitoring strategies as patients with ischemic stroke.

Predictors of Major Vascular Events in Patients With a Transient Ischemic Attack or Minor Ischemic Stroke and With Nonrheumatic Atrial Fibrillation

Stroke ◽  
1995 ◽  
Vol 26 (5) ◽  
pp. 801-806 ◽  
Author(s):  
J.C. van Latum ◽  
P.J. Koudstaal ◽  
G.S. Venables ◽  
J. van Gijn ◽  
L.J. Kappelle ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Ischemic Stroke ◽  
Transient Ischemic Attack ◽  
Vascular Events ◽  
Minor Ischemic Stroke ◽  
Ischemic Attack

scholarly journals Early Apixaban Use Following Stroke in Patients With Atrial Fibrillation

Stroke ◽  
2021 ◽  
Vol 52 (4) ◽  
pp. 1164-1171
Author(s):  
Arthur J. Labovitz ◽  
David Z. Rose ◽  
Michael G. Fradley ◽  
John N. Meriwether ◽  
Swetha Renati ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Ischemic Stroke ◽  
Controlled Trial ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Hemorrhagic Transformation ◽  
Early Initiation ◽  
Open Label ◽  
Unique Identifier ◽  
Symptomatic Intracerebral Hemorrhage

Background and Purpose: It is unknown when to start anticoagulation after acute ischemic stroke (AIS) from atrial fibrillation (AF). Early anticoagulation may prevent recurrent infarctions but may provoke hemorrhagic transformation as AF strokes are typically larger and hemorrhagic transformation-prone. Later anticoagulation may prevent hemorrhagic transformation but increases risk of secondary stroke in this time frame. Our aim was to compare early anticoagulation with apixaban in AF patients with stroke or transient ischemic attack (TIA) versus warfarin administration at later intervals. Methods: AREST (Apixaban for Early Prevention of Recurrent Embolic Stroke and Hemorrhagic Transformation) was an open-label, randomized controlled trial comparing the safety of early use of apixaban at day 0 to 3 for TIA, day 3 to 5 for small-sized AIS (<1.5 cm), and day 7 to 9 for medium-sized AIS (≥1.5 cm, excluding full cortical territory), to warfarin, in a 1:1 ratio at 1 week post-TIA, or 2 weeks post-AIS. Results: Although AREST ended prematurely after a national guideline focused update recommended direct oral anticoagulants over warfarin for AF, it revealed that apixaban had statistically similar yet generally numerically lower rates of recurrent strokes/TIA (14.6% versus 19.2%, P =0.78), death (4.9% versus 8.5%, P =0.68), fatal strokes (2.4% versus 8.5%, P =0.37), symptomatic hemorrhages (0% versus 2.1%), and the primary composite outcome of fatal stroke, recurrent ischemic stroke, or TIA (17.1% versus 25.5%, P =0.44). One symptomatic intracerebral hemorrhage occurred on warfarin, none on apixaban. Five asymptomatic hemorrhagic transformation occurred in each arm. Conclusions: Early initiation of anticoagulation after TIA, small-, or medium-sized AIS from AF does not appear to compromise patient safety. Potential efficacy of early initiation of anticoagulation remains to be determined from larger pivotal trials. Registration: URL: https://www.clinicaltrials.gov/ ; Unique identifier: NCT02283294.

Abstract 3681: Early Anticoagulation Is Not Associated With Hemorrhagic Transformation Of Ischemic Stroke In Patients With Atrial Fibrillation

Stroke ◽  
2012 ◽  
Vol 43 (suppl_1) ◽  
Author(s):  
H. B Brouwers ◽  
Svetlana Lorenzano ◽  
Lyndsey H Starks ◽  
David M Greer ◽  
Steven K Feske ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Clinical Data ◽  
Infarct Volume ◽  
Hemorrhagic Transformation ◽  
P Value ◽  
Long Term Outcome ◽  
Nihss Score

Purpose: Hemorrhagic transformation (HT) is a common and potentially devastating complication of ischemic stroke, however its prevalence, predictors, and outcome remain unclear. Early anticoagulation is thought to be a risk factor for HT which raises the clinical question when to (re)start anticoagulation in ischemic stroke patients who have a compelling indication, such as atrial fibrillation. We conducted a prospective cohort study to address this question and to identify association of hemorrhagic transformation with outcome measures in patients with atrial fibrillation in the setting of acute ischemic stroke. Materials and Methods: We performed a prospective study which enrolled consecutive patients admitted with acute ischemic stroke presenting to a single center over a three-year period. As part of the observational study, baseline clinical data and stroke characteristics as well as 3 month functional outcome were collected. For this sub-study, we restricted the analysis to subjects diagnosed with atrial fibrillation. CT and MRI scans were reviewed by experienced readers, blinded to clinical data, to assess for hemorrhagic transformation (using ECASS 2 criteria), microbleeds and infarct volumes in both admission and follow-up scans. Clinical and outcome data were analyzed for association with hemorrhagic transformation. Results: Of 94 patients, 63 had a history of atrial fibrillation (67.0%) and 31 had newly discovered atrial fibrillation (33.0%). We identified HT in 3 of 94 baseline scans (3.2%) and 22 of 48 follow-up scans (45.8%) obtained a median of 3 days post-stroke. In-hospital initiation of either anti-platelet (n = 36; OR 0.34 [95% CI 0.10-1.16], p-value = 0.09) or anticoagulation with unfractionated intravenous heparin or low molecular weight heparin (n = 72; OR 0.25 [95% CI 0.06-1.15], p-value = 0.08) was not associated with HT. Initial NIH Stroke Scale (NIHSS) score (median 13.0 [IQR 15.0] vs. 7.0 [IQR 10.0], p-value = 0.029) and baseline infarct volume (median 17 [IQR 42.03] vs. 5 [IQR 10.95], p-value = 0.011) were significantly higher in patients with HT compared to those without. Hemorrhagic transformation was associated with a significantly higher 48-hour median NIHSS score (20 [IQR 3.0] vs. 2 [IQR 3.25], p-value = 0.007) and larger final infarct volume (81.40 [IQR 82.75] vs. 9.95 [IQR 19.73], p-value < 0.001). Finally, we found a trend towards poorer 3-month modified Rankin Scale scores in subjects with HT (OR 11.25 [95% CI 0.97-130.22], p-value = 0.05). Conclusion: In patients with atrial fibrillation, initial NIHSS score and baseline infarct volume are associated with hemorrhagic transformation in acute ischemic stroke. Early initiation of antithrombotic therapy was not associated with hemorrhagic transformation. Patients with hemorrhagic transformation were found to have a poorer short and long term outcome and larger final infarct volumes.

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