Antagonizing dabigatran by idarucizumab in cases of ischemic stroke or intracranial hemorrhage in Germany—Updated series of 120 cases

2020 ◽  
Vol 15 (6) ◽  
pp. 609-618 ◽  
Author(s):  
Pawel Kermer ◽  
Christoph C Eschenfelder ◽  
Hans-Christoph Diener ◽  
Martin Grond ◽  
Yasser Abdalla ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Intracerebral Hemorrhage ◽  
Acute Ischemic Stroke ◽  
Intracranial Hemorrhage ◽  
Intracranial Bleeding ◽  
National Institutes Of Health ◽  
Product Launch ◽  
Tissue Type ◽  
Bleeding Complications ◽  
Hematoma Growth

Background Idarucizumab is a monoclonal antibody fragment with high affinity for dabigatran reversing its anticoagulant effects within minutes. Thereby, patients with acute ischemic stroke who are on dabigatran treatment may become eligible for thrombolysis with recombinant tissue-type plasminogen activator (rt-PA). In patients on dabigatran with intracerebral hemorrhage idarucizumab could prevent lesion growth. Aims To provide insights into the clinical use of idarucizumab in patients under effective dabigatran anticoagulation presenting with signs of acute ischemic stroke or intracranial hemorrhage. Methods Retrospective data collected from German neurological/neurosurgical departments administering idarucizumab following product launch from January 2016 to August 2018 were used. Results One-hundred and twenty stroke patients received idarucizumab in 61 stroke centers. Eighty patients treated with dabigatran presented with ischemic stroke and 40 patients suffered intracranial bleeding (intracerebral hemorrhage (ICH) in n = 27). In patients receiving intravenous thrombolysis with rt-PA following idarucizumab, 78% showed a median improvement of 7 points in National Institutes of Health Stroke Scale. No bleeding complications were reported. Hematoma growth was observed in 3 out of 27 patients with ICH. Outcome was favorable with a median National Institutes of Health Stroke Scale improvement of 4 points and modified Rankin score 0–3 in 61%. Six out of 40 individuals (15%) with intracranial bleeding died during hospital stay. Conclusion Administration of rt-PA after reversal of dabigatran activity with idarucizumab in case of acute ischemic stroke seems feasible, effective, and safe. In dabigatran-associated intracranial hemorrhage, idarucizumab appears to prevent hematoma growth and to improve outcome.

scholarly journals Antagonizing dabigatran by idarucizumab in cases of ischemic stroke or intracranial hemorrhage in Germany – A national case collection

2017 ◽  
Vol 12 (4) ◽  
pp. 383-391 ◽  
Author(s):  
Pawel Kermer ◽  
Christoph C Eschenfelder ◽  
Hans-Christoph Diener ◽  
Martin Grond ◽  
Yasser Abdalla ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Intracranial Hemorrhage ◽  
Therapeutic Option ◽  
Antibody Fragment ◽  
Product Launch ◽  
Bleeding Complications ◽  
Hematoma Growth ◽  
Lesion Growth ◽  
Case Collection ◽  
Overall Mortality

Background Idarucizumab is a monoclonal antibody fragment with high affinity for dabigatran that reverses its anticoagulant effects within minutes. It may exhibit the potential for patients under dabigatran therapy suffering ischemic stroke to regain eligibility for thrombolysis with rt-PA and may inhibit lesion growth in patients with intracerebral hemorrhage on dabigatran. Aims To provide insights into the clinical use of idarucizumab in patients under effective dabigatran anticoagulation presenting with signs of ischemic stroke or intracranial hemorrhage. Methods Retrospective data collected from German neurological/neurosurgical departments administering idarucizumab following product launch from January to August 2016 were used. Results Thirty-one patients presenting with signs of stroke received idarucizumab in 22 stroke centers. Nineteen patients treated with dabigatran presented with ischemic stroke and 12 patients suffered from intracranial bleeding. In patients receiving rt-PA thrombolysis following idarucizumab, 79% benefitted from i.v. thrombolysis with a median improvement of five points in NIHSS. No bleeding complications occurred. Hematoma growth was observed in 2 out of 12 patients with intracranial hemorrhage. The outcome was favorable with a median NIHSS improvement of 5.5 points and mRS 0–3 in 67%. Overall, mortality was low with 6.5% (one patient in each group). Conclusion Administration of rt-PA after reversing dabigatran activity with idarucizumab in case of ischemic stroke is feasible, easy to manage, effective, and appears to be safe. In dabigatran-associated intracranial hemorrhage, idarucizumab has the potential to prevent hematoma growth and improve outcome. Idarucizumab represents a new therapeutic option for patients under dabigatran treatment presenting with ischemic stroke or intracranial hemorrhage.

Bivalirudin for Endovascular Intervention in Acute Ischemic Stroke: Case Report

Neurosurgery ◽  
2004 ◽  
Vol 54 (1) ◽  
pp. 218-223 ◽  
Author(s):  
Mark R. Harrigan ◽  
Elad I. Levy ◽  
Bernard R. Bendok ◽  
L. Nelson Hopkins
Keyword(s):  
Ischemic Stroke ◽  
Middle Cerebral Artery ◽  
Acute Ischemic Stroke ◽  
Scale Score ◽  
Intracranial Hemorrhage ◽  
National Institutes Of Health ◽  
Left Middle Cerebral Artery ◽  
Computed Tomographic ◽  
Left Middle ◽  
Arterial Thrombolysis

Abstract OBJECTIVE AND IMPORTANCE Intra-arterial thrombolysis has been demonstrated to improve recanalization and outcomes among patients with acute ischemic stroke. However, thrombolytic agents have limited effectiveness and are associated with a significant risk of bleeding. Bivalirudin is a direct thrombin inhibitor that has been demonstrated in the cardiology literature to have a more favorable efficacy and bleeding profile than other antithrombotic medications. We report the use of bivalirudin during endovascular treatment of acute stroke, when hemorrhagic complications are not uncommon. CLINICAL PRESENTATION A 71-year-old woman with atrial fibrillation presented with right hemiparesis and aphasia and was found to have a National Institutes of Health Stroke Scale score of 10. Computed tomographic scans revealed no evidence of intracranial hemorrhage, aneurysm, or ischemic stroke. Cerebral angiography revealed thromboembolic occlusion of the superior division of the left middle cerebral artery. INTERVENTION For anticoagulation, a loading dose of bivalirudin was intravenously administered before the interventional procedure, followed by continuous infusion. Attempts to remove the clot with an endovascular snare failed to induce recanalization of the vessel. Bivalirudin was then administered intra-arterially. Immediate postprocedural angiography demonstrated restoration of flow in the left middle cerebral artery. Repeat computed tomographic scans demonstrated no intracranial hemorrhage. The patient's hemiparesis and aphasia were nearly resolved and her National Institutes of Health Stroke Scale score was 2 at the time of her discharge 5 days later. CONCLUSION To our knowledge, this is the first report of the use of bivalirudin for treatment of acute ischemic stroke. Bivalirudin may be a useful agent for intravenous anticoagulation and intra-arterial thrombolysis in this setting.

Abstract WMP117: Patterns of All Bleeding Complications Associated with r-tPA Use-experience of an Acadamic Center in China

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Hong Chang ◽  
Xiaojuan Wang ◽  
Yuchen Qiao ◽  
Jie Zhao ◽  
Haiqing Song
Keyword(s):  
Risk Factors ◽  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Intravenous Thrombolysis ◽  
Tissue Type ◽  
Bleeding Complications ◽  
High Systolic Blood Pressure ◽  
Gingival Bleeding ◽  
Hemorrhagic Event ◽  
Hemorrhagic Complications

Background and objective: Rapid administration of intravenous recombinant tissue-type plasminogen activator (rt-PA) is the standard treatment for patients with acute ischemic stroke (AIS). While hemorrhage represents as an important and unpredictable complication of thrombolytic treatment, few studies have specifically assessed the prevalence and predictors of bleeding complications among AIS patients in Asia. We assessed characteristics of hemorrhagic complications after intravenous thrombolysis in Chinese AIS patients. Methods: This single-academic-center study retrospectively evaluated 351 acute ischemic stroke patients who received rt-PA intravenously from April 2011 to April 2016. The occurrence and characteristics of any hemorrhagic complications, as well as their associated risk factors were recorded and summarized. Multivariate logistic regression was conducted to analyze significant predictors of bleeding. Results: 134 (38.1%) patients experienced one hemorrhagic event in one or more locations The top seven common sites were gingiva (49.3%), skin (18.3%), urinary system (10.4%), digestive tract (7.5%), intra-cranial cavity (7.5%), mouth (4.4%) and nasal cavity (2.2%). All the gingival bleeding occurred during 1 to 24 hours after thrombolysis and was the first sign of bleeding. Intracranial hemorrhage (both symptomatic and asymptomatic) occurred in 16 patients, of whom 4 presented first with gingival bleeding. Multivariate analysis showed that high systolic blood pressure (SBP) and National Institutes of Health Stroke Scale (NIHSS) score were independent risk factors for hemorrhage post thrombolysis (P<0.05). Conclusions: One out of three AIS patients in this study had a bleeding complication. The most common site of initial hemorrhage after intravenous thrombolysis was gingival, which frequently occurred as the initial bleeding site within 24 hours after thrombolysis. Consistent with literature, elevated SBP and higher NIHSS were the two key predictors of bleeding risk.

scholarly journals Intra-Arterial Adjunctive Medications for Acute Ischemic Stroke During Mechanical Thrombectomy

Stroke ◽  
2021 ◽  
Vol 52 (4) ◽  
pp. 1192-1202
Author(s):  
Vanessa H.E. Chen ◽  
Grace K.H. Lee ◽  
Choon-Han Tan ◽  
Aloysius S.T. Leow ◽  
Ying-Kiat Tan ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Intracranial Hemorrhage ◽  
Risk Ratio ◽  
Mechanical Thrombectomy ◽  
Large Vessel ◽  
Tissue Type ◽  
Large Vessel Occlusion ◽  
Vessel Occlusion ◽  
Symptomatic Intracranial Hemorrhage

Background and Purpose: In patients with acute ischemic stroke with large vessel occlusion, the role of intra-arterial adjunctive medications (IAMs), such as urokinase, tPA (tissue-type plasminogen activator), or glycoprotein IIb/IIIa inhibitors, during mechanical thrombectomy (MT) has not been clearly established. We aim to evaluate the efficacy and safety of concomitant or rescue IAM for acute ischemic stroke with large vessel occlusion patients undergoing MT. Methods: We searched Medline, Embase, and Cochrane Stroke Group Trials Register databases from inception until March 13, 2020. We analyzed all studies with patients diagnosed with acute ischemic stroke with large vessel occlusion in the anterior or posterior circulation that provided data for the two treatment arms, (1) MT+IAM and (2) MT only, and also reported on at least one of the following efficacy outcomes, recanalization and 90-day modified Rankin Scale, or safety outcomes, symptomatic intracranial hemorrhage and 90-day mortality. Data were collated in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Results: Sixteen nonrandomized observational studies with a total of 4581 patients were analyzed. MT only was performed in 3233 (70.6%) patients, while 1348 (29.4%) patients were treated with both MT and IAM. As compared with patients treated with MT alone, patients treated with combination therapy (MT+IAM) had a higher likelihood of achieving good functional outcome (risk ratio, 1.13 [95% CI, 1.03–1.24]) and a lower risk of 90-day mortality (risk ratio, 0.82 [95% CI, 0.72–0.94]). There was no significant difference in successful recanalization (risk ratio, 1.02 [95% CI, 0.99–1.06]) and symptomatic intracranial hemorrhage between the two groups (risk ratio, 1.13 [95% CI, 0.87–1.46]). Conclusions: In acute ischemic stroke with large vessel occlusion, the use of IAM together with MT may achieve better functional outcomes and lower mortality rates. Randomized controlled trials are warranted to establish the safety and efficacy of IAM as adjunctive treatment to MT.

scholarly journals Intracranial Hemorrhage After Reperfusion Therapies in Acute Ischemic Stroke Patients

2020 ◽  
Vol 11 ◽  
Author(s):  
Benjamin Maïer ◽  
Jean Philippe Desilles ◽  
Mikael Mazighi
Keyword(s):  
Blood Pressure ◽  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Functional Outcome ◽  
Intracranial Hemorrhage ◽  
Tissue Type ◽  
Anterior Circulation ◽  
Vessel Occlusion ◽  
Early Reperfusion ◽  
Iv Tpa

Reperfusion therapies are the mainstay of acute ischemic stroke (AIS) treatments and overall improve functional outcome. Among the established complications of intravenous (IV) tissue-type plasminogen activator (tPA), intracranial hemorrhage (ICH) is by far the most feared and has been extensively described by seminal works over the last two decades. Indeed, IV tPA is associated with increased odds of any ICH and symptomatic ICH responsible for increased mortality rate during the first week after an AIS. Despite these results, IV tPA has been found beneficial in several pioneering randomized trials and improves functional outcome at 3 months. Endovascular therapy (EVT) combined with IV tPA for AIS patients consecutive to an anterior circulation large-vessel occlusion does not increase ICH occurrence. Of note, EVT following IV tPA leads to significantly higher rates of early reperfusion than with IV tPA alone, with no difference in ICH, which challenges the paradigm of reperfusion as a major prognostic factor for ICH complications. However, several blood biomarkers (glycemia, platelet and neutrophil count), clinical factors (age, AIS severity, blood pressure management, diabetes mellitus), and neuroradiological factors (cerebral microbleeds, infarct size) have been identified as risk factors for ICH after reperfusion therapy. In the years to come, the ultimate goal will be to further improve either reperfusion rates and functional outcome, while reducing hemorrhagic complications. To this end, various approaches being investigated are discussed in this review, such as blood-pressure control after reperfusion or the use of new antiplatelet agents as an adjunct to IV tPA and exhibit reduced hemorrhagic potential during the early phase of AIS.

scholarly journals Antegrade or Retrograde Approach for the Management of Tandem Occlusions in Acute Ischemic Stroke: A Systematic Review and Meta-Analysis

2022 ◽  
Vol 12 ◽  
Author(s):  
Xiaoli Min ◽  
Jianhua Du ◽  
Xuesong Bai ◽  
Tao Wei ◽  
Adam A. Dmytriw ◽  
...  
Keyword(s):  
Systematic Review ◽  
Ischemic Stroke ◽  
Intracerebral Hemorrhage ◽  
Acute Ischemic Stroke ◽  
Intracranial Hemorrhage ◽  
Meta Analysis ◽  
Favorable Outcome ◽  
Retrograde Approach ◽  
Antegrade Approach ◽  
Reperfusion Rate

Background: Acute ischemic stroke (AIS) caused by tandem intracranial and extracranial occlusions is not rare. However, optimal strategy between antegrade (extracranial first) or retrograde (intracranial first) approaches still remains elusive. This systematic review and meta-analysis aim to compare the two approaches to provide updated clinical evidence of strategy selection.Methods: PubMed, Ovid, Web of Science, and the Cochrane Library were searched for literature comparing antegrade and retrograde approaches for patients with AIS with concomitant tandem occlusions. Outcomes including successful reperfusion [Throbolysis in Cerebral Infarction (TICI) 2b−3] and 90-day favorable outcome [modified Rankin Scale (mRS) 0–2], any intracerebral hemorrhage, symptomatic intracerebral hemorrhage, procedural complications, and mortality were evaluated. The risk of bias was assessed using the Newcastle–Ottawa Scale and illustrated in the Funnel plot. Heterogeneity was assessed by I2 statistic. Subgroup and sensitivity analyses were also performed.Results: A total of 11 studies accounting 1,517 patients were included. 831 (55%) patients were treated with an antegrade approach and 686 (45%) patients were treated with the retrograde approach. A higher successful reperfusion rate was achieved in retrograde group than that of antegrade group [83.8 vs. 78.0%; odds ratio (OR): 0.63, 95% CI: 0.40–0.99, p = 0.04]. 90-day favorable outcome (mRS 0–2 at 90 days) also showed significantly higher in retrograde group compared with antegrade group (47.3 vs. 40.2%; OR: 0.72, 95% CI: 0.58–0.89, p = 0.002). The incidence of any intracranial hemorrhage (ICH), symptomatic intracranial hemorrhage, 90-day mortality, and other complications did not differ between two groups.Conclusion: In AIS with tandem occlusions, the retrograde approach might achieve a higher successful reperfusion rate and better functional outcome with a comparable safety profile when compared with an antegrade approach. Further prospective controlled studies with more meticulous design and a higher level of evidence are needed to confirm these results.Systematic Review Registration: “PROSPERO” database (CRD 42020199093), https://www.crd.york.ac.uk/PROSPERO/.

scholarly journals Safety and Outcomes of Intravenous tPA in Acute Ischemic Stroke Patients With Prior Stroke Within 3 Months

2020 ◽  
Vol 13 (1) ◽  
Author(s):  
Shreyansh Shah ◽  
Li Liang ◽  
Andrzej Kosinski ◽  
Adrian F. Hernandez ◽  
Lee H. Schwamm ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Hospital Mortality ◽  
Acute Ischemic Stroke ◽  
Intracranial Hemorrhage ◽  
Tissue Type ◽  
Stroke Severity ◽  
Stroke Patients ◽  
Symptomatic Intracranial Hemorrhage ◽  
Prior Stroke ◽  
Iv Tpa

Background Guidelines recommend against the use of intravenous tPA (tissue-type plasminogen activator; IV tPA) in acute ischemic stroke patients with prior ischemic stroke within 3 months. However, there are limited data on the safety of IV tPA in this population. Methods and Results A retrospective observational study of patients ≥66 years of age linked to Medicare claims and treated with IV tPA at Get With The Guidelines–Stroke hospitals (February 2009 to December 2015). We identified 293 patients treated with IV tPA who had a prior ischemic stroke within 3 months and 30 655 with no history of stroke. Patients with prior stroke had a higher stroke severity (median National Institutes of Health Stroke Scale, 11 [6–19] versus 11 [6–18]; absolute standardized difference, 11.2%) and a higher prevalence of cardiovascular comorbidities. Patients with prior stroke had a higher unadjusted risk for symptomatic intracranial hemorrhage (7.7% versus 4.8%) and in-hospital mortality (12.6% versus 8.9%), but these differences were not statistically significant after adjustment. When stratified by prespecified time epochs, the elevated risk for symptomatic intracranial hemorrhage was seen only within the first 14 days (16.3% versus 4.8%; adjusted odds ratio [aOR], 3.7 [95% CI, 1.62–8.43]) but not in other epochs (2.1% versus 4.8%; aOR, 0.38 [95% CI, 0.05–2.79] for 15–30 days and 7.4% versus 4.8%; aOR, 1.36 [95% CI, 0.77–2.40] for 31–90 days). In addition, patients with prior stroke were significantly more likely to have a combined outcome of in-hospital mortality or discharge to hospice (25.9% versus 17.0%; aOR, 1.70 [95% CI, 1.21–2.38]), less likely to be discharged to home (28.3% versus 32.3%; aOR, 0.72 [95% CI, 0.54–0.98]), or to have good functional outcomes at discharge (modified Rankin Scale, 0–1; 11.3% versus 20.0%; aOR, 0.46 [95% CI, 0.24–0.89]). Conclusions Stroke providers need to continue to be vigilant about the safety of IV tPA in patients with prior stroke, particularly those with an event in the previous 14 days.

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