scholarly journals Safety and efficacy of intravenous thrombolysis in stroke patients on prior antiplatelet therapy in the WAKE-UP trial

2020 ◽  
Vol 2 (1) ◽  
Author(s):  
Benedikt M. Frey ◽  
◽  
Florent Boutitie ◽  
Bastian Cheng ◽  
Tae-Hee Cho ◽  
...  
Keyword(s):  
Antiplatelet Therapy ◽  
Intravenous Thrombolysis ◽  
Hemorrhagic Transformation ◽  
Favorable Outcome ◽  
Stroke Patients ◽  
Antiplatelet Treatment ◽  
Safety And Efficacy ◽  
History Of ◽  
Intravenous Alteplase

Abstract Background One quarter to one third of patients eligible for systemic thrombolysis are on antiplatelet therapy at presentation. In this study, we aimed to assess the safety and efficacy of intravenous thrombolysis in stroke patients on prescribed antiplatelet therapy in the WAKE-UP trial. Methods WAKE-UP was a multicenter, randomized, double-blind, placebo-controlled clinical trial to study the efficacy and safety of MRI-guided intravenous thrombolysis with alteplase in patients with an acute stroke of unknown onset time. The medication history of all patients randomized in the WAKE-UP trial was documented. The primary safety outcome was any sign of hemorrhagic transformation on follow-up MRI. The primary efficacy outcome was favorable functional outcome defined by a score of 0–1 on the modified Rankin scale at 90 days after stroke, adjusted for age and baseline stroke severity. Logistic regression models were fitted to study the association of prior antiplatelet treatment with outcome and treatment effect of intravenous alteplase. Results Of 503 randomized patients, 164 (32.6%) were on antiplatelet treatment. Patients on antiplatelet treatment were older (70.3 vs. 62.8 years, p <  0.001), and more frequently had a history of hypertension, atrial fibrillation, diabetes, hypercholesterolemia, and previous stroke or transient ischaemic attack. Rates of symptomatic intracranial hemorrhage and hemorrhagic transformation on follow-up imaging did not differ between patients with and without antiplatelet treatment. Patients on prior antiplatelet treatment were less likely to achieve a favorable outcome (37.3% vs. 52.6%, p = 0.014), but there was no interaction of prior antiplatelet treatment with intravenous alteplase concerning favorable outcome (p = 0.355). Intravenous alteplase was associated with higher rates of favorable outcome in patients on prior antiplatelet treatment with an adjusted odds ratio of 2.106 (95% CI 1.047–4.236). Conclusions Treatment benefit of intravenous alteplase and rates of post-treatment hemorrhagic transformation were not modified by prior antiplatelet intake among MRI-selected patients with unknown onset stroke. Worse functional outcome in patients on antiplatelets may result from a higher load of cardiovascular co-morbidities in these patients.

Abstract 188: Safety and Efficacy of off-label Intravenous Thrombolysis in Patients With Acute Ischemic Stroke: An Observational Study From the International Safe Implementation of Treatments in Stroke (SITS) Registry

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Sibu Mundiyanapurath ◽  
Katharina Hees ◽  
Niaz Ahmed ◽  
Nils Wahlgren ◽  
Lorenz Uhlmann ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Ischemic Stroke ◽  
Intravenous Thrombolysis ◽  
Favorable Outcome ◽  
Minor Stroke ◽  
Elevated Blood ◽  
Severe Stroke ◽  
Safety And Efficacy ◽  
Off Label ◽  
History Of

Introduction: Intravenous thrombolysis is the only approved pharmacological treatment for acute ischemic stroke. Due to strict license regulations, off-label treatment is common. We aimed to analyze the safety and efficacy of off-label thrombolysis. Methods: Retrospective analysis of 56258 patients from the Safe Implementation of Treatments in Stroke (SITS) thrombolysis registry was performed regarding 11 off-label criteria according to the European license for alteplase. Symptomatic intracranial hemorrhage (SICH) according to SITS was defined as primary safety endpoint and SICH according to the European Cooperative Acute Stroke Study II (ECASS II) definition and the National Institute of Neurological Disorders and Stroke (NINDS) definition as secondary safety endpoints. Favorable outcome, defined as modified Rankin Scale score 3 months after stroke between 0 and 2 was the primary efficacy endpoint. Multivariable logistic regression analyses after replacing missing values using multiple imputations were performed for the efficacy and safety endpoints. Results: In total, 16740 (30%) patients received off-label thrombolysis. SICH according to the SITS definition occurred in 1037 (1.8%) patients. The only two off-label criteria constituting independent positive and negative predictors for SICH according to the SITS definition were elevated blood pressure (OR 1.39; p=0.012) and minor stroke (OR 0.51; p=0.002). Very severe stroke, history of stroke and diabetes, age and high glucose levels were additional independent predictors of SICH according to the ECASS II and NINDS definition. Favorable outcome was found in 24834 patients (54.5%). Independent predictors of favorable outcome comprised of minor stroke (positive predictor) and very severe stroke, history of stroke and diabetes, age and elevated blood pressure (all negative predictors). Inclusion of SICH according to the ECASS II definition in the multivariable analysis did not change the OR of these off-label criteria. Conclusions: Thrombolysis appears to be safe and efficient for most of the off-label criteria. Individual risk-benefit evaluation should be performed before off-label thrombolysis, especially in patients with combinations of these off-label criteria.

Abstract 178: Persistent Occlusion After Intravenous Thrombolysis Is Not Associated with Symptomatic Intracerebral Hemorrhage.

Stroke ◽  
2013 ◽  
Vol 44 (suppl_1) ◽  
Author(s):  
Jana Novotna ◽  
Pavla Kadlecova ◽  
Adam Kobayashi ◽  
Miroslav Brozman ◽  
Viktor Svigelj ◽  
...  
Keyword(s):  
Intracerebral Hemorrhage ◽  
Treatment Time ◽  
Intravenous Thrombolysis ◽  
Conclusive Evidence ◽  
Stroke Patients ◽  
Stroke Subtype ◽  
Symptomatic Intracerebral Hemorrhage ◽  
History Of ◽  
Brain Artery

Introduction: There is no conclusive evidence if the association between status of brain artery and risk of intracerebral hemorhage after intravenous thrombolysis (IVT) exists. Therefore, we explored if the hyperdense cerebral artery sign (HCAS) on CT or CT-angiography (CTA)-evidenced occlusion at baseline and follow-up after intravenous thrombolysis (IVT) is associated with symptomatic intracerebral hemorrhage (SICH). Methods: The study population was the Safe Implementation of Treatments in Stroke-EAST (SITS-EAST) database with all stroke patients between February 2003 and December 2011 receiving IVT up to 4.5 hours after symptom onset. SICH was distinguished as per NINDS, ECASS II and SITS-MOST definitions. Arterial patency at baseline and on follow-up was assessed by the presence of HCAS on CT or by CTA. Logistic regression was used to adjust for differences in the following baseline variables: NIHSS baseline, age, sex, onset to treatment time, weight, early ischemic changes on CT, systolic blood pressure, glucose, actilyse dose, treatment with anticoagulation or antiplatelets, stroke subtype by ICD classification, history of hypertension, diabetes mellitus, atrial fibrillation, congestive heart failure, and previous stroke. Results: Of 8878 cases, baseline CT scans revealed HCAS in 1553 (19%) of 8375 patients and CTA-evidenced occlusion in 1606 (57%) of 2809 cases. On follow-up CT after IVT, HCAS persisted in 477 (36%) of 1327 cases and CTA-evidenced occlusion persisted in 185 (45%) of 411 cases. After adjustment, SICH per the NINDS definition was independently predicted at baseline both by the presence of HCAS (OR 1.57, 95%CI 1.20 to 2.05) and occlusion on CTA (OR 2.87, 95%CI 1.69 to 4.87). Also SICH per the ECASS II definition was independently predicted by the presence of occlusion on CTA (OR 2.61, 95%CI 1.34 to 5.05). In contrast, at follow-up neither persistent HCAS nor persistent CTA-evidenced occlusion was associated with SICH per any definition. Conclusions: In stroke patients receiving IVT, presence of clot at admission was an independent predictor of SICH. Persistent occlusion after IVT was not, however, associated with SICH.

Abstract P27: Safety and Efficacy of Alteplase in Ischemic Stroke Patients > 80 Years of Age in the Extended Time Window

Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
Christoph Stretz ◽  
Brian C Mac Grory ◽  
Nasir Fakhri ◽  
Anusha Boyanpally ◽  
Syed Daniyal Asad ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Functional Outcome ◽  
Primary Outcome ◽  
Intravenous Thrombolysis ◽  
Stroke Severity ◽  
Stroke Patients ◽  
Safety And Efficacy ◽  
Good Functional Outcome ◽  
Significant Difference ◽  
Intravenous Alteplase

Background: While patients > 80 years of age were originally excluded from the ECASS 3 trial showing benefit in the 3 – 4.5-hour window, recent studies have shown that intravenous alteplase is safe and benefits this population. We aimed to assess safety and efficacy of intravenous thrombolysis in stroke patients above 80 presenting both in the 3 and 3 – 4.5-hour windows. Methods: We analyzed data from 3 comprehensive stroke centers in the US of consecutive patients > 80 years of age presenting with acute ischemic stroke who received intravenous alteplase in both the 3 and 4.5-hour time windows over a 3-year period. We collected baseline demographic data, stroke severity as assessed by NIHSS scores, and use of mechanical thrombectomy (MT). Primary outcome was symptomatic intracerebral hemorrhage, as defined by ECASS 2 criteria (hemorrhagic transformation post thrombolysis with worsening of NIHSS score by ≥ 4 points). Secondary outcomes included assessment of efficacy, evaluated by good functional outcome (mRS 0 – 2) at time of discharge. Results: We identified 418 patients with ischemic stroke above 80 years (64.8% women) who received alteplase: 344 (82.3%) within 3 hour and 74 (17.7%) in the 3 to 4.5-hour window, with similar stroke severity by NIHSS scores (median [IQR] 13 [12-32] vs. 12 [6-20], p = 0.87). In addition, 147 patients received MT, 128 (37.2%) versus 19 (25.7%), (p= 0.059) in the 3 and 3-4.5-hour groups. The overall rate of sICH was 6.1% and 4.0% (p = 0.49), in the 3 and 3-4.5-hour groups, respectively. Good functional outcome was achieved in 16.7% at time of discharge, for 17.7% in the 3-hour group and for 12.2% in the 3 – 4.5-hour group (p= 0.24). Conclusions: In our multi-center cohort, the use of alteplase in patients above 80 was safe, with low sICH rates similar to the literature, irrespective of age. Given the rare occurrence of our primary outcome in a selected cohort of acute stroke patients, our study was not powered to detect a possible significant difference in sICH.

Abstract 200: Team of Neurohospitalists, Telestroke, and Nurse Stroke Coordinator Increases the Use of Intravenous Alteplase in a Community Hospital

Stroke ◽  
2014 ◽  
Vol 45 (suppl_1) ◽  
Author(s):  
H. McCord Smith ◽  
C. Van Morris ◽  
Shelley Nichols ◽  
Joanne Lockamy ◽  
Jeffrey A Switzer ◽  
...  
Keyword(s):  
Adverse Effect ◽  
Community Hospital ◽  
Standard Of Care ◽  
Favorable Outcome ◽  
Full Time ◽  
Short Supply ◽  
Safety And Efficacy ◽  
Model Combining ◽  
Intravenous Alteplase ◽  
Iv Tpa

Background and Purpose: The FDA approved IV tPA in 1996 for the treatment of AIS. Its safety and efficacy have been demonstrated in community hospitals (CH) and it is now the standard of care; but intravenous Alteplase (IV tPA) remains underemployed. It is used in fewer than 5% of AIS patients. Short supply of neurologic manpower and concern over adverse effect contribute to this underutilization. Our hypothesis was that a combination of onsite neurohospitalists (NH), telestroke (TS), nurse stroke coordinator (NC), and education of staff and community would increase IV tPA use in a mid-sized CH PSC without compromise of safety or outcome. Methods: The hospital is a 197 bed nonprofit hospital located 60 miles from Atlanta serving a population of 350,000 in 10 counties. The hospital has been certified as a PSC since August 2004; however, the volume of AIS admissions and use of IV tPA remained low through 2008. The stroke program thus was reorganized in 2009: two full-time NH were hired to provide onsite coverage daily from 8am to 6pm, the REACH™ TS System was installed to provide the remainder of coverage, a NC was hired, and an education plan for staff and community was implemented. Patients treated with IV tPA via TS were admitted to the neuro-ICU by medical hospitalists initially with NH assuming primary care of these patients within hours. AIS admission and IV tPA use data for 2002- 2008 were compared with those for 2009 - 2012. Outcomes, assessed at discharge, 2009 - 2012 were also examined. Favorable outcome was defined as a mRS of 0 or 1. Results: From 2002-2008, 25 of 933 AIS were treated with IV tPA: 3.6 per year (2.7%). In contrast, from 2009-2012, 105 of 802 AIS received IV tPA: 26.25 per year (13%) with favorable outcome in 47 (45%). Of 64 patients treated by NH, 28 (44%) achieved favorable outcome as did 19 of 41 (46%) TS patients. These outcomes were not statistically different (p=0.92). There were 5 deaths (3 NH, 2 TS), none attributable to tPA. There were no sICH. Conclusions: A model combining NH, TS, NC, and education in a CH PSC significantly increased the use of IV tPA without compromising safety or effectiveness. Such a model may be an option where resources are limited.

Abstract MP86: Effects of Immediate Blood Pressure Reduction on Death and Major Disability in Acute Ischemic Stroke Patients by History of Hypertension and Use of Antihypertensive Medications

Circulation ◽  
2015 ◽  
Vol 131 (suppl_1) ◽  
Author(s):  
Tan Xu ◽  
Yonghong Zhang ◽  
Yingxian Sun ◽  
Chung-Shiuan Chen ◽  
Jing Chen ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Treatment Group ◽  
Acute Ischemic Stroke ◽  
Hospital Discharge ◽  
Odds Ratio ◽  
Recurrent Stroke ◽  
Stroke Patients ◽  
Antihypertensive Medications ◽  
History Of

Introduction: The effects of blood pressure (BP) reduction on clinical outcomes among acute stroke patient remain uncertain. Hypothesis: We tested the effects of immediate BP reduction on death and major disability at 14 days or hospital discharge and 3-month follow-up in acute ischemic stroke patients with and without a previous history of hypertension or use of antihypertensive medications. Methods: The China Antihypertensive Trial in Acute Ischemic Stroke (CATIS) randomly assigned patients with ischemic stroke within 48 hours of onset and elevated systolic BP (SBP) to receive antihypertensive treatment (N=2,038) or to discontinue all antihypertensive medications (N=2,033) during hospitalization. Randomization was stratified by participating hospitals and use of antihypertensive medications. Study outcomes were assessed at 14 days or hospital discharge and 3-month post-treatment follow-up. The primary outcome was death and major disability (modified Rankin Scale score≥3), and secondary outcomes included recurrent stroke and vascular events. Results: Mean SBP was reduced 12.7% in the treatment group and 7.2% in the control group within 24 hours after randomization (P<0.001). Mean SBP was 137.3 mmHg in the treatment group and 146.5 in the control group at day 7 after randomization (P<0.001). At 14 days or hospital discharge, the primary and secondary outcomes were not significantly different between the treatment and control groups by subgroups. At the 3-month follow-up, recurrent stroke was significantly reduced in the antihypertensive treatment group among patients with a history of hypertension (odds ratio 0.43, 95% CI 0.24-0.75, P=0.003) and among patients with a history of use of antihypertensive medications (odds ratio 0.41, 95% CI 0.20-0.84, P=0.01). All-cause mortality (odds ratio 2.84, 95% CI 1.11-7.27, P=0.03) was increased among patients without a history of hypertension. Conclusion: Immediate BP reduction lowers recurrent stroke among acute ischemic stroke patients with a previous history of hypertension or use of antihypertensive medications at 3 months. On the other hand, BP reduction increases all-cause mortality among patients without a history of hypertension.

scholarly journals Neuroophthalmological outcomes associated with use of the Pipeline Embolization Device: analysis of the PUFS trial results

2015 ◽  
Vol 123 (4) ◽  
pp. 897-905 ◽  
Author(s):  
Daniel H. Sahlein ◽  
Mohammad Fouladvand ◽  
Tibor Becske ◽  
Isil Saatci ◽  
Cameron G. McDougall ◽  
...  
Keyword(s):  
Carotid Artery ◽  
Internal Carotid ◽  
Prospective Trial ◽  
Maximum Diameter ◽  
Pipeline Embolization Device ◽  
Safety And Efficacy ◽  
History Of ◽  
International Multicenter ◽  
Supraclinoid Internal Carotid Artery

OBJECT Neuroophthalmological morbidity is commonly associated with large and giant cavernous and supraclinoid internal carotid artery (ICA) aneurysms. The authors sought to evaluate the neuroophthalmological outcomes after treatment of these aneurysms with the Pipeline Embolization Device (PED). METHODS The Pipeline for Uncoilable or Failed Aneurysms (PUFS) trial was an international, multicenter prospective trial evaluating the safety and efficacy of the PED. All patients underwent complete neuroophthalmological examinations both before the PED procedure and at a 6-month follow-up. All examinations were performed for the purpose of this study and according to study criteria. RESULTS In total, 108 patients were treated in the PUFS trial, 98 of whom had complete neuroophthalmological follow-up. Of the patients with complete follow-up, 39 (40%) presented with a neuroophthalmological baseline deficit that was presumed to be attributable to the aneurysm, and patients with these baseline deficits had significantly larger aneurysms. In 25 of these patients (64%), the baseline deficit showed at least some improvement 6 months after PED treatment, whereas in 1 patient (2.6%), the deficits only worsened. In 5 patients (5%), new deficits had developed at the 6-month follow-up, while in another 6 patients (6%), deficits that were not originally assumed to be related to the aneurysm had improved by that time. A history of diabetes was associated with failure of the baseline deficits to improve after the treatment. The aneurysm maximum diameter was significantly larger in patients with a new deficit or a worse baseline deficit at 6 months postprocedure. CONCLUSIONS Patients treated with the PED for large and giant ICA aneurysms had excellent neuroophthalmological outcomes 6 months after the procedure, with deficits improving in most of the patients, very few deficits worsening, and few new deficits developing.

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