A randomized pilot study of the efficacy and safety of loading ticagrelor in acute ischemic stroke.

BACKGROUND: Ticagrelor is one of the most recent antiplatelet drugs to be approved to treat ischemic heart disease. Its efficacy may exceed aspirin in improving clinical outcomes in patients with acute ischemic stroke who are ineligible for rt-PA. OBJECTIVES: We evaluated the safety regarding hemorrhagic complications (as a primary endpoint) and the efficacy (as a secondary endpoint) of a 180-mg loading dose of ticagrelor given within 9 h from the onset of the first-ever non-cardioembolic ischemic stroke. METHODS: We conducted our study on patients aged 18-75 years who presented with their first clinically manifested non-cardioembolic ischemic stroke and were recruited from the emergency department OF Kafr El-Sheik University Hospitals, Egypt. Eligible patients randomly received ticagrelor or aspirin loading and maintenance doses. Screening, randomization, and initiation of treatment all occurred within the first 9 h of stroke onset. RESULTS: Eighty-five patients received ticagrelor, and 84 received aspirin. Patients who received ticagrelor had a better clinical outcome in terms of NIHSS improvement at 2 days and 1 week of discharge and a favorable mRS score after 1 week of discharge and at 90-day follow-up. There was no significant difference between the two groups regarding hemorrhagic adverse effects. CONCLUSION: This pilot study found that ticagrelor had a better clinical outcome than aspirin based on NIHSS and mRS in acute ischemic stroke patients who received it within 9 h from symptom onset and had a shorter hospital stay duration. Ticagrelor was non-inferior to aspirin regarding hemorrhagic complications. TRIAL REGISTRATION: We registered our trial on ClinicalTrials.gov, named after "ticagrelor versus aspirin in ischemic stroke," and with a clinical trial number (NCT03884530)-March 21, 2019.

A pilot study of the ticagrelor role in ischemic stroke secondary prevention.

INTRODUCTION: Ticagrelor is one of the most recent antiplatelet drugs used to treat ischemic heart disease. Its efficacy may equal or exceed aspirin in improving clinical outcomes in patients with acute ischemic stroke who are ineligible for rt-PA. AIM OF THE WORK: We aimed at evaluating the safety (as a primary endpoint) and efficacy (as a secondary endpoint) of a 180 mg loading dose of ticagrelor given within 9 h from the onset of first-ever ischemic stroke. METHODS: We conducted an open-label, randomized prospective controlled clinical trial between May 2019 and September 2020 on patients who presented with their first-ever ischemic stroke and were recruited from the emergency department, of Kafr el-sheik University Hospitals, Egypt. Eligible patients randomly received aspirin or ticagrelor loading and maintenance doses. Treatment began within 9 h of stroke onset. RESULTS: Aspirin was given to 84 patients; ticagrelor was given to 85. There was no significant difference between the 2 groups regarding the hemorrhagic and nonhemorrhagic complications. Patients who received ticagrelor had a better outcome regarding NIHSS improvement at 2 days and 1 week or discharge and a favorable mRS score after 1 week or discharge and at 90-day follow-up. CONCLUSION: Ticagrelor was noninferior to aspirin regarding safety profile. Compared with aspirin, ticagrelor had a better clinical outcome based on NIHSS and mRS in first-ever acute ischemic stroke patients who received it within 9 h from symptom onset, leading to a shorter hospital stay.

Door to Needle Count Down: A 3-Years Experience in an Egyptian University Stroke Center.

BACKGROUND: The purpose of this study is to share our experience in changing hospital strategies to achieve rapid thrombolysis in acute ischemic stroke (AIS) patients in 2 university stroke centers. Rapid reperfusion by shortening door to needle time (DTN) reduces morbidity and mortality for patients with AIS. Our aim is to evaluate the effect of applying certain logistic strategies to reduce DTN for thrombolysis and its impact on clinical outcome. METHODS: In this retrospective registry-based observational study from the SITS-ISTR Dataset, we studied AIS patients admitted to 2 stroke centers in Ain Shams University over 3 successive years from 2016 till 2018. We analyzed change of DTN and outcome at 3 months by modified Rankin scale over these 3 years. RESULTS: By the end of the 3 year period there was a 6.1% increase in number of patients receiving thrombolysis. There was a significant decrease of median DTN by 41%, and increase in percentage of patients receiving recombinant tissue plasminogen activator within a shorter DTN. Also, the number of patients with a favorable outcome (modified Rankin scale≤2) increased by 23.3%. There was insignificant difference regarding mortality rate. CONCLUSION: Applying a goal-directed corrective strategy to improve quality of service can, in a short time, reduce DTN and improve patient outcome.

Pre-hospital causes for delayed arrival in acute ischemic stroke before and during the COVID-19 pandemic: A study at two stroke centers in Egypt.

BACKGROUND: In the current study we investigated the causes of pre-hospital delay as this can compromise the patient's chance to receive thrombolytic therapy and thus impact stroke outcome. METHODS: We surveyed 254 patients regarding reasons for delayed and early arrival to hospital after acute ischemic stroke. The survey was performed over five months, spanning a period pre- and during COVID-19 (between December 7, 2019 and May 10, 2020). RESULTS: A total of 71.2% of patients arrived beyond four hours of onset of ischemic stroke. The commonest cause for delay pre-Covid-19 was receiving treatment in a non-stroke hospital, while that during COVID-19 was fear of infection and lock down issues. Not realizing the urgency of the condition and stroke during sleep were common in both periods. Early arrival because of the patient's previous experience with stroke accounted for approximately 25% of cases in both periods. The effect of media was more evident during COVID-19, accounting for 47.7% of cases. CONCLUSION: Pre-hospital delay secondary to misperception of the urgency of stroke and management in a non-stroke hospital reflect the lack of awareness among the public and medical staff. This concept is emphasized by early arrival secondary to previous experience with stroke and the pronounced effect of media in the time of COVID-19.

Borderzone Infarction and Small Vessel Disease in a Sample of Egyptian Stroke Patients: Differences and Similarities.

BACKGROUND: The anatomical location of white matter hyperintense lesions in small vessel disease are apparently similar to those of borderzone infarction. The objective of this study is to find clinical and radiological points of differentiation between the two vascular disorders in a sample of Egyptian patients which might have an impact on primary and secondary prevention. METHODS: Ischemic stroke patients with white matter lesions were categorized into two groups: small vessel disease and borderzone infarctions. NIHSS was done on admission. Risk factor profile was reported, and investigations done including: HbA1C, lipid profile, CRP, ECG, echocardiography, carotid duplex, brain MRI, MRA and MR perfusion study. RESULTS: 46 patients completed the study, 29 with SVD and 17 with BZI. Smoking, hypertension and recurrent stroke were more common in borderzone infarctions, but only diabetes was significantly higher (p = 0.047). Limb shaking was more observed in borderzone infarctions (p = 0.049). Radiologically: lacunar pattern was observed more in small vessel disease, while rosary pattern was more in borderzone infarctions (p = 0.04). FLAIR symmetrical lesions and microbleeds were more significant in small vessel disease (p = <0.001; 0.048, respectively). Perfusion study time to peak denoted evidence of significant hypoperfusion in all regions of interest in borderzone infarctions. CONCLUSION: Limb shaking, retinal claudication or syncope, with MRI showing rosary pattern of white matter hyperintensity, few microbleeds and markedly impaired perfusion favor the diagnosis of borderzone infarctions. On the other hand, presence of lacunae, FLAIR showing symmetrical WMH and microbleeds with minimal or no perfusion deficit suggests the diagnosis of small vessel disease.

Global Impact of COVID-19 on Stroke Care and IV Thrombolysis.

OBJECTIVE: To measure the global impact of COVID-19 pandemic on volumes of IV thrombolysis (IVT), IVT transfers, and stroke hospitalizations over 4 months at the height of the pandemic (March 1 to June 30, 2020) compared with 2 control 4-month periods. METHODS: We conducted a cross-sectional, observational, retrospective study across 6 continents, 70 countries, and 457 stroke centers. Diagnoses were identified by their ICD-10 codes or classifications in stroke databases. RESULTS: There were 91,373 stroke admissions in the 4 months immediately before compared to 80,894 admissions during the pandemic months, representing an 11.5% (95% confidence interval [CI] -11.7 to -11.3, p < 0.0001) decline. There were 13,334 IVT therapies in the 4 months preceding compared to 11,570 procedures during the pandemic, representing a 13.2% (95% CI -13.8 to -12.7, p < 0.0001) drop. Interfacility IVT transfers decreased from 1,337 to 1,178, or an 11.9% decrease (95% CI -13.7 to -10.3, p = 0.001). Recovery of stroke hospitalization volume (9.5%, 95% CI 9.2-9.8, p < 0.0001) was noted over the 2 later (May, June) vs the 2 earlier (March, April) pandemic months. There was a 1.48% stroke rate across 119,967 COVID-19 hospitalizations. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection was noted in 3.3% (1,722/52,026) of all stroke admissions. CONCLUSIONS: The COVID-19 pandemic was associated with a global decline in the volume of stroke hospitalizations, IVT, and interfacility IVT transfers. Primary stroke centers and centers with higher COVID-19 inpatient volumes experienced steeper declines. Recovery of stroke hospitalization was noted in the later pandemic months.

Factors related to time of stroke onset versus time of hospital arrival: A SITS registry-based study in an Egyptian stroke center.

BACKGROUND: High-quality data on time of stroke onset and time of hospital arrival is required for proper evaluation of points of delay that might hinder access to medical care after the onset of stroke symptoms. PURPOSE: Based on (SITS Dataset) in Egyptian stroke patients, we aimed to explore factors related to time of onset versus time of hospital arrival for acute ischemic stroke (AIS). MATERIAL AND METHODS: We included 1,450 AIS patients from two stroke centers of Ain Shams University, Cairo, Egypt. We divided the day to four quarters and evaluated relationship between different factors and time of stroke onset and time of hospital arrival. The factors included: age, sex, duration from stroke onset to hospital arrival, type of management, type of stroke (TOAST classification), National Institute of Health Stroke Scale (NIHSS) on admission and favorable outcome modified Rankin Scale (mRS ≤2). RESULTS: Pre-hospital: highest stroke incidence was in the first and fourth quarters. There was no significant difference in the mean age, sex, type of stroke in relation to time of onset. NIHSS was significantly less in onset in third quarter of the day. Percentage of patients who received thrombolytic therapy was higher with onset in the first 2 quarters of the day (p = <0.001). In-hospital: there was no difference in percentage of patients who received thrombolytic therapy nor in outcome across 4 quarters of arrival to hospital. CONCLUSION: Pre-hospital factors still need adjustment to improve percentage of thrombolysis, while in-hospital factors showed consistent performance.

Urban Versus Rural Egypt: Stroke Risk Factors and Clinical Profile: Cross-Sectional Observational Study.

BACKGROUND: Egypt is a densely populated country with living habits and health care services that differ from urban to rural regions. We aimed to study how characteristics of stroke vary among these regions. METHODS: This is a cross-sectional observational study of ischemic stroke, thus hemorrhagic and venous strokes were excluded. A total of 1475 ischemic stroke patients were recruited for analysis from a tertiary hospital in Cairo representing urban area and from a secondary care hospital in Suhag representing rural region. RESULTS: Analysis was done for 1143 ischemic stroke patients from urban and 332 from rural area. Onset to door was shorter in urban. Urban patients showed an older age and higher prevalence of hypertension and diabetes (65.9%, 48.6% respectively), while rural patients were characterized by female preponderance (51.5%), more dyslipidemia, smoking 44.6%, stroke in young 20.5%, atrial fibrillation 23.8% % and recurrent stroke 44.3%. Rural cases showed a severer deficit at onset and poorer outcome. CONCLUSION: Vascular risk factors, stroke type, and presentation tend to differ in Egypt according to the geographic distribution whether urban or rural. Studying patterns of such difference may aid in planning specific targeted preventive and therapeutic strategies for stroke in urban and rural Egypt.

Natalizumab treatment for multiple sclerosis: Middle East and North Africa regional recommendations for patient selection and monitoring.

BACKGROUND: Natalizumab, a highly specific α4-integrin antagonist, , has recently been registered across the Middle East and North Africa region. It improves clinical and magnetic resonance imaging (MRI) outcomes and reduces the rate of relapse and disability progression in relapsing-remitting multiple sclerosis (MS). Natalizumab is recommended for patients who fail first-line disease-modifying therapy or who have very active disease. Progressive multifocal leukoencephalopathy is a rare, serious adverse event associated with natalizumab. We aim to develop regional recommendations for the selection and monitoring of MS patients to be treated with natalizumab in order to guide local neurological societies. METHODS: After a review of available literature, a group of neurologists with expertise in the management of MS met to discuss the evidence and develop regional recommendations to guide appropriate use of natalizumab in the region. RESULTS: Disease breakthrough is defined as either clinical (relapse or disability progression) or radiological activity (new T2 lesion or gadolinium-enhancing lesions on MRI), or a combination of both. Natalizumab is recommended as an escalation therapy in patients with breakthrough disease based on its established efficacy in Phase III studies. Several factors including prior immunosuppressant therapy, anti-John Cunningham virus (JCV) antibody status and patient choice will affect the selection of natalizumab. In highly active MS, natalizumab is considered as a first-line therapy for naive patients with disabling relapses in association with MRI activity. The anti-JCV antibody test is used to assess anti-JCV antibody status and identify the risk of PML. While seronegative patients should continue treatment with natalizumab, anti-JCV antibody testing every 6 months and annual MRI scans are recommended as part of patient monitoring. In seropositive patients, the expected benefits of natalizumab treatment have to be weighed against the risks of PML. Clinical vigilance and follow-up MRI scans remain the cornerstone of monitoring. After 2 years of natalizumab therapy, monitoring should include more frequent MRI scans (every 3-4 months) for seropositive patients, and the risk-benefit ratio should be reassessed and discussed with patients. CONCLUSIONS: Recommendations have been developed to guide neurologists in the Middle East and North Africa on patient selection for natalizumab treatment and monitoring.