Mechanical Thrombectomy in Acute Ischemic Stroke Beyond the Time of Window
Condition: Acute Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional

Summary: 
      Background: intravenous alteplase appears to be much less effective at opening proximal
      occlusions of the major intracranial arteries, which account for more than one third of cases
      of acute anterior-circulation stroke and expanding time window using mechanical thrombectomy
      can improve clinical outcome in patients that would have only received conservative
      treatment.

      The aim of this work is to evaluate the effectiveness of endovascular therapy within 24 hours
      of symptom onset and to compare clinical outcome of endovascular therapy with the standard
      medical therapy at the end of 3rd month follow up.

      Material and Methods 57 subjects presenting with an acute ischemic stroke caused by occlusion
      of the proximal middle cerebral artery (M1 segment) or Internal carotid artery ( ICA segment)
      within 24 hours from symptom onset as documented by Ct, and or MRI perfusion were recruited
      consecutively from 2 University hospitals Ain shams University Hospital (32 Patients) and
      Aswan University (25 patients). Assessment of each subject was performed using NIHSS, and
      MRS, Aspect score, before intervention. Follow up was done using the same clinical scale one
      week and the 3 month after the onset.

      Primary outcome NIHSS and MRS at the end of 3 month after the onset. secondary outcome
      complications (cerebral Hge) and death at 3 months.
    

Detailed description: 
      Background Expanding time window using the emerging technologies for mechanical thrombectomy
      can improve chances of achieving successful thrombectomy and improve clinical outcome in
      patients that would have only received conservative treatment. The aim of this work is to
      evaluate the effectiveness and safety of endovascular therapy within 24 hours of symptom
      onset and to compare clinical outcome of endovascular therapy and standard medical therapy at
      the end of 3rd month.

      Subjects and Methods:

      This is a multicenteric case-control clinical trial (Ain shams and Aswan university
      hospitals), comparing clinical improvement and mortality/morbidity in patients presenting
      with acute ischemic stroke stroke caused by occlusion of the proximal middle cerebral artery
      (M1 segment) or Internal carotid artery (distal ICA segment) within 24 hours from symptom
      onset.

      Onset of stroke was defined as time they were last known to be well. Ischemic stroke is
      characterized by the sudden loss of blood circulation to an area of the brain, resulting in a
      corresponding loss of neurologic function. It included 57 patients with acute ischemic stroke
      due to large vessel occlusion (LVO) admitted either to neurology department of Ain shams
      university hospitals or Aswan university hospitals between during the period from Jan 2019
      and August 2019

      All patients were subjected to the following:

      A) Clinical assessment:

      Full history taking with special emphasis upon: Age and Sex of the patient, onset of
      symptoms; onset is defined as the point in time the patient was last seen well, presence of
      vascular risk factors, namely: diabetes mellitus, hypertension, cardiac diseases,
      dyslipidemia and smoking. History of receiving drugs prior to arrival to the hospital,
      especially anti-coagulants, and anti-platelets & IV thrombolytics.

      Complete general and neurological assessment including: complete general examination
      including blood pressure measurement using mercurial sphygmomanometer and random blood sugar
      assessment, neurological examination on admission with NIHSS assessment to determine initial
      NIHSS, neurological deficit was measured using (NIHSS) obtained on discharge and on day 90
      with the modified Rankin Scale (mRS) measured on discharge and after 3 months (Bonita and
      Beaglehole, 1988). A standard 12-lead ECG to delineate presence of ischemic changes or
      arrhythmias was also done Routine ER laboratory investigations including: complete blood
      count and coagulation profile and serum urea and creatinine.

      Hypertension was defined as self-report of hypertension with antihypertensive medication use,
      and/or systolic blood pressure greater than or equal to 140 mm Hg, and/or diastolic blood
      pressure greater than or equal to 90 mm Hg. Diabetes was defined as being on treatment for
      diabetes by self-report with antidiabetic drugs and/or having a fasting glucose level greater
      than or equal to 126 mg/dL, plasma glucose ≥ 200 mg/dl 2 h after a 75-g oral glucose load as
      in a glucose tolerance test, or glycated hemoglobin (HbA1C) ≥ 6.5%. Patients with past or
      current history of smoking were categorized as smokers. Dyslipidemia was defined as serum
      total cholesterol (TC) > 240, serum LDL-c > 160, serum triglycerides (TAG) > 200 and/or serum
      HDL-c < 40 (WHO 2006).

      B) Radiological assessment:

      Early ischemic changes and collateral circulation were assessed with the Alberta stroke
      program for early computed tomography (CT) ischemic score (ASPECTS) and with computed
      tomography angiography (CTA), magnetic resonance angiography (MRA) or digital subtraction
      angiography (DSA) for localization of the LVO.

      N.B: a CT scan was routinely performed between 24 and 36 h after treatment or before in case
      of any neurological worsening (≥4-point increase in NIHSS score) occurred.

      Procedure of endovascular intervention:

      All patients in the 1st group (vascular intervention group) underwent primary thrombectomy
      with either the Trevo (TR) stent or the Solitaire (ST) stent (according to the availability)
      within the first 24 hours of symptoms onset.

      All procedures were performed under the investigator's institutional mild sedation protocol.
      Some cases needed general anesthesia.

      Favorable outcome was defined as achieving functional independence "mRS of 0,1or 2 in 3
      months, poor outcome was defined as mRS of 3-5. Treatment starting is defined as femoral
      puncture.

      Vascular recanalization was defined as thrombolysis in cerebral ischemia (TICI) score.
      Successful recanalization was defined as TICI grade 2b to 3.

      Established device-related complications, namely, vascular perforation, arterial dissection,
      or embolization, were systematically collected. Symptomatic intracranial hemorrhage was
      defined as a hemorrhagic transformation on the 24-h computed tomography (CT) scan related to
      the deterioration in the patient's clinical condition in the judgment of the clinical
      investigator.Statistical analysis:

      Statistical analysis was performed using the Statistical Package for the Social Sciences (IBM
      SPSS statistics V23).

      Adjusted for age group (1=<70, 2= ≤70 years), Sex (female=0 or male=1), Diabetes mellitus
      (yes=1 or no=0), Hypertension (yes=1 or no=0),Cardiac (AF=1, IHD=2, Rheumatic heart=3, normal
      =4, AF +IHD =5) Smoking (yes=1 or no=0), Dyslipidemia (yes=1 or no=0), (B, correlation
      coefficient; CI, confidence interval; OR, odds ratio; SE, standard error; Wald statistics for
      logistic regression analysis.

      The outcome of interest was the change in NIHSS and mRS scores throughout 90 days. Continuous
      variables are expressed as mean + standard deviation and categorical variables with
      percentage of occurrence. For comparison of continuous variables, the Mann-Whitney test was
      used between-group comparison. Chi Square test was used for analysis of proportions. A p
      Value <0.05 was the threshold for statistical significance.
    

Intervention name(s): thrombectomy; non intervention group
Intervention type(s): Device; Other
Intervention description(s): Transfemoral a microcatheter with its distal end was positioned a few millimeters beyond the distal aspect of the clot, the guide wire was exchanged by Solitaire stent device. The device was held in place when 3 mm was out of the microcatheter. The microcatheter was slowly pulled back to deploy the TR or ST device over the clot.; medical treatment (Asprin, statin, nootropic drug)
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment