MD Conference Express ISC 2013 - (Page 24)
CLINICAL TRIAL HIGHLIGHTS
stroke, hemorrhagic stroke, myocardial infarction, or vascular
death) at 3 months. The primary safety outcome was combined
moderate and severe bleeding, according to the GUSTO
definition. Other safety outcomes included intracranial
hemorrhage, total mortality, and adverse events (including
serious adverse events). Study visits were performed on the day
of randomization at Day 21 and Day 90.
Subjects were mean 62.5 years of age and mostly men.
Approximately 72% of the enrolled patients had minor
stroke; mean time to randomization was 13 hours. At
3 months, the risk of recurrent stroke was significantly
lower among patients assigned to clopidogrel plus aspirin
compared with those receiving aspirin alone (HR, 0.68;
95% CI, 0.57 to 0.81; p<0.001). More patients on the dual
regimen were also free of the secondary outcome of
combined events (HR, 0.69; 95% CI, 0.58 to 0.82; p<0.001).
Patients on the dual regimen were also less likely to
experience a recurrent ischemic stroke (7.9% vs 11.4%;
HR, 0.67; 95% CI, 0.56 to 0.81; p<0.0001). The differences
on the remaining secondary outcomes of hemorrhagic
stroke, myocardial infarction, and cardiovascular death
were not statistically different. There was no difference
in the rates of severe, moderate, or mild bleeding, or
death from any cause. As the greatest separation of the
2 treatment arms appeared to occur during the first 21 days
post stroke, the authors suggested that the early period of
dual antiplatelet therapy may have been the major cause
of superior outcome.
Reversal of Chronic Hypoperfusion
to Improve Cognitive Function: The
RECON Trial
Written by Emma Hitt, PhD
Carotid artery disease is thought to be one of the causes
of cognitive dysfunction, but treatment of the associated
cerebral blood flow impairment has never been tested in a
randomized controlled trial [Marshall RS et al. Neurology
2012]. Randolph S. Marshall, MD, MS, Columbia University
Medical Center, New York, New York, USA, reported the
results of the Randomized Evaluation of Carotid Occlusion
and Neurocognition trial [RECON; NCT00390481].
The RECON trial randomized 41 patients with complete
internal carotid artery occlusion and hemispheral transient
ischemic attack (TIA) or minor stroke in the territory of the
carotid occlusion within 120 days prior to enrollment and
positron emission tomography (PET) oxygen extraction
fraction (OEF) >1.13, indicating stage II hemodynamic
failure. Patients had no prior diagnosis of dementia, Barthel
index ≥12/20 at the time of enrollment, and an education
level >4 years.
24
April 2013
Patients were randomized to receive surgical
extracranial-intracranial (EC-IC) bypass plus best medical
therapy or medical therapy alone to determine if reversing
chronic hypoperfusion with EC-IC bypass can improve
cognitive function or prevent its decline. Patients in
the surgical arm underwent PET 30 days after surgery
to measure OEF ratio. There were no differences in the
baseline characteristics of the surgical and medical arms.
All patients received 14 standardized tests as part of
the neurocognitive exam at baseline and after 2 years.
Left hemisphere-specific, right hemisphere-specific, and
global tests were included. Individual tests were Z-scored
based on age- and education-matched norms. Composite
Z-scores for each patient were determined based on the
average Z-score for left hemisphere plus global test scores if
the patient had left carotid occlusion, and right hemisphere
plus global scores if the patient had right carotid occlusion.
At baseline, there was no difference in cognitive scores
between the groups, but the average neurocognitive
composite Z-score across all patients was 1.2 standard
deviations below the age- and education-adjusted mean
(range, –3.7 to –0.3). There was a slight, but not significant,
improvement in cognitive score over 2 years for both
groups, but no significant difference was found between the
surgical and medical arms (Table 1).
Table 1. Unadjusted Cognitive Outcomes by Treatment Group
Medical (n=15)
Change in composite
neurocog Z-score
p Value
Surgical
(n=13)
0.2
(SE=0.14)
0.02
(SE=0.25)
0.17
[paired t test]
0.9
[paired test]
p Value
0.5
[two-sample
t test]
In the univariate analysis of factors correlating with
cognitive change, presentation with a TIA rather than a
stroke (p=0.01), improvement of depression over the 2
years (p=0.02), and a better baseline PET OEF ratio (p=0.04)
were associated with cognitive improvement. The first 2
variables were significant in multiple regression.
In the surgical group, the OEF dropped from 1.24 to
1.14. Only 3 out of 13 surgical patients had 30-day PET OEF
ratios ≤1.13, and none of the 13 patients achieved an OEF
ratio <1.067, which is considered the upper limit of normal.
Thus, hemodynamic normalization was not achieved by
EC-IC bypass in the RECON cohort.
Dr. Marshall concluded that there was "no evidence
to support superiority of EC-IC bypass surgery plus best
medical therapy in preserving or improving cognition over
medical therapy alone in patients with recently symptomatic
carotid artery occlusion and stage II hemodynamic failure."
Further investigation with medical interventions or more
effective reperfusion interventions is needed.
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Table of Contents for the Digital Edition of MD Conference Express ISC 2013
MD Conference Express ISC 2013
Contents
Defending the Stroke Guidelines
Stroke Update: An Overview of What Is Going on in the Area of Stroke
Brain Imaging Does Not Help Identify Patients Who May Benefit From Endovascular Treatments for Acute Ischemic Stroke
MISTIE II Trial: 365-Day Results Demonstrate Improved Outcomes and Cost Benefit
Addition of AMPLATZER PFO Occluder to Medical Therapy Is Beneficial in Patients With Cryptogenic Stroke and PFO
Intraoperative CT-Guided Endoscopic Surgery for ICH [ICES]
The EMBRACE Trial: Prolonged Ambulatory Cardiac Monitoring Improves the Detection and Treatment of Atrial Fibrillation in Patients With Cryptogenic Stroke
DP-b99 Does Not Improve Recovery Following Acute Ischemic Stroke
The Secondary Prevention of Small Subcortical Strokes Trial: Blood Pressure Intervention Results
Final Results of the Solitaire FR Thrombectomy for Acute Revascularization: The STAR Trial
Clopidogrel Plus Aspirin Reduces Risk of Recurrent Stroke: The CHANCE Trial
Reversal of Chronic Hypoperfusion to Improve Cognitive Function: The RECON Trial
Cardioembolic Stroke
IMS III
Novel Anticoagulants in Vascular Neurology Practice
Wake-Up Stroke
Virtual Reality in Stroke Rehabilitation
Reward Improves Long-Term Retention of a Motor Memory Through Induction of Offline Memory Gains
MD Conference Express ISC 2013
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