MD Conference Express ISC 2013 - (Page 21)
Table 1. Between-Group Comparison of Atrial
Fibrillation Detection
Repeat 30-Day
Holter Monitor
(n=285) (n=287) p Value
Absolute
Detection
Difference
(95% CI)
DP-b99 Does Not Improve Recovery
Following Acute Ischemic Stroke
Written by Phil Vinall
NNS
Primary Outcome
AF ≥30 seconds
(within 90 days)
3%
16%
<0.001
13%
(9%, 18%)
8
AF ≥30 seconds
(study monitors only)
2%
15%
<0.001
13%
(9%, 18%)
8
AF ≥2.5 minutes
2%
10%
<0.001
8%
(4%, 12%)
13
Any AF
4%
20%
<0.001
16%
(10%, 21%)
6
Secondary Outcomes
AF=atrial fibrillation; NNS=number needed to screen.
The absolute difference in AF detection between the
30-day and the repeat Holter groups was 13%, which
translates into a number needed to screen of 8 patients (to
identify one additional patient with AF). The prevalence
of AF detected was similar whether the index event was
an ischemic stroke or TIA; the yield was highest among
patients aged >75 years.
Table 2. Anticoagulant Use
Absolute
Treatment
Difference
(95% CI)
Repeat
Holter
(n=285)
30-Day
Monitor
(n=287)
At index event
1%
1%
At randomization
6%
5%
At 90 days
10%
18%
0.01
8%
(2%, 13%)
Switched from
AP to AC
5%
13%
0.001
8%
(3%, 13%)
Switched from
AC to AP
1%
1%
0.997
0
(–2%, 2%)
p Value
AC=anticoagulant; AP=antiplatelet.
Dr. Gladstone noted that this study indicates that a
substantial proportion of cryptogenic stroke or TIA patients
have undiagnosed paroxysmal AF (1 in 6 patients aged ≥55
years; 1 in 5 patients aged >75 years), and it provides the
strongest evidence to-date in support of prolonged cardiac
monitoring in such patients. The findings of this trial have
immediate implications for secondary stroke prevention.
Despite encouraging preclinical and Phase 2 trial results
[Angel I et al. Drug Dev Res 2002; Striem S et al. Neural
Plast 2003; Rosenberg G et al. Stroke 2004; Diener HC
et al. Stroke 2008; Barkalifa R et al. Eur J Pharmacol 2009],
data presented by Kennedy R. Lees, MD, University
of Glasgow, Glasgow, United Kingdom, showed that
DP-b99, a lipophilic moderate-affinity chelator of zinc, did
not improve outcome in patients with acute hemispheric
ischemic stroke [Lees KR et al. Stroke 2013].
DP-b99 is a membrane-activated metal ion chelator
that chelates ions such as zinc, a mineral that has been
associated with cell signaling as well as some deleterious
processes in ischemia. The rationale for the use of DP-b99
in ischemic stroke is that by chelating the zinc in the region
of the membrane, there will be an improvement in ischemic
damage. Although a small-scale Phase 2b study comparing
DP-b99 with placebo in patients with acute ischemic stroke
failed to reach its primary endpoint, its results suggested
that patients with National Institutes of Health Stroke Scale
(NIHSS) scores of 10 to 16 might realize some benefit from
treatment with DP-b99 [Diener HC et al. Stroke 2008].
The Efficacy and Safety Study of DP-b99 in Treating Acute
Ischemic Stroke trial [MACSI] was a Phase 3 study conducted
to determine if intravenous administration of DP-b99 up to
9 hours following stroke onset and then for 3 additional days
is effective in improving long-term outcomes. Patients with
ischemic stroke untreated by tissue plasminogen activator
(tPA), with a baseline NIHSS score of 10 to 16 and evidence of
language dysfunction, visual field defect, and/or neglect were
eligible. The primary study outcome was functional status
measured by modified Rankin Scale (mRS) score at 90 days
in the intention-to-treat population of patients with any posttreatment outcome, adjusted for initial severity. Functional
and neurological recovery were secondary measures. Home
time was an exploratory endpoint [Lees KR et al. Stroke 2013].
Planned follow-up was 3 months.
Enrollment was terminated at 446 patients after the
planned interim analysis determined futility, but follow-up
continued. On the primary endpoint, the mRS distributions
were similar between the DP-b99 and placebo groups
(p=0.10). Fewer patients in the DP-b99-treated group
achieved mRS ≤1 (20.6%) compared with placebo (28.8%;
p=0.05). Fewer patients in the DP-b99 group also attained
NIHSS ≤1 (19.3% vs 25.6% with placebo; p=0.10; adjusted
p=0.26). Mortality was similar between the DP-b99 and
placebo groups (16.5% vs 15.1%, respectively; p=0.68). Home
time was unchanged by treatment [Lees KR et al. Stroke 2013].
The outcomes were the same for all subgroups analyzed.
Official Peer-Reviewed Highlights from International Stroke Conference 2013
21
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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