Their definition of good outcomes is completely wrong. A good outcome is 100% recovery. At that level this would be a complete failure and we would be searching for the hyperacute therapies that stop the neuronal cascade of death.
http://www.medpagetoday.com/MeetingCoverage/ISC/37262?
The FDA-approved Solitaire FR (Flow Restoration) device was
successful at opening blocked vessels in patients with an acute ischemic
stroke and resulted in good outcomes, a nonrandomized study showed.
Revascularization
was achieved in 79.2% of patients, with a low rate of symptomatic
intracranial hemorrhage within 24 hours of the procedure (1.5%) and low
rates of death and device- or procedure-related serious adverse events
through 90 days (6.9% and 7.4%, respectively), according to Vitor
Pereira, MD, of University Hospitals of Geneva.
Also within the
first 90 days, most patients (57.2%) achieved a modified Rankin score of
2 or lower, indicating little or no disability, he reported at the
International Stroke Conference here.
The study "supports the
further investigation of this device in a randomized controlled trial
against best medical treatment," Pereira said during his presentation.
In
an interview, he explained that this trial -- which lacked a control
group -- demonstrated the real-world experience with the device in
high-volume, comprehensive stroke centers.
"We still need to
understand which population will benefit from the treatment to prepare
future randomized controlled trials," he said.
Pereira said it was
important to point out that the trial used a standard protocol for the
device, which established consistency in the procedure across centers.
"I think this is the best way to plan and to design future trials,
controlling all of the aspects that you can," he said.
The Solitaire FR device was approved by the FDA last year on the strength of the SWIFT trial,
which showed that the device was superior to the Merci retriever for
achieving revascularization. Solitaire FR is indicated for patients who
have failed treatment with IV recombinant tissue plasminogen activator
(tPA) or who are ineligible for IV tPA.
The current trial --
called STAR -- evaluated use of the device in patients presenting with
an acute ischemic stroke in the anterior circulation within 8 hours of
symptom onset at one of 14 centers across Europe, Australia, and Canada.
All of the centers had extensive experience with mechanical
thrombectomy devices and used the Solitaire FR device according to the
instructions for use -- use of a balloon guiding catheter and a
maximum number of three passes per occluded vessel.
The study
included 202 patients with a median age of 72. The occluded vessel was
the middle cerebral artery in 82% of the patients and the internal
carotid artery terminal in 18%.
More than half of the patients
(59%) received IV tPA before mechanical thrombectomy and the rest
underwent mechanical thrombectomy as the first treatment for their
stroke.
Endovascular treatment occurred within 3 hours in 25.6% of
the patients, in 3 to 4.5 hours in 37.9%, and beyond 4.5 hours in
36.4%. The median time from groin puncture to placement of the balloon
guiding catheter was 12 and the median time from balloon catheter
placement to revascularization was 20 minutes.
Successful
revascularization -- defined as a Thrombolysis in Cerebral Infarction
(TICI) score of 2b or greater -- was achieved in more than
three-quarters of the patients, as confirmed by a core lab.
The
median NIH Stroke Scale score steadily improved during the study -- it
was 17 before the procedure, 7 in the 24 hours after the procedure, 4 a
week to 10 days after the procedure or at discharge, and 1 at 90 days.
"The
time from groin puncture to recanalization was quite short and so
that's really exciting," according to Kyra Becker, MD, co-director of
the University of Washington Stroke Center at Harborview in Seattle and
vice chair of the program committee for this year's meeting.
But she cautioned against taking too much away from the study because of the lack of a control group.
"Even
the SWIFT trial, it shows that Solitaire is better than Merci, but it
doesn't mean that Merci works at all, so you don't really know that
Solitaire is better than nothing," she said.
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