Clot Remover Holds Up in Another Study

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.