Thursday, March 23, 2023
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Among the major trials getting attention this year:
Other highlights include data showing a sharp increase in use of thrombectomy for acute ischemic stroke, more evidence that exercise promotes recovery after stroke, and the promise of vagal nerve stimulation to improve arm function after stroke.
Flow diversion therapy with the Pipeline Embolization Device (PED, Medtronic), used to treat large aneurysms, also shows high rates of occlusion success in the treatment of small or medium-sized intracranial aneurysms, with low complication rates, according to the PREMIER study. PED is currently approved in the United States for the treatment of large/giant intracranial aneurysms greater than 10 mm in the internal carotid artery, with high rates of sustained, complete occlusion. Although this device is often used off-label for smaller aneurysms, research is lacking on results in these lesions. The current study is the first of its kind to assess the flow diverter for small or medium wide-neck aneurysms. The findings demonstrate that PED is "an effective and safe way to treat patients with small aneurysms," said lead investigator, Ricardo Hanel, MD, PhD, neurovascular surgeon with Lyerly Neurosurgery at Baptist Medical Center, Jacksonville, Florida.
Aspiration of a clot was as effective as using a stent retriever in achieving successful reperfusion in patients with an ischemic stroke of the anterior circulation in the ASTER trial. "Our results open the door for a new tool to remove the clot," said Bertrand Lapergue, MD, Foch Hospital University Versailles Saint Quentin en Yvelines, Suresnes, France. Dr Lapergue noted that the gold standard for mechanical thrombectomy in ischemic stroke is the stent retriever, which has now shown improvements in clinical outcomes vs tissue plasminogen activator alone in at least five clinical trials. An alternative technique is contact aspiration, in which a large-bore aspiration catheter is used to remove the blood clot via negative-pressure aspiration. The ASTER trial is the first prospective, randomized, multicenter, controlled, open-label study with blinded outcome evaluation to compare the two approaches.
Use of endovascular thrombectomy for acute ischemic stroke in the United States has risen sharply since the major randomized trials showing its efficacy were published in early 2015, according to new data from the American Heart Association/American Stroke Association "Get With the Guidelines - Stroke" registry. Eric Smith, MD, University of Calgary, Alberta, Canada, said the increase is related to both new hospitals providing endovascular therapy and higher case volumes at hospitals already delivering such care. A related study presented here showed outcomes were still good with endovascular treatment in stroke patients who did not meet top-tier evidence criteria, and the authors suggest that thrombectomy not be withheld from patients who do not meet the strict inclusion criteria of the randomized trials.
There does not appear to be any clear benefit or harm from lying flat vs sitting up in the first 24 hours after acute stroke, according to results of the Head Position in Acute Stroke Trial (HeadPoST). "Raising the head may be better to reduce acute swelling, but there is some thinking that lying flat may promote blood flow to the brain," said lead investigator, Craig S. Anderson, MD, George Institute of Global Health, Sydney, Australia. "But there is some concern that lying flat may increase the risk of saliva aspiration, which can lead to pneumonia." Results of HeadPoST show that "in acute stroke patients, positioning either lying flat or sitting up in the first 24 hours of hospitalization provides no difference in disability or safety outcomes, with no clear benefits or harms in any subgroups according to time from onset of symptoms, initial stroke severity, age, region, and type of stroke," he said. "So we can't make any clear recommendations about head positioning in acute stroke."
Triple antiplatelet therapy was not superior to guideline-recommended treatment with aspirin/dipyridamole or clopidogrel alone in preventing recurrent stroke in patients with a recent ischemic stroke or transient ischemic attack in the TARDIS trial. Although triple therapy showed a trend toward reduction in recurrent cerebral events, it was also associated with increased major bleeding, leading to a neutral net risk benefit, said lead investigator, Philip Bath, MD, University of Nottingham, United Kingdom. "Our conclusion is that triple therapy does not offer benefits over guideline-recommended strategies of clopidogrel or aspirin/dipyridamole," Dr Bath said. American Heart Association/American Stroke Association spokesperson Mark Alberts, MD, from Hartford Hospital, Connecticut, said, "TARDIS is a very well conducted study which shows that more is not better in terms of antiplatelet drugs in secondary stroke prevention."
A subgroup analysis of the Acute Stroke or Transient Ischaemic Attack Treated with Aspirin or Ticagrelor and Patient Outcomes (SOCRATES) trial suggests that treatment with the antiplatelet agent ticagrelor (Brilinta, AstraZeneca) shows stronger efficacy than aspirin in preventing recurrent acute stroke or transient ischemic attack (TIA) related to ipsilateral atherosclerotic stenosis. The findings "strengthen the case for targeting patients with documented atherosclerotic origin as the potential cause of the TIA/stroke, in that, in these patients, ticagrelor is far better than aspirin in preventing early recurrence," said senior author, Pierre Amarenco, MD, from University Paris Diderot, Paris, France.
Stroke patients given statins within 24 hours of their stroke show no greater improvement in neurologic function after 90 days compared with those who had statin therapy delayed to 7 days after admission, a study shows. The trial enrolled 270 patients with acute ischemic stroke at 13 centers in Japan. "The present randomized controlled trial involving patients with less severe acute ischemic stroke and preexisting dyslipidemia did not show a significant difference between early and delayed statin therapy to alleviate dependence at 90 days after onset," reported first author, Shinichi Yoshimura, MD, PhD, from the Hyogo College of Medicine, Nishinomiya City, Japan.
The antiplatelet cilostazol was noninferior to aspirin in preventing vascular events in patients with a recent ischemic stroke and a history of intracerebral hemorrhage (ICH) or multiple microbleeds in the PICASSO trial. Cilostazol also showed a strong trend toward less cerebral bleeding, but this finding did not reach statistical significance. Cilostazol appeared more effective than aspirin at reducing recurrent ischemic strokes but less effective at preventing myocardial infarction. Study presenter Sun U. Kwon Sr, MD, Asan Medical Center, Seoul, Korea, concluded that "cilostazol could be considered for secondary stroke prevention in ischemic stroke patients prone to cerebral hemorrhage but it may need consideration for MI risk." Commenting on the results, American Heart Association/American Stroke Association spokesperson, Mark J. Alberts, MD, chief of neurology at Hartford Hospital, Connecticut, said, "This is a well-done study, but I don't see the results changing practice in the US at this time."
Structured physical activity can improve brain function after stroke, according to review of 736 stroke patients enrolled in 14 trials testing various types of physical activity (aerobic, strength training, or a combination vs control) on neurocognitive function. "We found that a program as short as 12 weeks is effective at improving cognition, and even patients with chronic stroke can experience improvement in their cognition with an exercise intervention," said lead author, Lauren E. Oberlin, a graduate student at the University of Pittsburgh in Pennsylvania. Combining exercise with stretching, toning, and balance training resulted in the largest cognitive gains, she reported. "Integrating aerobic training into rehabilitation is very important, and for patients with mobility limitations, exercise can be modified so they can still experience increases in their fitness levels," Oberlin noted. "This has substantial effects on quality of life and functional improvement."
An implanted device that stimulates the vagus nerve showed promising improvement of arm function in stroke patients in a second small clinical study. While the primary endpoint — change in functional score after 6 weeks of therapy — was not significantly different between treatment groups, the improvement did appear to become significant after a further 60 days of treatment, as did responder rates. Lead investigator, Jesse Dawson, MD, University of Glasgow, United Kingdom, reported that the group receiving active stimulation with the device showed a 9-point improvement in upper-limb Fugl-Meyer (UEFM) score at this time point. "All in all, we feel this is quite promising," Dr Dawson said. "A 9-point change in this scale is highly likely to be clinically significant." At the end of the study, the control patients crossed over to receive 6 weeks of active stimulation, after which their UEFM scores also improved by a further 9 points. All patients are now continuing on active treatment for 2 years.
A new trial shows no benefit of hemostatic therapy with recombinant factor VII in the treatment of ICH but suggests potential utility of a neuroimaging strategy for patient selection. Patients with ICH were selected using computed tomography angiography (CTA) to look for a biomarker called the "spot sign," a bright area of contrast enhancement on the scan within the margin of the hematoma that indicates active bleeding and predicts further hematoma expansion and clinical deterioration. The results were from separate collaborative trials, called SPOTLIGHT in Canada and STOP-IT in the United States, with a harmonized protocol for pooled analysis. "In summary, this is our first attempt to use the CTA spot sign for patient selection in a randomized treatment trial of hemostatic therapy for ICH, but we did not see any benefit of therapy among the spot-positive patients who were enrolled into this study," lead author on the Canadian trial, David J. Gladstone, MD, PhD, University of Toronto, Ontario, concluded.
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