HOUSTON – Intracerebral clot aspiration was as safe and effective as stent retriever thrombectomy for restoring cerebral blood flow in a French multicenter, randomized trial with 381 acute ischemic stroke patients.
This study is the “first direct comparison of aspiration versus stent retrieval” as the initial strategy for clot removal in acute ischemic stroke, and it “opens the door to add a new tool” for clot removal, Bertrand Lapergue, MD, said at the International Stroke Conference sponsored by the American Heart Association.
Mitchel L. Zoler/Frontline Medical News
Dr. Bertrand Lapergue
The new results “are the first to show that aspiration first is as good as a stent retriever, but we need to also see the results from COMPASS,” a U.S. multicenter trial that is in the process of making the same comparison, commented Ricardo A. Hanel, MD, a vascular neurosurgeon at Baptist Health in Jacksonville, Fla. The COMPASS Trial: a Direct Aspiration First Pass Technique has now enrolled about two-thirds of its target patient number, and until the study is complete the role of direct aspiration for clot removal in stroke remains investigational for U.S. practice, said Dr. Hanel, a COMPASS investigator.
The aspiration catheter tested in ASTER is marketed by Penumbra and has already received Food and Drug Administration approval for revascularization of ischemic stroke patients. U.S. use of aspiration for treating acute ischemic stroke, however, has remained limited because there is no clear evidence of the method’s efficacy. Dr. Hanel said that he occasionally uses aspiration as an adjunct to clot removal with a stent retriever.
Mitchel L. Zoler/Frontline Medical News
Dr. Ricardo A. Hanel
ASTER’s primary endpoint was the percentage of patients who achieved thrombolysis in cerebral infarction (TICI) 2b or 3 flow at the end of treatment, which occurred in 85% of patients treated with aspiration first and in 83% of those treated by clot removal first, a difference that was not statistically significant, Dr. Lapergue reported. The rate of patients who achieved either TICI 2b or 3 flow after the initial strategy only was 63% with aspiration and 68% with clot removal, also a nonsignificant difference. The two strategies also showed no significant difference for any measured safety parameter. The results showed a trend toward more vasospasm with clot removal – a 6% rate, versus 3% with clot aspiration – but this did not reach statistical significance.
Results from additional analyses of the clinical outcomes of patients in the trial and of cost efficacy will be reported later in 2017, Dr. Lapergue said.
ASTER received an unrestricted research grant from Penumbra, a company that markets clot removal aspiration catheters. Dr. Lapergue had no personal disclosures. Dr. Hanel has been a consultant to and received grant support from Medtronic. He has received research grants from MicroVention and has an ownership interest in InNeuroCo.
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