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3-D stent retriever with aspiration noninferior to aspiration alone
A 3-D stent retriever with aspiration-based thrombectomy was noninferior to aspiration alone in the treatment of acute ischemic stroke, according to data published in JAMA Neurology.
According to the study, the trial represents the first class I evidence of noninferiority of the 3-D stent retriever in conjunction with aspiration (Penumbra System, Penumbra) vs. aspiration alone.
The researchers conducted a randomized noninferiority clinical trial at 25 North American centers. One hundred ninety-eight patients with large-vessel intracranial occlusion acute ischemic stroke with a NIH Stroke Scale score of at least 8 within 8 hours of onset were randomly assigned to the 3-D stent retriever with aspiration or aspiration alone in an intention-to-treat analysis.
The primary efficacy endpoint was the rate of modified Thrombolysis in Cerebral Infarction grade of 2 to 3 within a 15% noninferiority margin.
Primary safety endpoints of the study were adverse events at 24 hours.
The median baseline NIH Stroke Scale score was 18 (interquartile range, 14-23).
Recovery similar
In the 3-D stent retriever cohort, 87.2% of patients had a modified Thrombolysis in Cerebral Infarction grade of 2 to 3 vs. 82.3% of those in the aspiration-alone group (difference, 4.9%; 90% CI, –3.6 to 13.5).
The researchers found no other significant measurement differences between the two cohorts. There was an occurrence of device-related serious adverse events in 4.1% of patients in the 3-D stent retriever with aspiration vs. 5% of patients in the aspiration-only group (difference, –0.92%; 95% CI, –6.71 to 4.88) and procedure-related serious adverse events in 10.2% of those in the 3-D stent retriever group vs. 14% of those who were treated with aspiration alone (difference, –3.8; 95% CI, –12.86 to 5.27).
According to the results, a 90-day modified Rankin Scale score of 0 to 2 occurred in 45.3% of patents in the 3-D stent retriever with aspiration group and 45.8% of patients in the aspiration-only group (difference, –0.48%; 95% CI, –14.98 to 14.01).
“The results of both arms appear comparable and seem to be within a similar range of outcomes from the treatment arms of the recent positive endovascular [randomized controlled trials],” Raul G. Nogueria, MD, from the department of neurology at Emory University School of Medicine, and colleagues wrote.
Progress must continue
In an accompanying editorial, Diederik W.J. Dippel, MD, PhD, from the department of neurology and Erasmus MC Stroke Center, Erasmus Medical Center, University Medical Center in Rotterdam, the Netherlands, wrote that challenges remain.
“Our challenge for the near future will be to increase the proportion of patients recovering substantially after thrombectomy,” Dippel wrote. “We will have to continue evaluating new devices and improve our logistics, but we should be prepared to look beyond mechanical solutions and carefully reconsider medical approaches, such as antiplatelet and antithrombotic medication, in improving the outcomes after thrombectomy.” – by Dave Quaile
Disclosures: The study was funded by Penumbra. Dippel reports he was principal investigator of a trial funded by AngioCare BV, Dutch Heart Foundation, Medtronic/Covidien/EV3, MEDAC Gmbh/LAMEPRO, Penumbra, Stryker and Top Medical/Concentric. Nogueira reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.