Adjustable clot retriever improves reperfusion, outcomes in large vessel occlusion stroke
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An adjustable clot retriever device for large vessel occlusion ischemic stroke was demonstrated to be both more effective and safer compared with prior data on other stent-retriever devices, a speaker reported.
According to the results of the TIGER trial presented at the virtual International Stroke Conference, the adjustable clot retriever device (Tigertriever, Rapid Medical) improved the rate of successful reperfusion, reduced incidence of both 90-day all-cause mortality and symptomatic intracranial hemorrhage and conferred better 30-day functional outcomes compared with two other stent retriever devices (Solitaire, Medtronic; Trevo, Stryker). The results were simultaneously published in Stroke.
“Endovascular thrombectomy significantly improves outcome in acute ischemic stroke caused by large vessel occlusion, but there are limitations to the current self-expanding stent retriever technology,” Jeffrey L. Saver, MD, professor of neurology at UCLA David Geffen School of Medicine, said during the presentation. “In the pivotal trials, they failed to achieve successful reperfusion in one-quarter of patients and failed to achieve excellent reperfusion in two-thirds. In addition, they were associated with not infrequent occurrences of complications of embolization to a new territory and symptomatic intercranial hemorrhage. As a result, further advances in retriever technology are highly desirable.
“The Tigertriever is a novel readily adjustable, fully visible stent retriever,” Saver said. “The operator controls the radial expansion and force according to visual and tactile feedback; lines the device expansion with the target vessel diameter and adjusts the radial forces needed to penetrate the clot while minimizing vessel tension. It is also fully visible, giving better visual feedback and operator control,”
For the single-arm, prospective, multicenter trial, researchers compared the efficacy and safety of the Tigertriever with the Solitaire and Trevo devices evaluated in the TREVO, SWIFT, MR CLEAN, ESCAPE, REVASCAT and SWIFT PRIME trials.
Researchers enrolled 160 patients (mean age, 65 years; 62% men; median baseline NIH Stroke Scale score, 17) who presented with acute ischemic stroke with NIH Stroke Scale score of at least 8 due to large vessel occlusion within 8 hours of onset.
The primary efficacy endpoint was successful reperfusion, the primary safety endpoint was a composite of 90-day all-cause mortality and symptomatic intracranial hemorrhage and secondary efficacy endpoints included 3-month modified Rankin Scale score of 0 to 2 and first-pass successful reperfusion.
In the main-phase population (n = 117), the adjustable clot retriever achieved the primary endpoint in 84.6% of patients within three passes and without rescue therapy compared with 73.4% in previous trials (P for noninferiority < .0001; P for superiority < .01).
Excellent reperfusion after all interventions was achieved in 71.8% of patients within three passes; the frequency of first-pass excellent reperfusion was 41.4%; the first-pass successful reperfusion rate was 57.8%.
According to the study, the mean number of passes with the adjustable clot retriever was 1.8.
A modified Rankin Scale score between 0 and 2 at 3 months was achieved in 58% of patients compared with 43.5% in prior trials of the other two stent retrievers (P = .006).
The rate of 90-day all-cause mortality and symptomatic intracranial hemorrhage was 18.1% after thrombectomy using the adjustable clot retriever compared with 20.4% in the comparator trials (P for noninferiority = .004; P for superiority = .57).
Researchers reported that neurological deterioration of 4 NIH Stroke Scale points or more at 24 hours occurred in 7.7% of the cohort.
In addition, the rate of embolization to a previously uninvolved new territory was 2.6% among patients treated with the adjustable clot retriever compared with 7.4% in the comparator trials (P = .0403).
“These high rates of good long-term functional outcome likely reflect reduced total brain ischemia time due to high achieved reperfusion rates, early last known well-to-punctures times, and rapid puncture-to-reperfusion times,” the researchers wrote in Stroke. “The faster last known well-to-puncture times vs. historical comparator trials likely reflects interval evolution in endovascular workflow and systems of care, while the increased perfusion rates and rapid puncture-to-reperfusion times likely at least in part reflect intrinsic properties of the Tigertriever itself.”
In other findings, the rate of successful reperfusion, symptomatic intracranial hemorrhage at 24 hours and 90-day all-cause mortality were similar regardless of vessel size.
“The Tigertriever is a highly effective and safe device to remove thrombus in patients with large vessel occlusion who are eligible for mechanical thrombectomy,” Rishi Gupta, MD, MBA, director of neurocritical care at Wellstar Health System Kennestone Hospital in Marietta, Georgia, said during the presentation.
Reference:
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Saver J, et al. Late-Breaking Science X. Presented at: International Stroke Conference; March 17-19, 2021 (virtual meeting).
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