Novel Stent Retriever Is Effective, Safe in Large-Vessel Occlusive Stroke

March 25, 2021
By Nancy Melville YORK, Me -- March 23, 2021 -- A novel, radially adjustable stent retriever, Tigertriever, is highly effective and safe in the removal of thrombus in patients with large-vessel occlusive strokes, with revascularisation success that is superior to other currently approved devices, according to a study presented at the 2021 Virtual International Stroke Conference (ISC). “The Tigertriever device is a highly effective and safe device to remove thrombus in large-vessel occlusive stroke patients eligible for mechanical thrombectomy,” said Rishi Gupta, MD, Wellstar Health System, Marietta, Georgia. The Tigertriever device is designed to be fully visible, with adjustable features that enable control of the radial expansion and force with a visual and tactile feedback. The features also enable alignment with target-vessel diameters and adjustment of radial force as needed to allow for clot penetration. To compare the efficacy and safety of the device with established stent retrievers, the researchers conducted a prospective, single-arm study at 17 centres between 2018 and 2020. They enrolled 160 patients, including 43 in a run-in phase and 117 in the main phase. Inclusion criteria comprised having an acute ischaemic stroke with a National Institutes of Health Stroke Scale (NIHSS) score of ≥8 due to a large-vessel occlusion within 8 hours of onset. In the main study phase, the mean NIHSS score of Tigertriever-treated patients (mean age, 65 years) was 17.4. Of these patients, 79% had a pre-stroke modified Rankin scale (mRS) score of 0, and 19.7% had an mRS score of 1. Superiority with Tigertriever was achieved in regard to efficacy, with 84.6% of patients achieving successful reperfusion, defined as a core laboratory-adjudicated modified Thrombolysis in Cerebral Ischemia (mTICI) score of 2b to 3 within 3 passes of the Tigertriever device. The performance goal for the primary efficacy endpoint was 63.4%, and the historical rate was 73.4% (noninferiority PPP = .004) and lower than the historical rate of 20.4%. Of the patients treated with the Tigertriever, 30.7% experienced asymptomatic intracranial haemorrhage at 24 hours, 7.7% had neurological deterioration (an NIHSS increase of ≥4), and 2.6% had embolisation to an uninvolved territory, compared with 7.4% in historical controls (P = .04). Compared with the weighted average scores of 3 FDA-approved devices (Solitaire, Trevo, and Embotrap), Tigertriever had a higher rate of successful revascularisation (84.6% vs 78.9%) and higher mRS scores 0 to 2 at 90 days (58.0% vs 56.0%). The all-cause mortality at 90 days versus the other devices was slightly higher with Tigertriever (18.1% vs 16.0%). “Tigertriever achieved a successful reperfusion in large-vessel occlusion patients, with a high first-pass success rate, a high rate of functional independence of 58%, and a very low symptomatic intracranial haemorrhage rate of 1.7%,” said Dr. Gupta. Funding for this study was provided by Rapid Medical. ISC is sponsored by the American Heart Association and the American Stroke Association. [Presentation title: A New Class of Radially-Adjustable Stentrievers for Acute Ischemic Stroke: Primary Results of the Multicenter Tiger Trial. Abstract LB10]