Journal article
New Class of Radially Adjustable Stentrievers for Acute Ischemic Stroke: Primary Results of the Multicenter TIGER Trial
Stroke (1970), Vol.52(5), pp.1534-1544
05/2021
DOI: 10.1161/STROKEAHA.121.034436
PMID: 33739136
Abstract
Supplemental Digital Content is available in the text.
Background and Purpose:
The Tigertriever is a novel, radially adjustable, fully visible, stentriever that permits the operator to align radial expansion with target vessel diameters. This multicenter trial compared the Tigertriever’s effectiveness and safety compared with established stent retrievers.
Methods:
Single arm, prospective, multicenter trial comparing the Tigertriever to efficacy and safety performance goals derived from outcomes in 6 recent pivotal studies evaluating the Solitaire and Trevo stent-retriever devices with a lead-in and a main-study phase. Patients were enrolled if they had acute ischemic stroke with National Institutes of Health Stroke Scale score ≥8 due to large vessel occlusion within 8 hours of onset. The primary efficacy end point was successful reperfusion, defined as core laboratory-adjudicated modified Thrombolysis in Cerebral Ischemia score 2b-3 within 3 passes of the Tigertriever. The primary safety end point was a composite of 90-day all-cause mortality and symptomatic intracranial hemorrhage. Secondary efficacy end points included 3-month good clinical outcome (modified Rankin Scale score 0–2) and first-pass successful reperfusion.
Results:
Between May 2018 and March 2020, 160 patients (43 lead-in, 117 main phase) at 17 centers were enrolled and treated with the Tigertriever. The primary efficacy end point was achieved in 84.6% in the main-study phase group compared with the 63.4% performance goal and the 73.4% historical rate (noninferiority P<0.0001; superiority P<0.01). The first pass successful reperfusion rate was 57.8%. After all interventions, successful reperfusion (modified Thrombolysis in Cerebral Ischemia score ≥2b) was achieved in 95.7% and excellent reperfusion (modified Thrombolysis in Cerebral Ischemia score 2c-3) in 71.8%. The primary safety composite end point rate of mortality and symptomatic intracranial hemorrhage was 18.1% compared with the 30.4% performance goal and the 20.4% historical rate (noninferiority P=0.004; superiority P=0.57). Good clinical outcome was achieved in 58% at 90 days.
Conclusions:
The Tigertriever device was shown to be highly effective and safe compared with Trevo and Solitaire devices to remove thrombus in patients with large-vessel occlusive stroke eligible for mechanical thrombectomy.
Details
- Title: Subtitle
- New Class of Radially Adjustable Stentrievers for Acute Ischemic Stroke: Primary Results of the Multicenter TIGER Trial
- Creators
- Rishi Gupta - Wellstar Medical Group, Department of Neurosurgery, Wellstar Health System Kennestone Hospital Marietta, GA (R.G., A.K.)Edgar Samaniego - Departments of Neurology, Neurosurgery and Radiology University of Iowa Hospitals and Clinics, Iowa City (E.S.)Jeffrey L Saver - Department of Neurology and Comprehensive Stroke Center, University of California Los Angeles (J.L.S., D.S.L.)Elad Levy - Departments of Endovascular Neurosurgery and Stroke, St. Vincent Mercy Medical Center, Toledo, OH (E.L., O.O.Z.)Osama O Zaidat - Departments of Endovascular Neurosurgery and Stroke, St. Vincent Mercy Medical Center, Toledo, OH (E.L., O.O.Z.)Dileep Yavagal - Department of Neurology (D.Y.), University of Miami School of Medicine, FLDavid S Liebeskind - Department of Neurology and Comprehensive Stroke Center, University of California Los Angeles (J.L.S., D.S.L.)Ahmad Khaldi - Wellstar Medical Group, Department of Neurosurgery, Wellstar Health System Kennestone Hospital Marietta, GA (R.G., A.K.)Bradley Gross - Department of Neurosurgery, Stroke Institute, University of Pittsburgh Medical Center, PA (B.G., M.L.)Michael Lang - Wellstar Medical Group, Department of Neurosurgery, Wellstar Health System Kennestone Hospital Marietta, GA (R.G., A.K.)Sandra Narayanan - Neurology, University of Pittsburgh Medical Center, PA (S.N.)Brian Jankowitz - Department of Neurosurgery, Cooper University Health Care, Camden, NJ (B.J.)Kenneth Snyder - Department of Neurosurgery, State University of New York at Buffalo (K.S., A.S.. J.D.)Adnan Siddiqui - Department of Neurosurgery, State University of New York at Buffalo (K.S., A.S.. J.D.)Jason Davies - Department of Neurosurgery, State University of New York at Buffalo (K.S., A.S.. J.D.)Eugene Lin - Departments of Endovascular Neurosurgery and Stroke, St. Vincent Mercy Medical Center, Toledo, OH (E.L., O.O.Z.)Ameer Hassan - Department of Neurology, Valley Baptist Medical Center, Harlingen, TX (A.H.)Ricardo Hanel - Stroke and Cerebrovascular Surgery, Lyerly Neurosurgery/Baptist Neurological Institute, Jacksonville, FL (R.H., A.A.)Amin Aghaebrahim - Stroke and Cerebrovascular Surgery, Lyerly Neurosurgery/Baptist Neurological Institute, Jacksonville, FL (R.H., A.A.)Ritesh Kaushal - Advanced Neuroscience Network/Tenet South Florida, Delray Beach (R.K., A.M., N.M.-K.)Ali Malek - Advanced Neuroscience Network/Tenet South Florida, Delray Beach (R.K., A.M., N.M.-K.)Nils Mueller-Kronast - Advanced Neuroscience Network/Tenet South Florida, Delray Beach (R.K., A.M., N.M.-K.)Robert Starke - Department of Neurosurgery (R.S.), University of Miami School of Medicine, FLHormozd Bozorgchami - Oregon Health and Science University, Portland (H.B., G.N., M.H., R.P., J.L.)Gary Nesbit - Oregon Health and Science University, Portland (H.B., G.N., M.H., R.P., J.L.)Masahiro Horikawa - Oregon Health and Science University, Portland (H.B., G.N., M.H., R.P., J.L.)Ryan Priest - Oregon Health and Science University, Portland (H.B., G.N., M.H., R.P., J.L.)Jesse Liu - Oregon Health and Science University, Portland (H.B., G.N., M.H., R.P., J.L.)Ronald F Budzik - Department of Radiology, Riverside Radiology and Interventional Associates, Columbus, OH (R.F.B., P.P., N.V.)Peter Pema - Department of Radiology, Riverside Radiology and Interventional Associates, Columbus, OH (R.F.B., P.P., N.V.)Nirav Vora - Department of Radiology, Riverside Radiology and Interventional Associates, Columbus, OH (R.F.B., P.P., N.V.)M. Asif Taqi - Vascular Neurology of Southern California, Los Robles Hospital, Thousand Oaks (M.A.T.)Qingliang Tony Wang - Departments of Neurology, Surgery/Neurosurgery, and Comprehensive Stroke Center, Maimonides Medical Center/SUNY Downstate Health Sciences University, Brooklyn, NY (Q.T.W.)Erez Nossek - Department of Neurosurgery, New York University Medical School (E.N.)Guilherme Dabus - Department of Neurointerventional Surgery, Baptist Cardiac and Vascular Institute, Miami, FL (G.D., I.L.)Italo Linfante - Department of Neurointerventional Surgery, Baptist Cardiac and Vascular Institute, Miami, FL (G.D., I.L.)Ajit Puri - Department of Radiology, University of Massachusetts Medical School, Worcester (A.P.)Eitan Abergel - Department of Neuroradiology, Rambam Health Care, Haifa, Israel (E.A.)Sidney Starkman - Department of Emergency Medicine (S.S.), University of California Los AngelesSatoshi Tateshima - Department of Radiology and Neurosurgery (S.T.), University of California Los AngelesAshutosh P Jadhav - Department of Neurosurgery, Barrow Neurological Institute, Phoenix, AZ (A.P.J.)
- Resource Type
- Journal article
- Publication Details
- Stroke (1970), Vol.52(5), pp.1534-1544
- DOI
- 10.1161/STROKEAHA.121.034436
- PMID
- 33739136
- NLM abbreviation
- Stroke
- ISSN
- 0039-2499
- eISSN
- 1524-4628
- Publisher
- Lippincott Williams & Wilkins; Hagerstown, MD
- Language
- English
- Date published
- 05/2021
- Academic Unit
- Neurology; Radiology; Iowa Neuroscience Institute; Neurosurgery
- Record Identifier
- 9984070846002771
Metrics
104 Record Views