TY - JOUR
T1 - Impact of balloon guide catheter use on clinical and angiographic outcomes in the STRATIS stroke thrombectomy registry
AU - Zaidat, Osama O.
AU - Mueller-Kronast, Nils H.
AU - Hassan, Ameer E.
AU - Haussen, DIogo C.
AU - Jadhav, Ashutosh P.
AU - Froehler, Michael T.
AU - Jahan, Reza
AU - Ali Aziz-Sultan, Mohammad
AU - Klucznik, Richard P.
AU - Saver, Jeffrey L.
AU - Hellinger, Frank R.
AU - Yavagal, DIleep R.
AU - Yao, Tom L.
AU - Gupta, Rishi
AU - Martin, Coleman O.
AU - Bozorgchami, Hormozd
AU - Kaushal, Ritesh
AU - Nogueira, Raul G.
AU - Gandhi, Ravi H.
AU - Peterson, Eric C.
AU - Dashti, Shervin
AU - Given, Curtis A.
AU - Mehta, Brijesh P.
AU - Deshmukh, Vivek
AU - Starkman, Sidney
AU - Linfante, Italo
AU - McPherson, Scott H.
AU - Kvamme, Peter
AU - Grobelny, Thomas J.
AU - Hussain, Muhammad Shazam
AU - Thacker, Ike
AU - Vora, Nirav
AU - Chen, Peng Roc
AU - Monteith, Stephen J.
AU - Ecker, Robert D.
AU - Schirmer, Clemens M.
AU - Sauvageau, Eric
AU - Chebl, Alex Bou
AU - Derdeyn, Colin P.
AU - Maidan, Lucian
AU - Badruddin, Aamir
AU - Siddiqui, Adnan H.
AU - Dumont, Travis M.
AU - Alhajeri, Abdulnasser
AU - Taqi, Muhammad A.
AU - Asi, Khaled
AU - Carpenter, Jeffrey
AU - Boulos, Alan
AU - Jindal, Gaurav
AU - Puri, Ajit S.
AU - Chitale, Rohan
AU - Deshaies, Eric M.
AU - Robinson, David
AU - Kallmes, David F.
AU - Baxter, Blaise W.
AU - Jumaa, Mouhammed
AU - Sunenshine, Peter
AU - Majjhoo, Aniel
AU - English, Joey D.
AU - Suzuki, Shuichi
AU - Fessler, Richard D.
AU - Delgado-Almandoz, Josser
AU - Martin, Jerry C.
AU - Liebeskind, David S.
N1 - Funding Information:
Dr Zaidat reports research grant support from Stryker, Genentech, and Medtronic Neurovascular (modest); honoraria from Codman, Stryker, Penumbra, and Medtronic Neurovascular (modest); is an expert witness (modest); ownership interest in Galaxy Therapeutics, LLC (modest); and is a consultant/advisory board member at the National Institutes of Health (NIH) StrokeNet, Penumbra, Medtronic Neurovascular, Codman, and Stryker (modest). Dr Mueller-Kronast is a modest consultant for Medtronic Neurovascular. A.E. Hassan is a consultant and speaker for GE Healthcare, Medtronic, Stryker, MicroVention, Penumbra, and Genentech. Dr Froehler serves as a consultant for Balt USA, Medtronic, Stryker, NeurVana, Control Medical, and Vizai and has received research funding from Medtronic, Stryker, MicroVention, EndoPhys, and Penumbra. Dr Jahan serves as a consultant for Medtronic Neurovascular and Medina Medical. Dr Ali Aziz-Sultan is a proctor for Covidien and participates in training other physicians in the use of the embolic agent Onyx and the Pipeline embolization device. Dr Klucznik serves as a proctor and speaker for Medtronic. Dr Saver is an employee of the University of California, which has patent rights in retrieval devices for stroke; has received contracted payments for services as a scientific consultant advising on rigorous trial design and conduct to Medtronic/Covidien, Stryker, Neuravi/Cerenovus, and Boehringer Ingelheim (prevention only); and has received contracted stock options for services as a scientific consultant advising on rigorous trial design and conduct to Rapid Medical. Dr Hellinger is on the Speakers’Bureau for Medtronic and serves as a consultant to Penumbra and Cordis Neurovascular (Johnson and Johnson). Dr Yavagal receives modest honoraria from Medtronic, serves as an expert witness for Goldberg Segalla (modest), serves as a PI for the STRATIS (Systematic Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischemic Stroke) Registry (Medtronic), and received modest consulting fees from Medtronic, Neural Analytics, Rapid Medical, Cerenovus, and Johnson & Johnson, and is a consultant for Neuroanalystics (no compensation). Dr Yao serves as a consultant/proctor to Medtronic. Dr Gupta serves as a speaker for Genentech (modest); as a consultant to Medtronic (modest), Cerenovous (modest), and Stryker Neurovascular (significant); and as a consultant for Rapid Medical. Dr Bozorgchami is a modest consultant for Cerenovus, Stryker, and Neuravi. Dr Nogueira serves as a consultant to Genentech (modest), Medtronic (modest), Stryker Neurovascular (modest), Penumbra (no compensation), Neuravi/Cerenovus (modest), and Phenox (modest), Biogen (modest), and Anaconda (modest). Dr Given is on the Speakers’ Bureau and receives honoraria from Medtronic and Stryker. Dr Starkman is a site investigator in multicenter trials supported by Stryker and Covidien. Dr Linfante serves as a consultant and is on the Speakers’ Bureau for Medtronic Neurovascular, Codman, and Stryker. Dr Hussain is on the Clinical Events Committee for Pulsar. Dr Thacker serves as a consultant/proctor to Medtronic. Dr Schirmer has received honoraria from the American Association of Neurological Surgeons and Toshiba and has ownership interest in NTI and receives research support from NIH/NINDS. Dr Chebl has received honoraria from Medtronic. Dr Derdeyn reports ownership interest in Pulse Therapeutic, Honoraria from Bayer and W. L. Gore and Associates, and research grants (all clinical trial DSMBs) from Penumbra and Rapid Medical. Dr Siddiqui serves as a consultant to Amnis Therapeutics, Boston Scientific, Canon Medical Systems USA, Cerebrotech Medical Systems, Cerenovus, Claret Medical, Corindus, Inc, Endostream Medical, Guidepoint Global Consulting, Imperative Care, Integra, Medtronic, MicroVention, Northwest University, Penumbra, Rapid Medical, Rebound Therapeutics Corp, Serenity Medical, Inc, Silk Road Medical, StimMed, Stryker, Three Rivers Medical, VasSol, and W. L. Gore and Associates and has ownership interest in Amnis Therapeutics, Apama Medical, BlinkTBI, Cardinal Health, Cerebrotech Medical Systems, Claret Medical, Cognition Medical, Endostream Medical, Ltd, Imperative Care, Rebound Therapeutics Corp, Rist Therapeutics Corp, Serenity Medical, Inc, Silk Road Medical, StimMed, Synchron, Three Rivers Medical, and Viseon Spine and receives modest compensation from MUSC. Dr Taqi serves as a consultant to Stryker Neurovascular. Dr Puri has been a consultant on a fee-per-hour basis and has received research grants from Medtronic Neurovascular and Stryker Neurovascular. Dr Chitale has received research funding from MicroVention and Medtronic. Dr Deshaies is a consultant for ev3/ Medtronic Neurovascular, MicroVention, and Integra. Dr Kallmes is founder of Marblehead Medical, LLC, is an advisor to Boston Scientific, and receives research support Stryker and Neuravi. Dr Baxter is on the Speakers’ Bureau, has received honoraria, has ownership interest, and serves as a consultant to Penumbra and is a consultant for Stryker, Medtronic, Route 92, and Vizai. Dr Sunenshine serves as a consultant/proctor to Medtronic. Dr English has received honoraria from Medtronic, Stryker Neurovascular, and Penumbra. Dr Delgado-Almandoz is a significant consultant for Medtronic Neurovascular and Penumbra. Dr Liebeskind has received an NIH grant and serves as a consultant to Stryker and Medtronic. The other authors report no conflicts.
Funding Information:
This study was sponsored by Medtronic.
Publisher Copyright:
© 2019 American Heart Association, Inc.
PY - 2019/3/1
Y1 - 2019/3/1
N2 - Background and Purpose - Mechanical thrombectomy has been shown to improve clinical outcomes in patients with acute ischemic stroke. However, the impact of balloon guide catheter (BGC) use is not well established. Methods - STRATIS (Systematic Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischemic Stroke) was a prospective, multicenter study of patients with large vessel occlusion treated with the Solitaire stent retriever as first-line therapy. In this study, an independent core laboratory, blinded to the clinical outcomes, reviewed all procedures and angiographic data to classify procedural technique, target clot location, recanalization after each pass, and determine the number of stent retriever passes. The primary clinical end point was functional independence (modified Rankin Scale, 0-2) at 3 months as determined on-site, and the angiographic end point was first-pass effect (FPE) success rate from a single device attempt (modified Thrombolysis in Cerebral Infarction, ≥2c) as determined by a core laboratory. Achieving modified FPE (modified Thrombolysis in Cerebral Infarction, ≥2b) was also assessed. Comparisons of clinical outcomes were made between groups and adjusted for baseline and procedural characteristics. All participating centers received institutional review board approval from their respective institutions. Results - Adjunctive technique groups included BGC (n=445), distal access catheter (n=238), and conventional guide catheter (n=62). The BGC group had a higher rate of FPE following first pass (212/443 [48%]) versus conventional guide catheter (16/62 [26%]; P=0.001) and distal access catheter (83/235 [35%]; P=0.002). Similarly, the BGC group had a higher rate of modified FPE (294/443 [66%]) versus conventional guide catheter (26/62 [42%]; P<0.001) and distal access catheter (129/234 [55%]; P=0.003). The BGC group achieved the highest rate of functional independence (253/415 [61%]) versus conventional guide catheter (23/55 [42%]; P=0.007) and distal access catheter (113/218 [52%]; P=0.027). Final revascularization and mortality rates did not differ across the groups. Conclusions - BGC use was an independent predictor of FPE, modified FPE, and functional independence, suggesting that its routine use may improve the rates of early revascularization success and good clinical outcomes.
AB - Background and Purpose - Mechanical thrombectomy has been shown to improve clinical outcomes in patients with acute ischemic stroke. However, the impact of balloon guide catheter (BGC) use is not well established. Methods - STRATIS (Systematic Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischemic Stroke) was a prospective, multicenter study of patients with large vessel occlusion treated with the Solitaire stent retriever as first-line therapy. In this study, an independent core laboratory, blinded to the clinical outcomes, reviewed all procedures and angiographic data to classify procedural technique, target clot location, recanalization after each pass, and determine the number of stent retriever passes. The primary clinical end point was functional independence (modified Rankin Scale, 0-2) at 3 months as determined on-site, and the angiographic end point was first-pass effect (FPE) success rate from a single device attempt (modified Thrombolysis in Cerebral Infarction, ≥2c) as determined by a core laboratory. Achieving modified FPE (modified Thrombolysis in Cerebral Infarction, ≥2b) was also assessed. Comparisons of clinical outcomes were made between groups and adjusted for baseline and procedural characteristics. All participating centers received institutional review board approval from their respective institutions. Results - Adjunctive technique groups included BGC (n=445), distal access catheter (n=238), and conventional guide catheter (n=62). The BGC group had a higher rate of FPE following first pass (212/443 [48%]) versus conventional guide catheter (16/62 [26%]; P=0.001) and distal access catheter (83/235 [35%]; P=0.002). Similarly, the BGC group had a higher rate of modified FPE (294/443 [66%]) versus conventional guide catheter (26/62 [42%]; P<0.001) and distal access catheter (129/234 [55%]; P=0.003). The BGC group achieved the highest rate of functional independence (253/415 [61%]) versus conventional guide catheter (23/55 [42%]; P=0.007) and distal access catheter (113/218 [52%]; P=0.027). Final revascularization and mortality rates did not differ across the groups. Conclusions - BGC use was an independent predictor of FPE, modified FPE, and functional independence, suggesting that its routine use may improve the rates of early revascularization success and good clinical outcomes.
KW - Animals
KW - Brain ischemia
KW - Humans
KW - Stroke
KW - Thrombectomy
UR - http://www.scopus.com/inward/record.url?scp=85062164675&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85062164675&partnerID=8YFLogxK
U2 - 10.1161/STROKEAHA.118.021126
DO - 10.1161/STROKEAHA.118.021126
M3 - Article
C2 - 30776994
AN - SCOPUS:85062164675
SN - 0039-2499
VL - 50
SP - 697
EP - 704
JO - Stroke
JF - Stroke
IS - 3
ER -