TY - JOUR
T1 - Sonothrombolysis in patients with acute ischemic stroke with large vessel occlusion
T2 - An individual patient data meta-analysis
AU - Tsivgoulis, Georgios
AU - Katsanos, Aristeidis H.
AU - Eggers, Jürgen
AU - Larrue, Vincent
AU - Thomassen, Lars
AU - Grotta, James C.
AU - Seitidis, Georgios
AU - Schellinger, Peter D.
AU - Mavridis, Dimitris
AU - Demchuk, Andrew
AU - Novotny, Vojtech
AU - Molina, Carlos A.
AU - Veroniki, Areti Angeliki
AU - Köhrmann, Martin
AU - Soinne, Lauri
AU - Khanevski, Andrej Netland
AU - Barreto, Andrew D.
AU - Saqqur, Maher
AU - Psaltopoulou, Theodora
AU - Muir, Keith W.
AU - Fiebach, Jochen B.
AU - Rothlisberger, Travis
AU - Kent, Thomas A.
AU - Mandava, Pitchaiah
AU - Alexandrov, Anne W.
AU - Alexandrov, Andrei V.
N1 - Funding Information:
Dr Grotta reports grants from Genentech outside the submitted work. Dr Schellinger reports personal fees from Cerevast and personal fees from Boehringer Ingelheim during the conduct of the study. Dr Demchuk reports personal fees from Medtronic during the conduct of the study; has stock ownership from Circle NVI outside the submitted work; in addition, he has a patent to Circle NVI issued. Dr Soinne reports trial support from Cerevast Therapeutics, Inc (Redmond, WA) during the conduct of the study. Dr Muir reports personal fees and nonfinancial support from Boehringer Ingelheim, personal fees from ReNeuron, personal fees from Bayer, personal fees from Daiichi Sankyo, and personal fees from Biogen outside the submitted work. Dr Fiebach reports personal fees from Cerevast during the conduct of the study; personal fees from Abbvie, personal fees from AC Immune, personal fees from Artemida, personal fees from BioClinica, personal fees from Biogen, personal fees from BMS, personal fees from Brainomix, personal fees from Daiichi-Sankyo, personal fees from EISAI, personal fees from Guerbet, personal fees from Ionis Pharmaceuticals, personal fees from Julius Clinical, personal fees from jung diagnostics, personal fees from Eli Lilly, personal fees from Merck, and personal fees from Tau Rx outside the submitted work. T. Rothlisberger reports personal fees from Cerevast Therapeutics during the conduct of the study; personal fees from Cerevast Medical outside the submitted work.
Publisher Copyright:
© 2021 American Heart Association, Inc.
PY - 2021/12/1
Y1 - 2021/12/1
N2 - BACKGROUND AND PURPOSE: Evidence about the utility of ultrasound-enhanced thrombolysis (sonothrombolysis) in patients with acute ischemic stroke (AIS) is conflicting. We aimed to evaluate the safety and efficacy of sonothrombolysis in patients with AIS with large vessel occlusion, by analyzing individual patient data of available randomized-controlled clinical trials. METHODS: We included all available randomized-controlled clinical trials comparing sonothrombolysis with or without addition of microspheres (treatment group) to intravenous thrombolysis alone (control group) in patients with AIS with large vessel occlusion. The primary outcome measure was the rate of complete recanalization at 1 to 36 hours following intravenous thrombolysis initiation. We present crude odds ratios (ORs) and ORs adjusted for the predefined variables of age, sex, baseline stroke severity, systolic blood pressure, and onset-to-treatment time. RESULTS: We included 7 randomized controlled clinical trials that enrolled 1102 patients with AIS. A total of 138 and 134 confirmed large vessel occlusion patients were randomized to treatment and control groups respectively. Patients randomized to sonothrombolysis had increased odds of complete recanalization compared with patients receiving intravenous thrombolysis alone (40.3% versus 22.4%; OR, 2.17 [95% CI, 1.03–4.54]; adjusted OR, 2.33 [95% CI, 1.02–5.34]). The likelihood of symptomatic intracranial hemorrhage was not significantly different between the 2 groups (7.3% versus 3.7%; OR, 2.03 [95% CI, 0.68–6.11]; adjusted OR, 2.55 [95% CI, 0.76–8.52]). No differences in the likelihood of asymptomatic intracranial hemorrhage, 3-month favorable functional and 3-month functional independence were documented. CONCLUSIONS: Sonothrombolysis was associated with a nearly 2-fold increase in the odds of complete recanalization compared with intravenous thrombolysis alone in patients with AIS with large vessel occlusions. Further study of the safety and efficacy of sonothrombolysis is warranted.
AB - BACKGROUND AND PURPOSE: Evidence about the utility of ultrasound-enhanced thrombolysis (sonothrombolysis) in patients with acute ischemic stroke (AIS) is conflicting. We aimed to evaluate the safety and efficacy of sonothrombolysis in patients with AIS with large vessel occlusion, by analyzing individual patient data of available randomized-controlled clinical trials. METHODS: We included all available randomized-controlled clinical trials comparing sonothrombolysis with or without addition of microspheres (treatment group) to intravenous thrombolysis alone (control group) in patients with AIS with large vessel occlusion. The primary outcome measure was the rate of complete recanalization at 1 to 36 hours following intravenous thrombolysis initiation. We present crude odds ratios (ORs) and ORs adjusted for the predefined variables of age, sex, baseline stroke severity, systolic blood pressure, and onset-to-treatment time. RESULTS: We included 7 randomized controlled clinical trials that enrolled 1102 patients with AIS. A total of 138 and 134 confirmed large vessel occlusion patients were randomized to treatment and control groups respectively. Patients randomized to sonothrombolysis had increased odds of complete recanalization compared with patients receiving intravenous thrombolysis alone (40.3% versus 22.4%; OR, 2.17 [95% CI, 1.03–4.54]; adjusted OR, 2.33 [95% CI, 1.02–5.34]). The likelihood of symptomatic intracranial hemorrhage was not significantly different between the 2 groups (7.3% versus 3.7%; OR, 2.03 [95% CI, 0.68–6.11]; adjusted OR, 2.55 [95% CI, 0.76–8.52]). No differences in the likelihood of asymptomatic intracranial hemorrhage, 3-month favorable functional and 3-month functional independence were documented. CONCLUSIONS: Sonothrombolysis was associated with a nearly 2-fold increase in the odds of complete recanalization compared with intravenous thrombolysis alone in patients with AIS with large vessel occlusions. Further study of the safety and efficacy of sonothrombolysis is warranted.
KW - Doppler
KW - Ischemic stroke
KW - Meta-analysis
KW - Microsphere
KW - Odds ratio
KW - Thrombolysis
KW - Transcranial
KW - Ultrasonography
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UR - http://www.scopus.com/inward/citedby.url?scp=85121039692&partnerID=8YFLogxK
U2 - 10.1161/STROKEAHA.120.030960
DO - 10.1161/STROKEAHA.120.030960
M3 - Article
C2 - 34428930
AN - SCOPUS:85121039692
VL - 52
SP - 3786
EP - 3795
JO - Stroke
JF - Stroke
SN - 0039-2499
IS - 12
ER -