TY - JOUR
T1 - Endovascular therapy for stroke due to basilar-artery occlusion
AU - BASICS Study Group
AU - Langezaal, Lucianne C.M.
AU - Van Der Hoeven, Erik J.R.J.
AU - Mont'Alverne, Francisco J.A.
AU - De Carvalho, João J.F.
AU - Lima, Fabrício O.
AU - Dippel, Diederik W.J.
AU - Van Der Lugt, Aad
AU - Lo, Rob T.H.
AU - Boiten, Jelis
AU - Lycklama A Nijeholt, Geert J.
AU - Staals, Julie
AU - Van Zwam, Wim H.
AU - Nederkoorn, Paul J.
AU - Majoie, Charles B.L.M.
AU - Gerber, Johannes C.
AU - Mazighi, Mikael
AU - Piotin, Michel
AU - Zini, Andrea
AU - Vallone, Stefano
AU - Hofmeijer, Jeannette
AU - Martins, Sheila O.
AU - Nolte, Christian H.
AU - Szabo, Kristina
AU - Dias, Francisco A.
AU - Abud, Daniel G.
AU - Wermer, Marieke J.H.
AU - Remmers, Michel J.M.
AU - Schneider, Hauke
AU - Rueckert, Christina M.
AU - De Laat, Karlijn F.
AU - Yoo, Albert J.
AU - Van Doormaal, Pieter Jan
AU - Van Es, Adriaan C.G.M.
AU - Emmer, Bart J.
AU - Michel, Patrik
AU - Puetz, Volker
AU - Audebert, Heinrich J.
AU - Pontes-Neto, Octavio M.
AU - Vos, Jan Albert
AU - Kappelle, L. Jaap
AU - Algra, Ale
AU - Schonewille, Wouter J.
N1 - Publisher Copyright:
Copyright © 2021 Massachusetts Medical Society.
PY - 2021/5/20
Y1 - 2021/5/20
N2 - BACKGROUND The effectiveness of endovascular therapy in patients with stroke caused by basilarartery occlusion has not been well studied. METHODS We randomly assigned patients within 6 hours after the estimated time of onset of a stroke due to basilar-artery occlusion, in a 1:1 ratio, to receive endovascular therapy or standard medical care. The primary outcome was a favorable functional outcome, defined as a score of 0 to 3 on the modified Rankin scale (range, 0 to 6, with 0 indicating no disability, 3 indicating moderate disability, and 6 indicating death) at 90 days. The primary safety outcomes were symptomatic intracranial hemorrhage within 3 days after the initiation of treatment and mortality at 90 days. RESULTS A total of 300 patients were enrolled (154 in the endovascular therapy group and 146 in the medical care group). Intravenous thrombolysis was used in 78.6% of the patients in the endovascular group and in 79.5% of those in the medical group. Endovascular treatment was initiated at a median of 4.4 hours after stroke onset. A favorable functional outcome occurred in 68 of 154 patients (44.2%) in the endovascular group and 55 of 146 patients (37.7%) in the medical care group (risk ratio, 1.18; 95% confidence interval [CI], 0.92 to 1.50). Symptomatic intracranial hemorrhage occurred in 4.5% of the patients after endovascular therapy and in 0.7% of those after medical therapy (risk ratio, 6.9; 95% CI, 0.9 to 53.0); mortality at 90 days was 38.3% and 43.2%, respectively (risk ratio, 0.87; 95% CI, 0.68 to 1.12). CONCLUSIONS Among patients with stroke from basilar-artery occlusion, endovascular therapy and medical therapy did not differ significantly with respect to a favorable functional outcome, but, as reflected by the wide confidence interval for the primary outcome, the results of this trial may not exclude a substantial benefit of endovascular therapy. Larger trials are needed to determine the efficacy and safety of endovascular therapy for basilar-artery occlusion. (Funded by the Dutch Heart Foundation and others; BASICS ClinicalTrials.gov number, NCT01717755; Netherlands Trial Register number, NL2500.).
AB - BACKGROUND The effectiveness of endovascular therapy in patients with stroke caused by basilarartery occlusion has not been well studied. METHODS We randomly assigned patients within 6 hours after the estimated time of onset of a stroke due to basilar-artery occlusion, in a 1:1 ratio, to receive endovascular therapy or standard medical care. The primary outcome was a favorable functional outcome, defined as a score of 0 to 3 on the modified Rankin scale (range, 0 to 6, with 0 indicating no disability, 3 indicating moderate disability, and 6 indicating death) at 90 days. The primary safety outcomes were symptomatic intracranial hemorrhage within 3 days after the initiation of treatment and mortality at 90 days. RESULTS A total of 300 patients were enrolled (154 in the endovascular therapy group and 146 in the medical care group). Intravenous thrombolysis was used in 78.6% of the patients in the endovascular group and in 79.5% of those in the medical group. Endovascular treatment was initiated at a median of 4.4 hours after stroke onset. A favorable functional outcome occurred in 68 of 154 patients (44.2%) in the endovascular group and 55 of 146 patients (37.7%) in the medical care group (risk ratio, 1.18; 95% confidence interval [CI], 0.92 to 1.50). Symptomatic intracranial hemorrhage occurred in 4.5% of the patients after endovascular therapy and in 0.7% of those after medical therapy (risk ratio, 6.9; 95% CI, 0.9 to 53.0); mortality at 90 days was 38.3% and 43.2%, respectively (risk ratio, 0.87; 95% CI, 0.68 to 1.12). CONCLUSIONS Among patients with stroke from basilar-artery occlusion, endovascular therapy and medical therapy did not differ significantly with respect to a favorable functional outcome, but, as reflected by the wide confidence interval for the primary outcome, the results of this trial may not exclude a substantial benefit of endovascular therapy. Larger trials are needed to determine the efficacy and safety of endovascular therapy for basilar-artery occlusion. (Funded by the Dutch Heart Foundation and others; BASICS ClinicalTrials.gov number, NCT01717755; Netherlands Trial Register number, NL2500.).
UR - https://www.scopus.com/pages/publications/85106472718
U2 - 10.1056/NEJMoa2030297
DO - 10.1056/NEJMoa2030297
M3 - Article
C2 - 34010530
AN - SCOPUS:85106472718
SN - 0028-4793
VL - 384
SP - 1910
EP - 1920
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 20
ER -