TY - JOUR
T1 - Endovascular therapy for stroke due to basilar-artery occlusion
AU - Langezaal, Lucianne C.M.
AU - Van Der Hoeven, Erik J.R.J.
AU - BASICS Study Group
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 - Supported by the Dutch Heart Foundation, the Swiss Heart Foundation, the São Paulo Research Foundation, the National Council for Scientific and Technological Development in Brazil, the University Medical Center Utrecht, and St. Antonius Hospital Nieuwegein.
Publisher Copyright:Co pyright © 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 -