Endovascular Therapy for Stroke Due to Basilar-Artery Occlusion.
Details
Serval ID
serval:BIB_798EF9447DEB
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Endovascular Therapy for Stroke Due to Basilar-Artery Occlusion.
Journal
The New England journal of medicine
Working group(s)
BASICS Study Group
Contributor(s)
Schonewille W.J., Vos J.A., van der Hoeven EJRJ, Langezaal LCM, van Leersum M., van den Heuvel DAF, van Strijen MJL, Teunissen L.L., Dippel DWJ, van der Lugt A., van Es ACGM, van Doormaal P.J., Kappelle L.J., Lo T.H., van der Worp H.B., Boiten J., Lycklama À Nijeholt G.J., Nederkoorn P.J., Majoie CBLM, Coutinho J., Emmer B.J., Staals J., van Zwam W.H., Hofmeijer J., Martens J., Bernsen M.L., Wermer MJH, van Walderveen MAA, Remmers MJM, de Laat K.F., de Kort PLM, Mont'Alverne F.J., Carvalho JJF, Lima F.O., de Araújo Rocha F., de Almeida Bandeira D., Freitas de Lucena A., Coelho Silva H., Martins S.O., Pontes-Neto O.M., Dias F.A., Abud D.G., Cerantola R., Camilo M., Alves F.A., Martins R.K., Nakiri G., Castro-Afonso L.H., Puetz V., Gerber J.C., Pallesen L.P., Barlinn K., Barlinn J., Siepmann T., Bodechtel U., Schneider H., Reichmann H., von Kummer R., Grählert X., Djawid B., Pfeiffer R., Audebert H.J., Nolte C.H., Erdur H., Scheitz J.F., Szabo K., Griebe M., Groden C., Berlis A., Maurer C., Ertl M., Zickler P., Schneider C., Rueckert C., Staudacher T., Mazighi M., Piotin M., Ben Maacha M., Blanc R., Desilles J.P., Redjem H., Escalard S., Smajda S., Ciccio G., Maier B., Devoye F., Herbert S., Zini A., Vallone S., Bigliardi G., Dell'Acqua M.L., Rosafio F., Verganti L., Zelent G., Maffei S., Michel P., Meyer I., Herzig R., Algra A., Audebert H., Pontes-Neto O.M., Lyden P., Hoffman K.T., Raman R., Toni D., Tanck MWT, Yoo A.J., Pellikaan W., Bouyacoub N., Zweedijk B., de Meris J., Haase K., Simons M., Wittenberg T., Brade K., Bos E., Wojcieszek D., Greving J.P., Bredewoud F.
ISSN
1533-4406 (Electronic)
ISSN-L
0028-4793
Publication state
Published
Issued date
20/05/2021
Peer-reviewed
Oui
Volume
384
Number
20
Pages
1910-1920
Language
english
Notes
Publication types: Comparative Study ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Publication Status: ppublish
Abstract
The effectiveness of endovascular therapy in patients with stroke caused by basilar-artery occlusion has not been well studied.
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.
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).
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.).
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.
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).
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.).
Keywords
Aged, Arterial Occlusive Diseases/complications, Basilar Artery/diagnostic imaging, Confidence Intervals, Endovascular Procedures, Female, Fibrinolytic Agents/therapeutic use, Humans, Intention to Treat Analysis, Male, Middle Aged, Severity of Illness Index, Single-Blind Method, Stroke/drug therapy, Stroke/etiology, Stroke/mortality, Stroke/surgery, Thrombectomy/methods, Thrombolytic Therapy, Time-to-Treatment, Treatment Outcome, Vertebrobasilar Insufficiency/complications
Pubmed
Web of science
Create date
25/05/2021 7:35
Last modification date
05/06/2021 5:33
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