作者
Lucianne C.M. Langezaal,E.J. Hoeven,F. Mont’alverne,João José Freitas de Carvalho,Fabrício Oliveira Lima,Diederik W.J. Dippel,Aad van der Lugt,Rob Lo,Jelis Boiten,Geert J. Lycklama à Nijeholt,Julie Staals,Wim H. van Zwam,Gian Marco De Marchis,Charles B.L.M. Majoie,Johannes Gerber,Mikaël Mazighi,Michel Piotin,Andrea Zini,Stefano Vallone,Jeannette Hofmeijer,Sheila Cristina Ouriques Martins,Christian H. Nolte,Bo Norrving,Francisco Antunes Dias,Daniel Giansante Abud,Marieke J.H. Wermer,Michel Remmers,Hauke Schneider,Christina Rueckert,Karlijn F. de Laat,Albert J. Yoo,Pieter‐Jan van Doormaal,Adriaan C.G.M. van Es,Bart J. Emmer,Patrik Michel,Volker Puetz,Heinrich J. Audebert,Octávio Marques Pontes‐Neto,Jan Albert Vos,L. Jaap Kappelle,Ale Algra,Wouter J. Schonewille
摘要
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.).