Endovascular Therapy for Stroke Due to Basilar-Artery Occlusion.
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Langezaal Lucianne C M, van der Hoeven Erik J R J, Mont'Alverne Francisco J A, de Carvalho João J F, Lima Fabrício O, Dippel Diederik W J, van der Lugt Aad, Lo Rob T H, Boiten Jelis, Lycklama À Nijeholt Geert J, Staals Julie, van Zwam Wim H, Nederkoorn Paul J, Majoie Charles B L M, Gerber Johannes C, Mazighi Mikael, Piotin Michel, Zini Andrea, Vallone Stefano, Hofmeijer Jeannette, Martins Sheila O, Nolte Christian H, Szabo Kristina, Dias Francisco A, Abud Daniel G, Wermer Marieke J H, Remmers Michel J M, Schneider Hauke, Rueckert Christina M, de Laat Karlijn F, Yoo Albert J, van Doormaal Pieter-Jan, van Es Adriaan C G M, Emmer Bart J, Michel Patrik, Puetz Volker, Audebert Heinrich J, Pontes-Neto Octavio M, Vos Jan-Albert, Kappelle L Jaap, Algra Ale, Schonewille Wouter J, BASICS Study Group
Аннотация
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.).