Endovascular Therapy for Stroke Due to Basilar-Artery Occlusion

Lucianne C M Langezaal; Erik J R J van der Hoeven; Francisco J A Mont'Alverne; João J F de Carvalho; Fabrício O Lima; Diederik W J Dippel; Aad van der Lugt; Rob T H Lo; Jelis Boiten; Geert J Lycklama À Nijeholt; Julie Staals; Wim H van Zwam; Paul J Nederkoorn; Charles B L M Majoie; Johannes C Gerber; Mikael Mazighi; Michel Piotin; Andrea Zini; Stefano Vallone; Jeannette Hofmeijer; Sheila O Martins; Christian H Nolte; Kristina Szabo; Francisco A Dias; Daniel G Abud; Marieke J H Wermer; Michel J M Remmers; Hauke Schneider; Christina M 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; Octavio M Pontes-Neto; Jan-Albert Vos; L Jaap Kappelle; Ale Algra; Wouter J Schonewille; BASICS Study Group

doi:10.1056/NEJMoa2030297

Endovascular Therapy for Stroke Due to Basilar-Artery Occlusion

N Engl J Med. 2021 May 20;384(20):1910-1920. doi: 10.1056/NEJMoa2030297.

Authors

Lucianne C M Langezaal¹, Erik J R J van der Hoeven¹, Francisco J A Mont'Alverne¹, João J F de Carvalho¹, Fabrício O Lima¹, Diederik W J Dippel¹, Aad van der Lugt¹, Rob T H Lo¹, Jelis Boiten¹, Geert J Lycklama À Nijeholt¹, Julie Staals¹, Wim H van Zwam¹, Paul J Nederkoorn¹, Charles B L M Majoie¹, Johannes C Gerber¹, Mikael Mazighi¹, Michel Piotin¹, Andrea Zini¹, Stefano Vallone¹, Jeannette Hofmeijer¹, Sheila O Martins¹, Christian H Nolte¹, Kristina Szabo¹, Francisco A Dias¹, Daniel G Abud¹, Marieke J H Wermer¹, Michel J M Remmers¹, Hauke Schneider¹, Christina M Rueckert¹, Karlijn F de Laat¹, Albert J Yoo¹, Pieter-Jan van Doormaal¹, Adriaan C G M van Es¹, Bart J Emmer¹, Patrik Michel¹, Volker Puetz¹, Heinrich J Audebert¹, Octavio M Pontes-Neto¹, Jan-Albert Vos¹, L Jaap Kappelle¹, Ale Algra¹, Wouter J Schonewille¹; BASICS Study Group

Collaborators

BASICS Study Group:
W J Schonewille, J A Vos, E J R J van der Hoeven, L C M Langezaal, M van Leersum, D A F van den Heuvel, M J L van Strijen, L L Teunissen, D W J Dippel, A van der Lugt, A C G M van Es, P J van Doormaal, L J Kappelle, T H Lo, H B van der Worp, J Boiten, G J Lycklama À Nijeholt, P J Nederkoorn, C B L M Majoie, J Coutinho, B J Emmer, J Staals, W H van Zwam, J Hofmeijer, J Martens, M L Bernsen, M J H Wermer, M A A van Walderveen, M J M Remmers, K F de Laat, P L M de Kort, F J Mont'Alverne, J J F Carvalho, F O Lima, F de Araújo Rocha, D de Almeida Bandeira, A Freitas de Lucena, H Coelho Silva, S O Martins, O M Pontes-Neto, F A Dias, D G Abud, R Cerantola, M Camilo, F A Alves, R K Martins, G Nakiri, L H Castro-Afonso, V Puetz, J C Gerber, L P Pallesen, K Barlinn, J Barlinn, T Siepmann, U Bodechtel, H Schneider, H Reichmann, R von Kummer, X Grählert, B Djawid, R Pfeiffer, H J Audebert, C H Nolte, H Erdur, J F Scheitz, K Szabo, M Griebe, C Groden, A Berlis, C Maurer, M Ertl, P Zickler, C Schneider, C Rueckert, T Staudacher, M Mazighi, M Piotin, M Ben Maacha, R Blanc, J P Desilles, H Redjem, S Escalard, S Smajda, G Ciccio, B Maier, F Devoye, S Herbert, A Zini, S Vallone, G Bigliardi, M L Dell'Acqua, F Rosafio, L Verganti, G Zelent, S Maffei, P Michel, I Meyer, R Herzig, A Algra, H Audebert, O M Pontes-Neto, P Lyden, K T Hoffman, R Raman, D Toni, M W T Tanck, A J Yoo, W Pellikaan, N Bouyacoub, B Zweedijk, J de Meris, K Haase, M Simons, T Wittenberg, K Brade, E Bos, D Wojcieszek, J P Greving, F Bredewoud

Affiliation

¹ From the Departments of Radiology (L.C.M.L., E.J.R.J.H., J.-A.V.) and Neurology (W.J.S.), St. Antonius Hospital, Nieuwegein, the Departments of Neurology (D.W.J.D.) and Radiology and Nuclear Medicine (A.L., P.-J.D.), Erasmus University Medical Center, Rotterdam, the Departments of Radiology (R.T.H.L.) and Neurology (L.J.K.) and the Department of Neurology and Neurosurgery, Brain Center, and the Julius Center for Health Sciences and Primary Care (A.A.), University Medical Center Utrecht, and Utrecht University (A.A.), Utrecht, the Departments of Neurology (J.B.) and Radiology (G.J.L.N.), Haaglanden Medical Center, and the Department of Neurology, Haga Hospital (K.F.L.), The Hague, the Departments of Neurology (J.S.) and Radiology and Nuclear Medicine (W.H.Z.), Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Center, Maastricht, the Departments of Neurology (P.J.N.) and Radiology (C.B.L.M.M., B.J.E.), Amsterdam University Medical Center, Amsterdam, the Department of Neurology, Rijnstate Hospital, Arnhem, and the Department of Clinical Neurophysiology, University of Twente, Enschede (J.H.), the Departments of Neurology (M.J.H.W.) and Radiology (A.C.G.M.E.), Leiden University Medical Center, Leiden, and the Department of Neurology, Amphia Hospital, Breda (M.J.M.R.) - all in the Netherlands; the Interventional Neuroradiology Service (F.J.A.M.) and the Neurology Service (J.J.F.C., F.O.L.), Hospital Geral de Fortaleza, Fortaleza, the Department of Neurology, Federal University of Rio Grande do Sul and Hospital de Clinicas de Porto Alegre, Porto Alegre (S.O.M.), and the Stroke Service, Neurology Division, Department of Neuroscience and Behavioral Sciences (F.A.D., O.M.P.-N.), and the Interventional Neuroradiology Service, Department of Medical Imaging, Hematology and Oncology (D.G.A.), Ribeirão Preto Medical School, University of São Paulo, São Paulo - all in Brazil; the Institute of Neuroradiology (J.C.G.) and the Department of Neurology (V.P.), Dresden Neurovascular Center, University Hospital Carl Gustav Carus, and Medizinische Fakultät Carl Gustav Carus (H.S.), Technische Universität Dresden, Dresden, the Department of Neurology and Center for Stroke Research, Charité Universitätsmedizin Berlin, Berlin (C.H.N., H.J.A.), the Department of Neurology, University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim (K.S.), the Department of Neurology, University Hospital Augsburg, Augsburg (H.S.), and the Department of Neurology, Oberschwabenklinik, Ravensburg (C.M.R.) - all in Germany; Rothschild Foundation Hospital, INSERM Unité 1148, University of Paris, Paris (M.M., M.P.); the IRCCS Istituto delle Scienze Neurologiche di Bologna, Department of Neurology and Stroke Center, Maggiore Hospital, Bologna (A.Z.), and the Neuroradiology Unit, Department of Neuroscience, Ospedale Civile S. Agostino-Estense, Modena University Hospital, Modena (S.V.) - both in Italy; the Texas Stroke Institute, Fort Worth (A.J.Y.); and the Stroke Center, Neurology Service, Lausanne University Hospital, Lausanne, Switzerland (P.M.).

PMID: 34010530
DOI: 10.1056/NEJMoa2030297

Abstract

Background: The effectiveness of endovascular therapy in patients with stroke caused by basilar-artery 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.).

Publication types

Comparative Study
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

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*

Substances

Fibrinolytic Agents

Associated data

ClinicalTrials.gov/NCT01717755