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      The Basilar Artery International Cooperation Study (BASICS): study protocol for a randomised controlled trial

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          Abstract

          Background

          Despite recent advances in acute stroke treatment, basilar artery occlusion (BAO) is associated with a death or disability rate of close to 70%. Randomised trials have shown the safety and efficacy of intravenous thrombolysis (IVT) given within 4.5 h and have shown promising results of intra-arterial thrombolysis given within 6 h of symptom onset of acute ischaemic stroke, but these results do not directly apply to patients with an acute BAO because only few, if any, of these patients were included in randomised acute stroke trials.

          Recently the results of the Basilar Artery International Cooperation Study (BASICS), a prospective registry of patients with acute symptomatic BAO challenged the often-held assumption that intra-arterial treatment (IAT) is superior to IVT. Our observations in the BASICS registry underscore that we continue to lack a proven treatment modality for patients with an acute BAO and that current clinical practice varies widely.

          Design

          BASICS is a randomised controlled, multicentre, open label, phase III intervention trial with blinded outcome assessment, investigating the efficacy and safety of additional IAT after IVT in patients with BAO. The trial targets to include 750 patients, aged 18 to 85 years, with CT angiography or MR angiography confirmed BAO treated with IVT. Patients will be randomised between additional IAT followed by optimal medical care versus optimal medical care alone. IVT has to be initiated within 4.5 h from estimated time of BAO and IAT within 6 h. The primary outcome parameter will be favourable outcome at day 90 defined as a modified Rankin Scale score of 0–3.

          Discussion

          The BASICS registry was observational and has all the limitations of a non-randomised study. As the IAT approach becomes increasingly available and frequently utilised an adequately powered randomised controlled phase III trial investigating the added value of this therapy in patients with an acute symptomatic BAO is needed (clinicaltrials.gov: NCT01717755).

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          Most cited references17

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          Therapy of basilar artery occlusion: a systematic analysis comparing intra-arterial and intravenous thrombolysis.

          Heinrich Mattle, Perttu Lindsberg (2006)
          Basilar artery occlusion (BAO) is an infrequent form of acute stroke, which invariably leads to death or long-term disability if not recanalized. A traditional recanalization approach based on historical controls and pathophysiological consideration is local intra-arterial thrombolysis (IAT) in eligible patients. This necessitates diagnostic evaluation and treatment in stroke centers equipped with an interventional neuroradiological service on a 24-hour basis, but its superiority to the technically simple intravenous thrombolysis (IVT) remains unproven. We analyzed systematically published case series of substantial size reporting the outcome of BAO after IAT or IVT. In 420 BAO patients treated with IVT (76) and IAT (344), death or dependency were equally common: 78% (59 of 76) and 76% (260 of 344), respectively (P=0.82). Recanalization was achieved more frequently with IAT (225 of 344; 65%) than with IVT (40 of 76; 53%; P=0.05), but survival rates after IVT (38 of 76; 50%) and IAT (154 of 344; 45%) were equal (P=0.48). A total of 24% of patients treated with IAT and 22% treated with IVT reached good outcomes (P=0.82). Without recanalization, the likelihood of good outcome was close to nil (2%). Recanalization occurs in more than half of BAO patients treated with IAT or IVT, and 45% to 55% of survivors regain functional independence. Although improved therapy forms for BAO are necessary, hospitals not equipped for IAT may set up IVT protocols. The effect of IVT is probably not much different from the effect of IAT. IVT represents probably the best treatment that can be offered to victims of acute BAO in such hospitals.
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            The Interventional Management of Stroke (IMS) II Study.

            (2007)
            The purpose of this study was to further investigate the feasibility and safety of a combined intravenous and intra-arterial approach to recanalization for ischemic stroke. Subjects, ages 18 to 80, with a baseline NIHSS > or =10 had intravenous recombinant tissue plasminogen activator (rt-PA) started (0.6 mg/kg over 30 minutes) within 3 hours of onset. For subjects with an arterial occlusion at angiography, additional rt-PA was administered via the EKOS micro-infusion catheter or a standard microcatheter at the site of the thrombus up to a total dose of 22 mg over 2 hours of infusion or until thrombolysis. The 81 subjects had a median baseline NIHSS score of 19. The median time to initiation of intravenous rt-PA was 142 minutes as compared with 108 minutes for placebo and 90 minutes for rt-PA-treated subjects in the NINDS rt-PA Stroke Trial (P or =2.7) and better outcomes than NINDS rt-PA-treated subjects as measured by the Barthel Index and Global Test Statistic. A randomized trial of standard intravenous rt-PA as compared with a combined intravenous and intra-arterial approach is warranted and has begun.
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              Combined intravenous and intra-arterial recanalization for acute ischemic stroke: the Interventional Management of Stroke Study.

              (2004)
              To investigate the feasibility and safety of a combined intravenous (IV) and intra-arterial (IA) approach to recanalization in patients with ischemic stroke. Subjects ages 18 to 80 with an NIH Stroke Scale (NIHSS) > or =10 at baseline had IV recombinant tissue plasminogen activator (rt-PA) started (0.6 mg/kg, 60 mg maximum over 30 minutes) within 3 hours of onset. Additional rt-PA was then administered via microcatheter at the site of the thrombus up to a total dose of 22 mg over 2 hours of infusion or until thrombolysis. Primary comparisons were with similar subsets of placebo and rt-PA-treated subjects from the NINDS rt-PA Stroke Trial. The 80 subjects had a median baseline NIHSS score of 18. The median time to initiation of IV rt-PA was 140 minutes as compared with 108 minutes for placebo and 90 minutes for rt-PA-treated subjects in the NINDS rt-PA Stroke Trial. The 3-month mortality in Interventional Management Study (IMS) subjects (16%) was numerically lower but not statistically different than the mortality of placebo (24%) and rt-PA-treated subjects (21%) in the NINDS rt-PA Stroke Trial. The rate of symptomatic intracerebral hemorrhage (6.3%) in IMS subjects was similar to that of rt-PA-treated subjects (6.6%) but higher than the rate in placebo-treated subjects (1.0%, P=0.018) in the NINDS rt-PA Stroke Trial. IMS subjects had a significantly better outcome at 3 months than NINDS placebo-treated subjects for all outcome measures (odds ratios > or =2). A randomized trial of standard IV rt-PA as compared with a combined IV and IA approach is needed.
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                Author and article information

                Contributors
                Erik JRJ van der Hoeven
                Wouter J Schonewille
                Jan Albert Vos
                Ale Algra
                Heinrich J Audebert
                Eivind Berge
                Alfonso Ciccone
                Mikael Mazighi
                Patrik Michel
                Keith W Muir
                Víctor Obach
                Volker Puetz
                Andrea Zini
                Jaap L Kappelle
                Journal
                Journal ID (nlm-ta): Trials
                Journal ID (iso-abbrev): Trials
                Title: Trials
                Publisher: BioMed Central
                ISSN (Electronic): 1745-6215
                Publication date Collection: 2013
                Publication date (Electronic): 8 July 2013
                Volume: 14
                Page: 200
                Affiliations
                [1 ]Department of Radiology, St. Antonius Hospital, PO Box 2500, Nieuwegein, EM, 3430, The Netherlands
                [2 ]Department of Neurology, St. Antonius Hospital, PO Box 2500, Nieuwegein, EM, 3430, The Netherlands
                [3 ]Department of Neurology and Neurosurgery, Rudolf Magnus Institute for Neuroscience, University Medical Center Utrecht, HP G 03.228, PO Box 85500, Utrecht, GA, 3508, The Netherlands
                [4 ]Julius Center for health Sciences and Patient Care, University Medical Center Utrecht, HP STR 6.131, PO Box 85500, Utrecht, GA, 3508, The Netherlands
                [5 ]Center for Stroke Research Berlin and Department of Neurology, Charité Universitätsmedizin Berlin, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12200, Germany
                [6 ]Department of Internal Medicine, Oslo University Hospital Ullevål, Oslo, NO-0407, Norway
                [7 ]Department of Neurology and Stroke Unit, Carlo Poma Hospital, Strada Lago Paiolo 10, Mantua, 46100, Italy
                [8 ]Department of Neurology and Stroke Centre, Bichat University Hospital, 46 rue henri Huchard, Paris, 75018, France
                [9 ]Department of Clinical Neurosciences CHUV, BH/13/204 Rue du Bugnon 46, Lausanne, CH-1011, Switzerland
                [10 ]Institute of Neurosciences & Psychology, Southern General Hospital, University of Glasgow, Glasgow, G51 4TF, UK
                [11 ]Comprehensive Stroke Center, Hospital Clinic de Barcelona, Villarroel 170, Barcelona, 08036, Spain
                [12 ]Department of Neurology, Dresden University Stroke Centre, Technical University Dresden, Fetscherstraße 74, Dresden, 01307, Germany
                [13 ]Stanford University Medical Center, Stanford Stroke Center, 780 Welch Road, Suite 205, Palo Alto, CA, 94304, USA
                [14 ]Stroke Unit, Department of Neuroscience, University of Modena and Reggio Emilia, St. Agostino-Estense Hospital, Modena, AUSL, Italy
                Author notes
                On behalf of the BASICS study group.
                Article
                Publisher ID: 1745-6215-14-200
                DOI: 10.1186/1745-6215-14-200
                PMC ID: 3728222
                PubMed ID: 23835026
                SO-VID: 0e6f4221-b893-4dd3-8b91-427f3834407d
                Copyright © Copyright © 2013 van der Hoeven et al.; licensee BioMed Central Ltd.
                License:

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                Date received : 6 March 2013
                Date accepted : 2 July 2013
                Categories
                Subject: Study Protocol

                ScienceOpen disciplines: Medicine
                Keywords: basilar artery occlusion,basilar artery thrombosis,intra-arterial treatment,intravenous thrombolysis,stroke
                Data availability:
                ScienceOpen disciplines: Medicine
                Keywords: basilar artery occlusion, basilar artery thrombosis, intra-arterial treatment, intravenous thrombolysis, stroke

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