Das virtuelle internationale Schlaganfallstudien-Archiv (VISTA) – Bedeutung für die Schlaganfallforschung

Zusammenfassung

In den letzten 15 Jahren wurden viele kontrollierte Studien zur Behandlung des akuten Schlaganfalls durchgeführt. Das virtuelle internationale Schlaganfallstudienarchiv (VISTA) ist eine von der Industrie unabhängige Datenbank die prospektiv erhobene Daten aus vielen Therapiestudien für wissenschaftliche Analysen vorhält. Analysen der Datenbank zeigen eine schlechtere Prognose für Schlaganfallpatienten mit sehr hohen Blutdruckwerten bei der Aufnahme auf die Stroke Unit. Eine hämorrhagische Transformation eines ischämischen Insultes wird häufig bei kardioembolischen Insulten beobachtet und hat eine bimodale Verteilung. Bei Patienten mit später Transformation ist auch die Prognose schlechter. Bei bis zu 7 % aller Patienten mit frischer zerebraler Ischämie wird erstmals eine absolute Arrhythmie diagnostiziert. Es gibt in der Zwischenzeit gute Prognosemodelle, mit deren Hilfe sich die Langzeitprognose von zerebralen Ischämien und Blutungen vorhersagen lässt. Bei Blutungen hängt die Prognose vom initialen Wachstum der Blutung ab. Leider zeigt sich, dass die Prognose von Patienten die in Deutschland einen Schlaganfall erleiden, nicht besonders gut ist.

Abstract

In the last 15 years many studies have been performed on the treatment of acute stroke. The Virtual International Stroke Trials Archive (VISTA) is an investigator-initiated data base that contains prospectively collected data from patients with acute stroke recruited from controlled trials and is used to answer scientific questions. Analyses have shown that patients with very high blood pressure at the time of admission to a stroke unit have a poor prognosis. Haemorrhagic transformation of an ischaemic infarct is seen frequently in patients with cardio-embolic strokes. Haemorrhagic transformation follows a bimodal distribution with a poor prognosis when occurring late after stroke. In up to 7 % of patients with acute stroke, new onset atrial fibrillation is detected in the stroke unit. VISTA has enabled the establishment and validation of prognostic models for patients with ischaemic or haemorrhagic stroke. The most important risk factor for a poor prognosis in patients with cerebral bleeding is the growth of the initial haemorrhage. On a world-wide comparison, the prognosis of stroke patients in Germany is poorer than in many other countries.

Schlüsselwörter

klinische Studien - Schlaganfall - Datenbank - klinische Endpunkte - Prädiktoren

Keywords

clinical trials - stroke - database - outcome - predictors of outcome

Literatur

• 1 Diener H. Current status of neuroprotective drugs in stroke.  Europ J Anaesthesiol. 2000;  17 55-58
• 2 Lees K, Diener H C. Neuroprotection in stroke therapy.  Cerebr Blood Flow Metabol. 2002;  22 452-456
• 3 Savitz S I, Fisher M. Future of neuroprotection for acute stroke: In the aftermath of the SAINT trials.  Ann Neurol. 2007;  61 396-402
• 4 Schabitz W R, Fisher M. Perspectives on neuroprotective stroke therapy.  Biochem Soc Trans. 2006;  34 1271-1276
• 5 Ali M, Bath P M, Curram J. et al . The Virtual International Stroke Trials Archive.  Stroke. 2007;  38 1905-1910
• 6 Diener H C. for the European and Australian Lubeluzole Ischaemic Stroke Study Group . Multinational randomised controlled trial of lubeluzole in acute ischaemic stroke.  Cerebrovasc Dis. 1998;  8 172-181
• 7 Wahlgren N G, Mac Mahon D G, DeKeyser J. et al . Intravenous Nimodipine West European Stroke Trial (INWEST) of nimodipine in the treatment of acute ischaemic stroke.  Cerebrovasc Dis. 1994;  4 204-210
• 8 Hennerici M G, Kay R, Bogousslavsky J. et al . Intravenous ancrod for acute ischaemic stroke in the European Stroke Treatment with Ancrod Trial: a randomised controlled trial.  Lancet. 2006;  368 1871-1878
• 9 Davis S, Albers G W, Diener H C. et al . Termination of acute stroke studies involving selfotel treatment.  Lancet. 1997;  349 325-362
• 10 Lyden P, Shuaib A, Ng K. et al . Clomethiazole Acute Stroke Study in ischemic stroke (CLASS-I): final results.  Stroke. 2001;  33 122-129
• 11 Hacke W, Kaste M, Fieschi C. et al . Intravenous thrombolysis with recombinant tissue plasminogen activator for acute hemispheric stroke.  JAMA. 1995;  274 1017-1025
• 12 Donnan G, Hommel M, Davis S. et al . Streptokinase in acute ischemic stroke.  Lancet. 1994;  346 56
• 13 Hacke W K, Fieschi M, von Kummer C. for the Second European-Australasian Acute Stroke Study Investigators . Randomised double-blind placebo-controlled trial of thrombolytic therapy with intravenous alteplase in acute ischaemic stroke (ECASS II).  Lancet. 1998;  352 1245-1251
• 14 Bath P M, Lindenstrom E, Boysen G. et al . Tinzaparin in acute ischaemic stroke (TAIST): a randomised aspirin-controlled trial.  Lancet. 2001;  358 702-710
• 15 Sacco R L, DeRosa J T, Haley E C. et al . Glycine antagonist in neuroprotection for patients with acute stroke: GAIN Americas: a randomized controlled trial.  JAMA. 2001;  285 1719-1728
• 16 Lyden P D. Systemic review of nimodipine.  Stroke. 2001;  32 2433-2438
• 17 Lees K R, Asplund K, Carolei A. et al . Glycine antagonist (gavestinel) in neuroprotection (GAIN international) in patients with acute stroke: a randomised controlled trial.  Lancet. 2000;  355 1949-1954
• 18 Mendelow A D, Gregson B A, Fernandes H M. et al . Early surgery versus initial conservative treatment in patients with spontaneous supratentorial intracerebral haematomas in the International Surgical Trial in Intracerebral Haemorrhage (STICH): a randomised trial.  Lancet. 2005;  365 387-397
• 19 Diener H C, Cortens M, Ford G. et al . Lubeluzole in acute ischemic stroke treatment: a double-blind study with an 8-hour inclusion window comparing a 10 mg daily dose of lubeluzole with placebo.  Stroke. 2000;  31 2543-2551
• 20 Diener H C, Kaste M, Hacke W. for the LUB- INT-5 Lubeluzole Study Group . Lubeluzole in acute ischemic stroke: International trial.  J Neurol Sci. 1997;  150 (Suppl.) S273-S282
• 21 Marler J R. for the National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group . Tissue plasminogen activator for acute ischemic stroke.  N Engl J Med. 1995;  333 1581-1587
• 22 Sare G M, Ali M, Shuaib A. et al . Relationship between hyperacute blood pressure and outcome after ischemic stroke. Data from the VISTA collaboration.  Stroke. 2009 Apr 9 [Epub]; 
• 23 Leonardi-Bee J, Bath P, Phillips S. IST Collaborative Group . Blood pressure and clinical outcomes in the International Stroke Trial.  Stroke. 2002;  33 1315-1320
• 24 Yong M, Diener H C, Kaste M. et al . Characteristics of blood pressure profiles as predictors of long-term outcome after acute ischemic stroke.  Stroke. 2005;  36 2619-2625
• 25 Mahoney F I, Barthel D W. Functional evaluation: The Barthel Index.  Md State Med J. 1965;  14 61-65
• 26 Rankin J. Cerebral vascular accidents in patients over the age of 60, II: prognosis.  Scot Med J. 1957;  2 200-215
• 27 Whitehead J, Bolland K, Valdes-Marquez E. et al . Using historical lesion volume data in the design of a new phase II clinical trial in acute stroke.  Stroke. 2009;  40 1347-1352
• 28 Weimar C, Ziegler A, Koenig I. et al . Predicting functional outcome and survival after acute ischemic stroke.  J Neurol. 2002;  249 888-895
• 29 Hallevi H, Albright K C, Martin-Schild S. et al . Anticoagulation after cardioembolic stroke.  Cerebrovasc Dis. 2008;  26 38-40
• 30 Doufekias E, Segal A Z, Kizer J R. Cardiogenic and aortogenic brain embolism.  J Am Coll Cardiol. 2008;  51 1049-1059
• 31 EAFT Group . Secondary prevention in non-rheumatic atrial fibrillation after transient ischaemic attack or minor stroke.  Lancet. 1993;  342 1255-1262
• 32 Diener H, Aichner F, Bode C. et al .Primär- und Sekundärprävention der zerebralen Ischämie. In: Diener H, Putzki N, Berlit P, Deuschl G, Elger C, Gold R et al., eds Leitlinien für Diagnostik und Therapie in der Neurologie. 4. Auflage ed. Stuttgart; Thieme 2008: 261-287
• 33 Kamel H, Lees K R, Lyden P. et al . Delayed detection of atrial fibrillation after ischemic stroke.  Stroke. 2009, in print; 
• 34 Grau A J, Weimar C, Buggle F. et al . Risk factors, outcome, and treatment in subtypes of ischemic stroke: the German stroke data bank.  Stroke. 2001;  32 2559-2566
• 35 Prosser J, MacGregor L, Lees K R. et al . Predictors of early cardiac morbidity and mortality after ischemic stroke.  Stroke. 2007;  38 2295-2302
• 36 Di Legge S, Fang J, Saposnik G. et al . The impact of lesion side on acute stroke treatment.  Neurology. 2005;  65 81-86
• 37 Fink J N. Underdiagnosis of right-brain stroke.  Lancet. 2005;  366 349-351
• 38 Fink J N, Frampton C M, Leyden P. on behalf of the VISTA Investigators . Does hemispheric lateralization influence functional and cardiovascular outcomes after stroke?.  Stroke. 2008;  39 3335-3340
• 39 Weimar C, Konig I R, Kraywinkel K. et al . Age and National Institutes of Health Stroke Scale Score within 6 hours after onset are accurate predictors of outcome after cerebral ischemia: development and external validation of prognostic models.  Stroke. 2004;  35 158-162
• 40 Weimar C, Ho T W, Katsarava Z. et al, German Stroke Study Collaboration . Improving patient selection for clinical acute stroke trial.  Cerebrovasc Dis. 2006;  21 386-389
• 41 König I, Ziegler A, Bluhmki E. et al . Predicting long-term outcome after acute ischemic stroke. A simple index works in patients from controlled clinical trials.  Stroke. 2008;  39 1821-1826
• 42 Saini M, Shuaib A. et al . on behalf of the VISTA Investigators. Is hyperthermia a poor prognostic factor in acute stroke patients?.  Stroke . 2009, submitted; 
• 43 Ali M, Atula S, Bath P M. et al . Stroke outcome in clinical trial patients deriving from different countries.  Stroke. 2009;  40 35-40
• 44 Luengo-Fernandez R, Gray A M, Rothwell P M. Effect of urgent treatment for transient ischaemic attack and minor stroke on disability and hospital costs (EXPRESS study): a prospective population-based sequential comparison.  Lancet Neurol. 2009;  8 235-243
• 45 Rothwell P M, Giles M F, Chandratheva A. et al . Effect of urgent treatment of transient ischaemic attack and minor stroke on early recurrent stroke (EXPRESS study): a prospective population-based sequential comparison.  Lancet. 2007;  370 1432-1442
• 46 Ali M, Lyden P, Sacco R L. et al . Natural history of complications after intracerebral haemorrhage.  Eur J Neurol. 2009;  16 624-626
• 47 Mayer S A, Brun N C, Begtrup K. et al . Recombinant activated factor VII for acute intracerebral hemorrhage.  N Engl J Med. 2005;  352 777-785
• 48 Mayer S A, Brun N C, Broderick J. et al . Safety and feasibility of recombinant factor VIIa for acute intracerebral hemorrhage.  Stroke. 2005;  36 74-79
• 49 Mayer S A, Brun N C, Begtrup K. et al . Efficacy and safety of recombinant activated factor VII for acute intracerebral hemorrhage.  N Engl J Med. 2008;  358 2127-2137
• 50 Weimar C, Ziegler A, Sacco R L. et al . Predicting recovery after intracerebral hemorrhage – An external validation in patients from controlled clinical trials.  J Neurol. 2009;  256 464-469