XVII. European Stroke Conference
Nice, France

Oral Session:

Acute stroke: complications and early outcome
Date: Thursday 15 May 2008  
Time: 10:30 - 10:40 -  Room: Rhodes
Chair: G. Özdemir, Turkey and J. Norris, United Kingdom

01
An operational definition of post-thrombolysis symptomatic hemorrhagic transformation
P. RENOU    C. ROSSO    S. DELTOUR    S. CROZIER    Y. SAMSON                                   
 

Urgences Cérébrovasculaires, Groupe Hospitalier Pitié-Salpêtrière. Paris

FRANCE

BACKGROUND Post-thrombolysis hemorrhagic transformations (HT) are classified with various clinical and/or radiological criteria resulting in different rates of severe hemorrhages. Here, we assessed three methods of HT classification by testing their independent association with poor outcome after adjusting for other potential clinical and radiological prognosis variables. METHODS We compared 124 consecutive stroke patients with any type of HT after MRI-based intravenous rt-PA treatment and 80 control patients without HT treated with the same procedure. All patients had a control MRI after 24 to 48 hours and additional MRI and/or CT in case of clinical deterioration. HT within the first week were classified with three different methods: (a) the largest volume measured on any imaging modality, (b) the ECASS classification on the same imaging examination, and (c) a clinical classification as symptomatic hemorrhage, defined as NIHSS increase>/=4 points attributed to hemorrhage by the clinicians. Multivariate statistics were used to determine the level of association with poor prognosis (three months mRs >/= 4) after adjustment for age, gender, initial NIHSS, glucose level, time to treatment, DWI infarct volume, ADC value and arterial recanalisation. RESULTS Three types of HAT were independently associated with poor outcome: hemorrhage volume greater than 15 ml (adjusted OR: 22, CI: 3-144, p=0,002), parenchymal hematoma (PH1 and PH2) (adjusted OR: 8, CI: 2-34, p=0,004) and symptomatic hemorrhages (adjusted OR: 32, CI 4-280, p=0,002). DISCUSSION The three definitions of severe HAT are independently associated with poor outcome. Hemorrhage volume greater than 15 ml or clinical definition of symptomatic hemorrhage may be better predictors than the ECASS classification

Acute stroke: complications and early outcome
Date: Thursday 15 May 2008  
Time: 10:40 - 10:50 -  Room: Rhodes
Chair: G. Özdemir, Turkey and J. Norris, United Kingdom

02
MMP-9-related Mechanisms of t-PA-induced Hemorrhagic Transformation: A Genomic, Proteomic and Histological Analysis in Human Stroke.
J. Montaner    A. Rosell    E. Cuadrado    I. Fernández-Cadenas    A. del Rio    O. Maisterra     M. Ribó     M. Rubiera     C.A. Molina    J. Álvarez-Sabín
 

Neurovascular Research Lab, Stroke Unit, Vall d’Hebron Hospital, Barcelona. www.lin-bcn.com

SPAIN

Introduction: Precise mechanism of t-PA-induced-metalloproteinase-9 (MMP-9) dysregulation causing hemorrhagic transformation (HT) remains to be elucidated before attempting to block it. Methods: Polymorphisms (16 SNPs) covering whole MMP-9 gene and promoter regions were analyzed by SNPlex in 540 t-PA-treated patients. MMP-9 mRNA extracted from white blood cell fraction (RiboPureTM-Blood kit) before t-PA administration and 1h post-t-PA was measured by TaqMan rt-PCR protocol (n=54). MMP-9 was serially measured in plasma samples by ELISA. MMP-9 was analyzed by zymography and immunohistochemistry performed to localize MMP-9 and to assess collagen IV integrity in basal lamina (C-IV) in 5 cases of fatal ischemic strokes with hemorrhagic complications. Laser Capture Microdissection was performed to isolate HT vessels. Results: One SNP in the MMP-9 gene was associated with HT appearance following t-PA treatment (p=0.034), after a logistic regression adjusted by risk factors. MMP-9 mRNA after t-PA was higher among those with HT (p=0.034) and MMP-9 plasma levels peaked 2-3h after t-PA administration (p<0.001) and were higher in cases with HT (p<0.05). Brain level of the cleaved MMP-9 85kDa-form was elevated in hemorrhagic compared to non-hemorrhagic and contralateral areas (p=0.033 and p<0.0001). Strong MMP-9-positive neutrophil infiltration surrounding brain microvessels was associated with severe C-IV degradation and blood extravasation. Microdissection confirmed neutrophils as the main source of MMP-9. Ex-vivo treatment of neutrophils with t-PA showed MMP-9 granules release. Conclusion: Brain bleedings following thrombolysis are at least in part mediated by t-PA-induced-MMP-9 effects at multiple biological levels converting this pathway in a potentially useful therapeutic target.

Acute stroke: complications and early outcome
Date: Thursday 15 May 2008  
Time: 10:50 - 11:00 -  Room: Rhodes
Chair: G. Özdemir, Turkey and J. Norris, United Kingdom

03
Leukoaraiosis is associated with risk of haemorrhagic transformation and poor outcome in ischaemic stroke: data from the ‘Tinzaparin in Acute Ischaemic Stroke Trial’ (TAIST)
G.M.Sare    P.M.Bath    L.J.Gray    T. Moulin    F. Woimant                                   
For the TAIST Investigators

Institute of Neuroscience, University of Nottingham

UNITED KINGDOM

Introduction: Leukoaraiosis is a chronic condition affecting the deep white matter of the brain. Leukoaraiosis is associated with microbleeds on MRI and bleeding following thrombolysis. However, the risk of haemorrhagic transformation and functional outcome in patients with leukoaraiosis and acute ischaemic stroke is not clear, particularly in the presence of anticoagulation. Methods: TAIST was a randomised controlled trial assessing the safety and efficacy of tinzaparin versus aspirin in 1,484 patients with acute ischaemic stroke. Patients had a CT brain scan at baseline and after 10 days. Scans were adjudicated for the presence of leukoaraiosis at baseline, and haemorrhagic transformation at day 10. Functional outcome measures (modified Rankin scale) was measured at 180 days. Relationships were adjusted for age, sex, baseline severity, history of hypertension, baseline systolic blood pressure, smoking, time to enrolment and treatment group. Outcome was additionally adjusted for causal stroke subtype. Results: Patients with leukoaraiosis treated with heparin were not more likely to bleed than those treated with aspirin (odds ratio, OR, 1.11, 95% confidence interval, CI, 0.75-1.66). Patients with leukoaraiosis were significantly more likely to have had a lacunar stroke (OR 1.46, 95% CI 1.10-1.93) and were less likely to have haemorrhagic transformation on day 10 CT (OR 0.65, 95% CI 0.46-0.93) the latter when controlling for lacunar subtype. Despite this, patients with leukoaraiosis had a worse functional outcome measured by the modified Rankin scale (OR 0.47, 95% CI 0.29-0.80). Discussion: Leukoaraiosis is not associated with increased haemorrhagic transformation after ischaemic stroke even in the presence of heparin, but is associated with poor functional outcome.

Acute stroke: complications and early outcome
Date: Thursday 15 May 2008  
Time: 11:00 - 11:10 -  Room: Rhodes
Chair: G. Özdemir, Turkey and J. Norris, United Kingdom

04
ANGIOEDEMA ASSOCIATED WITH rtPA TREATMENT FOR ACUTE ISCHEMIC STROKE
A. Valadas    F. Falcão    T. Melo                                                 
 

Santa Maria Hospital, Lisbon

PORTUGAL

Background: The most feared complication of recombinant tissue plasminogen activator (rtPA) treatment for acute ischemic stroke is haemorrhagic transformation. However, other less frequent complications can be life threatening. Methods: Patients with acute ischemic stroke admitted at Stroke Unit and treated with rtPA are prospectively registered in a database. All cases with angioedema occurring during or after rtPA treatment were selected and reported in this study. Results: Between June 2003 and December 2007, 170 patients with acute ischemic stroke and treated with rtPA were included in the database and angioedema was found in 6 (3,5%). Five patients had middle cerebral artery stroke, four of which with insular compromise, and 1 had brainstem stroke. Five patients, previously or early during the acute stroke, received angiotensin-converting enzyme inhibitor (ACEi). In 4 cases the swelling began in the tongue (in 2 patients contralateral to the ischemic cerebral hemisphere), 1 case presented with oedema of the face and generalized urticaria and 1 case with cough and dysphonia. In 5 cases angioedema appeared soon after the end of rtPA perfusion and in 1 case during the perfusion. The six patients were treated with histamine antagonists and corticosteroids and in 2 epinephrine was administered. Two patients had severe lingual and oropharyngeal oedema and needed mechanic ventilation. In all cases there was a good response to treatment with total regression of the angioedema. Discussion: Angioedema is associated with rtPA treatment for acute ischemic stroke in about 4% of the cases, usually in patients treated previously with ACEi. In the current protocols there is no restriction to the use of ACEi and no orolingual vigilance is required during and after rtPA administration. More studies will be needed to evaluate the risk of ACEi use during rtPA treatment and to include safety measures to detect and control angioedema.

Acute stroke: complications and early outcome
Date: Thursday 15 May 2008  
Time: 11:10 - 11:20 -  Room: Rhodes
Chair: G. Özdemir, Turkey and J. Norris, United Kingdom

05
CT angiography rapidly identifies an ischemic stroke population with poor prognosis despite thrombolysis within 3 hours from onset
V. Puetz    I. Dzialowski    N. Steffenhagen    S. Subramaniam    M.D. Hill    S.B.Coutts    A. Krol    C. O'Reilly    A.M.Demchuk      Calgary CTA Study Group
 

University of Calgary, Calgary Stroke Program

GERMANY

Objective: Thrombus burden and extent of ischemic core impact prognosis in acute stroke. A malignant profile of early brain ischemia has been demonstrated in the DEFUSE trial. We sought to determine if such a malignant profile could be predicted in the first 3 hours from onset in thrombolyzed patients using CT-angiography (CTA). Methods: We studied consecutive patients (04/02-09/07) with acute anterior circulation ischemic stroke who received CTA before thrombolysis within 3 hours from onset. We assessed the Alberta Stroke Program Early CT Score (ASPECTS) on CTA source images (CTASI) with 3-readers-consensus. For clot burden score (CBS), intracranial anterior circulation arteries were allotted 10 points for contrast opacification on CTA. 2 points each were subtracted for absent contrast opacification in the proximal M1, distal M1 or supraclinoid ICA and 1 point each for M2 branches, A1 or infraclinoid ICA. We analyzed parenchymal hematoma (PH) rates, independent outcome (mRS<=2) and fatal outcome at 3 months for categorized combined CTASI-ASPECTS score and CBS score groups where 0 is worst and 20 is best. Results: We identified 114 patients (46% women, mean age 70+/-14 years) who underwent CTA before treatment with tPA within 3 hours from onset. Mean onset-to-tPA time was 125+/-34 minutes. 22 patients received additional intraarterial thrombolysis. Patients with extensive early hypocontrastion on CTASI and/or extensive clot burden (combined CTASI-ASPECTS and CBS score <=10) had 50% (12/24) mortality and only 4% (1/24) were functionally independent at 3 months. Of patients with less affected scores (combined CTASI ASPECTS and CBS score 11-20), 57% (51/90) were functionally independent and 10% (9/90) were deceased. PH rates were 30% vs. 8% (combined score <=10 vs. 11-20), respectively. Conclusion: Rapidly obtainable CTA information combining infarct core extent (CTASI ASPECTS) and thrombus burden (CBS) identifies a large hyperacute stroke population (21%) who have a very high mortality and very low likelihood of good outcome if thrombolyzed within 3 hours.

Acute stroke: complications and early outcome
Date: Thursday 15 May 2008  
Time: 11:20 - 11:30 -  Room: Rhodes
Chair: G. Özdemir, Turkey and J. Norris, United Kingdom

06
Recurrent events in TIA and minor stroke: What events are happening and to which patients?
S.B.Coutts    M.D.Hill    C.R.Campos    Y.B.Choi    S. Subramaniam    J.C.Kosior    A.M.Demchuk                     
for the VISION study group

University of Calgary

CANADA

Background: The risk of a recurrent stroke following TIA or minor stroke is high. Clinical trials are needed to assess acute treatment options in these patients. We sought to evaluate the type of recurrent events and to identify which subsets of patients are at risk for recurrent events. Methods: 180 patients with TIA or minor stroke were examined within 12 hours and underwent brain MRI within 24 hours. 162 patients had a follow up MRI at 30 days. Any neurological deterioration was recorded and a combination of clinical and MRI factors were used to create a combined event classification. Subgroups of patients analyzed included classical TIA, patients with NIHSS=0, and patients with NIHSS>0 in Emergency Department (ED). Results: Overall there were 38 events in 36 patients (20% event rate); 20 were symptomatic and 18 were silent (only evident because of the follow up MRI). 18/20 (90%) symptomatic events were associated with progression of presenting symptoms, compared to 2/20 (10%) with a clear recurrent stroke distinct from the original event. We found a low risk of recurrent stroke among classical definition TIA patients (1.1%). Patients with an NIHSS=0 in the ED, had an intermediate event rate (6.6%) between TIA (classical – 1.1%) and NIHSS>0 (14.4%) (χ2 test for trend, p=0.02). All clinical categories of patient (TIA (7.4%), stroke (12.9%), NIHSS=0 (10.6%) and NIHSS>0 (9.2%)) accumulated silent lesions on MRI. Conclusions: The high proportion of TIA and minor stroke patients who progress from their initial symptoms has not been recognised previously. True recurrent events, in a new location in the brain, after TIA and minor stroke are actually uncommon. A low risk of recurrence was found in patients with classical TIA and those with no neurological deficits on initial assessment. However even patients, who had an extremely low rate of clinically overt events e.g. classical TIA patients, were at risk for accumulating silent events on MRI.

Acute stroke: complications and early outcome
Date: Thursday 15 May 2008  
Time: 11:30 - 11:40 -  Room: Rhodes
Chair: G. Özdemir, Turkey and J. Norris, United Kingdom

07
ADP-Induced Platelet Aggregation in Acute Ischemic Stroke Patients on Aspirin Therapy
J.K.Cha    S.-H.Choi    S.W.Kim    M.J.Kang    J.I.ung                                   
 

College of Medicine, Dong-A University

SOUTH KOREA

Background: Aspirin is an important tool to prevent the progression of acute ischemic stroke. In this study, we evaluated the relationship between the extent of ADP (adenosine diphosphate)-induced platelet aggregation and outcome in acute ischemic stroke patients on aspirin therapy. Methods: We selected 116 acute ischemic stroke patients who had been prescribed aspirin and evaluated the optically evaluated ADP-induced platelet aggregation test after 5 days of taking it and investigated prognosis of 90 days after ischemic events. For survival analysis, we used Kaplan-Myer curve. Results: After stratification of the subjected patients by tertiles of ADP induced platelet aggregation, the events rates were 7.1%, 12.1%, and 30% (p=0.023). In multiple logistic regression analysis, old age over 70 year (OR, 6.99; 95% CI, 1.45 to 33.71; p= 0.001), the history of myocardial infarction (OR, 12.33; 95% CI 1.42 to 100.72; p=0.019), and the highest tertile of ADP induced platelet aggregation had independent significance to the risk of primary end points after acute ischemic stroke (OR, 6.67; 95% CI 1.57 to 28.37; p=0.010). Conclusions: This study showed that the increased ADP induced platelet aggregation under using aspirin is associated with poor outcome after acute ischemic stroke. Further studies will be needed to confirm the effect of ADP induced platelet aggregation on the prognosis in acute ischemic stroke patients on aspirin therapy.

Acute stroke: complications and early outcome
Date: Thursday 15 May 2008  
Time: 11:40 - 11:50 -  Room: Rhodes
Chair: G. Özdemir, Turkey and J. Norris, United Kingdom

08
Fatigue is associated with measures of low daytime blood pressure in Stroke and TIA.
J.A.Harbison    S.M.Walsh    R.A.Kenny                                                 
 

Trinity College Dublin

IRELAND

Fatigue affects up to 72% of patients following stroke. There is a reported association between idiopathic forms of chronic fatigue and hypotension. We hypothesised that, in patients with stroke or TIA, an association may exist between fatigue and measures of hypotension detected on ambulatory blood pressure (BP) monitoring. Methods: Subjects recruited from a secondary prevention clinic underwent 24 hour ambulatory blood pressure monitoring and completed a Fatigue Severity Scale (FSS). Results Fifty-four subjects were included (59% female, mean age 69 years). Mean FSS was 3.9 and 26 (48%) has a FSS>4.0 indicative of significant fatigue. Mean 24-hour BP for all subjects was 137/73 (SD 34/22). There was no significant difference in mean systolic (SBP), diastolic (DBP) or 24-hour mean arterial pressure (MAP) between patients with and those without significant fatigue. Patients with stroke suffered worse fatigue than those with TIA (mean FSS 4.3 vs 3.2 p=0.014). Subjects with FSS>4.0 suffered episodes of more profound daytime hypotension (Mean daytime minimum SBP 103.7 vs 119.5mmHg p=0.007 daytime minimum MAP 71.1 vs 82.7mmHg, p=0.003). FSS correlated with minimum daytime SBP (r= -0.337, p=0.013), daytime minimum MAP (r=-0.431, p<0.001) and with the pressure difference between 24-hour mean and daytime minimum SBP (r=-0.408, p=0.002). On regression analysis presence of stroke (p=0.002) and MAP pressure difference (p<0.001) were independently associated with fatigue severity (R2 =0.345). Conclusion: In subjects who have suffered a Stroke or TIA, fatigue is associated with measures of hypotension on ambulatory monitoring. Patients with stroke suffered more fatigue than those with TIA.

Acute stroke: complications and early outcome
Date: Thursday 15 May 2008  
Time: 11:50 - 12:00 -  Room: Rhodes
Chair: G. Özdemir, Turkey and J. Norris, United Kingdom

09
STROKE PATIENTS WITH AND WITHOUT EARLY POSTSTROKE SEIZURES (EPS): DIFFERENCES IN NITRERGIC AND PROTEOLYTIC INDICES IN CEREBROSPINAL FLUID (CSF)
A. Guekht    N. Gulyaeva    I. Khaimovsky    A. Lebedeva    M. Onufriev    L. Brylev    E. Gusev                     
 

Russian State Medical University, Inst. of Higher Nervous Activity&Neurophysiol., RAS, Moscow

RUSSIAN FEDERATION

Background and purpose: EPS occur in 5-10% of all stroke patients and have deleterious impact on stroke outcome. EPS are associated with excessive neuronal excitability. The objective of the study was to compare neurochemical indices related to nitrergic system and major proteases executing neuronal cell death in CSF of patients with and without EPS. Methods: Twenty six patients with first-ever acute ischemic stroke were investigated: 14 - with and 12- without EPS. Groups were similar in age, gender, NIHSS values. NOx levels were measured using a fluorescent probe diaminonaphtalene. Proteolytic activities were assayed fluorometrically using specific substrates for caspase-3, calpain, and cathepsin B. Results: No increase in NO metabolites (NOx) level in CSF characteristic for acute stroke (5.5+/- 0.64 vs. 2.2+/- 0.43 µmol/l in controls, P=0.01) could be detected in EPS patients (2.6+/- 0,40 µmol/l). While no difference in cathepsin B-inhibiting CSF activity could be revealed between two stroke groups, the calpain-inhibiting activity was more expressed in EPS patients (45.6+/- 1.9% of residual activity vs. 56.4+/- 2.9%, P<0.05 ), while caspase-3-activating activity was more significant in CSF of patients without EPS (132.5+/- 4.7% vs. 115.5+/- 3.3, P<0.03) Discussion: The excessive generation of NO characteristic for ischemic brain is regarded as one of significant neuroprotective factors. We assume that EPS are related to the impaired ability of the brain to urgently increase NOS activity in response to an ischemic situation. The CSF of patients with EPS demonstrates higher ability to inhibit major cell death-related proteases (calpain and caspase-3) suggesting a higher risk for ischemia-induced neurodegeneration in these patients. Supported by RHSF grants

Acute stroke: complications and early outcome
Date: Thursday 15 May 2008  
Time: 12:00 - 12:10 -  Room: Rhodes
Chair: G. Özdemir, Turkey and J. Norris, United Kingdom

10
Hyperosmolar Hypothermic Normoglycemia (H2N) for Preventing Cerebral Edema after Large Hemispheric Infarction –an Ongoing Feasibility Study
K.E.Wartenberg    C. Reichelt    G. Gahn    S.A.Mayer                                          
 

Carl Gustav Carus University Hospital Dresden Columbia University, New York,

GERMANY

Introduction: Large hemispheric infarction carries a mortality rate of 40–80%. Despite the introduction of decompressive hemicraniectomy, the medical management of brain edema after large hemispheric infarction is still not satisfactory. Methods: We treated 34 patients with large hemispheric infarctions between August 2006 and December 2007 with the combination of insulin infusion (target glucose 4.6-6.1 mmol/L), mild hypothermia (33-35˚C) using a surface cooling or intravascular heat exchange device, and hypertonic saline (3% sodium chloride acetate) at a rate 1ml/kg (goal sodium 150-155 mmol/L) within 72 hours of symptom onset. Primary outcome was progression or evolution of the midline shift on computed tomography (CT). Secondary outcome measures were modified Rankin Scale (mRS) at 3 months and complications. Results: Of the 34 patients 15 had right-sided infarctions and median age was 65.5 (range 38-83) years. Baseline NIHSS was 18.6±5.3. H2N was started on average on the day 1 of symptom onset (range 0-4 days); median duration of treatment was 10 (range 3-20) days. Mean septal midline shift was 1.3±2.9 mm on admission, peaked at 8.3±5.8 mm, and was 1.9±1.7 mm on discontinuation of the protocol. At 3 months, 17 patients had died; support had been actively withdrawn in 13 cases. The mRS was 1 in 1 patient, 3 in 3 patients, 4 in 2 patients and 5 in 11 patients. Complications included pulmonary edema (n=25), aspiration and ventilator-acquired pneumonia (n=8), tracheobronchitis (n=17), sepsis and septic shock (n=9), urinary tract infection (n=6), atrial fibrillation with rapid ventricular response (n=11), acute renal failure (n=9), coagulopathy (n=6), thrombocytopenia (n=16), leucopenia (n=4), anemia (n=9), and paralytic ileus (n=2). Conclusions: The combination of mild hypothermia (33-35°C), infusion of hypertonic saline, and insulin infusion offers a feasible alternative strategy to minimize massive cerebral edema after large hemispheric infarction and needs to be studied in a standardized trial.

Acute stroke: complications and early outcome
Date: Thursday 15 May 2008  
Time: 12:10 - 12:20 -  Room: Rhodes
Chair: G. Özdemir, Turkey and J. Norris, United Kingdom

11
Management and outcome of acute stroke, a study of 105 043 patients reported to the Swedish National Quality Register for Stroke Care (Riks-Stroke)
A. Terent    S. Åsberg    K. Henriksson    B. Farahmand    K. Asplund    B. Norrving    B. Stegmayr    P.O.Wester    K. Hulter Åsberg       
 

The Stroke Unit at Uppsala University Hospital

SWEDEN

Background: Stroke unit care has proven superior to care at general wards in randomised controlled trials (RCTs). The number of hospital beds has been reduced, and today stroke patients are admitted to stroke units (SU), general wards (GW), observational units (OU), intensive care units (ICU) and other type of wards (OW). We have compared the long-term survival of stroke patients treated at different ward types in Sweden. Methods: Stroke patients who were registered in the Swedish National Quality Register for Stroke Care (Riks-Stroke), from January 1st 2001 through December 31st 2005 were followed until January 31st 2007 by linking Riks-Stroke with the Causes of Death Register. Kaplan–Meier analyses were used to estimate survival times and Cox regression to adjust for different case mix. Results: Sixty per cent of the patients were admitted to SUs, 22.7% to GWs, 11.2% to OUs, 3.7% to ICUs and 2.4% to OWs. The mean survival time in days (95% CI) was 1432 (1425–1441) in SUs, 1252 (1239–1264) in GWs, 1349 (1331–1367) in OUs, 1222 (1188–1256) in ICUs and 1435 (1396–1473) in OWs. These relationships persisted after adjustment for age, sex, type of stroke (intracerebral haemorrhage, cerebral infarction) and living conditions. The inclusion of other variables, i.e. level of consciousness, vascular risk factors and medication, does not change outcome data. Discussion: Stroke unit care appears to be associated with better long-term survival than care at other types of wards. The greatest difference was found between Sus and GWs; this is in line with RCTs and previous observations in Riks-Stroke. The difference between Sus and ICUs is not conclusive in the present study and needs to be further explored.

Acute stroke: complications and early outcome
Date: Thursday 15 May 2008  
Time: 12:20 - 12:30 -  Room: Rhodes
Chair: G. Özdemir, Turkey and J. Norris, United Kingdom

12
Effect of intravenous thrombolysis in acute ischaemic stroke on outcome in daily practice; data from the PRACTISE study.
M.-Dirks    L.W.Niessen     P.J.Koudstaal     J.D.van Wijngaarden     R.J.van Oostenbrugge    C.L.Franke     D.W.J.Dippel                     
on behalf of the practise investigators

ErasmusMC

THE NETHERLANDS

Background: Thrombolysis with intravenous thrombolysis has been proven effective for treatment of patients with acute ischaemic stroke randomised clinical trials. In daily practice, the effect of thrombolysis may be less because of co-morbidity, less strict contra-indications and treatment by less experienced doctors. The aim of the current study was to assess the effectiveness of thrombolysis in an unselected observational cohort of patients within the setting of the PRACTISE trial, a multi-centre cluster-randomised trial of high intensity versus regular intensity implementation of thrombolysis for acute ischaemic stroke. Methods: Data were collected of all consecutive patients admitted within 24 hours from onset of symptoms with acute stroke for 2 years in 12 representative hospitals in the Netherlands. Contra-indications for thrombolysis and protocol violations were assessed. Within the cohort of patients with an ischaemic stroke admitted within 4 hours outcomes were measured using the modified Rankin scale. Data were analysed with a logistic regression model, using the sliding dichotomy approach. Results: Of the 5517 stroke patients included in the study, 1658 were admitted with an ischaemic stroke within 4 hours from onset, of whom 698 (42%) were treated with thrombolysis; 10 patients were treated with thrombolysis in the presence of contra-indications (1.4%.) The odds-ratio for improved outcome after thrombolysis was 1.6 (95% CI 1.3 – 2.1) after adjustment for age, sex, stroke severity, co-morbidity, and solid contra-indications for thrombolysis. Discussion: This study confirms that intravenous thrombolysis for acute ischaemic stroke improves outcome also in standard practice, outside the setting of a randomised clinical trial.