XVII. European Stroke Conference
Nice, France
Poster Session: Large clinical trials (RCTs)
Session:
Poster Session II
Date:
Thursday 15 May 2008
Time:
12:30 - 14:00
Room:
Agora 3
Patients with successfully treated carotid stenosis have a higher than expected 5 year risk of stroke
R.L.Featherstone
J. Ederle
L.H.Bonati
J. Dobson
M.M.Brown
On behalf of the CAVATAS investigators
Stroke Research Group, UCL Institute of Neurology, Box 6 The National Hospital, London, WC1N 3BG
UNITED KINGDOM
BACKGROUND: Data from the Framingham study have been used to estimate long-term risk of heart disease and stroke. These models are used by trialists in power calculations and by patients and clinicians to assess personal risk. It is important to assess the accuracy of their predictions in different populations. METHODS: We used baseline characteristics of patients in a randomised controlled trial comparing carotid endarterectomy with endovascular interventions for mainly symptomatic carotid stenosis, the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS), to calculate the 5 year risk of coronary heart disease (CHD) and, for patients who survived 30 days after procedure without a stroke, the 5 year stroke risk. Calculations were made using models based on Framingham data (Wolf et al. Stroke. 1991; 22: 312. Anderson et al Circulation. 1991; 83:362). Analysis was on treatment received (265 surgery, 221 angioplasty/stenting). Calculated risks were compared to actual outcomes. RESULTS: The calculated 5 year stroke risk was 6.7% (95% Confidence Limit +/-0.75%) in endovascular patients and 6.6% (CL +/-0.66%) in surgery patients, compared with observed rates of 12.1 and 10.5% respectively. The calculated 5 year risk of CHD was 17.7% (CL +/-0.95%) in angioplasty patients and 17.5% (CL +/-0.82%) in the endarterectomy group compared with observed rates of 18.5% and 16.2% respectively. DISCUSSION: Endovascular and surgical patients had similar long term outcomes. Calculated risks for both groups were closer to observed event rates for CHD than for stroke, where the observed event rate was twice the predicted rate. The data demonstrate that patients with carotid stenosis have a higher than expected long-term risk of stroke even after successful carotid intervention.
Session:
Poster Session II
Date:
Thursday 15 May 2008
Time:
12:30 - 14:00
Room:
Agora 3
Long-term efficacy of carotid angioplasty versus endarterectomy: Results of the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS-CEA)
J. Ederle
L.H.Bonati
J. Dobson
R.L.Featherstone
M.M.Brown
CAVATAS Investigators
Stroke Research, Department of Brain Repair & Rehabilitation, UCL Institute of Neurology
UNITED KINGDOM
Introduction: A number of trials have published short-term results of endovascular treatment versus endarterectomy for symptomatic carotid stenosis, but the long-term efficacy remains largely unknown. We therefore report long-term data from the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS). Methods: 504 patients were randomly assigned to either endovascular treatment (angioplasty or stenting) versus surgery and followed for up to 11 years by an independent neurologist (median follow up 5 years). Major outcome events were recorded and analysed by intention to treat. A Cox regression model was used to calculate hazard ratios and a log rank test to compare treatments. Results: During long-term follow up, 20 patients in the endovascular group suffered a disabling stroke compared to 21 patients in the surgery group (hazard ratio (HR) 1.047, 95% confidence interval (CI) 0.567 – 1.931, p = 0.883). The outcome of disabling stroke or death occurred in 117 patients in the endovascular group and in 121 patients in the surgery group (HR 0.982, 95% CI 0.76 – 1.27, p = 0.891). The outcome of disabling stroke or death within 30 days of treatment plus ipsi-lateral stroke more than 30 days after treatment occurred in 37 patients in the endovascular group and 31 patients in the surgery group (HR 0.838, 95% CI 0.52 – 1.35, p = 0.468). Discussion: Endovascular treatment and endarterectomy were equally effective at preventing stroke up to 11 years after treatment. Other factors such as local expertise, cost-effectiveness or patient preference may be important considerations in the future when advising patients about the treatment of symptomatic carotid stenosis.
Session:
Poster Session II
Date:
Thursday 15 May 2008
Time:
12:30 - 14:00
Room:
Agora 3
Thrombolysis for stroke – what are the ‘grey areas’ of uncertainty and are they changing? Results from the Third International Stroke Trial (IST-3)
P.A.Sandercock
J Wardlaw
R Lindley
M Dennis
S Lewis
The IST-3 Collaborative Group
University of Edinburgh
UNITED KINGDOM
Introduction: Intravenous recombinant tissue plasminogen activator (rt-PA) is approved for use in selected patients with ischaemic stroke who can be treated within 3 hours of symptom onset. IST-3 seeks to determine whether a wider range of patients may benefit. Methods: IST-3 is an international, multi-centre, randomised controlled trial of intravenous rt-PA in acute ischaemic stroke within 6 hours of onset.. Patients are eligible if there is no clear indication for, or clear contraindication to, thrombolytic therapy and the clinician considers the treatment is, for that particular patient ‘promising but unproven’. For protocol details see www.ist3.com. We aimed to describe a) the baseline characteristics of the patients (and so identify participating clinicians ‘grey area of uncertainty’), and b) whether this has changed since the start. Results. Of the first 1000 patients randomized (by 16 December 2007), at baseline: 69% were aged >70 years and 38% >80 years. Median NIHSS was 11 (IQR 6-17). Infarct subtype was TACI (45%), PACI (37%), LACI (13%) & POCI (5%). The median time to randomization was 4.0 hrs (IQR 3.3-4.8). In each consecutive series of 250 patients, there was no significant change in the median time to randomization, (median times varied between 3.9 and 4.3 hours). The age of the patients has increased, with 33% aged over 80 in the first 250 patients compared to 49% in the most recent 250. There has been a decrease in the proportion with TACI from 57% to 43%. Conclusion IST-3 is chiefly recruiting the categories of patient in whom additional randomized evidence is most needed (age >80, 3-5 hours, LACI, POCI), and the proportion of patients in this clinically important ‘grey area’ has increased over the course of the trial.
Session:
Poster Session II
Date:
Thursday 15 May 2008
Time:
12:30 - 14:00
Room:
Agora 3
The HTA and BUPA Foundation: Surgeons experience in Carotid Stenting
A.H.Halliday
K.J.Phekoo
on behalf of ACST-2 Collaborators
St George's University of London
UNITED KINGDOM
Background: Carotid stenting (CAS) is a newer treatment and a recent meta analysis concluded that CAS should only be performed within randomised control led trials. Currently there is no published evidence for asymptomatic patients. The European Stroke Initiative also recommends that CAS in asymptomatic patients should only be considered in the context of randomised controlled trials. The Asymptomatic Carotid Surgery Trial -2 (ACST-2) is a large simple, international randomised trial of CEA versus CAS for stroke prevention. Method for Track Record Approval: Collaborators interested in ACST-2 documented: i) their total experience (a minimum of 25 CEA or CAS had to be performed in two years), ii) the time taken to obtained their experience, iii) the numbers of symptomatic and of asymptomatic patients seen; and, for both, iv) the number of strokes (fatal or non-fatal) and v) non-stroke deaths within 1 month of the procedure. Records were anonymised and reviewed by the technical management committee. Results: The first 73 track records submitted between March and November 2007 were reviewed. 84% collaborators were approved either for CEA or CAS or both procedures. A total of 33,029 procedures were performed of which 83% were CEA procedures. The mean total for CEA and CAS was 642 and 160 respectively. 21 surgeons (38%) performed both procedures: for CEA a total of 20,913 (range 50-4000) had been performed and for CAS 3,712 (range 33 – 800). 22 surgeons (39%) performed a total of 6,691 (range 43 – 1184, mean 642) CEA only and 13 radiologists (23%) performed a total of 1713 (range 35-600, mean 132) CAS only. Conclusion: The experience of a relatively new procedure such as stenting with an established procedure such as endarterectomy will need ongoing monitoring as the ACST-2 trial progresses. However, our initial results shows that 38% of our collaborators are surgeons who perform both CEA and CAS, and their range of experience was comparable to participating interventionalists performing only CAS.
Session:
Poster Session II
Date:
Thursday 15 May 2008
Time:
12:30 - 14:00
Room:
Agora 3
Easy and accurate new scale for evaluating consciousness level of patients with stroke: The Emergency Coma Scale
C. Takahashi
H. Okudera
T. Ohta
Department of Crisis Medicine, Graduate School of Medicine, University of Toyama
JAPAN
Background: The proverb “ Time is money” precisely apply to the critical care for stroke patients. Finally, in 2005, Tissue Plasminogen Activater (t-PA) was approved in Japan, and rapid and accurate medical care came to be required at pre-hospital and Emergency Room (ER). The reduction of “ Onset to Door Time” is one of the our critical issues. The Emergency Coma Scale (ECS) we developed in 2003 is a new scale to evaluate the conscious level of patients especially in the field of Neurological Emergency. It is simple and understandable scale and has the both merits of Glasgow Coma Scale (GCS) (1974, Teasdale) and Japan Coma Scale (JCS) (1974, Ohta). To evaluate utility, simplicity, and accuracy of this new coma scale, we started the multi-center comparative study named E-COMET among the 33 medical facilities including 16 University hospitals in Japan. Methods: We compared the agreements of the three scale-scores (ECS, GCS, and JCS) among the multiple raters including medical doctors, residents, nurses, paramedics and medical students at ER. All patients transported to ER of the designated medical facilities by ambulance are investigated their consciousness level by the ECS, GCS, and JCS. Then we performed statistical analyses about these data. Result: From our interim report, the agreement of the scores among multiple all raters at the ECS represented higher agreements than the other scales. The agreements on ECS classified by the types of diseases were strong in cerebrovascular disease and Traumatic Brain Injury (TBI). On the other hand, among the raters who never used any scales the ECS also represented higher agreements than the other two scales. Conclusion: We thought the ECS represented validity enough to be used extensively in neurological emergency settings. The fact, no coma scale–users represented the highest agreements on ECS suggested that the ECS may be more understandable than the conventional coma scales. The reduction of “ Onset to Door Time” in stroke may be possible by introducing the ECS into staff education.