22. European Stroke Conference 6 Large clinical trials (RCTs) B 11:20 - 11:30 Equivalent long-term disability after carotid artery stenting and endarterectomy in pa-tients randomised in the International Carotid Stenting Study (ICSS) R.L. Featherstone1, D. Doig2, F, Kennedy3, J Dobson4, M.M. Brown5 ICSS Investigators UCL Institute of Neurology, London, UNITED KINGDOM1,UCL Institute of Neurology, London, UNITED KINGDOM2, UCL Institute of Neurology, London, UNITED KINGDOM3, London School of Hygiene and Tropical Medicine, London, UNITED KINGDOM4, UCL Insti-tute of Neurology, London, UNITED KINGDOM5 Background: ICSS is a randomised trial of carotid stenting (CAS) versus endarterectomy (CEA) for symptomatic carotid stenosis. The long-term rate of fatal or disabling stroke did not differ between the arms, but there was an excess of any stroke in the CAS arm, mostly with-in 30 days of treatment. However, there was an excess of myocardial infarction, cranial nerve palsy and major post-operative haematoma after CEA. The long-term consequence of these outcome events on disability was uncertain. Methods: Patients with recently symptomatic ca-rotid stenosis (≥50%) were randomly allocated to CAS or CEA. Patients were followed at least annually for up to 10 years. Disability was measured using the modified Rankin Scale (mRS) at randomisation and each follow up. Patients who died were given an mRS of 6. We performed an intention to treat analysis comparing the ordinal distribution of mRS in patients in the CEA arm with the CAS arm at the end of follow up or death using the permutation test described by Howard et al (Stroke 2012). Results: Of 1710 patients, 842 in the CEA arm and 842 in the CAS arm had mRS recorded at randomisation and follow up. Mean time from randomisation to final follow up or death was 4 years in both arms. Median baseline mRS was 1 in both arms. The median increase in mRS between baseline and final follow up was 0 in both arms with a mean increase of 0.95 for CAS and 0.81 for CEA (p=0.13). There was no significant difference be-tween the two arms in the distribution of mRS scores at final follow up (p=0.9, figure). The per-mutation analysis suggested that 40% of patients allocated CAS had a better outcome than they would have done with CEA, 39% of patients have a better outcome with CEA and 21% had no change in disability. Conclusion: The impact of CAS and CEA on long-term disability is simi-lar. Any adverse effects of the excess of peri-operative stroke on long-term disability after CAS appear to be balanced by the effect of other events after CEA. 5 Large clinical trials (RCTs) B 11:10 - 11:20 Ambulance based stroke thrombolysis compared to conventional care - results of PHAN-TOM- S (the pre-hospital acute neurological treatment and optimization of medical care in stroke patients) H.J. Audebert1, A. Kunz2, B. Winter3, C. Waldschmidt4, J. Weber5, M. Wendt6, M. Rozanski7, A. Baumann8, S. Kazcmarek9, P. Kellner10, J.B. Fiebach11, A. Hartmann12, B.-M. Mackert13, M. Endres14, M. Ebinger15 for the STEMO-consortium Charité - Universitätsmedizin Berlin; Center for Stroke Research Berlin, Berlin, GER-MANY1, Charité - Universitätsmedizin Berlin; Center for Stroke Research Berlin, , 2, Charité - Universitätsmedizin Berlin; Center for Stroke Research Berlin, , 3, Charité - Universitätsme-dizin Berlin; Center for Stroke Research Berlin, , 4, , , 5, Charité - Universitätsmedizin Berlin; Center for Stroke Research Berlin, , 6, Charité - Universitätsmedizin Berlin; Center for Stroke Research Berlin, , 7, Berliner Feuerwehr, , 8, Berliner Feuerwehr, , 9, Berliner Feuerwehr; Vivantes Klinikum am Friedrichshain, , 10, Charité - Universitätsmedizin Berlin; Center for Stroke Research Berlin, , 11, Klinikum Frankfurt (Oder), Frankfurt a. d. O., 12, Vivantes Auguste-Viktoria-Klinikum, Berlin, 13, Charité - Universitätsmedizin Berlin; Center for Stroke Research Berlin, , 14, Charité - Universitätsmedizin Berlin; Center for Stroke Rese-arch Berlin 15 Background The effects of thrombolysis in acute ischemic stroke are time dependent. Pre-hospital throm-bolysis in a stroke emergency mobile (STEMO) with integrated CT-scanner and point-of-care laboratory may save time to treatment. PHANTOM-S is a registered large clinical study (NCT 01382862) investigating the effect of pre-hospital thrombolysis on time to treatment in an urban setting. Here, we report preliminary results of PHANTOM-S. Methods After a three months pilot phase, weeks were randomly assigned to either STEMO or regular care. Primary endpoint was the reduction in time from alarm (call) to thrombolytic treatment. Secondary endpoints included thrombolysis rate, symptomatic intracerebral hemorrhage (sICH) and mortality (after 7 and 90 days) in thrombolysed patients. The dispatch center used a stroke identification algorithm before deploying either STEMO or regular ambulances if STEMO was not available. On arrival, the emergency physician (neurologist) on board assessed the patient and called the neuroradiologist for CT indication. After scanning and exclusion of contraindica-tions, patients received intravenous tissue Plasminogen Activator (tPA) and were brought to the nearest appropriate hospital. Results The catchment area in Berlin, Germany, was defined by a 75% probability of reaching emer-gency sites within 16 minutes covering more than one million inhabitants. From May 1st 2011 to December 31st 2012, more than 6,000 code strokes were activated by the Berlin dispatch center. During STEMO weeks, more than 1,300 patients received acute medical care in STE-MO. From 619 STEMO patients with pre-hospital diagnosis of ischemic or hemorrhagic stroke, 170 patients received tPA in the ambulance. Conclusion At the ESC 2013, we will report the average call-to-needle time, thrombolysis rate, sICH rate and mortality in thrombolysed patients treated in STEMO vs. Regular care. We will also pro-vide short-term outcomes of patients not thrombolysed or with non-stroke diagnosis. 108 © 2013 S. Karger AG, Basel Scientific Programme
Karger_ESC London_2013
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