22. European Stroke Conference 4 Large clinical trials (RCTs) C 12:15 - 12:30 DESTINY II - Decompressive Surgery for the Treatment of malignant INfarction of the middle cerebral arterY. Primary and one-year resuklts of a randomized controlled inter-ventional trial in patients older than 60 years E. Jüttler1, J. Woitzik2, H. Amiri3, P. Schiller4, M. Gondan5, A. Unterberg6, W. Hacke7 DESTINY II Study Group University of Heidelberg, Department of Neurology, Heidleberg, GERMANY1,University of Heidelberg, Department of Neurology, Heidelberg, GERMANY2, University of Heidelberg, Department of Neurology, Heidelberg, GERMANY3, University of Heidelberg, Institute of Medical Biometry and Informatics, Heidelberg, GERMANY4, University of Heidelberg, Insti-tute of Medical Biometry and Informatics, Heidelberg, GERMANY5, University of Heidelberg, Department of Neurosurgery, Heidelberg, GERMANY6, University of Heidelberg, Department of Neurology, Heidelberg, GERMANY75 Patients with malignant middle cerebral artery (MCA) infarcts have a poor prognosis even with maximum intensive care treatment. Early hemicraniectomy reduces mortality without in-creasing the risk of very severe disability in patients up to 60 years. Data from observational studies, suggest that older patients may not profit from hemicraniectomy. DESTINY II (IS-RCTN21702227) is a randomized trial testing the efficacy of early hemicraniectomy in pa-tients with malignant MCA infarction older than 60 years. A total of 112 patients (49 randomly assigned to the surgical group and 63 to the conservative group) were included. At 6 months mortality or most severe disability (mRS score 5 or 6, primary endpoint) was significantly high-er in the conservative group compared with hemicraniectomy (84.1% vs. 59.2%; p=0.0038). In the shift analysis, outcome was also improved with surgery as compared with conservative treatment (P<0.001). 39.4% of survivors had a mRS score of 5, 51.6% had a mRS score of 4, and 9.1% had a mRS of 3. Secondary endpoints at one year including overall mortality, neuro-logical status (NIHSS), disability (mRS), ADL (Barthel Index), QoL (SF-36, EuroQoL 5D), de-pression (HDRS), and retrospective agreement to treatment will also be reported. 3 Large clinical trials (RCTs) C 12:00 - 12:15 The CLOTS Trial 3: the effect of intermittent pneumatic compression on risk of proximal deep vein thrombosis (DVT) in immobile acute stroke patients. M.S. Dennis1 CLOTS trials collaboration University of Edinburgh, Edinburgh, UNITED KINGDOM1 Background: DVTs are common after stroke and may lead to pulmonary emboli, an important cause of death. Intermittent pneumatic compression (IPC) reduces the risk of post surgical DVT but has not been adequately tested in stroke. National stroke guidelines currently recommend that IPC should be “considered”. The CLOTS trial 3 aimed to evaluate IPC in stroke. Methods: A multicentre, parallel group, randomised trial in immobile patients hospitalised with acute stroke. It compared routine care (which may include anticoagulants) plus IPC for up to 30 days with routine care alone. Patients were enrolled from day of admission (Day 0) to Day 3. A web based central randomisation system allocating patients in a ratio of 1:1 ensured alloca-tion concealment. Patients had a screening compression duplex ultrasound (CDU) of both legs performed by a technician blinded to treatment allocation at about 7-10 days and where practi-cal 25-30 days after enrolment. The primary outcome included symptomatic or asymptomatic DVTs in the popliteal or femoral veins detected on a screening CDU or within 30 days. Later clinical venous thromboembolic events, Oxford handicap scale and EQ5D-3L were assessed at 6 months via GPs, postal and telephone questionnaires. Full methods are available at http:// www.trialsjournal.com/content/13/1/26 Results: From 2009 to 2012, 105 UK centres enrolled 2876 patients, median age 76 yrs (range 23-102) and 1492 (51.9%) women. 371(12.9%) had haemorrhagic strokes. 1244 (43.2%) were enrolled on Day 0 or 1 with the remainder on Day 2&3. 2620 (98%) of 2672 surviving patients had a first screening CDU and 1893 of 2439 (77.6%) in whom a second was planned, but 289 had died and 112 had their second CDU cancelled because the first had shown a primary out-come. 300 (10.4%) had our primary outcome providing 90% power to detect a 4% absolute re-duction (12.4% to 8.4%) in risk of proximal DVT. Conclusion: The results of CLOTS Trial 3 reporting the effect of IPC will be presented. 192 © 2013 S. Karger AG, Basel Scientific Programme
Karger_ESC London_2013
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