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52. Introduction: How Participation Relates to Science and Technology and How Science and Technology Shapes Participation

Author

Maat, H., Chataway, J., and Waldman, L.

Subjects
Technology education, Outline of social science, Political science, Geography, Planning and Development, Technology and Agrarian Development, Life Science, Engineering ethics, Development, Social science, Science, technology, society and environment education, CERES, Science, technology and society, Leerstoelgroep Technologie en agrarische ontwikkeling
Published
2007

54. Drug repurposing : a systematic approach to evaluate candidate oral neuroprotective interventions for secondary progressive multiple sclerosis

Author

Vesterinen, HM, Connick, P, Irvine, CMJ, Sena, ES, Egan, KJ, Carmichael, GG, Tariq, A, Pavitt, S, Chataway, J, Macleod, MR, and Chandran, S

Subjects
RM, Science, IBUDILAST, FLUOXETINE, THERAPY, DISEASE, DOUBLE-BLIND, ANIMAL-MODELS, DESIGN, RC0321, Medicine, QUALITY, TRIAL
Abstract

ObjectiveTo develop and implement an evidence based framework to select, from drugs already licenced, candidate oral neuroprotective drugs to be tested in secondary progressive multiple sclerosis.DesignSystematic review of clinical studies of oral putative neuroprotective therapies in MS and four other neurodegenerative diseases with shared pathological features, followed by systematic review and meta-analyses of the in vivo experimental data for those interventions. We presented summary data to an international multi-disciplinary committee, which assessed each drug in turn using pre-specified criteria including consideration of mechanism of action.ResultsWe identified a short list of fifty-two candidate interventions. After review of all clinical and pre-clinical evidence we identified ibudilast, riluzole, amiloride, pirfenidone, fluoxetine, oxcarbazepine, and the polyunsaturated fatty-acid class (Linoleic Acid, Lipoic acid; Omega-3 fatty acid, Max EPA oil) as lead candidates for clinical evaluation.ConclusionsWe demonstrate a standardised and systematic approach to candidate identification for drug rescue and repurposing trials that can be applied widely to neurodegenerative disorders.

Published
2015

55. International Dimension of research collaboration

Author

Pankowska, P.K.P., McGrath- Hoareau, C., Horvath, V., Baruch, B., Gunashekar, S., Culbertson, S., and Chataway, J.

Subjects
SDG 17 - Partnerships for the Goals
Abstract

Grand challenges, such as global warming or chronic and infectious diseases, are increasingly global and complex. Solving these challenges often requires international research collaboration. The European Commission is playing an increasing role in supporting research and innovation through Horizon 2020, the European Union's comprehensive Framework Programme for Research and Technological Development.This policy brief provides an overview of the main research priorities, the main collaborative efforts in international research collaboration regarding grand challenges, and summarises the outcomes of an expert and stakeholders' workshop conducted on the 3rd of April 2014. The brief is written to inform the European Research and Innovation Area Board regarding the state of research collaboration on grand challenges and what the EU could do to further improve research collaboration on these grand challenges.

Published
2014

56. International Dimension of research collaboration

Author

Paulina Karolina Pankowska, Mcgrath- Hoareau, C., Horvath, V., Baruch, B., Gunashekar, S., Culbertson, S., Chataway, J., and Sociology

Subjects
SDG 17 - Partnerships for the Goals
Abstract

Grand challenges, such as global warming or chronic and infectious diseases, are increasingly global and complex. Solving these challenges often requires international research collaboration. The European Commission is playing an increasing role in supporting research and innovation through Horizon 2020, the European Union's comprehensive Framework Programme for Research and Technological Development. This policy brief provides an overview of the main research priorities, the main collaborative efforts in international research collaboration regarding grand challenges, and summarises the outcomes of an expert and stakeholders' workshop conducted on the 3rd of April 2014. The brief is written to inform the European Research and Innovation Area Board regarding the state of research collaboration on grand challenges and what the EU could do to further improve research collaboration on these grand challenges.

Published
2014

59. Interferon β-1b-neutralizing antibodies 5 years after clinically isolated syndrome

Author

Hartung, Hp, Strasser Fuchs, S, Berger, T, Vass, K, Sindic, C, Dubois, B, Dive, D, Debruyne, J, Metz, L, Rice, G, Duquette, P, Lapierre, Y, Freedman, M, Traboulsee, A, O'Connor, P, Stourac, P, Taláb, R, Zapletalová, O, Kováøová, I, Medová, E, Fiedler, J, Frederiksen, J, Brochet, B, Moreau, T, Vermersch, P, Pelletier, J, Edan, G, Clanet, M, Clavelou, P, Lebrun Frenay, C, Gout, O, Kallela, M, Pirttilä, T, Ruutiainen, J, Koivisto, K, Reunanen, M, Elovaara, I, Villringer, A, Altenkirch, H, Wessel, K, Steinke, W, Kölmel, H, Oschmann, P, Diem, R, Dressel, A, Hoffmann, F, Baum, K, Jung, S, Petereit, Hf, Reske, D, Sailer, M, Köhler, J, Sommer, N, Hohlfeld, R, Henn, Kh, Steinbrecher, A, Tumani, H, Gold, R, Rieckmann, P, Komoly, R, Gács, G, Jakab, G, Csiba, L, Vécsei, L, Miller, A, Karussis, D, Chapman, J, Ghezzi, A, Comi, G, Gallo, Paolo, Cosi, V, Durelli, L, Anten, B, Visser, L, Myhr, Km, Szczudlik, A, Selmaj, K, Stelmasiak, Z, Podemski, R, Maciejek, Z, Cunha, L, Sega Jazbec, S, Montalba, X, Arbizu, T, Saiz, A, Bárcena, J, Arroyo, R, Fernández, O, Izquierdo, G, Casanova, B, Lycke, J, Kappos, L, Mattle, H, Beer, K, Coleman, R, Chataway, J, O'Riordan, J, and Howell, S. .

Published
2012

60. Interferon β-1b-neutralizing antibodies 5 years after clinically isolated syndrome

Author

Hartung, Hp, Strasser Fuchs, S, Berger, T, Vass, K, Sindic, C, Dubois, B, Dive, D, Debruyne, J, Metz, L, Rice, G, Duquette, P, Lapierre, Y, Freedman, M, Traboulsee, A, O'Connor, P, Stourac, P, Taláb, R, Zapletalová, O, Kováøová, I, Medová, E, Fiedler, J, Frederiksen, J, Brochet, B, Moreau, T, Vermersch, P, Pelletier, J, Edan, G, Clanet, M, Clavelou, P, Lebrun Frenay, C, Gout, O, Kallela, M, Pirttilä, T, Ruutiainen, J, Koivisto, K, Reunanen, M, Elovaara, I, Villringer, A, Altenkirch, H, Wessel, K, Steinke, W, Kölmel, H, Oschmann, P, Diem, R, Dressel, A, Hoffmann, F, Baum, K, Jung, S, Petereit, Hf, Reske, D, Sailer, M, Köhler, J, Sommer, N, Hohlfeld, R, Henn, Kh, Steinbrecher, A, Tumani, H, Gold, R, Rieckmann, P, Komoly, R, Gács, G, Jakab, G, Csiba, L, Vécsei, L, Miller, A, Karussis, D, Chapman, J, Ghezzi, A, Comi, G, Gallo, Paolo, Cosi, V, Durelli, L, Anten, B, Visser, L, Myhr, Km, Szczudlik, A, Selmaj, K, Stelmasiak, Z, Podemski, R, Maciejek, Z, Cunha, L, Sega Jazbec, S, Montalba, X, Arbizu, T, Saiz, A, Bárcena, J, Arroyo, R, Fernández, O, Izquierdo, G, Casanova, B, Lycke, J, Kappos, L, Mattle, H, Beer, K, Coleman, R, Chataway, J, O'Riordan, J, Howell, S. ., Neurology, Radiology and nuclear medicine, NCA - Multiple Sclerosis and Other Neuroinflammatory Diseases, UCL - SSS/IONS/CEMO - Pôle Cellulaire et moléculaire, and UCL - (SLuc) Service de neurologie

Subjects
Multiple Sclerosis, Injections, Subcutaneous, Relapse rate, Brain mri, Medicine, Humans, Longitudinal Studies, Prospective Studies, Clinically isolated syndrome, biology, business.industry, Immunogenicity, Interferon-beta, Antibodies, Neutralizing, Titer, Interferon β 1b, Cross-Sectional Studies, Immunology, biology.protein, Neurology (clinical), Antibody, business, Demyelinating Diseases, Follow-Up Studies, Interferon beta-1b
Abstract

To determine the frequency and consequences of neutralizing antibodies (NAbs) in patients with a first event suggestive of multiple sclerosis (MS) treated with interferon β-1b (IFNβ-1b).In the Betaseron/Betaferon in Newly Emerging MS For Initial Treatment (BENEFIT) study, patients were randomly assigned to 250 μg IFNβ-1b (Betaferon) or placebo subcutaneously every other day for 2 years or until diagnosis of clinically definite MS (CDMS). Patients were then offered open-label IFNβ-1b for up to 5 years. NAb status was assessed every 6 months by the myxovirus protein A induction assay. A titer20 NU/mL was considered NAb-positive, with low (≥20-100 NU/mL), medium (≥100-400 NU/mL), and high (≥400 NU/mL) titer categories. Here we examine early-treated patients, who received IFNβ-1b for up to 5 years.NAbs were measured in 277 of 292 early-treated patients and detected at least once in 88 (31.8%) patients, with 53 (60.2%) reverting to NAb negativity by year 5. Time to CDMS, time to confirmed disability progression, and annualized relapse rate did not differ between NAb-positive and NAb-negative patients or between periods of NAb positivity vs NAb negativity within patients. Increases in newly active lesion number and T2 lesion volume and conversion to McDonald MS were associated with NAb positivity and were more pronounced with higher titers.Although NAb positivity was associated with increased brain MRI activity, no discernible effects on clinical outcomes were found. This finding may reflect the greater power of MRI compared with clinical outcomes to detect the treatment effects of IFNβ-1b and may also result from temporal changes in NAb titers and biology.

Published
2011

61. Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomised controlled trial

Author

Ederle, J., Dobson, J., Featherstone, R. L., Bonati, L. H., Worp, H. B., Borst, G. J., Lo, T. H., Gaines, P., Dorman, P. J., Macdonald, S., Lyrer, P. A., Hendriks, J. M., Mccollum, C., Nederkoorn, P. J., Brown, M. M., Algra, A., Bamford, J., Beard, J., Bland, M., Bradbury, A. W., Clifton, A., Hacke, W., Halliday, A., Malik, I., Mas, J. L., Mcguire, A. J., Sidhu, P., Venables, G., Bradbury, A., Collins, R., Molynewc, A., Naylor, R., Warlow, C., Ferro, J. M., Thomas, D., Coward, L., Featherstone, R. F., Tindall, H., Mccabe, D. J. H., Wallis, A., Brooks, M., Chambers, B., Chan, A., Chu, P., Clark, D., Dewey, H., Donnan, G., Fell, G., Hoare, M., Molan, M., Roberts, A., Roberts, N., Beiles, B., Bladin, C., Clifford, C., Grigg, M., New, G., Bell, R., Bower, S., Chong, W., Holt, M., Saunder, A., Than, P. G., Gett, S., Leggett, D., Mcgahan, T., Quinn, J., Ray, M., Wong, A., Woodruff, P., Foreman, R., Schultz, D., Scroop, R., Stanley, B., Allard, B., Atkinson, N., Cambell, W., Davies, S., Field, P., Milne, P., Mitchell, P., Tress, B., Yan, B., Beasley, A., Dunbabin, D., Stary, D., Walker, S., Cras, P., D Archambeau, O., Hendriks, J. M. H., Schil, P., Bosiers, M., Deloose, K., Buggenhout, E., Letter, J., Devos, V., Ghekiere, J., Vanhooren, G., Astarci, P., Hammer, F., Lacroix, V., Peters, A., Verhelst, R., Dejaegher, L., Peeters, A., Verbist, J., Blair, J. F., Caron, J. L., Daneault, M., Giroux, M. F., Guilbert, F., Lanthier, S., Lebrun, L. H., Oliva, V., Raymond, J., Roy, D., Soulez, G., Weill, A., Hill, M., Hu, W., Hudion, M., Morrish, W., Sutherland, G., Wong, J., Alback, A., Harno, H., Ijas, P., Kaste, M., Lepantalo, M., Mustanoja, S., Paananen, T., Porras, M., Puutala, J., Railo, M., Sairanen, T., Soinne, L., Vehmas, A., Vikatmaa, P., Goertler, M., Halloul, Z., Skalej, M., Brennan, P., Kelly, C., Leahy, A., Moroney, J., Thornton, J., Koelemay, M. J. W., Reekers, J. A. A., Roos, Y. B. W. E. M., Koudstaal, P. J., Pattynama, P. M. T., Lugt, A., Dijk, L. C., Sambeek, L. R. H. M., Urk, H., Verhargen, H. J. M., Bruininckx, C. M. A., Bruijn, S. F., Keunen, R., Knippenberg, B., Mosch, A., Treurniet, F., Dijk, L., Overhagen, H., Wever, J., Beer, F. C., Den Berg, J. S. P., Hasselt, B. A. A. M., Zeilstra, D. J., Boiten, J., Otterloo, J. C. A. D., Vries, A. C., Nieholt, G. J. L. A., Kallen, B. F. W., Blankensteijn, J. D., Leeuw, F. E., Kool, L. J. S., Vliet, J. A., Kort, G. A. P., Kapelle, L. J., Mali, W. P. T. M., Moll, F., Verhagen, H., Barber, P. A., Bourchier, R., Hill, A., Holden, A., Stewart, J., Bakke, S. J., Krohg-Sorensen, K., Skjelland, M., Tennoe, B., Bialek, P., Biejat, Z., Czepiel, W., Czlonkowska, A., Dowzenko, A., Jedrzejewska, J., Kobayashi, A., Lelek, M., Polanski, J., Kirbis, J., Milosevic, Z., Zvan, B., Vasco, J., Blasco, J., Chamorro, A., Macho, J., Obach, V., Riambau, V., San Roman, L., Branera, J., Canovas, D., Estela, J., Gaibar, A. G., Perendreu, J., Bjorses, K., Gottsater, A., Ivancev, K., Maetzsch, T., Sonesson, B., Berg, B., Delle, M., Formgren, J., Gillgren, P., Kall, T. B., Konrad, P., Nyman, N., Takolander, R., Andersson, T., Malmstedt, A., Soderman, M., Wahlgren, C., Wahlgren, N., Binaghi, S., Hirt, L., Michel, P., Ruchat, P., Engelter, S. T., Fluri, F., Guerke, L., Jacob, A. L., Kirsch, E., Radue, E. W., Stierli, P., Wasner, M., Wetznel, S., Bonvin, C., Kalangos, A., Lovblad, K., Murith, N., Ruefenacht, D., Sztajzel, R., Higgins, N., Kirkpatrick, P. J., Martin, P., Adam, D., Bell, J., Crowe, P., Gannon, M., Henderson, M. J., Sandler, D., Shinton, R. A., Scriven, J. M., Wilmink, T., D Souza, S., Egun, A., Guta, R., Punekar, S., Seriki, D. M., Thomson, G., Brennan, A., Enevoldson, T. P., Gilling-Smith, G., Gould, D. A., Harris, P. L., Mcwilliams, R. G., Nasser, H. C., White, R., Prakash, K. G., Serracino-Inglott, F., Subramanian, G., Smyth, J. V., Walker, M. G., Clarke, M., Davis, M., Dixit, S. A., Dolman, P., Dyker, A., Ford, G., Golkar, A., Jackson, R., Jayakrishnan, V., Lambert, D., Lees, T., Louw, S., Mendelow, A. D., Rodgers, H., Rose, J., Stansby, G., Wyatt, M., Baker, T., Baldwin, N., Jones, L., Mitchell, D., Munro, E., Thornton, M., Baker, D., Davis, N., Hamilton, G., Mccabe, D., Platts, A., Tibballs, J., Cleveland, T., Dodd, D., Lonsdale, R., Nair, R., Nassef, A., Nawaz, S., Belli, A., Cloud, G., Markus, H., Mcfarland, R., Morgan, R., Pereira, A., Thompson, A., Chataway, J., Cheshire, N., Gibbs, R., Hammady, M., Jenkins, M., Wolfe, J., Adiseshiah, M., Bishop, C., Brew, S., Brookes, J., Jager, R., Kitchen, N., Ashleigh, R., Butterfield, S., Gamble, G. E., Nasim, A., O Neill, P., Edwards, R. D., Lees, K. R., Mackay, A. J., Moss, J., Rogers, P., Developmental Genetics, International Carotid Stenting Study, ACS - Amsterdam Cardiovascular Sciences, Neurology, Surgery, Radiology and Nuclear Medicine, and ANS - Amsterdam Neuroscience

Subjects
Male, medicine.medical_specialty, SURGERY, medicine.medical_treatment, Carotid endarterectomy, 030204 cardiovascular system & hematology, Neuroinformatics [DCN 3], 03 medical and health sciences, 0302 clinical medicine, Risk Factors, Angioplasty, medicine, Humans, Carotid Stenosis, cardiovascular diseases, ANGIOPLASTY, Stroke, Endarterectomy, Aged, Endarterectomy, Carotid, Intention-to-treat analysis, Cardiovascular diseases [NCEBP 14], business.industry, Stent, General Medicine, Interim analysis, medicine.disease, 3. Good health, Surgery, Female, Stents, Human medicine, Carotid stenting, business, 030217 neurology & neurosurgery, Angioplasty, Balloon
Abstract

Contains fulltext : 88112.pdf (Publisher’s version ) (Closed access) BACKGROUND: Stents are an alternative treatment to carotid endarterectomy for symptomatic carotid stenosis, but previous trials have not established equivalent safety and efficacy. We compared the safety of carotid artery stenting with that of carotid endarterectomy. METHODS: The International Carotid Stenting Study (ICSS) is a multicentre, international, randomised controlled trial with blinded adjudication of outcomes. Patients with recently symptomatic carotid artery stenosis were randomly assigned in a 1:1 ratio to receive carotid artery stenting or carotid endarterectomy. Randomisation was by telephone call or fax to a central computerised service and was stratified by centre with minimisation for sex, age, contralateral occlusion, and side of the randomised artery. Patients and investigators were not masked to treatment assignment. Patients were followed up by independent clinicians not directly involved in delivering the randomised treatment. The primary outcome measure of the trial is the 3-year rate of fatal or disabling stroke in any territory, which has not been analysed yet. The main outcome measure for the interim safety analysis was the 120-day rate of stroke, death, or procedural myocardial infarction. Analysis was by intention to treat (ITT). This study is registered, number ISRCTN25337470. FINDINGS: The trial enrolled 1713 patients (stenting group, n=855; endarterectomy group, n=858). Two patients in the stenting group and one in the endarterectomy group withdrew immediately after randomisation, and were not included in the ITT analysis. Between randomisation and 120 days, there were 34 (Kaplan-Meier estimate 4.0%) events of disabling stroke or death in the stenting group compared with 27 (3.2%) events in the endarterectomy group (hazard ratio [HR] 1.28, 95% CI 0.77-2.11). The incidence of stroke, death, or procedural myocardial infarction was 8.5% in the stenting group compared with 5.2% in the endarterectomy group (72 vs 44 events; HR 1.69, 1.16-2.45, p=0.006). Risks of any stroke (65 vs 35 events; HR 1.92, 1.27-2.89) and all-cause death (19 vs seven events; HR 2.76, 1.16-6.56) were higher in the stenting group than in the endarterectomy group. Three procedural myocardial infarctions were recorded in the stenting group, all of which were fatal, compared with four, all non-fatal, in the endarterectomy group. There was one event of cranial nerve palsy in the stenting group compared with 45 in the endarterectomy group. There were also fewer haematomas of any severity in the stenting group than in the endarterectomy group (31 vs 50 events; p=0.0197). INTERPRETATION: Completion of long-term follow-up is needed to establish the efficacy of carotid artery stenting compared with endarterectomy. In the meantime, carotid endarterectomy should remain the treatment of choice for patients suitable for surgery. FUNDING: Medical Research Council, the Stroke Association, Sanofi-Synthelabo, European Union.

Published
2010

63. Fast facts: multiple sclerosis

Author

Chataway, J.

Subjects
Fast facts: multiple sclerosis (Book) -- Book reviews, Books -- Book reviews, Health, Psychology and mental health
Published
2006

64. Long-term effect of early treatment with interferon beta-1b after a first clinical event suggestive of multiple sclerosis: 5-year active treatment extension of the phase 3 BENEFIT trial

Author

Strasser Fuchs, S, Berger, T, Vass, K, Sindic, C, Dubois, B, Dive, D, Debruyne, J, Metz, L, Rice, G, Duquette, P, Lapierre, Y, Freedman, M, Traboulsee, A, O'Connor, P, Stourac, P, Taláb, R, Zapletalová, O, Kovárová, I, Medová, E, Fiedler, J, Frederiksen, J, Brochet, B, Moreau, T, Vermersch, P, Pelletier, J, Edan, G, Clanet, M, Clavelou, P, Lebrun Frenay, C, Gout, O, Kallela, M, Pirttilä, T, Ruutiainen, J, Koivisto, K, Reunanen, M, Elovaara, I, Villringer, A, Altenkirch, H, Wessel, K, Hartung, Hp, Steinke, W, Kölmel, H, Oschmann, P, Diem, R, Dressel, A, Hoff, F, Baum, K, Jung, S, Felicitas Petereit, H, Reske, D, Sailer, M, Köhler, J, Sommer, N, Hohlfeld, R, Henn, Kh, Steinbrecher, A, Tumani, H, Gold, R, Rieckmann, P, Komoly, R, Gács, G, Jakab, G, Csiba, L, Vécsei, L, Miller, A, Karussis, D, Chapman, J, Ghezzi, A, Comi, G, Gallo, Paolo, Cosi, V, Durelli, L, Anten, B, Visser, L, Myhr, Km, Szczudlik, A, Selmaj, K, Stelmasiak, Z, Podemski, R, Maciejek, Z, Cunha, L, Sega Jazbec, S, Montalbán, X, Arbizu, T, Saiz, A, Bárcena, J, Arroyo, R, Fernández, O, Izquierdo, G, Casanova, B, Lycke, J, Kappos, L, Mattle, H, Beer, K, Coleman, R, Chataway, J, O'Riordan, J, Howell, S, Miller, Dh, Polman, Ch, Bauer, L, Ghazi, M, Pohl, C, Sandbrink, R, Barkhof, F, Uitdehaag, B, de Vera, A, Wu, S, Radü, Ew, Mcfarland, Hf, Kesselring, J, Petkau, Aj, Toyka, K. V., Dubois, Bénédicte, Neurology, Radiology and nuclear medicine, NCA - Multiple Sclerosis and Other Neuroinflammatory Diseases, and UCL - SSS/IONS/CEMO - Pôle Cellulaire et moléculaire

Subjects
Adult, Male, Questionnaires, medicine.medical_specialty, Multiple Sclerosis, Kaplan-Meier Estimate, Placebo, Risk Assessment, Young Adult, Disability Evaluation, Double-Blind Method, Surveys and Questionnaires, Internal medicine, medicine, Humans, Proportional Hazards Models, Intention-to-treat analysis, Expanded Disability Status Scale, Clinically isolated syndrome, business.industry, Multiple sclerosis, Interferon beta-1b, Hazard ratio, Interferon-beta, medicine.disease, Magnetic Resonance Imaging, Surgery, Tolerability, Data Interpretation, Statistical, Disease Progression, Female, Neurology (clinical), business
Abstract

BACKGROUND: The Betaferon/Betaseron in newly emerging multiple sclerosis for initial treatment (BENEFIT) trial investigated the effect of treatment with interferon beta-1b after a clinically isolated syndrome. The 5-year active treatment extension compares the effects of early and delayed treatment with interferon beta-1b on time to clinically definite multiple sclerosis (CDMS) and other disease outcomes, including disability progression. METHODS: Patients with a first event suggestive of multiple sclerosis and a minimum of two clinically silent lesions in MRI were randomly assigned to receive interferon beta-1b 250 microg (n=292; early treatment) or placebo (n=176; delayed treatment) subcutaneously every other day for 2 years, or until diagnosis of CDMS. All patients were then eligible to enter a prospectively planned follow-up phase with open-label interferon beta-1b up to a maximum of 5 years after randomisation. Patients and study personnel remained unaware of initial treatment allocation throughout the study. Primary endpoints were time to CDMS, time to confirmed disability progression measured with the expanded disability status scale, and the functional assessment of multiple sclerosis trial outcomes index (FAMS-TOI) at 5 years. Analysis of the primary endpoints was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00185211. FINDINGS: 235 (80%) patients from the early treatment and 123 (70%) from the delayed treatment group completed the 5-year study. Early treatment reduced the risk of CDMS by 37% (hazard ratio [HR] 0.63, 95% CI 0.48-0.83; p=0.003) compared with delayed treatment. The risk for confirmed disability progression was not significantly lower in the early treatment group (0.76, 0.52-1.11; p=0.177). At 5 years, median FAMS-TOI scores were 125 in both groups. No significant differences in other disability related outcomes were recorded. Frequency and severity of adverse events remained within the established safety and tolerability profile of interferon beta-1b. INTERPRETATION: Effects on the rate of conversion to CDMS and the favourable long-term safety and tolerability profile support early initiation of treatment with interferon beta-1b, although a delay in treatment by up to 2 years did not affect long-term disability outcomes. FUNDING: Bayer Schering Pharma. ispartof: The Lancet Neurology vol:8 issue:11 pages:987-997 ispartof: location:England status: published

Published
2009

65. Rationale and design of a randomized, double-blind, parallel-group study of terutroban 30 mg/day versus aspirin 100 mg/day in stroke patients: the prevention of cerebrovascular and cardiovascular events of ischemic origin with terutroban in patients with a history of ischemic stroke or transient ischemic attack (PERFORM) study

Author

Bousser, M, Amarenco, P, Chamorro, A, Fisher, M, Ford, I, Fox, K, Hennerici, M, Mattle, H, Rothwell, P, Julian, D, Fieschi, G, Fieschi, C, Boysen, G, Pocock, S, Conard, J, Orgogozo, J, Inzitari, D, Erkinjuntti, T, Pasquier, F, O'Brien, J, Mas, J, Gueret, P, Lenzi, G, Leys, D, Lopez Sendon, J, Norrving, B, Ferro, J, Thygesen, K, Cowpply, B, P, Ameriso, S, Donnan, D, Lang, W, Thijs, V, Fernandes, J, Stamenova, P, Teal, P, Lavados, P, Lu, C, Poljakovic, Z, Kalita, Z, Kaste, M, Moulin, T, Vemmos, K, Diener, H, Wong, L, Nagy, Z, Chopra, J, Mccormack, P, Gensini, G, Budrys, V, Droste, D, Tan, K, Benomar, A, Cantu Brito, C, Barber, A, Koudstaal, P, Thomassen, L, Czlonkowska, A, Cunha, L, Bajenaru, O, Yakhno, N, Chen, C, Lisy, L, Zvan, B, Bryer, A, Kim, J, Vivancos, J, Wahlgren, N, Liu, S, Poungvarin, N, Hentati, F, Bahar, S, Mischenko, T, Lees, K, Abdel Masih, M, Barboza, A, Cirio, J, Crespo, E, Escaray, G, Esnaola, M, Rojas Estol, C, Ferrari, J, Fraiman, H, Garrote, M, Gatto, E, Giannaula, R, Gori, H, Herrera, G, Ioli, P, Losano, J, Povedano Reich, E, Rey, R, Rotta Escalante, R, Saredo, G, Zurru, M, Anderson, C, Bladin, C, Crimmins, D, Davis, S, Donnan, G, Dunbabin, D, Frayne, J, Gates, P, Hankey, G, Helme, R, Herkes, G, Karrasch, J, Kimber, T, Jannes, J, Landau, P, Levi, C, Lueck, C, Markus, R, Phan, T, Schwartz, R, Schultz, D, Blacker, D, Read, S, Williams, M, Aichner, F, Auff, E, Bancher, C, Binder, H, Brainin, M, Brucke, T, Eggers, C, Fertl, E, Ladurner, G, Lalouschek, W, Mamoli, B, Mitrovic, N, Noisternig, G, Schmidt, R, Vosko, M, Willeit, J, Zaruba, E, Boon, P, Bourgeois, P, Caekebeke, J, Cals, N, Cras, P, Desfontaines, P, De Deyn, P, Dieudonne, L, De Klippel, N, Laloux, P, Maertens de Noordhout, A, Merlevede, K, Michotte, A, Pandolfo, M, Peeters, A, Peeters, D, Tack, P, Van Buggenhout, E, Van Landegem, W, Vanhooren, G, Vermylen, P, Annes, M, Brondani, R, De Carvalho, J, Cendes, F, Fabio, S, Ferraz, A, De Freitas, G, Gagliardi, R, Gomes Neto, A, Haussen, S, Kowacs, P, Martins, S, Minelli, C, Moro, C, Noujaim, J, Rocha, M, Da Silva, M, Silveira, J, Yamamoto, F, Zetola, V, Baldaranov, D, Deleva, N, Haralanov, L, Milanov, I, Mintchev, D, Petrova, N, Shotekov, P, Stamenov, B, Zahariev, Z, Arts, R, Bayer, N, Beaudry, M, Berger, L, Bozek, C, Collier, T, Cote, R, Desai, H, Durocher, A, Hachinski, V, Hill, M, Hoppe, B, Howse, D, Mackey, A, Maharaj, M, Minuk, J, Moddel, G, Novak, D, Penn, A, Rabinovitch, H, Selchen, D, Shuaib, A, Silva, J, Silver, F, Spence, D, Stotts, G, Tamayo, A, Teitelbaum, J, Veloso, F, Voll, C, Winder, T, Barrientos Uribe, N, Galdames Poblete, D, Garcia Figueroa, P, Gasic Yaconi, K, Jaramillo Munoz, A, Lavados Germain, P, Lavados Montes, M, Nancupil Bello, C, Prina Pacheco, L, Vargas Canas, A, Venegas, F, Chen, P, H, Cheng, Y, Cui, L, Di, Q, Dong, Q, Fan, D, Feng, H, Huang, Y, Li, J, Li, W, Li, Z, Lin, H, Liu, M, Miao, L, Ren, H, Wang, Y, Wu, J, Zhang, W, Zhao, G, Zhao, H, Zhou, H, Antoncic, I, Demarin, V, Lusic, I, Pavlicek, I, Soldo Butkovic, S, Bar, M, Bauer, J, Kalina, M, Kanovsky, P, Jura, R, Neumann, J, Rektor, I, Skoda, O, Vaclavik, D, Eerola, A, Hillbom, M, Kinnunen, E, Koivisto, K, Numminen, H, Rissanen, A, Roine, R, Sivenius, J, Alamowitch, S, Autret, A, Avendano, S, Bataillard, M, Berthier, E, Besson, G, Bille Turc, F, Boulliat, J, Boulesteix, J, Brosset, C, Cesaro, P, Albucher, J, Clavelou, P, Colamarino, R, Crassard, I, de Broucker, T, de Bray, J, Desbordes, P, Diot, E, Ducrocq, X, Ellie, E, Faucheux, J, Giroud, M, Godefroy, O, Guillon, B, Huttin, H, Just, A, Lamy, C, Lejeune, P, Lucas, C, Macian Montoro, F, Mackowiak, A, Maillet Vioud, M, Pico, F, Milandre, L, Milhaud, D, Malbec, M, Neau, J, Pinel, J, Robin, C, Rodier, G, Rosolacci, T, Rouanet, F, Rouhart, F, Sablot, D, Servan, J, Smadja, D, Trouillas, P, Valance, J, Viader, F, Viallet, F, Wolff, V, Zagnoli, F, Zuber, M, Angerer, M, Becker, U, Berlit, P, Berrouschot, J, Biniek, R, Bitsch, A, Brodhun, R, Dichgans, M, Druschky, K, Dux, R, Faiss, J, Ferbert, A, Gahn, G, Grotemeyer, K, Goertler, M, Grau, A, Griewing, B, Grond, M, Haan, J, Haberl, R, Hamann, G, Hamer, H, Harms, L, Heide, W, Henningsen, H, Hetzel, A, Hoffmann, F, Huber, R, Isenmann, S, Jander, S, Joerg, J, Kaps, M, Kastrup, A, Kessler, C, Koehler, W, Koelmel, H, Lichy, C, Luckner, K, Malessa, R, Mallmann, A, Meyding Lamade, U, Molitor, H, Mueller Jensen, A, Muellges, W, Noth, J, Nueckel, M, Ochs, G, Poppert, H, Roether, J, Rosenkranz, M, Sander, D, Schaebitz, W, Schlachetzki, F, Schlegel, U, Schmid, E, Schneider, D, Schwarz, M, Seidel, G, Sieble, M, Sliwka, U, Stingele, R, Stoegbauer, F, Szabo, K, Topper, R, Treib, J, Weissenborn, K, Widder, B, Witte, O, Karageorgiou, K, Mitsikostas, D, Papadimitriou, A, Papathanasopoulos, P, Chan, H, Ng, P, Tsoi, T, Bartos, L, Csanyi, A, Csiba, L, Csornai, M, Dioszeghy, P, Fazekas, A, Harcos, P, Horvath, S, Kaposzta, Z, Kerenyi, L, Kincses, J, Koves, A, Nikl, J, Panczel, G, Pongracz, E, Sebestyen, K, Semjen, J, Szabo, M, Szegedi, N, Valikovics, A, Varszegi, R, Vecsei, L, Borah, N, Ichaporia, N, Kaul, S, Meenakshi Sundaram, S, Mehndiratta, M, Misra, U, Murthy, J, Nayak, D, Poncha, F, Shah, A, Singh, G, Srinivasa, R, Venkateswarlu, K, Wadia, R, Collins, R, Harbison, J, Hickey, P, Kelly, P, Murphy, S, Adami, A, Agnelli, G, Agostoni, E, Anzola, G, Arnaboldi, M, Bassi, P, Billo, G, Bottacchi, E, Bovi, P, Cappa, S, Cappelletti, C, Carolei, A, Cavallini, A, Chiodo Grandi, F, Comi, G, Consoli, D, Corsi, F, Costanzo, E, De Falco, F, Devetag, F, Di Lazzaro, V, Di Piero, V, Diomedi, M, Fattorello Salimbeni, C, Federico, F, Feleppa, M, Ferrarese, C, Gandolfo, C, Giaccaglini, E, Giaquinto, S, Giobbe, D, Giometto, B, Greco, G, Guidetti, D, Guidotti, M, Iudice, A, Lembo, G, Marengo, C, Marini, P, Melis, M, Micieli, G, Musolino, R, Mutani, R, Neri, G, Parati, E, Pastore, L, Porazzi, D, Prati, P, Procaccianti, G, Rasura, M, Rossini, P, Santilli, I, Semplicini, A, Silvestrini, M, Tanganelli, P, Tedeschi, G, Tezzon, F, Tola, M, Villani, A, Zanferrari, C, Zarcone, D, Bickuviene, I, Gumbrevicius, G, Obelieniene, D, Skaringa, A, Virketiene, I, Tharakan, J, Aleman Pedroza, J, Escamilla Garza, J, Fernandez Vera, J, Leal Cantu, R, Leon Flores, L, Lopez Ruiz, M, Reyes Gutierrez, G, Reyes Morales, S, Rivera Castano, L, Rodrigues Leyva, I, Ruiz Sandoval, J, Vega Boada, F, Belahsen, F, Kissani, N, Mosseddaq, R, Slassi, I, Yahyaoui, M, Boiten, J, Bornebroek, M, De Kort, P, De Leeuw, H, Donders, R, Franke, C, Hertzberger, L, Jansen, B, Kappelle, L, Keizer, K, Kuster, J, Limburg, M, Mulleners, W, Pop, P, Van Den Berg, J, Van Gemert, H, Verbiest, H, Weinstein, H, Clark, M, Fink, J, Gommans, J, Jayathissa, S, Kilfoyle, D, Kumar, A, Hurtig, U, Indredavik, B, Kloster, R, Salvesen, R, Drozdowski, W, Fryze, W, Klimek, A, Kochanowski, J, Kozubski, W, Ksiazkiewicz, B, Kwiecinski, H, Kuczynska Zardzewialy, A, Motta, E, Nowacki, P, Nyka, W, Opala, G, Pierzchala, K, Pniewski, J, Podemski, R, Selmaj, K, Stelmasiak, Z, Stepien, A, Strzelecka Gorzynska, M, Szczudlik, A, Wajgt, A, Wiszniewska, M, Wlodek, A, Canhao, P, Correia, C, Grilo Goncalves, J, Machado Candido, J, Salgado, A, Bulboaca, A, Campeanu, A, Lazar, T, Marginean, I, Minea, D, Pascu, I, Pereanu, M, Perju Dumbrava, L, Popescu, C, Simu, M, Stefanache, F, Toldisan, I, Tuta, S, Zaharia, C, Alifirova, V, Arkhipov, S, Balunov, O, Balyazin, V, Belkin, A, Belova, A, Boiko, A, Bogdanov, E, Butko, D, Chukhlovina, M, Doronin, B, Ermilova, E, Evzelman, M, Fedin, A, Fedorova, N, Golikov, K, Golovkin, V, Gusev, E, Gustov, A, Jakupov, E, Kamchatnov, P, Khabirov, F, Kirienko, A, Klimov, I, Klocheva, E, Kotov, S, Kuznetsov, A, Laskov, V, Levin, Y, Mashkova, N, Nazarov, A, Novikova, L, Odinak, M, Parfenov, V, Pilipenko, P, Pokrovsky, A, Poverennova, I, Rodoman, G, Roshkovskaya, L, Shirokov, E, Shmyriov, V, Sholomov, I, Skoromets, A, Skvortsova, V, Spirin, N, Stakhovskaya, L, Sharov, M, Sherman, M, Shutov, A, Strachunskaya, E, Stulin, I, Suslina, Z, Volosevitch, A, Vorobiev, P, Vorobyeva, O, Voronkova, L, Voskresenskaya, O, Zhuliov, N, Chan, B, Chang, H, Ramani, N, Brozman, M, Dvorak, M, Dzugan, J, Garay, R, Gdovinova, Z, Gurcik, L, Krastev, G, Kukumberg, P, Kurca, E, Meluch, S, Nyeky, M, Turcani, P, Vyletelka, J, Klanjscek, G, Zujovic, E, Zupan, M, Bester, F, Carr, J, Coetzee, C, Frost, A, Gardiner, J, Giampaolo, D, Kesler, S, Lurie, D, Retief, C, Roos, J, Bae, H, Cha, J, Cho, K, Heo, J, Kim, E, Lee, B, Lee, K, Lee, J, Rha, J, Yoon, B, Alvarez Sabin, J, Arboix Damunt, A, De Arce Borda, A, Asensi Alvarez JM, Bermejo Pareja, F, Botia Paniagua, E, Casado, I, Naranjo, I, Castillo Sanchez, J, Chamorro Sanchez, A, Davalos Errando, A, Diaz Marin, C, Diez Tejedor, E, Egido Herrero JA, Fernandez Bolanos, R, Fernandez Fernandez, O, Figuerola Roig, A, Geffner Sclarsky, D, Gil Nunez, A, Gomez Sanchez JC, Gomez Escalonilla Escobar CI, Gonzalez Masegosa, A, Gonzalez Menacho, J, Gracia Fleta, F, Izquierdo Ayuso, G, Jimenez Hernandez, D, Jimenez Martinez, C, Lago Martin, A, Lainez Andres JM, Larracoechea Jausoro, J, Lopez Fernandez JC, Maestre Moreno, J, Marti Vilalta JL, Martin Gonzalez, R, Masjuan Vallejo, J, Medina Rodriguez, A, Molto Jorda JM, Moreno Carre tero MJ, Moris de le Tassa, G, Morlan Gracia, L, Mostacero Miguez, E, Osuna Pulido, T, Pareja Martinez, A, Pinedo Brochado, A, Pons Amate JM, Rodriguez Alvarez JR, Roquer Gonzalez, J, Sanahuja Montesinos, J, Sanchez Sanchez MC, Segura Martin, T, Serena Leal, J, Tejada Garcia, J, Trejo Gabriel JM, Vivancos Mora, J, Andersson, B, Bysell, S, Cederin, B, Laska, A, Lindgren, A, Petersson, T, Wallen, T, Baumgartner, R, Beer, H, Hirt, L, Hungerbuehler, H, Lyrer, P, Michel, P, Mueller, F, Tettenborn, B, Chang, K, Jeng, J, Lien, L, Lin, R, Liu, C, Po, H, Wu, S, Chankrachang, S, Laptikultham, S, Nidhinandana, S, Pongpakdee, S, Benammou, S, Frih Ayed, M, Gouider, R, Mhiri, C, M'Rabet, A, Mrissa, R, Balkan, S, Can, U, Dalkara, T, Kirbas, D, Kumral, E, Ozdemir, G, Ozeren, A, Ozmenoglu, M, Ozturk, S, Lebedynets, V, Maly, V, Moskovko, S, Orzheshkovskyy, V, Smolanka, V, Yavors'Ka, V, Zozulya, I, Bamford, J, Barber, M, Barer, D, Baron, J, Bath, P, Broughton, D, Brown, M, Chataway, J, Curless, R, Darawil, K, Datta, P, Dennis, M, Durairaj, R, Egbuji, J, Ellis, S, Ford, G, Freeman, A, Fulcher, R, Gray, C, Harrington, F, Hudson, C, Iveson, E, James, M, Jenkinson, D, Kalra, L, Kelly, D, Krishnamoorthy, S, Langhorne, P, Magorrian, M, Macleod, M, Macwalter, R, Markus, H, Muhiddin, K, Muir, K, Murphy, P, Power, M, Price, C, Rashed, K, Robinson, T, Rudd, A, Sanmuganathan, P, Sharma, J, Shaw, L, Shetty, H, Smithard, D, Tyrrell, P, Vahidassr, M, Venables, G, Watt, M, White, R, Bousser, M, Amarenco, P, Chamorro, A, Fisher, M, Ford, I, Fox, K, Hennerici, M, Mattle, H, Rothwell, P, Ferrarese, C, PERFORM study, I, PERFORM STUDY, Investigator, Tedeschi, Gioacchino, Cras, Patrick, De Deyn, Peter Paul, and et al.

Subjects
perform study, Male, Thromboxane, International Cooperation, Receptors, Thromboxane, antiplatelet therapy, terutroban, Cardiovascular Disease, Receptors, 80 and over, Stroke, Aged, 80 and over, Aspirin, Ischemic Attack, Transient, Ischemic Attack, Transient, Double-Blind Method, Endpoint Determination, Dose-Response Relationship, Drug, Humans, Aged, Propionates, Naphthalenes, Treatment Outcome, Platelet Aggregation Inhibitors, Cardiovascular Diseases, Middle Aged, Female, Propionic Acids, Neurology, Terutroban, Anesthesia, tp receptor antagonist, stroke, secondary prevention, aspirin, Cardiology, Platelet aggregation inhibitor, Settore MED/26 - Neurologia, stroke prevention, Drug, Cardiology and Cardiovascular Medicine, medicine.drug, Human, medicine.medical_specialty, Dose-Response Relationship, Internal medicine, medicine, Dementia, In patient, business.industry, Platelet Aggregation Inhibitor, schemic, medicine.disease, DementiaI, transient ischemic attack, Ischemic stroke, Human medicine, Neurology (clinical), business, Propionic Acid, Naphthalene
Abstract

Background: Ischemic stroke is the leading cause of mortality worldwide and a major contributor to neurological disability and dementia. Terutroban is a specific TP receptor antagonist with antithrombotic, antivasoconstrictive, and antiatherosclerotic properties, which may be of interest for the secondary prevention of ischemic stroke. This article describes the rationale and design of the Prevention of cerebrovascular and cardiovascular Events of ischemic origin with teRutroban in patients with a history oF ischemic strOke or tRansient ischeMic Attack (PERFORM) Study, which aims to demonstrate the superiority of the efficacy of terutroban versus aspirin in secondary prevention of cerebrovascular and cardiovascular events. Methods and Results: The PERFORM Study is a multicenter, randomized, double-blind, parallel-group study being carried out in 802 centers in 46 countries. The study population includes patients aged ≥55 years, having suffered an ischemic stroke (≤3 months) or a transient ischemic attack (≤8 days). Participants are randomly allocated to terutroban (30 mg/day) or aspirin (100 mg/day). The primary efficacy endpoint is a composite of ischemic stroke (fatal or nonfatal), myocardial infarction (fatal or nonfatal), or other vascular death (excluding hemorrhagic death of any origin). Safety is being evaluated by assessing hemorrhagic events. Follow-up is expected to last for 2–4 years. Assuming a relative risk reduction of 13%, the expected number of primary events is 2,340. To obtain statistical power of 90%, this requires inclusion of at least 18,000 patients in this event-driven trial. The first patient was randomized in February 2006. Conclusions: The PERFORM Study will explore the benefits and safety of terutroban in secondary cardiovascular prevention after a cerebral ischemic event.

Published
2009

71. A practical approach to diagnosing adult onset leukodystrophies

Author

Ahmed, R. M., primary, Murphy, E., additional, Davagnanam, I., additional, Parton, M., additional, Schott, J. M., additional, Mummery, C. J., additional, Rohrer, J. D., additional, Lachmann, R. H., additional, Houlden, H., additional, Fox, N. C., additional, and Chataway, J., additional

Published
2013
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72. The potential benefit of stem cell therapy after stroke: an update

Author

Banerjee, S, Williamson, DA, Habib, N, Chataway, J, Banerjee, S, Williamson, DA, Habib, N, and Chataway, J

Abstract

Stroke is a leading cause of death and disability worldwide. Stem cell therapy is an emerging therapeutic modality with evidence of significant benefits in preclinical stroke models. A number of phase I and II clinical trials have now been completed, with several more currently under way. Translation to the bedside, however, remains a long way off, and there are many questions that remain unanswered. This review will summarize the current evidence and ongoing clinical trials worldwide, and explore the challenges to making this a realistic treatment option for the future.

Published
2012

73. Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomised controlled trial.

Author

Giroux M.-F., Prakash K.G., Serracino-Inglott F., Subramanian G., Symth J.V., Walker M.G., Clarke M., Davis M., Dixit S.A., Dorman P., Dyker A., Ford G., Golkar A., Jackson R., Jayakrishnan V., Lambert D., Lees T., Louw S., Mendelow A.D., Rodgers H., Rose J., Stansby G., Wyatt M., Baker T., Baldwin N., Jones L., Mitchell D., Munro E., Thornton M., Baker D., Davis N., Hamilton G., Platts A., Tibballs J., Beard J., Cleveland T., Dodd D., Gaines P., Lonsdale R., Nair R., Nassef A., Nawaz S., Venables G., Belli A., Clifton A., Cloud G., Halliday A., Markus H., McFarland R., Morgan R., Pereira A., Thompson A., Chataway J., Cheshire N., Gibbs R., Hammady M., Jenkins M., Malik I., Wolfe J., Adiseshiah M., Bishop C., Brew S., Brookes J., Jager R., Kitchen N., Ashleigh R., Butterfield S., Gamble G.E., Nasim A., O'Neill P., Wong J., Edwards R.D., Lees K.R., MacKay A.J., Moss J., Rogers P., Ederle J., Dobson J., Featherstone R.L., Bonati L.H., van der Worp H.B., de Borst G.J., Hauw Lo T., Dorman P.J., Macdonald S., Lyrer P.A., McCollum C., Nederkoorn P.J., Brown M.M., Algra A., Bamford J., Bland M., Hacke W., Mas J.L., McGuire A.J., Sidhu P., Bradbury A., Collins R., Molyneux A., Naylor R., Warlow C., Ferro M., Thomas D., Featherstone R.F., Tindall H., McCabe D., Wallis A., Coward L., Brooks M., Chambers B., Chan A., Chu P., Clark D., Dewey H., Donnan G., Fell G., Hoare M., Molan M., Roberts A., Roberts N., Beiles B., Bladin C., Clifford C., Grigg M., New G., Bell R., Bower S., Chong W., Holt M., Saunder A., Than P.G., Gett S., Leggett D., McGahan T., Quinn J., Ray M., Wong A., Woodruff P., Foreman R., Schultz D., Scroop R., Stanley B., Allard B., Atkinson N., Cambell W., Davies S., Field P., Milne P., Mitchell P., Tress B., Yan B., Beasley A., Dunbabin D., Stary D., Walker S., Cras P., d'Archambeau O., Hendriks J.M.H., Van Schil P., Bosiers M., Deloose K., van Buggenhout E., De Letter J., Devos V., Ghekiere J., Vanhooren G., Astarci P., Hammer F., Lacroix V., Verhelst R., DeJaegher L., Peeters A., Verbist J., Blair J.-F., Caron J.L., Daneault N., Guilbert F., Lanthier S., Lebrun L.-H., Oliva V., Raymond J., Roy D., Soulez G., Weill A., Hill M., Hu W., Hudion M., Morrish W., Sutherland G., Alback A., Harno H., Ijas P., Kaste M., Lepantalo M., Mustanoja S., Paananen T., Porras M., Putaala J., Railo M., Sairanen T., Soinne L., Vehmas A., Vikatmaa P., Goertler M., Halloul Z., Skalej M., Brennan P., Kelly C., Leahy A., Moroney J., Thornton J., Koelemay M.J.W., Reekers J.A.A., Roos Y.B.W.E.M., Hendriks J.M., Koudstaal P.J., Pattynama P.M.T., van der Lugt A., van Dijk L.C., van Sambeek M.R.H.M., van Urk H., Verhagen H.J.M., Bruijninckx C.M.A., de Bruijn S.F., Keunen R., Knippenberg B., Mosch A., Treurniet F., van Dijk L., van Overhagen H., Wever J., de Beer F.C., van den Berg J.S.P., van Hasselt B.A.A.M., Zeilstra D.J., Boiten J., de Mol van Otterloo J.C.A., de Vries A.C., Lycklama a Nijeholt G.J., van der Kallen B.F.W., Blankensteijn J.D., De Leeuw F.E., Schultze Kool L.J., van der Vliet J.A., de Kort G.A.P., Kapelle L.J., Lo T.H., Mali W.P.T.M., Moll F., Verhagen H., Barber P.A., Bourchier R., Hill A., Holden A., Stewart J., Bakke S.J., Krohg-Sorensen K., Skjelland M., Tennoe B., Bialek P., Biejat Z., Czepiel W., Czlonkowska A., Dowzenko A., Jedrzejewska J., Kobayashi A., Lelek M., Polanski J., Kirbis J., Milosevic Z., Zvan B., Blasco J., Chamorro A., Macho J., Obach V., Riambau V., San Roman L., Branera J., Canovas D., Estela J., Gimenez Gaibar A., Perendreu J., Bjorses K., Gottsater A., Ivancev K., Maetzsch T., Sonesson B., Berg B., Delle M., Formgren J., Gillgren P., Kall T.-B., Konrad P., Nyman N., Takolander R., Andersson T., Malmstedt J., Soderman M., Wahlgren C., Wahlgren N., Binaghi S., Hirt L., Michel P., Ruchat P., Engelter S.T., Fluri F., Guerke L., Jacob A.L., Kirsch E., Radue E.-W., Stierli P., Wasner M., Wetzel S., Bonvin C., Kalangos A., Lovblad K., Murith N., Ruefenacht D., Sztajzel R., Higgins N., Kirkpatrick P.J., Martin P., Adam D., Bell J., Bradbury A.W., Crowe P., Gannon M., Henderson M.J., Sandler D., Shinton R.A., Scriven J.M., Wilmink T., D'Souza S., Egun A., Guta R., Punekar S., Seriki D.M., Thomson G., Brennan J.A., Enevoldson T.P., Gilling-Smith G., Gould D.A., Harris P.L., McWilliams R.G., Nasser H.-C., White R., Giroux M.-F., Prakash K.G., Serracino-Inglott F., Subramanian G., Symth J.V., Walker M.G., Clarke M., Davis M., Dixit S.A., Dorman P., Dyker A., Ford G., Golkar A., Jackson R., Jayakrishnan V., Lambert D., Lees T., Louw S., Mendelow A.D., Rodgers H., Rose J., Stansby G., Wyatt M., Baker T., Baldwin N., Jones L., Mitchell D., Munro E., Thornton M., Baker D., Davis N., Hamilton G., Platts A., Tibballs J., Beard J., Cleveland T., Dodd D., Gaines P., Lonsdale R., Nair R., Nassef A., Nawaz S., Venables G., Belli A., Clifton A., Cloud G., Halliday A., Markus H., McFarland R., Morgan R., Pereira A., Thompson A., Chataway J., Cheshire N., Gibbs R., Hammady M., Jenkins M., Malik I., Wolfe J., Adiseshiah M., Bishop C., Brew S., Brookes J., Jager R., Kitchen N., Ashleigh R., Butterfield S., Gamble G.E., Nasim A., O'Neill P., Wong J., Edwards R.D., Lees K.R., MacKay A.J., Moss J., Rogers P., Ederle J., Dobson J., Featherstone R.L., Bonati L.H., van der Worp H.B., de Borst G.J., Hauw Lo T., Dorman P.J., Macdonald S., Lyrer P.A., McCollum C., Nederkoorn P.J., Brown M.M., Algra A., Bamford J., Bland M., Hacke W., Mas J.L., McGuire A.J., Sidhu P., Bradbury A., Collins R., Molyneux A., Naylor R., Warlow C., Ferro M., Thomas D., Featherstone R.F., Tindall H., McCabe D., Wallis A., Coward L., Brooks M., Chambers B., Chan A., Chu P., Clark D., Dewey H., Donnan G., Fell G., Hoare M., Molan M., Roberts A., Roberts N., Beiles B., Bladin C., Clifford C., Grigg M., New G., Bell R., Bower S., Chong W., Holt M., Saunder A., Than P.G., Gett S., Leggett D., McGahan T., Quinn J., Ray M., Wong A., Woodruff P., Foreman R., Schultz D., Scroop R., Stanley B., Allard B., Atkinson N., Cambell W., Davies S., Field P., Milne P., Mitchell P., Tress B., Yan B., Beasley A., Dunbabin D., Stary D., Walker S., Cras P., d'Archambeau O., Hendriks J.M.H., Van Schil P., Bosiers M., Deloose K., van Buggenhout E., De Letter J., Devos V., Ghekiere J., Vanhooren G., Astarci P., Hammer F., Lacroix V., Verhelst R., DeJaegher L., Peeters A., Verbist J., Blair J.-F., Caron J.L., Daneault N., Guilbert F., Lanthier S., Lebrun L.-H., Oliva V., Raymond J., Roy D., Soulez G., Weill A., Hill M., Hu W., Hudion M., Morrish W., Sutherland G., Alback A., Harno H., Ijas P., Kaste M., Lepantalo M., Mustanoja S., Paananen T., Porras M., Putaala J., Railo M., Sairanen T., Soinne L., Vehmas A., Vikatmaa P., Goertler M., Halloul Z., Skalej M., Brennan P., Kelly C., Leahy A., Moroney J., Thornton J., Koelemay M.J.W., Reekers J.A.A., Roos Y.B.W.E.M., Hendriks J.M., Koudstaal P.J., Pattynama P.M.T., van der Lugt A., van Dijk L.C., van Sambeek M.R.H.M., van Urk H., Verhagen H.J.M., Bruijninckx C.M.A., de Bruijn S.F., Keunen R., Knippenberg B., Mosch A., Treurniet F., van Dijk L., van Overhagen H., Wever J., de Beer F.C., van den Berg J.S.P., van Hasselt B.A.A.M., Zeilstra D.J., Boiten J., de Mol van Otterloo J.C.A., de Vries A.C., Lycklama a Nijeholt G.J., van der Kallen B.F.W., Blankensteijn J.D., De Leeuw F.E., Schultze Kool L.J., van der Vliet J.A., de Kort G.A.P., Kapelle L.J., Lo T.H., Mali W.P.T.M., Moll F., Verhagen H., Barber P.A., Bourchier R., Hill A., Holden A., Stewart J., Bakke S.J., Krohg-Sorensen K., Skjelland M., Tennoe B., Bialek P., Biejat Z., Czepiel W., Czlonkowska A., Dowzenko A., Jedrzejewska J., Kobayashi A., Lelek M., Polanski J., Kirbis J., Milosevic Z., Zvan B., Blasco J., Chamorro A., Macho J., Obach V., Riambau V., San Roman L., Branera J., Canovas D., Estela J., Gimenez Gaibar A., Perendreu J., Bjorses K., Gottsater A., Ivancev K., Maetzsch T., Sonesson B., Berg B., Delle M., Formgren J., Gillgren P., Kall T.-B., Konrad P., Nyman N., Takolander R., Andersson T., Malmstedt J., Soderman M., Wahlgren C., Wahlgren N., Binaghi S., Hirt L., Michel P., Ruchat P., Engelter S.T., Fluri F., Guerke L., Jacob A.L., Kirsch E., Radue E.-W., Stierli P., Wasner M., Wetzel S., Bonvin C., Kalangos A., Lovblad K., Murith N., Ruefenacht D., Sztajzel R., Higgins N., Kirkpatrick P.J., Martin P., Adam D., Bell J., Bradbury A.W., Crowe P., Gannon M., Henderson M.J., Sandler D., Shinton R.A., Scriven J.M., Wilmink T., D'Souza S., Egun A., Guta R., Punekar S., Seriki D.M., Thomson G., Brennan J.A., Enevoldson T.P., Gilling-Smith G., Gould D.A., Harris P.L., McWilliams R.G., Nasser H.-C., and White R.

Abstract

Background: Stents are an alternative treatment to carotid endarterectomy for symptomatic carotid stenosis, but previous trials have not established equivalent safety and efficacy. We compared the safety of carotid artery stenting with that of carotid endarterectomy. Method(s): The International Carotid Stenting Study (ICSS) is a multicentre, international, randomised controlled trial with blinded adjudication of outcomes. Patients with recently symptomatic carotid artery stenosis were randomly assigned in a 1:1 ratio to receive carotid artery stenting or carotid endarterectomy. Randomisation was by telephone call or fax to a central computerised service and was stratified by centre with minimisation for sex, age, contralateral occlusion, and side of the randomised artery. Patients and investigators were not masked to treatment assignment. Patients were followed up by independent clinicians not directly involved in delivering the randomised treatment. The primary outcome measure of the trial is the 3-year rate of fatal or disabling stroke in any territory, which has not been analysed yet. The main outcome measure for the interim safety analysis was the 120-day rate of stroke, death, or procedural myocardial infarction. Analysis was by intention to treat (ITT). This study is registered, number ISRCTN25337470. Finding(s): The trial enrolled 1713 patients (stenting group, n=855; endarterectomy group, n=858). Two patients in the stenting group and one in the endarterectomy group withdrew immediately after randomisation, and were not included in the ITT analysis. Between randomisation and 120 days, there were 34 (Kaplan-Meier estimate 4.0%) events of disabling stroke or death in the stenting group compared with 27 (3.2%) events in the endarterectomy group (hazard ratio [HR] 1.28, 95% CI 0.77-2.11). The incidence of stroke, death, or procedural myocardial infarction was 8.5% in the stenting group compared with 5.2% in the endarterectomy group (72 vs 44 events; HR 1.69, 1.

Published
2010

74. Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomised controlled trial

Author

Ederle, Jörg, Dobson, Joanna, Featherstone, Roland L., Bonati, Leo H., van der Worp, H. Bart, de Borst, Gert J., Hauw Lo, T., Gaines, Peter, Dorman, Paul J., Macdonald, Sumaira, Lyrer, Philippe A., Hendriks, Johanna M., McCollum, Charles, Nederkoorn, Paul J., Brown, Martin M., Algra, A., Bamford, J., Bland, M., Hacke, W., Mas, J.L., McGuire, A.J., Sidhu, P., Bradbury, A., Collins, R., Molyneux, A., Naylor, R., Warlow, C., Ferro, M., Thomas, D., Featherstone, R.F., Tindall, H., McCabe, D.J.H., Wallis, A., Coward, L., Brooks, M., Chambers, B., Chan, A., Chu, P., Clark, D., Dewey, H., Donnan, G., Fell, G., Hoare, M., Molan, M., Roberts, A., Roberts, N., Beiles, B., Bladin, C., Clifford, C., Grigg, M., New, G., Bell, R., Bower, S., Chong, W., Holt, M., Saunder, A., Than, P.G., Gett, S., Leggett, D., McGahan, T., Quinn, J., Ray, M., Wong, A., Woodruff, P., Foreman, R., Schultz, D., Scroop, R., Stanley, B., Allard, B., Atkinson, N., Cambell, W., Davies, S., Field, P., Milne, P., Mitchell, P., Tress, B., Yan, B., Beasley, A., Dunbabin, D., Stary, D., Walker, S., Cras, P., d'Archambeau, O., Hendriks, J.M.H., Van Schil, P., Bosiers, M., Deloose, K., van Buggenhout, E., De Letter, J., Devos, V., Ghekiere, J., Vanhooren, G., Astarci, P., Hammer, F., Lacroix, V., Peeters, A., Verhelst, R., DeJaegher, L., Verbist, J., Blair, J.-F., Caron, J.L., Daneault, N., Giroux, M.-F., Guilbert, F., Lanthier, S., Lebrun, L.-H., Oliva, V., Raymond, J., Roy, D., Soulez, G., Weill, A., Hill, M., Hu, W., Hudion, M., Morrish, W., Sutherland, G., Wong, J., Albäck, A., Harno, H., Ijäs, P., Kaste, M., Lepäntalo, M., Mustanoja, S., Paananen, T., Porras, M., Putaala, J., Railo, M., Sairanen, T., Soinne, L., Vehmas, A., Vikatmaa, P., Goertler, M., Halloul, Z., Skalej, M., Brennan, P., Kelly, C., Leahy, A., Moroney, J., Thornton, J., Koelemay, M.J.W., Reekers, J.A.A., Roos, Y.B.W.E.M., Hendriks, J.M., Koudstaal, P.J., Pattynama, P.M.T., van der Lugt, A., van Dijk, L.C., van Sambeek, M.R.H.M., van Urk, H., Verhagen, H.J.M., Bruijninckx, C.M.A., de Bruijn, S.F., Keunen, R., Knippenberg, B., Mosch, A., Treurniet, F., van Dijk, L., van Overhagen, H., Wever, J., de Beer, F.C., van den Berg, J.S.P., van Hasselt, B.A.A.M., Zeilstra, D.J., Boiten, J., de Mol van Otterloo, J.C.A., de Vries, A.C., Lycklama a Nijeholt, G.J., van der Kallen, B.F.W., Blankensteijn, J.D., De Leeuw, F.E., Schultze Kool, L.J., van der Vliet, J.A., de Kort, G.A.P., Kapelle, L.J., Lo, T.H., Mali, W.P.T.M., Moll, F., Verhagen, H., Barber, P.A., Bourchier, R., Hill, A., Holden, A., Stewart, J., Bakke, S.J., Krohg-Sørensen, K., Skjelland, M., Tennøe, B., Bialek, P., Biejat, Z., Czepiel, W., Czlonkowska, A., Dowzenko, A., Jedrzejewska, J., Kobayashi, A., Lelek, M., Polanski, J., Kirbis, J., Milosevic, Z., Zvan, B., Blasco, J., Chamorro, A., Macho, J., Obach, V., Riambau, V., San Roman, L., Branera, J., Canovas, D., Estela, Jordi, Gimenez Gaibar, A., Perendreu, J., Björses, K., Gottsater, A., Ivancev, K., Maetzsch, T., Sonesson, B., Berg, B., Delle, M., Formgren, J., Gillgren, P., Kall, T.-B., Konrad, P., Nyman, N., Takolander, R., Andersson, T., Malmstedt, J., Soderman, M., Wahlgren, C., Wahlgren, N., Binaghi, S., Hirt, L., Michel, P., Ruchat, P., Engelter, S.T., Fluri, F., Guerke, L., Jacob, A.L., Kirsch, E., Radue, E.-W., Stierli, P., Wasner, M., Wetzel, S., Bonvin, C., Kalangos, A., Lovblad, K., Murith, N., Ruefenacht, D., Sztajzel, R., Higgins, N., Kirkpatrick, P.J., Martin, P., Adam, D., Bell, J., Bradbury, A.W., Crowe, P., Gannon, M., Henderson, M.J., Sandler, D., Shinton, R.A., Scriven, J.M., Wilmink, T., D'Souza, S., Egun, A., Guta, R., Punekar, S., Seriki, D.M., Thomson, G., Brennan, J.A., Enevoldson, T.P., Gilling-Smith, G., Gould, D.A., Harris, P.L., McWilliams, R.G., Nasser, H.-C., White, R., Prakash, K.G., Serracino-Inglott, F., Subramanian, G., Symth, J.V., Walker, M.G., Clarke, M., Davis, M., Dixit, S.A., Dorman, P., Dyker, A., Ford, G., Golkar, A., Jackson, R., Jayakrishnan, V., Lambert, D., Lees, T., Louw, S., Mendelow, A.D., Rodgers, H., Rose, J., Stansby, G., Wyatt, M., Baker, T., Baldwin, N., Jones, L., Mitchell, D., Munro, E., Thornton, M., Baker, D., Davis, N., Hamilton, G., McCabe, D., Platts, A., Tibballs, J., Beard, J., Cleveland, T., Dodd, D., Gaines, P., Lonsdale, R., Nair, R., Nassef, A., Nawaz, S., Venables, G., Belli, A., Clifton, A., Cloud, G., Halliday, A., Markus, H., McFarland, R., Morgan, R., Pereira, A., Thompson, A., Chataway, J., Cheshire, N., Gibbs, R., Hammady, M., Jenkins, M., Malik, I., Wolfe, J., Adiseshiah, M., Bishop, C., Brew, S., Brookes, J., Jäger, R., Kitchen, N., Ashleigh, R., Butterfield, S., Gamble, G.E., Nasim, A., O'Neill, P., Edwards, R.D., Lees, K.R., MacKay, A.J., Moss, J., Rogers, P., Ederle, Jörg, Dobson, Joanna, Featherstone, Roland L., Bonati, Leo H., van der Worp, H. Bart, de Borst, Gert J., Hauw Lo, T., Gaines, Peter, Dorman, Paul J., Macdonald, Sumaira, Lyrer, Philippe A., Hendriks, Johanna M., McCollum, Charles, Nederkoorn, Paul J., Brown, Martin M., Algra, A., Bamford, J., Bland, M., Hacke, W., Mas, J.L., McGuire, A.J., Sidhu, P., Bradbury, A., Collins, R., Molyneux, A., Naylor, R., Warlow, C., Ferro, M., Thomas, D., Featherstone, R.F., Tindall, H., McCabe, D.J.H., Wallis, A., Coward, L., Brooks, M., Chambers, B., Chan, A., Chu, P., Clark, D., Dewey, H., Donnan, G., Fell, G., Hoare, M., Molan, M., Roberts, A., Roberts, N., Beiles, B., Bladin, C., Clifford, C., Grigg, M., New, G., Bell, R., Bower, S., Chong, W., Holt, M., Saunder, A., Than, P.G., Gett, S., Leggett, D., McGahan, T., Quinn, J., Ray, M., Wong, A., Woodruff, P., Foreman, R., Schultz, D., Scroop, R., Stanley, B., Allard, B., Atkinson, N., Cambell, W., Davies, S., Field, P., Milne, P., Mitchell, P., Tress, B., Yan, B., Beasley, A., Dunbabin, D., Stary, D., Walker, S., Cras, P., d'Archambeau, O., Hendriks, J.M.H., Van Schil, P., Bosiers, M., Deloose, K., van Buggenhout, E., De Letter, J., Devos, V., Ghekiere, J., Vanhooren, G., Astarci, P., Hammer, F., Lacroix, V., Peeters, A., Verhelst, R., DeJaegher, L., Verbist, J., Blair, J.-F., Caron, J.L., Daneault, N., Giroux, M.-F., Guilbert, F., Lanthier, S., Lebrun, L.-H., Oliva, V., Raymond, J., Roy, D., Soulez, G., Weill, A., Hill, M., Hu, W., Hudion, M., Morrish, W., Sutherland, G., Wong, J., Albäck, A., Harno, H., Ijäs, P., Kaste, M., Lepäntalo, M., Mustanoja, S., Paananen, T., Porras, M., Putaala, J., Railo, M., Sairanen, T., Soinne, L., Vehmas, A., Vikatmaa, P., Goertler, M., Halloul, Z., Skalej, M., Brennan, P., Kelly, C., Leahy, A., Moroney, J., Thornton, J., Koelemay, M.J.W., Reekers, J.A.A., Roos, Y.B.W.E.M., Hendriks, J.M., Koudstaal, P.J., Pattynama, P.M.T., van der Lugt, A., van Dijk, L.C., van Sambeek, M.R.H.M., van Urk, H., Verhagen, H.J.M., Bruijninckx, C.M.A., de Bruijn, S.F., Keunen, R., Knippenberg, B., Mosch, A., Treurniet, F., van Dijk, L., van Overhagen, H., Wever, J., de Beer, F.C., van den Berg, J.S.P., van Hasselt, B.A.A.M., Zeilstra, D.J., Boiten, J., de Mol van Otterloo, J.C.A., de Vries, A.C., Lycklama a Nijeholt, G.J., van der Kallen, B.F.W., Blankensteijn, J.D., De Leeuw, F.E., Schultze Kool, L.J., van der Vliet, J.A., de Kort, G.A.P., Kapelle, L.J., Lo, T.H., Mali, W.P.T.M., Moll, F., Verhagen, H., Barber, P.A., Bourchier, R., Hill, A., Holden, A., Stewart, J., Bakke, S.J., Krohg-Sørensen, K., Skjelland, M., Tennøe, B., Bialek, P., Biejat, Z., Czepiel, W., Czlonkowska, A., Dowzenko, A., Jedrzejewska, J., Kobayashi, A., Lelek, M., Polanski, J., Kirbis, J., Milosevic, Z., Zvan, B., Blasco, J., Chamorro, A., Macho, J., Obach, V., Riambau, V., San Roman, L., Branera, J., Canovas, D., Estela, Jordi, Gimenez Gaibar, A., Perendreu, J., Björses, K., Gottsater, A., Ivancev, K., Maetzsch, T., Sonesson, B., Berg, B., Delle, M., Formgren, J., Gillgren, P., Kall, T.-B., Konrad, P., Nyman, N., Takolander, R., Andersson, T., Malmstedt, J., Soderman, M., Wahlgren, C., Wahlgren, N., Binaghi, S., Hirt, L., Michel, P., Ruchat, P., Engelter, S.T., Fluri, F., Guerke, L., Jacob, A.L., Kirsch, E., Radue, E.-W., Stierli, P., Wasner, M., Wetzel, S., Bonvin, C., Kalangos, A., Lovblad, K., Murith, N., Ruefenacht, D., Sztajzel, R., Higgins, N., Kirkpatrick, P.J., Martin, P., Adam, D., Bell, J., Bradbury, A.W., Crowe, P., Gannon, M., Henderson, M.J., Sandler, D., Shinton, R.A., Scriven, J.M., Wilmink, T., D'Souza, S., Egun, A., Guta, R., Punekar, S., Seriki, D.M., Thomson, G., Brennan, J.A., Enevoldson, T.P., Gilling-Smith, G., Gould, D.A., Harris, P.L., McWilliams, R.G., Nasser, H.-C., White, R., Prakash, K.G., Serracino-Inglott, F., Subramanian, G., Symth, J.V., Walker, M.G., Clarke, M., Davis, M., Dixit, S.A., Dorman, P., Dyker, A., Ford, G., Golkar, A., Jackson, R., Jayakrishnan, V., Lambert, D., Lees, T., Louw, S., Mendelow, A.D., Rodgers, H., Rose, J., Stansby, G., Wyatt, M., Baker, T., Baldwin, N., Jones, L., Mitchell, D., Munro, E., Thornton, M., Baker, D., Davis, N., Hamilton, G., McCabe, D., Platts, A., Tibballs, J., Beard, J., Cleveland, T., Dodd, D., Gaines, P., Lonsdale, R., Nair, R., Nassef, A., Nawaz, S., Venables, G., Belli, A., Clifton, A., Cloud, G., Halliday, A., Markus, H., McFarland, R., Morgan, R., Pereira, A., Thompson, A., Chataway, J., Cheshire, N., Gibbs, R., Hammady, M., Jenkins, M., Malik, I., Wolfe, J., Adiseshiah, M., Bishop, C., Brew, S., Brookes, J., Jäger, R., Kitchen, N., Ashleigh, R., Butterfield, S., Gamble, G.E., Nasim, A., O'Neill, P., Edwards, R.D., Lees, K.R., MacKay, A.J., Moss, J., and Rogers, P.

Abstract

Background: Stents are an alternative treatment to carotid endarterectomy for symptomatic carotid stenosis, but previous trials have not established equivalent safety and efficacy. We compared the safety of carotid artery stenting with that of carotid endarterectomy. Methods: The International Carotid Stenting Study (ICSS) is a multicentre, international, randomised controlled trial with blinded adjudication of outcomes. Patients with recently symptomatic carotid artery stenosis were randomly assigned in a 1:1 ratio to receive carotid artery stenting or carotid endarterectomy. Randomisation was by telephone call or fax to a central computerised service and was stratified by centre with minimisation for sex, age, contralateral occlusion, and side of the randomised artery. Patients and investigators were not masked to treatment assignment. Patients were followed up by independent clinicians not directly involved in delivering the randomised treatment. The primary outcome measure of the trial is the 3-year rate of fatal or disabling stroke in any territory, which has not been analysed yet. The main outcome measure for the interim safety analysis was the 120-day rate of stroke, death, or procedural myocardial infarction. Analysis was by intention to treat (ITT). This study is registered, number ISRCTN25337470. Findings: The trial enrolled 1713 patients (stenting group, n=855; endarterectomy group, n=858). Two patients in the stenting group and one in the endarterectomy group withdrew immediately after randomisation, and were not included in the ITT analysis. Between randomisation and 120 days, there were 34 (Kaplan-Meier estimate 4·0%) events of disabling stroke or death in the stenting group compared with 27 (3·2%) events in the endarterectomy group (hazard ratio [HR] 1·28, 95% CI 0·77-2·11). The incidence of stroke, death, or procedural myocardial infarction was 8·5% in the stenting group compared with 5·2% in the endarterectomy group (72 vs 44 events; HR 1·69, 1·16-2

Published
2010

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