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1. Status update and interim results from the asymptomatic carotid surgery trial-2 (ACST-2)

Author

Bulbulia, R, Gray, W, Naughten, A, den Hartog, A, Delmestri, A, Wallis, C, le Conte, S, Macdonald, S, Radak, D, Nessi, F, Torsello, G, Hendriks, J, Bjorses, K, Davidovic, L, Tusini, N, Gillgren, P, Casana, R, Tolva, V, Bausback, Y, Mehrzad, A, Gottsäter, A, Esisi, B, Cras, P, Hendriks, Jm, Lauwers, P, Hertoghs, M, Van Schil, P, De Jaegher, L, Peeters, P, Verbist, J, Dendooven, D, De Letter, J, Vanhooren, G, Astarci, P, Capron, I, Choghari, C, Hammer, F, Lacroix, V, Peeters, A, Verhelst, R, Bosiers, M, De Meester, K, Deloose, K, Van Buggenhout, E, Vinck, E, Geenens, M, Hemelsoet, D, Van Herzeele, I, Vermassen, F, De Koster, G, Desiron, Q, Maertens de Noordhout, A, Malmendier, D, Massoz, M, Saad, G, Cirelli, S, Dormal, P, Lerut, P, Thues, E, Coutts, S, Demchuk, A, Hill, M, Hudon, M, Klein, G, Mcclelland, M, Morrish, W, Samis, G, Sutherland, G, Watson, T, Wong, J, Liu, B, Liu, Cw, Barankova, L, Chlouba, V, Fiedler, J, Priban, V, Sterba, L, Kalabova, L, Kriz, Z, Krupa, P, Privara, M, Reif, M, Souckova, L, Staffa, R, Vlachovsky, R, Vojtisek, B, Hrbac, T, Kuliha, M, Prochazka, V, Roubec, M, Skoloudik, D, Abd Allah, F, Eldessoki, Mh, Kassem, Hh, Gharieb, Hs, Cardon, Jm, Le Gallou Wittenberg, A, Allaire, E, Becquemin, Jp, Cochennec, F, Desgranges, P, Hosseini, H, Kobeiter, H, Marzelle, J, Bergeron, P, Padovani, R, Trastour, Jc, Biermaier, B, Gissler, Hm, Klotzsch, C, Pfeiffer, T, Schneider, R, Soehl, L, Wennrih, M, Botsios, S, Branzan, D, Braunlich, S, Holzer, H, Lenzer, J, Reichenbecher, C, Piorkowski, C, Schuster, J, Scheinert, D, Schmidt, A, Ulrich, M, Werner, M, Coster, A, Engelhardt, A, Ratusinski, Cm, Berekoven, B, Frerker, K, Gordon, V, Bellenis, I, Polydorou, A, Polydorou, V, Tavernarakis, A, Ioannou, N, Terzoudi, M, Chatzinikou, E, Giannoukas, A, Hadjigeorgiou, G, Koutsias, S, Ralli, S, Rousas, N, Nemes, B, Jàrànyi, Z, Szabo, A, Varga, D, Barzo, P, Bodosi, M, Fako, E, Fulop, B, Kuncz, A, Nagy, E, Nemeth, T, Pazdernyik, S, Skoba, K, Voros, E, Haider, Sn, Harbison, J, Madhavan, P, Moore, D, Beyar, R, Hoffman, A, Karram, T, Kerner, A, Nikolsky, E, Nitecki, S, Amatucci, G, Vittorio, P, Frederico, Marinazzo, D, Regina, G, Giaquinta, A, Patti, F, Veroux, M, Veroux, P, Adobbati, L, Bertoni, G, Bianchi, P, Cireni, L, Martello, L, Arcuri, L, Casoni, F, Coppi, G, Moratto, R, Veronesi, J, Bajardi, G, Savettieri, G, Corbetta, R, Odero, A, Quaretti, P, Thyrion, Z, Cao, P, Caso, V, Derango, P, Farchioni, L, Parlani, G, Malferrari, G, Strozzi, F, Vecchiati, E, Biello, Antonella, Capoccia, Laura, Menna, Danilo, Rizzo, ANNA RITA, Sbarigia, Enrico, Speziale, Francesco, Toni, D, Giovanni, M, Meola, G, Nano, G, Occiuto, Mt, Stegher, S, Tealdi, D, Accrocca, F, Ambrogi, C, Barbazza, R, Marcucci, G, Cappelli, A, de Donato, G, Palasciano, G, Pieragalli, D, Setacci, C, Settaci, F, Labate, C, Ferrero, E, Ferri, M, Viazzo, A, Castelli, P, Delodovici, Ml, Ferrario, M, Piffaretti, G, Tomei, G, Furui, E, Inoue, T, Kondo, R, Matsumoto, Y, Shimizu, H, Aidashova, B, Kospanov, N, Lyssenko, R, Mussagaliev, D, De Borst GJ, Den Hartog AG, Lo, R, Moll, F, Toorop, R, Van Der Worp HB, Vonken, Ej, Bakke, S, Krohg Sorensen, K, Skjelland, M, Andziak, P, Drelichowski, S, Dratwicki, M, Gil, R, Iwanowski, W, Koncewicz, K, Nowicki, M, Pniewski, J, Rzezak, J, Seweryniak, P, Bialek, P, Biejat, Z, Czepel, W, Czlonkowska, A, Dowzenko, A, Jedzrejewska, J, Kobayashi, A, Leszezyuski, J, Malek, A, Polanski, J, Proczka, R, Skorski, M, Szostek, M, Aleksic, N, Babic, S, Kolar, J, Sagic, D, Tanaskovic, S, Colic, M, Jovanovic, D, Koncar, I, Bartko, D, Beno, P, Rusnak, F, Zelenak, K, Gasparini, M, Grad, A, Kompara, I, Milosevic, Z, Flis, V, Matela, J, Miksic, K, Milotic, F, Mrdja, B, Stirn, B, Tetickovic, E, Chamorro, A, Obach, V, Riambau, V, Roman, S, Blanco, E, Izquierdo, Ay, Guerra, M, Campbell, E, Lindgren, H, Nyberg, J, Plate, G, Parsson, H, Qvarfordt, P, Acosta, S, Brandt, K, Dias, N, Gottsater, A, Holst, J, Kristmundsson, T, Kuhme, T, Kolbel, T, Lindblad, B, Lindh, M, Malina, M, Ohrlander, T, Resch, T, Rönnle, V, Sonesson, B, Warvsten, M, Zdanowski, Z, Bengt, B, Delle, M, Formgren, J, Jarl, L, Kall, Tb, Konrad, P, Nyman, N, Skioldebrand, C, Steuer, J, Takolander, R, Ahlhelm, Fj, Bonati, L, Engelter, Ss, Eugster, T, Gensicke, H, Lyrer, P, Mariani, L, Stierli, P, Stippich, C, Wolff, T, Brown, E, Butler, N, Day, Dj, Hayes, P, Higgins, N, Jumilla, E, Martin, P, Mitchell, J, Varty, K, Birt, A, Davies, P, George, J, Graham, A, Jonker, L, Joseph, T, Kelsall, N, Potts, C, Wilson, T, Davey, P, Hayman, R, Tervitt, G, Abdul Hamiq, A, Bryce, J, Chetter, I, Ettles, D, Lakshminarayan, R, Mitchelsonm, K, Rhymes, C, Robinson, G, Scott, P, Vickers, A, Baht, H, Balogun, I, Burger, I, Cowie, L, Gunathilagan, G, Hargroves, D, Insall, R, Jones, S, Rudenko, H, Senaratne, J, Thomas, G, Thomson, A, Enevoldson, P, Nahser, H, O'Brian, I, Torella, F, Watling, D, White, R, Clifton, A, Eley, C, Khanom, N, O'Reilly, J, Pereira, A, Bicknell, C, Cheshire, N, Gibbs, R, Hamady, M, James, A, Jenkins, M, Lacey, A, Mireskandari, M, Sachs, T, Wolfe, J, Hardy, D, Justin, F, Phiri, L, Sekaran, L, Sethuraman, S, Tate, L, Akyea Mensah, J, Chrisopoulou, A, Smyth, Jv, Nichol, I, Parry, A, Young, G, Clarke, M, Davis, M, Dixit, A, Dyker, A, Ford, G, Jackson, R, Kappadath, S, Lambert, D, Lees, T, Louw, S, Parr, N, Stansby, G, Wales, L, Wealleans, V, Wilson, L, Wyatt, M, Dorman, P, Hughes, A, Jones, D, Mendelow, Ad, Rodgers, H, Macsweeney, S, Mcconachie, N, Southam, A, Sunman, W, Briley, D, Darby, C, Handa, A, Hands, L, Kuker, W, Michael, K, Perkins, J, Schulz, U, Smith, D, Teal, R, Donnelly, M, D'Souza, S, Asehosem Egun, A, Gregory, B, Kelly, C, Punekar, S, Raj, S, Seriki, D, Thomson, G, Beard, J, Cleveland, T, Humphreys, J, Jenkins, A, King, C, Lonsdale, R, Nair, R, Nawaz, S, Okhuoya, F, Turner, D, Venables, G, Brown, J, Durairajan, R, Guyler, P, Harman, P, Jakeways, M, Khuoge, C, Kundu, A, Loganathan, T, Sinha, D, Thompson, V, Tysoe, S, Barer, Brown, A, Crawford, S, Dunlop, P, Majmudar, Mitchell, D, O'Brien, O'Connell, Scott, Vetrivel, S, Ashleigh, R, Butterfield, S, Gamble, G, Ghosh, J, Mccollum, C, Welch, M, Welsh, S, Kazan, V, Nazzal, M, Ramsey Williams, V, Halliday, A, Davies, C, Peto, R, Gray, A, Mihaylova, B, Potter, J, Flather, M, Mansfield, A, Farrell, B, Rahimi, K, Simpson, D, Thomas, D, Gough, M, Rothwell, P, Giles, M, Leopold, P, Belli, A, Sandercock, P, Gray, R, Shearman, C, Molyneux, A, Hayter, E, Lay, M, Munday, A, Young, A, Delmestri, A., Halliday, A, Bulbulia, R, Gray, W, Naughten, A, den Hartog, A, Delmestri, A, Wallis, C, le Conte, S, Macdonald, S, Tolva, V, Cras, Patrick, Hendriks, Jeroen, Lauwers, Patrick, van Schil, Paul, ACST-2 Collaborative Group, UCL - SSS/IONS/NEUR - Clinical Neuroscience, UCL - SSS/IREC/CARD - Pôle de recherche cardiovasculaire, UCL - SSS/IREC/IMAG - Pôle d'imagerie médicale, UCL - (SLuc) Service de chirurgie cardiovasculaire et thoracique, UCL - (SLuc) Service de radiologie, and UCL - (SLuc) Service de neurologie

Subjects
Male, Time Factors, Carotid artery stenosis, Carotid artery stenting, Carotid endarterectomy, Randomized controlled trial, Stroke, medicine.medical_treatment, Myocardial Infarction, Severity of Illness Index, law.invention, law, Risk Factors, MED/22 - CHIRURGIA VASCOLARE, Carotid Stenosis, Endarterectomy, Endarterectomy, Carotid, Middle Aged, Treatment Outcome, Female, Stents, medicine.symptom, Cardiology and Cardiovascular Medicine, medicine.medical_specialty, Aged, Angioplasty, Asymptomatic Diseases, Cardiovascular Agents, Humans, Patient Selection, Risk Assessment, Asymptomatic, medicine, Carotid, business.industry, Vascular surgery, medicine.disease, Surgery, Cardiovascular agent, Human medicine, business
Abstract

Objectives: ACST-2 is currently the largest trial ever conducted to compare carotid artery stenting (CAS) with carotid endarterectomy (CEA) in patients with severe asymptomatic carotid stenosis requiring revascularization. Methods: Patients are entered into ACST-2 when revascularization is felt to be clearly indicated, when CEA and CAS are both possible, but where there is substantial uncertainty as to which is most appropriate. Trial surgeons and interventionalists are expected to use their usual techniques and CE-approved devices. We report baseline characteristics and blinded combined interim results for 30-day mortality and major morbidity for 986 patients in the ongoing trial up to September 2012. Results: A total of 986 patients (687 men, 299 women), mean age 68.7 years (SD ± 8.1) were randomized equally to CEA or CAS. Most (96%) had ipsilateral stenosis of 70-99% (median 80%) with contralateral stenoses of 50-99% in 30% and contralateral occlusion in 8%. Patients were on appropriate medical treatment. For 691 patients undergoing intervention with at least 1-month follow-up and Rankin scoring at 6 months for any stroke, the overall serious cardiovascular event rate of periprocedural (within 30 days) disabling stroke, fatal myocardial infarction, and death at 30 days was 1.0%. Conclusions: Early ACST-2 results suggest contemporary carotid intervention for asymptomatic stenosis has a low risk of serious morbidity and mortality, on par with other recent trials. The trial continues to recruit, to monitor periprocedural events and all types of stroke, aiming to randomize up to 5,000 patients to determine any differential outcomes between interventions. Clinical trial: ISRCTN21144362. © 2013 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.

Published
2016

2. 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
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3. 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, 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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, 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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
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4. Boer(in) in hoofd, hart en nieren : onderzoek naar sociale duurzaamheid in de Vlaamse land-en tuinbouw anno 2012

Author

Van Buggenhout, E. and Van Buggenhout, E.

Abstract

Het doel van het rapport is om via een enquête bij de deelnemers van het Landbouwmonitoringnetwerk (LMN) een antwoord te bieden op de vraag: hoe is het anno 2012 gesteld met de sociale duurzaamheid in de land - en tuinbouwsector, met als casestudie de sociale duurzaamheid bij de LMN - deelnemers? Sociale duurzaamheid in de Vlaamse land – en tuinbouwsector was tot nog toe behoorlijk onontgonnen terrein. Ook voor AMS (Afdeling Monitoring en Studie) was het een primeur om de LMN - deelnemers over een dergelijk thema te bevragen en op die manier de mens achter de bedrijfsleider beter te leren kennen. Wat houdt hen bezig? Hoe vullen zij hun leven in buiten hun beroep? Zijn zij gelukkig?

Published
2013

5. 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

6. 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

8. 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, RL, Bonati, LH, van der Worp, HB, de Borst, GJ, Lo, TH, Gaines, P, Dorman, PJ, Macdonald, S, Lyrer, PA, Hendriks, JM, McCollum, C, Nederkoorn, PJ, Brown, MM, Algra, A, Bamford, J, Beard, J, Bland, M, Bradbury, AW, Clifton, A, Hacke, W, Halliday, A, Malik, I, Mas, JL, McGuire, AJ, Sidhu, P, Venables, G, Bradbury, A, Collins, R, Molynewc, A, Naylor, R, Warlow, C, Ferro, JM, Thomas, D, Coward, L, Featherstone, RF, Tindall, H, McCabe, DJH, 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, PG, 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, JMH, 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, JL, 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, 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, MJW, Reekers, JAA, Roos, YBWEM, Koudstaal, PJ, Pattynama, PMT, van der Lugt, A, van Dijk, LC, van Sambeek, MRHM, van Urk, H, Verhagen, HJM, Bruininckx, CMA, de Bruijn, SF, Keunen, R, Knippenberg, B, Mosch, A, Treurniet, F, van Dijk, L, van Overhagen, H, Wever, J, de Beer, FC, van den Berg, JSP, van Hasselt, BAAM, Zeilstra, DJ, Boiten, J, van Otterloo, JCADM, de Vries, AC, Nieholt, GJLA, van der Kallen, BFW, Blankensteijn, JD, De Leeuw, FE, Kool, LJS, van der Vliet, JA, de Kort, GAP, Kapelle, LJ, Mali, WPTM, Moll, F, Verhagen, H, Barber, PA, Bourchier, R, Hill, A, Holden, A, Stewart, J, Bakke, SJ, 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, ST, Fluri, F, Guerke, L, Jacob, AL, 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, PJ, Martin, P, Adam, D, Bell, J, Crowe, P, Gannon, M, Henderson, MJ, Sandler, D, Shinton, RA, Scriven, JM, Wilmink, T, D'Souza, S, Egun, A, Guta, R, Punekar, S, Seriki, DM, Thomson, G, Brennan, A, Enevoldson, TP, Gilling-Smith, G, Gould, DA, Harris, PL, McWilliams, RG, Nasser, H-C, White, R, Prakash, KG, Serracino-Inglott, F, Subramanian, G, Symth, JV, Walker, MG, Clarke, M, Davis, M, Dixit, SA, Dolman, P, Dyker, A, Ford, G, Golkar, A, Jackson, R, Jayakrishnan, V, Lambert, D, Lees, T, Louw, S, Mendelow, AD, 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, Jaeger, R, Kitchen, N, Ashleigh, R, Butterfield, S, Gamble, GE, Nasim, A, O'Neill, P, Edwards, RD, Lees, KR, MacKay, AJ, Moss, J, Rogers, P, Ederle, J, Dobson, J, Featherstone, RL, Bonati, LH, van der Worp, HB, de Borst, GJ, Lo, TH, Gaines, P, Dorman, PJ, Macdonald, S, Lyrer, PA, Hendriks, JM, McCollum, C, Nederkoorn, PJ, Brown, MM, Algra, A, Bamford, J, Beard, J, Bland, M, Bradbury, AW, Clifton, A, Hacke, W, Halliday, A, Malik, I, Mas, JL, McGuire, AJ, Sidhu, P, Venables, G, Bradbury, A, Collins, R, Molynewc, A, Naylor, R, Warlow, C, Ferro, JM, Thomas, D, Coward, L, Featherstone, RF, Tindall, H, McCabe, DJH, 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, PG, 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, JMH, 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, JL, 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, 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, MJW, Reekers, JAA, Roos, YBWEM, Koudstaal, PJ, Pattynama, PMT, van der Lugt, A, van Dijk, LC, van Sambeek, MRHM, van Urk, H, Verhagen, HJM, Bruininckx, CMA, de Bruijn, SF, Keunen, R, Knippenberg, B, Mosch, A, Treurniet, F, van Dijk, L, van Overhagen, H, Wever, J, de Beer, FC, van den Berg, JSP, van Hasselt, BAAM, Zeilstra, DJ, Boiten, J, van Otterloo, JCADM, de Vries, AC, Nieholt, GJLA, van der Kallen, BFW, Blankensteijn, JD, De Leeuw, FE, Kool, LJS, van der Vliet, JA, de Kort, GAP, Kapelle, LJ, Mali, WPTM, Moll, F, Verhagen, H, Barber, PA, Bourchier, R, Hill, A, Holden, A, Stewart, J, Bakke, SJ, 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, ST, Fluri, F, Guerke, L, Jacob, AL, 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, PJ, Martin, P, Adam, D, Bell, J, Crowe, P, Gannon, M, Henderson, MJ, Sandler, D, Shinton, RA, Scriven, JM, Wilmink, T, D'Souza, S, Egun, A, Guta, R, Punekar, S, Seriki, DM, Thomson, G, Brennan, A, Enevoldson, TP, Gilling-Smith, G, Gould, DA, Harris, PL, McWilliams, RG, Nasser, H-C, White, R, Prakash, KG, Serracino-Inglott, F, Subramanian, G, Symth, JV, Walker, MG, Clarke, M, Davis, M, Dixit, SA, Dolman, P, Dyker, A, Ford, G, Golkar, A, Jackson, R, Jayakrishnan, V, Lambert, D, Lees, T, Louw, S, Mendelow, AD, 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, Jaeger, R, Kitchen, N, Ashleigh, R, Butterfield, S, Gamble, GE, Nasim, A, O'Neill, P, Edwards, RD, Lees, KR, MacKay, AJ, 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, 1.16-2.45

12. Delayed cerebral thrombosis complicating bacterial meningitis.

Author

Depoortere S, Toeback J, Lunskens S, Van Buggenhout E, Oedit R, and Hemelsoet D

Subjects
Brain pathology, Female, Humans, Middle Aged, Endocarditis, Intracranial Thrombosis diagnostic imaging, Intracranial Thrombosis drug therapy, Intracranial Thrombosis etiology, Meningitis, Bacterial complications, Meningitis, Bacterial diagnosis, Meningitis, Bacterial drug therapy, Meningitis, Pneumococcal complications, Meningitis, Pneumococcal diagnosis, Meningitis, Pneumococcal drug therapy
Abstract

Background: Delayed cerebral thrombosis has been described as a potential cause of cerebrovascular complications in patients with bacterial meningitis. We report a case of delayed cerebral thrombosis in a 63-year-old woman admitted for pneumococcal meningitis. Initially, there was a good clinical evolution under treatment with steroids and antibiotics. On day 8 after admission, she was found with a decreased level of consciousness. Her neurological condition gradually worsened. Repeated brain imaging showed extensive ischemic lesions. Despite treatment with high-dose corticosteroids, the patient died., Methods: A literature search was conducted. Data on patient characteristics, diagnosis, treatment and outcome were collected., Results: To date, 28 cases with delayed cerebral thrombosis following bacterial meningitis have been reported. Streptococcus pneumoniae was the pathogen in 89% of cases. Clinical deterioration occurred in all patients, with a duration varying from 5 to 40 days between admission and deterioration. Most common symptom was altered consciousness (83%), followed by hemiparesis (52%). Brain imaging typically shows new infarctions (96%). Fifty-six percent of patients were treated with corticosteroids after deterioration. Outcome was poor with mortality rate of 46%., Conclusion: Delayed cerebral thrombosis presents as a clinical deterioration, typically a sudden decline in consciousness, more than 5 days after meningitis onset. Brain imaging shows new widespread ischemic lesions. Diagnosis should be made carefully, based on clinical findings and brain imaging, after excluding endocarditis. The underlying etiology remains unknown. When delayed cerebral thrombosis is suspected, high-dose corticosteroids should be started empirically. The prognosis remains poor with high mortality rates.

Published
2022
Full Text
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14. Dural arteriovenous malformation involving the Galenic system and producing hydrocephalus.

Author

van Buggenhout E, van Zandijcke M, Dehaene I, and Dom R

Subjects
Ataxia etiology, Brain pathology, Cerebrospinal Fluid Shunts, Dura Mater blood supply, Gait, Humans, Hydrocephalus surgery, Intracranial Arteriovenous Malformations diagnostic imaging, Intracranial Arteriovenous Malformations pathology, Male, Middle Aged, Radiography, Hydrocephalus etiology, Intracranial Arteriovenous Malformations complications, Meningeal Arteries abnormalities
Abstract

The case of a man with a large arteriovenous malformation, fed by meningeal arteries and draining into the Galenic system is reported. Mental deterioration and gait ataxia were attributed to an associated noncommunicating hydrocephalus. The symptoms recurred two months after successful ventriculoatrial shunting.

Published
1985

15. [Case of opsoclonus].

Author

Norré ME, Van Buggenhout E, Hens L, Carton H, and Dom R

Subjects
Humans, Male, Middle Aged, Brain Stem pathology, Encephalitis complications, Eye Movements, Movement Disorders pathology
Published
1982

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