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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

14. Kinetic analysis of the blood clearance and organ uptake curves of IgG-coated red cells in HLA-typed controls and patients with Wegener's granulomatosis.

Author

Woude, Fokko, Beekhuis, Henk, Beelen, Josée, and Hauw The, T.

Abstract

Reticuloendothelial function and HLA type were studied in 22 controls and 15 patients with Wegener's granulomatosis (WG). IgG-coated red cells were injected intravenously and half-life times of blood disappearance and liver spleen uptake curves were related to the degree of antibody coating. Erythrocytes with 13,990 molecules of IgG per cell gave biexponential blood disapperance curves and were suitable for measuring splenic reticuloendothelial function. Half-life times thus obtained were not significantly different for individuals with the HLA-DR2 or DR3 phenotype. In WG patients with major disease activity, blood clearance of the injected cells was considerably decreased. Kinetic analysis of blood disappearance and spleen uptake curves revealed that this was partly due to a decrease in reversible trapping of the cells in the spleen. This suggests that a blocking effect of circulating immune complexes on splenic Fc receptors is not likely to be the sole cause of the observed hyposplenism. [ABSTRACT FROM AUTHOR]

Published
1986
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15. Abnormal reticuloendothelial function in patients with active vasculitis and idiopathic membranous glomerulopathy.

Author

Woude, Fokko, Albertus Piers, D., Giessen, Marijke, Hoedemaeker, Philip, Hauw The, T., and Hem, Gjalt

Abstract

Reticuloendothelial function was assessed in 11 patients with systemic lupus erythematosus, 8 patients with Wegener's granulomatosus, and 20 patients with idiopathic membranous glomerulopathy by using autologous Tc-labeled heat-damaged red blood cells. With this method organ uptake could be measured by quantitative scintigraphy. There was no relation between the T of the blood disappearance curve and the T of the splenic uptake curve. The T of the blood disappearance curve was normal in all three patient groups. However, there was asignificant shift from spleen to liver uptake in patients with active systemic lupus erythermatosus, active Wegener's granulomatosus, and membranous glomerulopathy in comparison with a control group. There was no relation with age, level of circulating immune complexes, complement level, kidney function, or immunosuppressive treatment. We conclude that an increease of the liver component of reticulo-endotherlial function may compensate abnormalities in splenic function. This stresses the importance of quantitative scanning to detect such abnormalities. The study provides evidence for disease related hyposplenism in patients with active systemic lupus erythematosus, active Wegener's granulomatosus, and membranous glomerulopathy. [ABSTRACT FROM AUTHOR]

Published
1983
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16. Poor induction of interleukin-2 receptor expression on CD8bright+ cells in whole blood cell cultures with CD3 mAb. Implications for immunotherapy with CD3 mAb

Author

Janssen, Richard A. J., Heijn, Agnes A., Hauw The, T., and de Leij, Lou

Abstract

To induce better stimulation of T cells during recombinant interleukin-2 (rIL-2) therapy of renal cell carcinoma patients, pretreatment with low-dose CD3 monoclonal antibody (mAb) has been proposed. However, in our clinic, such a treatment did not induce additional activation of T cells. To investigate this we performed whole blood cell cultures with rIL-2 or CD3 mAb as a stimulant. Cultures using isolated blood mononuclear cells were used as a control. When stimulated by the addition of rIL-2, the lymphocyte composition and activation of whole blood cultures did not differ from those of mononuclear cell (MNC) cultures. However, when stimulation was performed with CD3 mAb, CD8bright+ cells in whole blood cultures were not or only minimally induced to express CD25 or IL-2 receptor ß (IL-2R\). This is in contrast to the situation found in MNC cultures where all CD8bright+ cells expressed CD25 or IL-2Rß to a high extent at the end of culture. When rIL-2 or recombinant interferon ? (rIFN?) was added to whole blood cultures together with CD3 mAb, significantly more CD8bright+ cells were induced to express CD25 or IL-2Rß. These results suggest that whole blood cultures represent the in vivo situation better than MNC cultures. In addition, the results suggest that, also in vivo, administration of low-dose CD3 mAb alone might not be sufficient to induce IL-2R expression on CD8bright+ cells, and would therefore not induce additional specific T cell activation in rIL-2-based immunotherapy. The presented results suggest that in vivosimultaneous administration of rIFN? or rIL-2 with low-dose CD3 mAb might induce better stimulation of CD8+ T cells than CD3 mAb only.

Published
1994
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17. Humoral immune-response against human cytomegalovirus (hcmv)-specific proteins after hcmv infection in lung transplantation as detected with recombinant and naturally-occurring proteins

Author

Zanten, J., Martin Harmsen, Giessen, M., Wim van der Bij, Prop, J., Leij, L., Hauw The, T., and Groningen Institute for Organ Transplantation (GIOT)

Subjects
BLOOD LEUKOCYTES, VIRUS INFECTION, ANTIGENEMIA, ANTIBODIES
Abstract

The humoral immune response to four intracellularly located cytomegalovirus (CMV) proteins was studied in 15 lung transplant recipients experiencing active CMV infections. Five patients had primary infections, and 10 had secondary infections. Antibodies of the immunoglobulin M (IgM) and IgG classes were measured in an enzyme-linked immunosorbent assay (ELISA) system in which procaryotically expressed recombinant proteins were used as a substrate and also in a monoclonal antibody-based capture ELISA which uses naturally occurring proteins as a substrate. The proteins investigated were the lower matrix protein pp65 (ppUL83), the major DNA-binding protein p52 (ppUL44), and the two immediate early proteins IE1 and IE2 (different splicing products of UL123). Higher levels of antibodies were found to pp65 and especially to p52 than to the immediate early antigens. Antibody levels detected in the recombinant protein-based ELISAs were generally lower than antibody responses detected with the matching antigen capture ELISA. Moreover, some patients appeared to have antibodies mainly to epitopes present on naturally occurring proteins. The antibody responses detected in both assays were related to the viral load during infection as assessed by the CMV antigenemia test, which is a quantitative marker for CMV load. It was found that although epitopes on naturally occurring proteins induce higher antibody responses and responses in more patients, antibodies directed to epitopes present on the recombinant proteins were inversely related to the viral load during a CMV infection. Therefore, antibodies to epitopes on the recombinant proteins might be more clinically relevant in this group of lung transplant recipients.

18. Legionella pneumophila pneumonia associated with reactivation of cytomegalovirus infection.

Author

Löwenberg A, Sluiter HJ, and Hauw The T

Subjects
Antibodies, Viral analysis, Cytomegalovirus immunology, Humans, Legionella immunology, Male, Middle Aged, Recurrence, Simplexvirus immunology, Bacterial Infections complications, Cytomegalovirus Infections complications, Pneumonia complications
Abstract

Two patients with Legionella pneumophila infection (serogroup 1) associated with a reactivated cytomegalovirus infection are described. Predisposing underlying factors were not evident.

Published
1985
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19. Pulmonary dysfunction is common during a cytomegalovirus infection after renal transplantation even in asymptomatic patients. Possible relationship with complement activation.

Author

van Son WJ, Tegzess AM, Hauw The T, Duipmans J, Slooff MJ, van der Mark TW, and Peset R

Subjects
Adult, Anaphylatoxins analysis, Complement C3 analysis, Complement C3a, Complement C3d, Female, Graft Rejection, Humans, Male, Middle Aged, Pulmonary Diffusing Capacity, Complement Activation, Cytomegalovirus Infections physiopathology, Kidney Transplantation, Lung physiopathology
Abstract

In 24 patients with a cadaveric renal allograft, serial measurements after transplantation were made of the diffusing capacity for carbon monoxide (DLCO) together with serial measurements of C3d, the stable conversion product of the complement factor C3, and determinations of the anaphylatoxin C3a. Twelve patients were studied during an active cytomegalovirus (CMV) infection, and 12 patients were studied during allograft rejection or during a stable phase after renal transplantation (control subjects). No patients had pulmonary symptoms nor abnormal chest radiographs or arterial blood gas determinations. During an active CMV infection, DLCO was significantly reduced compared with the measurements made during allograft rejection or during a stable phase after renal transplantation. This was true both with (p less than 0.01) and without (p less than 0.01) correction for the hemoglobin concentration. Serum C3d levels were increased in 8 of the 12 patients with a CMV infection, but not in any of the patients in the control group. In 8 patients with a CMV infection, measurements were made of the anaphylatoxin C3a, and were found to be significantly higher than the levels in the control population (p less than 0.01). We conclude that our data are consistent with pulmonary dysfunction in every patient with an active CMV infection. The concomitant findings of complement activation and formation of anaphylatoxins suggest a causal relationship of the complement activation and a decreased DLCO, although further studies are warranted to determine the exact role of complement in the pulmonary events during an active CMV infection after renal transplantation.(ABSTRACT TRUNCATED AT 250 WORDS)

Published
1987
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