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4. 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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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

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

7. 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

12. 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

13. Aortic graft infection: the value of percutaneous drainage.

Author

Bélair M, Soulez G, Oliva VL, Lapérrière J, Gianfelice D, Blair JF, Sarrazin J, and Thèrasse E

Subjects
Aged, Anti-Bacterial Agents, Aorta, Abdominal surgery, Aortic Diseases surgery, Case-Control Studies, Drug Therapy, Combination therapeutic use, Female, Humans, Male, Polyethylene Terephthalates, Prosthesis-Related Infections mortality, Retrospective Studies, Treatment Outcome, Blood Vessel Prosthesis adverse effects, Drainage methods, Prosthesis-Related Infections therapy
Abstract

Objective: The goal of this study was to compare patients with aortic graft infection treated by primary percutaneous drainage with patients who initially underwent surgery., Materials and Methods: A retrospective review of 23 consecutive patients treated for aortic graft infection was performed. Eleven patients were initially treated with percutaneous drainage and 12 were treated with surgery. The morbidity, mortality, and postprocedural reintervention rates and clinical outcome were analyzed for each group., Results: The septic process resolved in nine (82%) of 11 patients treated with percutaneous drainage. Of these nine patients, four were treated with percutaneous drainage alone. Drainage was followed by removal of the infected prosthetic graft in the remaining five patients. In the surgical group, sepsis resolved in only four patients (33%) (p = .036). No periprocedural deaths occurred in the percutaneous drainage group, whereas six patients in the surgical group died in the perioperative period (p = .014)., Conclusion: Percutaneous drainage can be used as an initial form of treatment in the management of aortic graft infections. Surgery after percutaneous drainage appears to be safer than surgery alone.

Published
1998
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14. [Diagnostic and therapeutic observations drawn from the surgical experiences of 108 traumatic ruptures of the descending thoracic aorta].

Author

Verdant A, Pagé A, and Blair JF

Subjects
Accidental Falls, Accidents, Traffic, Acute Disease, Adolescent, Adult, Aged, Aorta, Thoracic diagnostic imaging, Aorta, Thoracic surgery, Aortic Rupture diagnostic imaging, Aortic Rupture surgery, Blood Pressure, Chronic Disease, Female, Heart Bypass, Left instrumentation, Heart Bypass, Left methods, Humans, Hypertension etiology, Male, Middle Aged, Palpation, Paraplegia etiology, Postoperative Complications, Pulse, Radiography, Skiing injuries, Survival Rate, Thoracic Injuries complications, Aorta, Thoracic injuries, Aortic Rupture diagnosis
Abstract

Traumatic rupture of the thoracic aorta should be suspected when automobile (62.9%), motorcycle (11.1%), ski-doo (2.7%), deltaplane (0.9%), or skiing accidents (0.9%), cause a sudden and rapid deceleration. It was also encountered with a vertical fall of 10 meters and more (4.6%), when a pedestrian was struck by a vehicle (4.6%) or the chest damaged by a high velocity flying object (4.6%). A lateral impact was found in 33% of injured patients and 52.7% were not wearing seat belts. Ruptured aorta was found as a single lesion in only 12% of the cases and among associated orthopedic lesions (63.8%) and abdominal injuries (28.7%), about 2/3 of them involved the left side of the body. The most reliable clinical sign of descending aortic rupture is the pseudo-coarctation syndrome found in 53% in the acute phase by simple pulse palpation and in 56% with blood pressure measurements. As soon as the diagnosis is suspected, associated hypertension present in 50% should be medically treated to avoid sudden exsanguination. Surgical repair should be undertaken with a perfusion technique which is an integral part of the ressuscitation procedure. A Gott shunt was used in 81 patients and a partial left heart bypass with a Bio-Medicus pump in 25 cases. This active atrioaortic bypass is physiologically superior. The pump flow (3727 +/- 612 ml/min.) is superior to the shunt flow (2833 +/- 576 ml/min.). Proximal pressure with the pump is better controlled (111 +/- 20 mmHg) than with the shunt (152 +/- 30 mmHg) and the mean distal pressure obtained with the pump is higher (81 +/- 19 mmHg) than with the shunt (64 +/- 22 mmHg). One case of paraplegia occured (0.9%) with an unfunctionnal Gott shunt. The survival rate is 95.4% (63/66 cases) in the acute phase and 100% (42/42 cases) in the chronic phase.

Published
1998

15. Comparison of streptokinase and urokinase in local thrombolysis of peripheral arterial occlusions for lower limb salvage.

Author

Dubé M, Soulez G, Thérasse E, Cartier P, Blair JF, Roy P, Robillard P, Bruneau L, Van Nguyen P, and Cusson JR

Subjects
Arterial Occlusive Diseases pathology, Arterial Occlusive Diseases surgery, Arterial Occlusive Diseases therapy, Critical Care, Female, Fibrinolytic Agents administration & dosage, Fibrinolytic Agents adverse effects, Humans, Infusions, Intra-Arterial, Length of Stay, Male, Middle Aged, Plasminogen Activators administration & dosage, Plasminogen Activators adverse effects, Recombinant Proteins, Retrospective Studies, Risk Factors, Safety, Streptokinase administration & dosage, Streptokinase adverse effects, Time Factors, Treatment Outcome, Urokinase-Type Plasminogen Activator administration & dosage, Urokinase-Type Plasminogen Activator adverse effects, Arterial Occlusive Diseases drug therapy, Fibrinolytic Agents therapeutic use, Leg blood supply, Plasminogen Activators therapeutic use, Streptokinase therapeutic use, Thrombolytic Therapy adverse effects, Thrombolytic Therapy methods, Urokinase-Type Plasminogen Activator therapeutic use
Abstract

Purpose: To compare the efficacy and safety of streptokinase (SK) and urokinase (UK) in the treatment of local thrombolysis., Patients and Methods: Over a 24-month period, 40 patients with 45 lower limb arterial occlusions of less than 45 days duration underwent intraarterial fibrinolysis. Twenty occlusions were treated with recombinant UK and tissue culture-derived UK, and 25 occlusions were treated with SK. The study was retrospective, but the two groups were very homogeneous in terms of vascular surgical history, medical risk factors, and occlusion characteristics., Results: Complete lysis (95% or more) was achieved in 84% of SK infusions and 89% of UK infusions. Endoluminal and surgical interventions as well as clinical outcomes of SK and UK treatment were comparable. However, infusion time was significantly longer for SK treatment: 28.5 hours versus 19.1 hours for UK treatment (P = .035). Complication rates were not statistically significantly different. Average length of stay in the intensive care unit was identical (2.2 days) for both groups, and the difference in hospital stay was not statistically significant (7.7 days for SK vs 8.7 days for UK)., Conclusion: At the concentrations and doses used, the efficacy and safety of SK and UK were comparable, despite longer SK infusion time.

Published
1996
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17. Carotid artery duplex scanning in preoperative assessment for coronary artery revascularization: the association between peripheral vascular disease, carotid artery stenosis, and stroke.

Author

Salasidis GC, Latter DA, Steinmetz OK, Blair JF, and Graham AM

Subjects
Adult, Aged, Aged, 80 and over, Carotid Artery, Internal, Carotid Stenosis complications, Carotid Stenosis surgery, Endarterectomy, Carotid adverse effects, Female, Humans, Male, Middle Aged, Postoperative Complications, Predictive Value of Tests, Regression Analysis, Risk Factors, Sensitivity and Specificity, Ultrasonography, Carotid Stenosis diagnostic imaging, Cerebrovascular Disorders etiology, Coronary Artery Bypass adverse effects, Peripheral Vascular Diseases complications
Abstract

Purpose: The purpose of this study was to identify high-risk populations for severe carotid artery disease (SCD) and neurologic events (NE) after nonemergency isolated coronary artery bypass graft procedures (CABG)., Methods: Between February 1989 and July 1992, 387 patients underwent preoperative carotid artery duplex scanning as part of a preoperative assessment for nonemergency cardiac procedures. Of these patients, 376 had isolated CABG, and 11 had combined carotid endarterectomy (CEA) and CABG. Patient demographics, risk factors, and preoperative neurologic symptoms were recorded and analyzed. Severe carotid artery disease was defined as a 80% or greater stenosis of either internal carotid artery by carotid artery duplex scanning. Patients were evaluated for neurologic events (cerebrovascular accident, transient ischemic attack, amaurosis fugax, or reversible ischemic neurologic deficits) during the in-hospital postoperative period., Results: The prevalence of SCD was 8.5% (33 patients). The 33 patients with SCD were significantly older (65.6 +/- 6.5 years vs 62.5 +/- 10.4 years, p = 0.02), had previous CEA (27.3% vs 2.0%, p = 0.00001), had preoperative neurologic symptoms (21.2% vs 5.9%, p = 0.002), and had peripheral vascular disease (PVD) (63.6% vs 16.9%, p = 0.00001). The sensitivity of PVD for SCD is 63.6% (n = 21/33) (specificity 83.1%, positive predictive value 25.9%, negative predictive value 96.1%). In patients undergoing CABG alone, those who had postoperative NE were older (69.6 +/- 6.7 years vs 62.5 +/- 10.3 years, p = 0.036) and more likely to have PVD (50% vs 19.7%, p = 0.034), SCD (40% vs 4.9%, p = 0.001) and previous CEA (40% vs 2.7%, p = 0.0002). The incidence of postoperative NE in patients with SCD was 18.2% vs 1.7% in patients without SCD (p = 0.001). The sensitivity of SCD for NE was 40% (n = 4/10) (specificity 95.1%, positive predictive value 18.2%, negative predictive value 98.3%)., Conclusions: PVD may be helpful to identify patients at high risk for severe carotid artery stenosis. Postoperative NE in patients with CABG are associated with increasing age, carotid artery stenosis greater than 80%, previous CEA, and PVD.

Published
1995
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18. Public policy implications of HIV/AIDS in adolescents.

Author

Blair JF and Hein KK

Subjects
Adolescent, Adolescent Behavior, Adult, Condoms, Female, Guidelines as Topic, HIV Infections epidemiology, Humans, Male, School Health Services legislation & jurisprudence, School Health Services organization & administration, Sex Education, United States, HIV Infections prevention & control, Health Policy, School Health Services standards
Published
1994

19. Biologic characteristics of long-term autogenous vein grafts: a dynamic evolution.

Author

Reifsnyder T, Towne JB, Seabrook GR, Blair JF, and Bandyk DF

Subjects
Adult, Aged, Aged, 80 and over, Blood Flow Velocity, Chi-Square Distribution, Color, Female, Follow-Up Studies, Graft Occlusion, Vascular diagnostic imaging, Graft Occlusion, Vascular epidemiology, Graft Occlusion, Vascular physiopathology, Humans, Male, Middle Aged, Reoperation statistics & numerical data, Risk Factors, Saphenous Vein diagnostic imaging, Saphenous Vein physiopathology, Time Factors, Transplantation, Autologous, Ultrasonography, Saphenous Vein transplantation
Abstract

Purpose: The venous conduit as an arterial substitute has dynamic biologic properties that affect its durability. This study evaluated the morphologic and physiologic characteristics of 72 lower extremity vein grafts functioning at 4.5 to 21.6 years (median 6.6 years)., Methods: The entire graft was imaged with use of color duplex ultrasonography and then classified as normal (class I), abnormal but not graft-threatening (class II), or abnormal and graft-threatening (class III) for the proximal, middle, and distal thirds. Thirty-one grafts (43%) were classified as normal, whereas 41 (57%) were classified as abnormal, with 58 class II and 15 class III segments., Results: Three types of abnormalities were found by duplex imaging: nonstenotic wall plaques, discrete stenoses, and aneurysmal dilation. Aneurysms developed in five of seven grafts that had required thrombectomy in the distant past (mean of 40 months). There were 70 postoperative revisions in 38 limbs (53%). In 23 (60%) the conduit was revised, in 11 (29%) the revisions corrected progression of native artery atherosclerotic disease, and in 4 (11%) both types of revisions were required. Eleven grafts were revised in the first 30 days to correct technical errors. Eighteen limbs were revised between 1 and 24 months, with 12 (67%) of the revisions correcting stenotic lesions in the conduit or at one of the anastomoses. After 24 months 12 (67%) of 18 limbs were revised to correct progression of occlusive disease in the inflow or outflow vessels. At the time of this study 18 (67%) of the 27 conduits revised for intrinsic lesions were abnormal by color duplex imaging, and they harbored 12 (80%) of the 15-graft-threatening lesions., Conclusions: Autogenous vein remains the most durable arterial conduit, but vigilant surveillance is essential because the atherosclerotic environment continually produces lesions that may imperil the longevity of the graft.

Published
1993
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20. Pitfalls in the use of color-flow duplex ultrasound for screening of suspected arterial injuries in penetrated extremities.

Author

Bergstein JM, Blair JF, Edwards J, Towne JB, Wittmann DH, Aprahamian C, and Quebbeman EJ

Subjects
Angiography standards, Humans, Mass Screening methods, Physical Examination standards, Prospective Studies, Sensitivity and Specificity, Trauma Centers, Ultrasonography methods, Wisconsin epidemiology, Wounds, Penetrating epidemiology, Arm blood supply, Arteries injuries, Leg blood supply, Mass Screening standards, Ultrasonography standards, Wounds, Penetrating diagnostic imaging
Abstract

We compared color-flow duplex ultrasonographic scanning (CFD) to arteriography in 67 patients who sustained 75 penetrating injuries to the extremities without obvious arterial injury. There were 72 negative and three (4.0%) positive CFD studies and no failed attempts. With arteriography as the "gold standard," CFD had a specificity of 99% and a sensitivity of 50%, positive and negative predictive values of 66% and 97%, and an accuracy of 96%. Small pseudoaneurysms were missed in an axillary and an aberrant radial artery, and a genicular artery pseudoaneurysm was misread as originating from the popliteal artery. Cautious interpretation of negative studies appears warranted, particularly in the axilla and in bifurcated arteries. Extremity arteries should be completely imaged to rule out aberrant anatomy. Questionable studies should be confirmed arteriographically. With these caveats, color-flow duplex scanning may be useful for screening extremities with penetrating injuries thought to harbor occult arterial injuries.

Published
1992
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21. [In situ femoro-popliteal bypass grafts. Study of 85 cases using Cartier's technique].

Author

Chapleau D, Lassonde J, Blair JF, and Laurendeau F

Subjects
Actuarial Analysis, Adult, Aged, Aged, 80 and over, Arteriovenous Shunt, Surgical mortality, Female, Follow-Up Studies, Humans, Male, Middle Aged, Postoperative Complications, Risk Factors, Saphenous Vein surgery, Arteriovenous Shunt, Surgical methods, Coronary Disease surgery, Femoral Artery surgery, Intermittent Claudication surgery, Popliteal Artery surgery
Abstract

From January 1985 to december 1989, 83 patients (69 men, 14 women) underwent an in situ femoro-popliteal bypass using a semi-closed technique and the valvulotome developed by Dr Paul Cartier. Most patients (67%) were operated for severe ischemia while 33% were for claudication. HTA was present in 31% of patients, diabetes in 38% and CAD in 57%. Mean preoperative ABI was 0.33 +/- 0.20 and mean ankle pressure was 50 +/- 30 mm of Hg. Arteriographic popliteal run-off showed three vessels in 21 cases (25%), two vessels in 17 cases (20%) and one vessel in 38 cases (45%). Nine patients (10%) presented an isolated popliteal artery. Bypass was constructed below knee in 62 patients (73%) and above knee in 23 (27%). Five mortalities (5.8%) and two major complications (2.3%) were related to surgery. Four early graft failures (4.4%) were noted but 3 were successfully reoperated. Postoperative ABI was 0.71 +/- 0.23 mm of Hg and 81% of patients had complete relief of their symptoms. With a mean follow-up 19 months, graft patency was 91% +/- 6% and 84% +/- 11% at one and two years and was not influenced by operative indication: hypertension, diabetes, preoperative ABI, arteriographic findings or distal anastomotic site. Overall survival was 80% +/- 10% and 69 +/- 13 at one and two years. The in situ technique using the Cartier valvulotomes is an excellent operation and compares favourably with other techniques.

Published
1991

22. [Prospective study of arterial pressure during pregnancy. Prediction of hypertensive complications].

Author

Moutquin JM, Bilodeau R, Raynault P, Amyot G, Blair JF, Labelle L, Rainville C, and Gagnon L

Subjects
Blood Pressure, Blood Pressure Determination, Disease Susceptibility, Female, Humans, Parity, Pregnancy, Prospective Studies, Pre-Eclampsia diagnosis
Abstract

A prospective study of measure of blood pressure was conducted in 366 pregnant women at each antenatal visit, using an automatic random-zéro sphygmomanometer. In fourteen patients, among 244 primigravidae, who developed preeclampsia, systolic and diastolic arterial blood pressures were already significantly elevated by 13-16 weeks of pregnancy. This difference was sustained throughout until delivery. In addition, the systolic and diastolic arterial blood pressure, in those women destined to develop preeclampsia, did not show a dip between 13-20 weeks as in the normotensive group. There was no difference in arterial blood pressure during pregnancy between primigravidae and multigravidae who remained normotensive.

Published
1982

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