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Comparison of sibrafiban with aspirin for prevention of cardiovascular events after acute coronary syndromes: a randomised trial
Topol, CE; Califf, RM; Simes, RJ; Van de Werf, F; Diaz, R; Paolasso, E; Aylward, PE; Keech, A; Klein, W; Piegas, L; Tomov, I; Armstrong, PW; Widimsky, P; Grande, P; Halinen, M; Vahanian, A; Neuhaus, K; Dimas, AP; Preda, I; Kristinsson, A; Tzivoni, D; Ardissino, D; White, HD; Madsen, S; Sugrue, D; Sadowski, Z; Seabra-Gomes, R; Apetrei, E; Dalby, A; Betriu, A; Pfisterer, M; Verheugt, F; Fox, K; Bates, ER; Gibler, WB; Granger, CB; Harrington, RA; Hochman, JS; Holmes, DR; Kleiman, NS; Lee, KL; Moliterno, DJ; Newby, LK; Ohman, EM; Califf, R; Newby, K; Zillman, L; Lee, K; Lemons, P; McCourt, B; Campbell, C; Tardiff, B; Snapp, J; Bassett, K; Hodgson, P; Hannan, K; Kandzari, L; Hawkins, S; Hinman-Smith, E; McDougal, M; Raffetto, K; Thompson, D; Wehrle, T; Ange, C; Brown, R; Grissom, G; Heuckel, M; McCall, J; Pennachi, W; Spychala, M; Veasey, S; Pullium, M; Journey, T; Quintero, K; Mark, D; Davidson-Ray, L; Diner, L; Nelson, C; Sowers, C; Webb, G; Young, M; Bhapkar, M; Pacchiana, C; Sparapani, R; Tuttle, R; Weaver, D; Borzak, S; Douthat, L; Topol, E; Moliterno, D; Konczos, L; Baishnab, R; Baishnab, R; Bakos, A; Blashford, L; Bratsch, J; Brown, K; Cadorini, E; Carlson, J; Clemmons, P; DelValle, M; Drabik, M; Fu, G; Gates, K; Gibson, Y; Heil, L; Hill, N; Klancar, R; McHale, B; Montague, E; Pasca, N; Pergi, L; Randall, R; Rosso, R; Sankovich, K; Smith, D; Wisniewski, L; Witkowski, M; Zovkic, V; Alexander, K; Bhatt, D; Brener, S; Campbell, L; Cho, L; Cole, C; Deedy, M; Foody, J; Gassler, J; Ghaffari, S; Haas, G; Kapadia, S; Lauer, M; Lauer, MS; Lincoff, M; Lutton, S; Marso, S; Mukherjee, D; Patel, V; Penn, M; Robbins, M; Roe, M; Sila, C; Thamilarasan, M; Wagner, G; Armstrong, P; Bestilny, S; Van de Werf, F; Budts, W; Graux, S; Luyten, A; Simes, J; Keech, A; Kava, M; Bower, T; Chan, S; Crampton, L; Monro, C; Nayak, M; Parente, G; Riley, V; Wilton, D; Aylward, P; Dolan, S; Thomas, C; White, H; Scott, M; Frye, R; Alpert, J; Bertrand, M; Ryan, T; Fisher, L; Asarch, L; Smith, M; Lim, L; Bokslag, M; Chiu, P; Chung, J; Collins, S; Dougherty, C; Guimaraes, D; Hakim, Z; Mathieson, J; Montgomery, L; Novotny, B; Steiner, B; Wittke, B;
Duke Clin Res Inst, Durham, NC 27715 USA Duke Clin Res Inst Durham NC USA27715 lin Res Inst, Durham, NC 27715 USA Cleveland Clin Fdn, Cleveland, OH 44195 USA Cleveland Clin Fdn Cleveland OH USA 44195 in Fdn, Cleveland, OH 44195 USA Univ Calgary, Canadian VIGOUR Ctr, Edmonton, AB, Canada Univ Calgary Edmonton AB Canada anadian VIGOUR Ctr, Edmonton, AB, Canada Leuven Coordinating Ctr, Louvain, Belgium Leuven Coordinating Ctr Louvain Belgium rdinating Ctr, Louvain, Belgium Univ Sydney, Natl Hlth & Med Res Council Clin Trials Ctr, Sydney, NSW 2006, Australia Univ Sydney Sydney NSW Australia 2006 ls Ctr, Sydney, NSW 2006, Australia Flinders Coordinating Ctr, Adelaide, SA, Australia Flinders Coordinating Ctr Adelaide SA Australia Adelaide, SA, Australia Green lane Coordinating Ctr, Auckland, New Zealand Green lane CoordinatingCtr Auckland New Zealand Auckland, New Zealand Mayo Clin & Mayo Fdn, Rochester, MN 55905 USA Mayo Clin & Mayo Fdn Rochester MN USA 55905 Fdn, Rochester, MN 55905 USA Univ Arizona, Hlth Sci Ctr, Tucson, AZ 85721 USA Univ Arizona Tucson AZ USA 85721 zona, Hlth Sci Ctr, Tucson, AZ 85721 USA Univ Lille, Lille, France Univ Lille Lille FranceUniv Lille, Lille, France Boston Univ, Med Ctr, Boston, MA 02215 USA Boston Univ Boston MA USA 02215 oston Univ, Med Ctr, Boston, MA 02215 USA Univ Washington, Seattle, WA 98195 USA Univ Washington Seattle WA USA 98195 iv Washington, Seattle, WA 98195 USA F Hoffmann La Roche & Co Ltd, CH-4002 Basel, Switzerland F Hoffmann La Roche & Co Ltd Basel Switzerland CH-4002 asel, Switzerland
Titolo Testata:
fascicolo: 9201, volume: 355, anno: 2000,
pagine: 337 - 345
Tipo documento:
Settore Disciplinare:
Clinical Medicine
Life Sciences
Indirizzi per estratti:
Indirizzo: Newby, LK Duke Clin Res Inst, Box 17969, Durham, NC 27715 USA Duke Clin Res Inst Box 17969 Durham NC USA 27715 m, NC 27715 USA
C.E. Topol et al., "Comparison of sibrafiban with aspirin for prevention of cardiovascular events after acute coronary syndromes: a randomised trial", LANCET, 355(9201), 2000, pp. 337-345


Background Aspirin lowers risks of death and myocardial infarction in patients with acute coronary syndromes. Intravenous glycoprotein IIIb/IIIa receptor antagonists further reduce the rates of ischaemic events in these patients, but the efficacy of long-term oral glycoprotein IIb/IIIa receptor blockade has not been established. We tested whether the oral glycoprotein IIb/IIIa receptor antagonist sibrafiban would prevent more cardiovascular events than aspirin, when given within 7 days of, and sustained for 90 days after, an acute coronary syndrome event. Methods 9233 patients who had stabilised after an acute coronary syndrome event were randomly assigned aspirin (80 mg orally twice daily) or low-doseor high-dose sibrafiban. Sibrafiban doses (3.0 mg, 4.5 mg, or 6.0 mg) werebased on a model accounting for weight and serum creatinine and designed to achieve at least 25% steady-state inhibition of platelet aggregation (lowdose) or at least 50% inhibition (high dose). The primary endpoint was thecomposite of death, non-fatal infarction or reinfarction, or severe recurrent ischaemia at 90 days. Analysis was by intention to treat. Findings The 90-day rate of the primary endpoint did not differ significantly between the groups assigned aspirin (302 [9.8%]), low-dose sibrafiban (310 [10.1%]; odds ratio 1.03 [95% Cl 0/8.-1.21]), and high-dose sibrafiban (303 [10.1%]; 1.03 [0.87-1.21]). The groups did not differ significantly inthe rates of the component events or secondary efficacy endpoints. Major bleeding was more common with high-dose sibrafiban (171 [5.7%]) than with aspirin (120 [3.9%]) or low-dose sibrafiban (159 [5.2%]). Interpretation Sibrafiban showed no additional benefit over aspirin for secondary prevention of major ischaemic events after an acute coronary syndrome, and was associated with more dose-related bleeding.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 12/07/20 alle ore 05:07:37