Abstract BACKGROUND: There is substantial variability in the perioperative administration of aspirin in patients undergoing noncardiac surgery, both among patients who are already on an aspirin regimen and among those who are not. METHODS: Using a 2-by-2 factorial trial design, we randomly assigned 10,010 patients who were preparing to undergo noncardiac surgery and were at risk for vascular complications to receive aspirin or placebo and clonidine or placebo. The results of the aspirin trial are reported here. The patients were stratified according to whether they had not been taking aspirin before the study (initiation stratum, with 5628 patients) or they were already on an aspirin regimen (continuation stratum, with 4382 patients). Patients started taking aspirin (at a dose of 200 mg) or placebo just before surgery and continued it daily (at a dose of 100 mg) for 30 days in the initiation stratum and for 7 days in the continuation stratum, after which patients resumed their regular aspirin regimen. The primary outcome was a composite of death or nonfatal myocardial infarction at 30 days. RESULTS: The primary outcome occurred in 351 of 4998 patients (7.0%) in the aspirin group and in 355 of 5012 patients (7.1%) in the placebo group (hazard ratio in the aspirin group, 0.99; 95% confidence interval [CI], 0.86 to 1.15; P=0.92). Major bleeding was more common in the aspirin group than in the placebo group (230 patients [4.6%] vs. 188 patients [3.8%]; hazard ratio, 1.23; 95% CI, 1.01, to 1.49; P=0.04). The primary and secondary outcome results were similar in the two aspirin strata. CONCLUSIONS: Administration of aspirin before surgery and throughout the early postsurgical period had no significant effect on the rate of a composite of death or nonfatal myocardial infarction but increased the risk of major bleeding. (Funded by the Canadian Institutes of Health Research and others; POISE-2 ClinicalTrials.gov number, NCT01082874.). Comment in The yin and yang of perioperative medicine. [N Engl J Med. 2014

Aspirin in patients undergoing noncardiac surgery / Devereaux, Pj; Mrkobrada, M; Sessler, Di; Leslie, K; Alonso Coello, P; Kurz, A; Villar, Jc; Sigamani, A; Biccard, Bm; Meyhoff, Cs; Parlow, Jl; Guyatt, G; Robinson, A; Garg, Ax; Rodseth, Rn; Botto, F; Lurati Buse, G; Xavier, D; Chan, Mt; Tiboni, M; Cook, D; Kumar, Pa; Forget, P; Malaga, G; Fleischmann, E; Amir, M; Eikelboom, J; Mizera, R; Torres, D; Wang, Cy; Vanhelder, T; Paniagua, P; Berwanger, O; Srinathan, S; Graham, M; Pasin, L; Le Manach, Y; Gao, P; Pogue, J; Whitlock, R; Lamy, A; Kearon, C; Baigent, C; Chow, C; Pettit, S; Chrolavicius, S; Yusuf, S; DeBeer J, POISE 2 I. n. v. e. s. t. i. g. a. t. o. r. s.; Mizera, R; Patel, A; Vanhelder, T; Cook, D; Dechert, W; Jackson, P; Tiboni, M; Allard, R; Dumerton Shore, D; Mccourt, J; Parlow, Jl; Jones, Pm; Lavi, R; Lavi, S; Moor, R; Dresser, Gk; Garg, Ax; Gros, Ml; Schumann, Vc; Baur, M; Macdonald, C; Wirzba, B; Regalado, O; Srinathan, Sk; Ong, Dd; Todd, A; Abbas, S; Beattie, Ws; Chan, Vw; Chin, Kj; Wijeysundera, Dn; Graham, Mm; Irwin, M; Jacka, M; El Beheiry, H; Mcmullen, Sm; Macdonald, P; Akhtar, Z; Ayad, S; Buttar, M; Deroee, A; Eshraghi, Y; Fergany, A; Finnigan, P; Fu, A; Grady, M; Helper, S; Hesler, B; Honar, H; Hutcherson, M; Krebs, V; Kurz, A; Lee, J; Malik, M; Podolyak, A; Salmasi, V; Sessler, Di; Arora, H; Coombs, Rf; Kumar, Pa; Martinelli, Sm; Bergese, Sd; Melibary, Sb; Uribe, Aa; Jordan, M; Miller, Sa; Cata, Jp; Nemergut, Ec; Candiotti, Ka; Memtsoudis, Sg; Mckay, Re; Montes, Fr; Parra, Ga; Rojas, Mf; Plata, R; Vásquez, Sm; Sarquis, T; Haider, Z; Jane, Nb; Lanjewar, Pp; Rahate, Pv; Mehra, Br; Premendaran, B; Abraham, V; George, P; Kumar, P; Gaikwad, Sb; Mohan, Nv; Sidhu, G; Alvarez, J; Gonzalez, R; Maestre, M; Popova, E; Urrutia, G; de Nadal, M; González Suárez, S; González Tallada, A; Plou, P; Mena, E; Riveira, C; del Valle, S; Tena, B; Lang, Sa; Ludbrook, Gl; Painter, Tw; Terblanche, Nc; Osborne, C; Mahood, Jr; Leslie, K; Myles, Ps; Sivalingam, P; Riedel, B; Elhalawani, I; Biccard, Bm; Drummond, L; Mugabi, A; Naidoo, P; Myburgh, Al; Porrill, Os; Diedericks, Bj; Turton, Ew; Bøgeskov, M; Dahl, Rm; Madsen, Mv; Søndergaard, Es; Bauer, Ne; Martinsen, Kr; Chan, Mt; Choi, Gy; Gin, T; Ng, Ss; Bidgoli, Sj; Van der Linden, Pj; De Kock, M; Forget, P; Fleischmann, E; Kabon, B; Luf, F; Radonic, M; Amir, M; Ishtiaq, O; Safdar, J; Acuna Villaorduna, A; Barrionuevo, P; Castaneda Guarderas, A; Caballero, Ja; Lau, Ve; Aphang Lam, Mr; Lembo, R; Pasin, L; Gossetti, Bruno; Jara, X; Leon, P; Torres, D; Ong, Gs; Wang, Cy; Lee, Hs; Seeberger, Ee; Seeberger, Md; Alfonsi, P; Coriat, P; Piriou, V; Vizcaychipi, Mp; Rech, Rl; Bergo, Rr; Walker, S; Devereaux, Pj; Sessler, Di; Kurz, A; Mrkobrada, M; Lurati Buse, G; Botto, F; Rodseth, R; Robinson, A; Guyatt, G; Lemanach, Y; Pogue, J; Pettit, S; Chrolavicius, S; Yusuf, S; Botto, F; Díaz, R; Leslie, K; Fleischmann, E; Forget, P; Berwanger, O; Devereaux, Pj; Mrkobrada, M; Torres, D; Villar, Jc; Cortés, Ol; Meyhoff, Cs; Wetterslev, J; Alfonsi, P; Hoeft, A; Wittmann, M; Chan, M; Sigamani, A; Xavier, D; Landoni, G; Wang, Cy; Ishtiaq, O; Malaga, G; Biccard, Bm; Alonso Coello, P; Conen, D; Balaji, P; Kurz, A; Robinson, A; Sovereign, T; Blake, L; Sephton, J; Serra, A; Agrippa, C; Lawrence, M; Gao, P; Pettit, S; Chrolavicius, S; Leslie, K; Alonso Coello, P; Biccard, B; Chan, M; Meyhoff, Cs; Villar, Jc; Xavier, D; Wang, Cy; Landoni, G; Berwanger, O; Jacka, M; Malaga, G; Chow, C; Gluud, C; Baigent, C; Karthikeyan, G; Devereaux, Pj; Alfonsi, P; Alonso Coello, P; Auerbach, A; Baigent, C; Balaji, P; Beattie, S; Berwanger, O; Biccard, Bm; Botto, F; Buckley, N; Chan, M; Chow, C; Chrolavicius, S; Conen, D; Cook, D; Douketis, J; Eikelboom, J; Forget, P; Garg, Ax; Gerstein, H; Ghali, W; Graham, M; Guyatt, G; Hart, R; Hill, M; Hoeft, A; Jacka, M; Karthikeyan, G; Kearon, C; Kurz, A; Lamy, A; Landoni, G; Lemanach, Y; Leslie, K; Lurati Buse, G; Malaga, G; Mcalister, F; Mcauley, D; Meyhoff, Cs; Miller, S; Mrkobrada, M; O'Donnell, M; Pais, P; Parlow, J; Pogue, J; Robinson, A; Rodseth, R; Schricker, T; Sessler, D; Simunovic, M; Srinathan, S; Teoh, K; Torres, D; Urrutia, G; Villar, Jc; Walsh, M; Wang, Cy; Wetterslev, J; Whitlock, R; Wijeysundera, D; Xavier, D; Yang, H; Yusuf, S; Guyatt, G; Botto, F; Alonso Coello, P; Alshalash, S; Alvarez, J; Bessissow, A; Douketis, J; Duceppe, E; Fleischmann, E; Hart, R; Hill, M; Khalid, Z; Khan, J; Kurz, A; Lauw, M; Le Manach, Y; Lurati Buse, G; Martinsen, K; Meyhoff, Cs; Mrkobrada, M; Neary, J; Oczkowski, W; O'Donnell, M; Paniagua, P; Papina, M; Pasin, L; Popova, E; Rodseth, R; Seeberger, M; Tandon, V; Thomas, S; Tiboni, M; Torres, D; Wetterslev, J; Friedman, L; Cheng, D; Johnstone, D; Lowenstein, E; Roberts, R.. - In: THE NEW ENGLAND JOURNAL OF MEDICINE. - ISSN 0028-4793. - STAMPA. - 370 (16):Apr 17(2014), pp. 1494-1503. [10.1056/NEJMoa1401105]

Aspirin in patients undergoing noncardiac surgery

GOSSETTI, Bruno;
2014

Abstract

Abstract BACKGROUND: There is substantial variability in the perioperative administration of aspirin in patients undergoing noncardiac surgery, both among patients who are already on an aspirin regimen and among those who are not. METHODS: Using a 2-by-2 factorial trial design, we randomly assigned 10,010 patients who were preparing to undergo noncardiac surgery and were at risk for vascular complications to receive aspirin or placebo and clonidine or placebo. The results of the aspirin trial are reported here. The patients were stratified according to whether they had not been taking aspirin before the study (initiation stratum, with 5628 patients) or they were already on an aspirin regimen (continuation stratum, with 4382 patients). Patients started taking aspirin (at a dose of 200 mg) or placebo just before surgery and continued it daily (at a dose of 100 mg) for 30 days in the initiation stratum and for 7 days in the continuation stratum, after which patients resumed their regular aspirin regimen. The primary outcome was a composite of death or nonfatal myocardial infarction at 30 days. RESULTS: The primary outcome occurred in 351 of 4998 patients (7.0%) in the aspirin group and in 355 of 5012 patients (7.1%) in the placebo group (hazard ratio in the aspirin group, 0.99; 95% confidence interval [CI], 0.86 to 1.15; P=0.92). Major bleeding was more common in the aspirin group than in the placebo group (230 patients [4.6%] vs. 188 patients [3.8%]; hazard ratio, 1.23; 95% CI, 1.01, to 1.49; P=0.04). The primary and secondary outcome results were similar in the two aspirin strata. CONCLUSIONS: Administration of aspirin before surgery and throughout the early postsurgical period had no significant effect on the rate of a composite of death or nonfatal myocardial infarction but increased the risk of major bleeding. (Funded by the Canadian Institutes of Health Research and others; POISE-2 ClinicalTrials.gov number, NCT01082874.). Comment in The yin and yang of perioperative medicine. [N Engl J Med. 2014
2014
01 Pubblicazione su rivista::01a Articolo in rivista
Aspirin in patients undergoing noncardiac surgery / Devereaux, Pj; Mrkobrada, M; Sessler, Di; Leslie, K; Alonso Coello, P; Kurz, A; Villar, Jc; Sigamani, A; Biccard, Bm; Meyhoff, Cs; Parlow, Jl; Guyatt, G; Robinson, A; Garg, Ax; Rodseth, Rn; Botto, F; Lurati Buse, G; Xavier, D; Chan, Mt; Tiboni, M; Cook, D; Kumar, Pa; Forget, P; Malaga, G; Fleischmann, E; Amir, M; Eikelboom, J; Mizera, R; Torres, D; Wang, Cy; Vanhelder, T; Paniagua, P; Berwanger, O; Srinathan, S; Graham, M; Pasin, L; Le Manach, Y; Gao, P; Pogue, J; Whitlock, R; Lamy, A; Kearon, C; Baigent, C; Chow, C; Pettit, S; Chrolavicius, S; Yusuf, S; DeBeer J, POISE 2 I. n. v. e. s. t. i. g. a. t. o. r. s.; Mizera, R; Patel, A; Vanhelder, T; Cook, D; Dechert, W; Jackson, P; Tiboni, M; Allard, R; Dumerton Shore, D; Mccourt, J; Parlow, Jl; Jones, Pm; Lavi, R; Lavi, S; Moor, R; Dresser, Gk; Garg, Ax; Gros, Ml; Schumann, Vc; Baur, M; Macdonald, C; Wirzba, B; Regalado, O; Srinathan, Sk; Ong, Dd; Todd, A; Abbas, S; Beattie, Ws; Chan, Vw; Chin, Kj; Wijeysundera, Dn; Graham, Mm; Irwin, M; Jacka, M; El Beheiry, H; Mcmullen, Sm; Macdonald, P; Akhtar, Z; Ayad, S; Buttar, M; Deroee, A; Eshraghi, Y; Fergany, A; Finnigan, P; Fu, A; Grady, M; Helper, S; Hesler, B; Honar, H; Hutcherson, M; Krebs, V; Kurz, A; Lee, J; Malik, M; Podolyak, A; Salmasi, V; Sessler, Di; Arora, H; Coombs, Rf; Kumar, Pa; Martinelli, Sm; Bergese, Sd; Melibary, Sb; Uribe, Aa; Jordan, M; Miller, Sa; Cata, Jp; Nemergut, Ec; Candiotti, Ka; Memtsoudis, Sg; Mckay, Re; Montes, Fr; Parra, Ga; Rojas, Mf; Plata, R; Vásquez, Sm; Sarquis, T; Haider, Z; Jane, Nb; Lanjewar, Pp; Rahate, Pv; Mehra, Br; Premendaran, B; Abraham, V; George, P; Kumar, P; Gaikwad, Sb; Mohan, Nv; Sidhu, G; Alvarez, J; Gonzalez, R; Maestre, M; Popova, E; Urrutia, G; de Nadal, M; González Suárez, S; González Tallada, A; Plou, P; Mena, E; Riveira, C; del Valle, S; Tena, B; Lang, Sa; Ludbrook, Gl; Painter, Tw; Terblanche, Nc; Osborne, C; Mahood, Jr; Leslie, K; Myles, Ps; Sivalingam, P; Riedel, B; Elhalawani, I; Biccard, Bm; Drummond, L; Mugabi, A; Naidoo, P; Myburgh, Al; Porrill, Os; Diedericks, Bj; Turton, Ew; Bøgeskov, M; Dahl, Rm; Madsen, Mv; Søndergaard, Es; Bauer, Ne; Martinsen, Kr; Chan, Mt; Choi, Gy; Gin, T; Ng, Ss; Bidgoli, Sj; Van der Linden, Pj; De Kock, M; Forget, P; Fleischmann, E; Kabon, B; Luf, F; Radonic, M; Amir, M; Ishtiaq, O; Safdar, J; Acuna Villaorduna, A; Barrionuevo, P; Castaneda Guarderas, A; Caballero, Ja; Lau, Ve; Aphang Lam, Mr; Lembo, R; Pasin, L; Gossetti, Bruno; Jara, X; Leon, P; Torres, D; Ong, Gs; Wang, Cy; Lee, Hs; Seeberger, Ee; Seeberger, Md; Alfonsi, P; Coriat, P; Piriou, V; Vizcaychipi, Mp; Rech, Rl; Bergo, Rr; Walker, S; Devereaux, Pj; Sessler, Di; Kurz, A; Mrkobrada, M; Lurati Buse, G; Botto, F; Rodseth, R; Robinson, A; Guyatt, G; Lemanach, Y; Pogue, J; Pettit, S; Chrolavicius, S; Yusuf, S; Botto, F; Díaz, R; Leslie, K; Fleischmann, E; Forget, P; Berwanger, O; Devereaux, Pj; Mrkobrada, M; Torres, D; Villar, Jc; Cortés, Ol; Meyhoff, Cs; Wetterslev, J; Alfonsi, P; Hoeft, A; Wittmann, M; Chan, M; Sigamani, A; Xavier, D; Landoni, G; Wang, Cy; Ishtiaq, O; Malaga, G; Biccard, Bm; Alonso Coello, P; Conen, D; Balaji, P; Kurz, A; Robinson, A; Sovereign, T; Blake, L; Sephton, J; Serra, A; Agrippa, C; Lawrence, M; Gao, P; Pettit, S; Chrolavicius, S; Leslie, K; Alonso Coello, P; Biccard, B; Chan, M; Meyhoff, Cs; Villar, Jc; Xavier, D; Wang, Cy; Landoni, G; Berwanger, O; Jacka, M; Malaga, G; Chow, C; Gluud, C; Baigent, C; Karthikeyan, G; Devereaux, Pj; Alfonsi, P; Alonso Coello, P; Auerbach, A; Baigent, C; Balaji, P; Beattie, S; Berwanger, O; Biccard, Bm; Botto, F; Buckley, N; Chan, M; Chow, C; Chrolavicius, S; Conen, D; Cook, D; Douketis, J; Eikelboom, J; Forget, P; Garg, Ax; Gerstein, H; Ghali, W; Graham, M; Guyatt, G; Hart, R; Hill, M; Hoeft, A; Jacka, M; Karthikeyan, G; Kearon, C; Kurz, A; Lamy, A; Landoni, G; Lemanach, Y; Leslie, K; Lurati Buse, G; Malaga, G; Mcalister, F; Mcauley, D; Meyhoff, Cs; Miller, S; Mrkobrada, M; O'Donnell, M; Pais, P; Parlow, J; Pogue, J; Robinson, A; Rodseth, R; Schricker, T; Sessler, D; Simunovic, M; Srinathan, S; Teoh, K; Torres, D; Urrutia, G; Villar, Jc; Walsh, M; Wang, Cy; Wetterslev, J; Whitlock, R; Wijeysundera, D; Xavier, D; Yang, H; Yusuf, S; Guyatt, G; Botto, F; Alonso Coello, P; Alshalash, S; Alvarez, J; Bessissow, A; Douketis, J; Duceppe, E; Fleischmann, E; Hart, R; Hill, M; Khalid, Z; Khan, J; Kurz, A; Lauw, M; Le Manach, Y; Lurati Buse, G; Martinsen, K; Meyhoff, Cs; Mrkobrada, M; Neary, J; Oczkowski, W; O'Donnell, M; Paniagua, P; Papina, M; Pasin, L; Popova, E; Rodseth, R; Seeberger, M; Tandon, V; Thomas, S; Tiboni, M; Torres, D; Wetterslev, J; Friedman, L; Cheng, D; Johnstone, D; Lowenstein, E; Roberts, R.. - In: THE NEW ENGLAND JOURNAL OF MEDICINE. - ISSN 0028-4793. - STAMPA. - 370 (16):Apr 17(2014), pp. 1494-1503. [10.1056/NEJMoa1401105]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11573/558006
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