Aspirin in Patients Undergoing Noncardiac Surgery
Por:
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, Buse, GL, Xavier, D, Chan, MTV, 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
Publicada:
17 abr 2014
Resumen:
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.)
Filiaciones:
Devereaux, PJ:
McMaster Univ, Populat Hlth Res Inst, Hamilton, ON L8S 4L8, Canada
McMaster Univ, Dept Clin Epidemiol & Biostat, Hamilton, ON, Canada
McMaster Univ, Dept Med, Hamilton, ON, Canada
Mrkobrada, M:
McMaster Univ, Populat Hlth Res Inst, Hamilton, ON L8S 4L8, Canada
London Hlth Sci Ctr, Dept Med, London, ON, Canada
Sessler, DI:
Cleveland Clin, Dept Outcomes Res, Inst Anesthesiol, Cleveland, Qld, Australia
Leslie, K:
Royal Melbourne Hosp, Dept Anaesthesia & Pain Management, Melbourne, Vic, Australia
Alonso-Coello, P:
Biomed Res Inst, Iberoamer Cochrane Ctr, Barcelona, Spain
Kurz, A:
Cleveland Clin, Dept Outcomes Res, Inst Anesthesiol, Cleveland, Qld, Australia
Villar, JC:
Univ Autonoma Bucaramanga, Bogota, Colombia
Fdn Cardioinfantil, Bogota, Colombia
Sigamani, A:
St Johns Natl Acad Hlth Sci, Dept Pharmacol, Div Clin Res & Training, Bangalore, Karnataka, India
Biccard, BM:
Univ KwaZulu Natal, Dept Anaesthet, Perioperat Res Grp, Nelson R Mandela Sch Med, Durban, South Africa
Meyhoff, CS:
Univ Copenhagen, Herlev Hosp, Dept Anesthesiol, DK-2730 Herlev, Denmark
Parlow, JL:
Kingston Gen Hosp, Dept Anesthesiol & Perioperat Med, Kingston, ON K7L 2V7, Canada
Queens Univ, Kingston, ON, Canada
Guyatt, G:
McMaster Univ, Dept Clin Epidemiol & Biostat, Hamilton, ON, Canada
McMaster Univ, Dept Med, Hamilton, ON, Canada
Robinson, A:
McMaster Univ, Populat Hlth Res Inst, Hamilton, ON L8S 4L8, Canada
Garg, AX:
Univ Western Ontario, Dept Med, Div Nephrol, London, ON, Canada
Rodseth, RN:
Univ KwaZulu Natal, Dept Anaesthet, Perioperat Res Grp, Nelson R Mandela Sch Med, Durban, South Africa
Botto, F:
McMaster Univ, Populat Hlth Res Inst, Hamilton, ON L8S 4L8, Canada
Inst Cardiovasc Buenos Aires, Estudios Clin Latino Amer, Buenos Aires, DF, Argentina
Buse, GL:
McMaster Univ, Populat Hlth Res Inst, Hamilton, ON L8S 4L8, Canada
Univ Basel Hosp, Dept Anesthesia, CH-4031 Basel, Switzerland
Xavier, D:
St Johns Natl Acad Hlth Sci, Dept Pharmacol, Div Clin Res & Training, Bangalore, Karnataka, India
Chan, MTV:
Chinese Univ Hong Kong, Dept Anaesthesia & Intens Care, Hong Kong, Hong Kong, Peoples R China
Tiboni, M:
McMaster Univ, Dept Med, Hamilton, ON, Canada
Cook, D:
McMaster Univ, Dept Clin Epidemiol & Biostat, Hamilton, ON, Canada
McMaster Univ, Dept Med, Hamilton, ON, Canada
Kumar, PA:
Univ N Carolina, Dept Anesthesiol, Chapel Hill, NC USA
Forget, P:
Clin Univ St Luc, Brussels, Belgium
Malaga, G:
Univ Peruana Cayetano Heredia, Lima, Peru
Fleischmann, E:
Med Univ Vienna, Dept Anesthesia & Intens Care, Vienna, Austria
Amir, M:
Shifa Int Hosp, Dept Surg, Islamabad, Pakistan
Eikelboom, J:
McMaster Univ, Populat Hlth Res Inst, Hamilton, ON L8S 4L8, Canada
McMaster Univ, Dept Clin Epidemiol & Biostat, Hamilton, ON, Canada
McMaster Univ, Dept Med, Hamilton, ON, Canada
Mizera, R:
McMaster Univ, Dept Med, Hamilton, ON, Canada
Torres, D:
Clin Santa Maria, Dept Anesthesiol, Santiago, Chile
Wang, CY:
Univ Malaya, Dept Anesthesiol, Kuala Lumpur, Malaysia
VanHelder, T:
McMaster Univ, Dept Anesthesia, Hamilton, ON, Canada
Paniagua, P:
Biomed Res Inst, Dept Anesthesiol, Barcelona, Spain
Berwanger, O:
Hosp Coracao, Res Inst HCor, Sao Paulo, Brazil
Srinathan, S:
Univ Manitoba, Dept Surg, Winnipeg, MB R3T 2N2, Canada
Graham, M:
Univ Alberta, Dept Med, Edmonton, AB, Canada
Pasin, L:
Ist Sci San Raffaele, I-20132 Milan, Italy
Le Manach, Y:
McMaster Univ, Populat Hlth Res Inst, Hamilton, ON L8S 4L8, Canada
McMaster Univ, Dept Clin Epidemiol & Biostat, Hamilton, ON, Canada
McMaster Univ, Dept Anesthesia, Hamilton, ON, Canada
Gao, P:
McMaster Univ, Populat Hlth Res Inst, Hamilton, ON L8S 4L8, Canada
Pogue, J:
McMaster Univ, Populat Hlth Res Inst, Hamilton, ON L8S 4L8, Canada
McMaster Univ, Dept Clin Epidemiol & Biostat, Hamilton, ON, Canada
Whitlock, R:
McMaster Univ, Populat Hlth Res Inst, Hamilton, ON L8S 4L8, Canada
McMaster Univ, Dept Surg, Hamilton, ON L8S 4L8, Canada
McMaster Univ, Dept Crit Care, Hamilton, ON L8S 4L8, Canada
Lamy, A:
McMaster Univ, Populat Hlth Res Inst, Hamilton, ON L8S 4L8, Canada
McMaster Univ, Dept Surg, Hamilton, ON L8S 4L8, Canada
Kearon, C:
McMaster Univ, Dept Clin Epidemiol & Biostat, Hamilton, ON, Canada
McMaster Univ, Dept Med, Hamilton, ON, Canada
Baigent, C:
Univ Oxford, Clin Trial Serv Unit, Oxford, England
Univ Oxford, Epidemiol Studies Unit, Oxford, England
Chow, C:
George Inst Global Hlth, Sydney, NSW, Australia
Univ Sydney, Sydney, NSW 2006, Australia
Pettit, S:
McMaster Univ, Populat Hlth Res Inst, Hamilton, ON L8S 4L8, Canada
Chrolavicius, S:
McMaster Univ, Populat Hlth Res Inst, Hamilton, ON L8S 4L8, Canada
Yusuf, S:
McMaster Univ, Populat Hlth Res Inst, Hamilton, ON L8S 4L8, Canada
McMaster Univ, Dept Clin Epidemiol & Biostat, Hamilton, ON, Canada
McMaster Univ, Dept Med, Hamilton, ON, Canada
|