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1. Core Outcome Measures for Perioperative and Anaesthetic Care (COMPAC): a modified Delphi process to develop a core outcome set for trials in perioperative care and anaesthesia

Author

Bartoszko, J., Beattie, W.S., Bellomo, R., Buggy, D., Cabrini, L., Canet, J., Cook, T., Cooper, D.J., Corcoran, T., Devereaux, P.J., Eckenhoff, R., Evered, L., Gan, T.J., Gin, T., Grocott, H., Haller, G., Howell, S., Jayarajah, M., Kalkman, C., Karkouti, K., Kavanagh, B., Klein, A., Landoni, G., Leslie, K., McIlroy, D.R., Mazer, D., Moller, A., Mythen, M., Neuman, M., Pearse, R., Peyton, P., Prowle, J., Richards, T., Scott, D.A., Sessler, D., Shaw, A., Short, T., Shulman, M., Silbert, B., Singer, M., Sneyd, J.R., Story, D., van Dijk, D., van Klei, W., Boney, Oliver, Moonesinghe, S. Ramani, Myles, Paul S., and Grocott, Michael P.W.

Published
2022
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2. Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine initiative: clinical indicators

Author

Myles, P., Grocott, M., Biccard, B., Blazeby, J., Boney, O., Chan, M., Diouf, E., Fleisher, L., Kalkman, C., Kurz, A., Moonesinghe, R., Wijeysundera, D., Gan, T.J., Peyton, P., Sessler, D., Tramèr, M., Cyna, A., De Oliveira, G.S., Jr., Wu, C., Jensen, M., Kehlet, H., Botti, M., Haller, G., Cook, T., Neuman, M., Story, D., Gruen, R., Bampoe, S., Evered, L., Scott, D., Silbert, B., van Dijk, D., Grocott, H., Eckenhoff, R., Rasmussen, L., Eriksson, L., Beattie, S., Landoni, G., Leslie, K., Howell, S., Nagele, P., Richards, T., Lamy, A., Lalu, M., Pearse, R., Mythen, M., Canet, J., Moller, A., Gin, T., Schultz, M., Pelosi, P., Gabreu, M., Futier, E., Creagh-Brown, B., Abbott, T., Klein, A., Corcoran, T., Jamie Cooper, D., Dieleman, S., McIlroy, D., Bellomo, R., Shaw, A., Prowle, J., Karkouti, K., Billings, J., Mazer, D., Jayarajah, M., Murphy, M., Bartoszko, J., Sneyd, R., Morris, S., George, R., Shulman, M., Lane-Fall, M., Nilsson, U., Stevenson, N., Cooper, J.D.J., van Klei, W., Cabrini, L., Miller, T., Pace, N., Jackson, S., Buggy, D., Short, T., Riedel, B., Gottumukkala, V., Alkhaffaf, B., Johnson, M., Haller, Guy, Bampoe, Sohail, Cook, Tim, Fleisher, Lee A., Grocott, Michael P.W., Neuman, Mark, Story, David, and Myles, Paul S.

Published
2019
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3. Tranexamic acid in coronary artery surgery: One-year results of the Aspirin and Tranexamic Acid for Coronary Artery Surgery (ATACAS) trial

Author

Myles, Paul, Smith, Julian, Cooper, D. James, Silbert, Brendan, McNeil, John, Marasco, Silvana, Esmore, Donald, Krum, Henry, Tonkin, A., Buxton, B., Heritier, S., Merry, A., Liew, D., McNeil, J., Forbes, A., Cooper, D.J., Wallace, S., Meehan, A., Myles, P., Galagher, W., Farrington, C., Ditoro, A., Wutzlhofer, L., Story, D., Peyton, P., Baulch, S., Sidiropoulos, S., Potgieter, D., Baker, R.A., Pesudovs, B., O'Loughlin J Wells, E., Coutts, P., Bolsin, S., Osborne, C., Ives, K., Smith, J., Hulley, A., Christie-Taylor, G., Painter, T., Lang, S., Mackay, H., Cokis, C., March, S., Bannon, P.G., Wong, C., Turner, L., Scott, D., Silbert, B., Said, S., Corcoran, P., de Prinse, L., Bussières, J.S., Gagné, N., Lamy, A., Semelhago, L., Chan, M.T.V., Underwood, M., Choi, G.S.Y., Fung, B., Landoni, G., Lembo, R., Monaco, F., Simeone, F., Marianello, D., Alvaro, G., De Vuono, G., van Dijk, D., Dieleman, J., Numan, S., McGuinness, S., Parke, R., Raudkivi, P., Gilder, E., Byrne, K., Dunning, J., Termaat, J., Mans, G., Jayarajah, M., Alderton, J., Waugh, D., Platt, M.J., Pai, A., Sevillano, A., Lal, A., Sinclair, C., Kunst, G., Knighton, A., Cubas, G.M., Saravanan, P., Millner, R., Vasudevan, V., Patteril, M., Lopez, E., Basu, R., Lu, J., Myles, Paul S., Smith, Julian A., Kasza, Jessica, Jayarajah, Mohandas, Painter, Thomas, Bussières, Jean S., McGuinness, Shay, Byrne, Kelly, Chan, Matthew T.V., Landoni, Giovanni, Wallace, Sophie, and Forbes, Andrew

Published
2019
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4. Systematic review and consensus definitions for standardised endpoints in perioperative medicine: postoperative cancer outcomes

Author

Gan, T.J., Peyton, P., Tramèr, M., Cyna, A., De Oliveira, G.S., Jr., Wu, C., Jensen, M., Kehlet, H., Botti, M., Boney, O., Haller, G., Grocott, M., Cook, T., Fleisher, L., Neuman, M., Story, D., Gruen, R., Bampoe, S., Evered, Lis, Scott, D., Silbert, B., van Dijk, D., Kalkman, C., Chan, M., Grocott, H., Eckenhoff, R., Rasmussen, L., Eriksson, L., Beattie, S., Wijeysundera, D., Landoni, G., Biccard, B., Howell, S., Nagele, P., Richards, T., Lamy, A., Lalu, M., Pearse, R., Mythen, M., Canet, J., Moller, A., Gin, T., Schultz, M., Pelosi, P., Gabreu, M., Futier, E., Creagh-Brown, B., Abbott, T., Klein, A., Corcoran, T., Jamie Cooper, D., Dieleman, S., Diouf, E., McIlroy, D., Bellomo, R., Shaw, A., Prowle, J., Karkouti, K., Billings, J., Mazer, D., Jayarajah, M., Murphy, M., Bartoszko, J., Sneyd, R., Morris, S., George, R., Moonesinghe, R., Shulman, M., Lane-Fall, M., Nilsson, U., Stevenson, N., van Klei, W., Cabrini, L., Miller, T., Jackson, S., Alkhaffaf, B., Buggy, D.J., Freeman, J., Johnson, M.Z., Leslie, K., Riedel, B., Sessler, D.I., Kurz, A., Gottumukkala, V., Short, T., Pace, N., and Myles, P.S.

Published
2018
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5. A systematic review and consensus definitions for standardised end-points in perioperative medicine: pulmonary complications

Author

Myles, P., Gan, T.J., Kurz, A., Peyton, P., Sessler, D., Tramèr, M., Cyna, A., De Oliveira, G.S., Jr., Wu, C., Jensen, M., Kehlet, H., Botti, M., Boney, O., Haller, G., Grocott, M., Cook, T., Fleisher, L., Neuman, M., Story, D., Gruen, R., Bampoe, S., Evered, Lis, Scott, D., Silbert, B., van Dijk, D., Kalkman, C., Chan, M., Grocott, H., Eckenhoff, R., Rasmussen, L., Eriksson, L., Beattie, S., Wijeysundera, D., Landoni, G., Leslie, K., Biccard, B., Howell, S., Nagele, P., Richards, T., Lamy, A., Gabreu, M., Klein, A., Corcoran, T., Jamie Cooper, D., Dieleman, S., Diouf, E., McIlroy, D., Bellomo, R., Shaw, A., Prowle, J., Karkouti, K., Billings, J., Mazer, D., Jayarajah, M., Murphy, M., Bartoszko, J., Sneyd, R., Morris, S., George, R., Moonesinghe, R., Shulman, M., Lane-Fall, M., Nilsson, U., Stevenson, N., van Klei, W., Cabrini, L., Miller, T., Pace, N., Jackson, S., Buggy, D., Short, T., Riedel, B., Gottumukkala, V., Alkhaffaf, B., Johnson, M., Abbott, T.E.F., Fowler, A.J., Pelosi, P., Gama de Abreu, M., Møller, A.M., Canet, J., Creagh-Brown, B., Mythen, M., Gin, T., Lalu, M.M., Futier, E., Grocott, M.P., Schultz, M.J., and Pearse, R.M.

Published
2018
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7. Standardizing end points in perioperative trials: towards a core and extended outcome set

Author

Myles, P. S., Grocott, M. P. W., Boney, O., Moonesinghe, S. R., Myles, Paul, Grocott, Michael, Biccard, Bruce, Boney, Oliver, Chan, Matthew, Fleisher, Lee, Kalkman, Cor, Kurz, Andrea, Moonesinghe, Ramani, Wijeysundera, Duminda, Bartoszko, J., Beattie, W. S., Bellomo, R., Buggy, D., Cabrini, L., Canet, J., Cook, T., Cooper, D. J., Corcoran, T., Devereaux, P. J., Eckenhoff, R., Evered, L., Gan, T. J., Gin, T., Grocott, H., Haller, G., Howell, S., Jayarajah, M., Kalkman, C., Karkouti, K., Kavanagh, B., Klein, A., Landoni, G., Leslie, K., McIlroy, D. R., Mazer, D., Moller, A., Mythen, M., Neuman, M., Neuman, M., Pearse, R., Peyton, P., Prowle, J., Richards, T., Scott, D. A., Sessler, D., Shaw, A., Short, T., Shulman, M., Silbert, B., Singer, M., Sneyd, J. R., Story, D., van Dijk, D., and van Klei, W.

Published
2016
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8. Core Outcome Measures for Perioperative and Anaesthetic Care (COMPAC): a modified Delphi process to develop a core outcome set for trials in perioperative care and anaesthesia

Author

Boney, Oliver, primary, Moonesinghe, S. Ramani, additional, Myles, Paul S., additional, Grocott, Michael P.W., additional, Bartoszko, J., additional, Beattie, W.S., additional, Bellomo, R., additional, Buggy, D., additional, Cabrini, L., additional, Canet, J., additional, Cook, T., additional, Cooper, D.J., additional, Corcoran, T., additional, Devereaux, P.J., additional, Eckenhoff, R., additional, Evered, L., additional, Gan, T.J., additional, Gin, T., additional, Grocott, H., additional, Haller, G., additional, Howell, S., additional, Jayarajah, M., additional, Kalkman, C., additional, Karkouti, K., additional, Kavanagh, B., additional, Klein, A., additional, Landoni, G., additional, Leslie, K., additional, McIlroy, D.R., additional, Mazer, D., additional, Moller, A., additional, Mythen, M., additional, Neuman, M., additional, Pearse, R., additional, Peyton, P., additional, Prowle, J., additional, Richards, T., additional, Scott, D.A., additional, Sessler, D., additional, Shaw, A., additional, Short, T., additional, Shulman, M., additional, Silbert, B., additional, Singer, M., additional, Sneyd, J.R., additional, Story, D., additional, van Dijk, D., additional, and van Klei, W., additional

Published
2022
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9. Systematic review and consensus definitions for the Standardized Endpoints in Perioperative Medicine (StEP) initiative: cardiovascular outcomes

Author

Beattie, WS, Lalu, M, Bocock, M, Feng, S, Wijeysundera, DN, Nagele, P, Fleisher, LA, Kurz, A, Biccard, B, Leslie, K, Howell, S, Landoni, G, Grocott, H, Lamy, A, Richards, T, Myles, P, Cooper, DJ, Gan, TJ, Peyton, P, Sessler, D, Tramèr, M, Cyna, A, De Oliveira, GS, Wu, C, Jensen, M, Kehlet, H, Botti, Mari, Boney, O, Haller, G, Grocott, M, Cook, T, Fleisher, L, Neuman, M, Story, D, Gruen, R, Bampoe, S, Evered, L, Scott, D, Silbert, B, van Dijk, D, Kalkman, C, Chan, M, Eckenhoff, R, Rasmussen, L, Eriksson, L, Beattie, S, Wijeysundera, D, Bartlett, RJ, McMonnies, R, Gerstl, J, Jay, M, Kishlyansky, D, Machina, M, Bobcock, M, Pearse, R, Mythen, M, Canet, J, Moller, A, Gin, T, Schultz, M, Pelosi, P, Gabreu, M, Futier, E, Creagh-Brown, B, Abbott, T, Klein, A, Corcoran, T, Dieleman, S, Diouf, E, McIlroy, D, Bellomo, R, Shaw, A, Prowle, J, Karkouti, K, Billings, J, Mazer, D, Jayarajah, M, Murphy, M, Bartoszko, J, Sneyd, R, Morris, S, George, R, Moonesinghe, R, Shulman, M, Lane-Fall, M, Nilsson, U, Stevenson, N, Cooper, J, van Klei, W, Cabrini, L, Miller, T, Pace, N, Jackson, S, Buggy, D, Short, T, Riedel, B, Gottumukkala, V, Alkhaffaf, B, Beattie, WS, Lalu, M, Bocock, M, Feng, S, Wijeysundera, DN, Nagele, P, Fleisher, LA, Kurz, A, Biccard, B, Leslie, K, Howell, S, Landoni, G, Grocott, H, Lamy, A, Richards, T, Myles, P, Cooper, DJ, Gan, TJ, Peyton, P, Sessler, D, Tramèr, M, Cyna, A, De Oliveira, GS, Wu, C, Jensen, M, Kehlet, H, Botti, Mari, Boney, O, Haller, G, Grocott, M, Cook, T, Fleisher, L, Neuman, M, Story, D, Gruen, R, Bampoe, S, Evered, L, Scott, D, Silbert, B, van Dijk, D, Kalkman, C, Chan, M, Eckenhoff, R, Rasmussen, L, Eriksson, L, Beattie, S, Wijeysundera, D, Bartlett, RJ, McMonnies, R, Gerstl, J, Jay, M, Kishlyansky, D, Machina, M, Bobcock, M, Pearse, R, Mythen, M, Canet, J, Moller, A, Gin, T, Schultz, M, Pelosi, P, Gabreu, M, Futier, E, Creagh-Brown, B, Abbott, T, Klein, A, Corcoran, T, Dieleman, S, Diouf, E, McIlroy, D, Bellomo, R, Shaw, A, Prowle, J, Karkouti, K, Billings, J, Mazer, D, Jayarajah, M, Murphy, M, Bartoszko, J, Sneyd, R, Morris, S, George, R, Moonesinghe, R, Shulman, M, Lane-Fall, M, Nilsson, U, Stevenson, N, Cooper, J, van Klei, W, Cabrini, L, Miller, T, Pace, N, Jackson, S, Buggy, D, Short, T, Riedel, B, Gottumukkala, V, and Alkhaffaf, B

Published
2021

12. Stopping vs. Continuing Aspirin before Coronary Artery Surgery

Author

Myles PS, Smith JA, Forbes A, Silbert B, Jayarajah M, Painter T, Cooper DJ, Marasco S, McNeil J, Bussières JS, Wallace S, ATACAS Investigators of the ANZCA Clinical Trials Network, Landoni G, Myles, P, Smith, Ja, Forbes, A, Silbert, B, Jayarajah, M, Painter, T, Cooper, Dj, Marasco, S, Mcneil, J, Bussières, J, Wallace, S, ATACAS Investigators of the ANZCA Clinical Trials, Network, and Landoni, G

Subjects
Male, medicine.medical_specialty, Postoperative Hemorrhage, 030204 cardiovascular system & hematology, Placebo, Coronary artery disease, 03 medical and health sciences, Postoperative Complications, 0302 clinical medicine, Double-Blind Method, Preoperative Care, medicine, Humans, Blood Transfusion, 030212 general & internal medicine, Myocardial infarction, Coronary Artery Bypass, Stroke, Aged, Aspirin, business.industry, Platelet Aggregation Inhibitor, Coronary Artery Bypa, Medicine (all), Thrombosis, General Medicine, Perioperative, Length of Stay, Middle Aged, medicine.disease, Surgery, Bypass surgery, Thrombosi, Commentary, Female, Postoperative Complication, business, Platelet Aggregation Inhibitors, Human, medicine.drug
Abstract

BACKGROUND Most patients with coronary artery disease receive aspirin for primary or secondary prevention of myocardial infarction, stroke, and death. Aspirin poses a risk of bleeding in patients undergoing surgery, but it is unclear whether aspirin should be stopped before coronary artery surgery. METHODS We used a 2-by-2 factorial trial design to randomly assign patients who were scheduled to undergo coronary artery surgery and were at risk for perioperative complications to receive aspirin or placebo and tranexamic acid or placebo. The results of the aspirin trial are reported here. Patients were randomly assigned to receive 100 mg of aspirin or matched placebo preoperatively. The primary outcome was a composite of death and thrombotic complications (nonfatal myocardial infarction, stroke, pulmonary embolism, renal failure, or bowel infarction) within 30 days after surgery. RESULTS Among 5784 eligible patients, 2100 were enrolled; 1047 were randomly assigned to receive aspirin and 1053 to receive placebo. A primary outcome event occurred in 202 patients in the aspirin group (19.3%) and in 215 patients in the placebo group (20.4%) (relative risk, 0.94; 95% confidence interval, 0.80 to 1.12; P = 0.55). Major hemorrhage leading to reoperation occurred in 1.8% of patients in the aspirin group and in 2.1% of patients in the placebo group (P = 0.75), and cardiac tamponade occurred at rates of 1.1% and 0.4%, respectively (P = 0.08). CONCLUSIONS Among patients undergoing coronary artery surgery, the administration of preoperative aspirin resulted in neither a lower risk of death or thrombotic complications nor a higher risk of bleeding than that with placebo. (Funded by the Australian National Health and Medical Research Council and others; Australia New Zealand Clinical Trials Registry number, ACTRN12605000557639.).

Published
2016
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14. Characterization of Iron deficiency in patients with chronic heart failure: A prospective, multicentric, observational study from India

Author

Jain, Dharmendra, primary, Desai, BhupenN, additional, Rathi, RajeevKumar, additional, Shekhar, Chandra, additional, Sahoo, PrasantKumar, additional, Burkule, Nitin, additional, Mohanty, SitanshuSekhar, additional, Sharma, SohanKumar, additional, Sidhu, GursaranKaur, additional, Halder, UttamKumar, additional, and Jayarajah, M, additional

Published
2020
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15. Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine initiative: clinical indicators

Author

Haller, Guy, primary, Bampoe, Sohail, additional, Cook, Tim, additional, Fleisher, Lee A., additional, Grocott, Michael P.W., additional, Neuman, Mark, additional, Story, David, additional, Myles, Paul S., additional, Myles, P., additional, Grocott, M., additional, Biccard, B., additional, Blazeby, J., additional, Boney, O., additional, Chan, M., additional, Diouf, E., additional, Fleisher, L., additional, Kalkman, C., additional, Kurz, A., additional, Moonesinghe, R., additional, Wijeysundera, D., additional, Gan, T.J., additional, Peyton, P., additional, Sessler, D., additional, Tramèr, M., additional, Cyna, A., additional, De Oliveira, G.S., additional, Wu, C., additional, Jensen, M., additional, Kehlet, H., additional, Botti, M., additional, Haller, G., additional, Cook, T., additional, Neuman, M., additional, Story, D., additional, Gruen, R., additional, Bampoe, S., additional, Evered, L., additional, Scott, D., additional, Silbert, B., additional, van Dijk, D., additional, Grocott, H., additional, Eckenhoff, R., additional, Rasmussen, L., additional, Eriksson, L., additional, Beattie, S., additional, Landoni, G., additional, Leslie, K., additional, Howell, S., additional, Nagele, P., additional, Richards, T., additional, Lamy, A., additional, Lalu, M., additional, Pearse, R., additional, Mythen, M., additional, Canet, J., additional, Moller, A., additional, Gin, T., additional, Schultz, M., additional, Pelosi, P., additional, Gabreu, M., additional, Futier, E., additional, Creagh-Brown, B., additional, Abbott, T., additional, Klein, A., additional, Corcoran, T., additional, Jamie Cooper, D., additional, Dieleman, S., additional, McIlroy, D., additional, Bellomo, R., additional, Shaw, A., additional, Prowle, J., additional, Karkouti, K., additional, Billings, J., additional, Mazer, D., additional, Jayarajah, M., additional, Murphy, M., additional, Bartoszko, J., additional, Sneyd, R., additional, Morris, S., additional, George, R., additional, Shulman, M., additional, Lane-Fall, M., additional, Nilsson, U., additional, Stevenson, N., additional, Cooper, J.D.J., additional, van Klei, W., additional, Cabrini, L., additional, Miller, T., additional, Pace, N., additional, Jackson, S., additional, Buggy, D., additional, Short, T., additional, Riedel, B., additional, Gottumukkala, V., additional, Alkhaffaf, B., additional, and Johnson, M., additional

Published
2019
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16. Aspirin in coronary artery surgery: 1-year results of the Aspirin and Tranexamic Acid for Coronary Artery Surgery trial.

Author

Forbes A., McNeil J., Bussieres J.S., McGuinness S., Chan M.T.V., Wallace S., Myles P.S., Smith J.A., Kasza J., Silbert B., Jayarajah M., Painter T., Cooper D.J., Marasco S., Forbes A., McNeil J., Bussieres J.S., McGuinness S., Chan M.T.V., Wallace S., Myles P.S., Smith J.A., Kasza J., Silbert B., Jayarajah M., Painter T., Cooper D.J., and Marasco S.

Abstract

Background: Aspirin may reduce the risk of vascular graft thrombosis after cardiovascular surgery. We previously reported the 30-day results of a trial evaluating aspirin use before coronary artery surgery. Here we report the 1-year outcomes evaluating late thrombotic events and disability-free survival. Method(s): Using a factorial design, we randomly assigned patients undergoing coronary artery surgery to receive aspirin or placebo and tranexamic acid or placebo. The results of the aspirin comparison are reported here. The primary 1-year outcome was death or severe disability, the latter defined as living with a modified Katz activities of daily living score < 8. Secondary outcomes included a composite of myocardial infarction, stroke and death from any cause through to 1 year after surgery. Result(s): Patients were randomly assigned to aspirin (1059 patients) or placebo (1068 patients). The rate of death or severe disability was 4.1% in the aspirin group and 3.5% in the placebo group (relative risk, 1.17; 95% confidence interval, 0.76-1.81; P =.48). There was no significant difference in the rates of myocardial infarction (P =.11), stroke (P =.086), or death (P =.24), or a composite of these cardiovascular end points (P =.68). With the exception of those with a low European System for Cardiac Operative Risk Evaluation score (P =.03), there were no interaction effects on these outcomes with tranexamic acid (all tests of interaction P >.10). Conclusion(s): In patients undergoing coronary artery surgery, preoperative aspirin did not reduce death or severe disability, or thrombotic events through to 1 year after surgery.Copyright © 2018 The American Association for Thoracic Surgery

Published
2019

17. Tranexamic acid in coronary artery surgery: One-year results of the Aspirin and Tranexamic Acid for Coronary Artery Surgery (ATACAS) trial.

Author

Krum H., Marianello D., Alvaro G., De Vuono G., van Dijk D., Dieleman J., Numan S., Parke R., Raudkivi P., Gilder E., Dunning J., Termaat J., Mans G., Alderton J., Waugh D., Platt M.J., Pai A., Sevillano A., Lal A., Sinclair C., Kunst G., Knighton A., Cubas G.M., Saravanan P., Myles P.S., Smith J.A., Kasza J., Silbert B., Jayarajah M., Painter T., Cooper D.J., Marasco S., McNeil J., Bussieres J.S., McGuinness S., Byrne K., Chan M.T.V., Landoni G., Wallace S., Forbes A., Esmore D., Tonkin A., Buxton B., Heritier S., Merry A., Liew D., Meehan A., Galagher W., Farrington C., Ditoro A., Wutzlhofer L., Story D., Peyton P., Baulch S., Sidiropoulos S., Potgieter D., Baker R.A., Pesudovs B., O'Loughlin J Wells E., Coutts P., Bolsin S., Osborne C., Ives K., Hulley A., Christie-Taylor G., Lang S., Mackay H., Cokis C., March S., Bannon P.G., Wong C., Turner L., Scott D., Said S., Corcoran P., de Prinse L., Gagne N., Lamy A., Semelhago L., Underwood M., Choi G.S.Y., Fung B., Lembo R., Monaco F., Simeone F., Millner R., Vasudevan V., Patteril M., Lopez E., Basu R., Lu J., Krum H., Marianello D., Alvaro G., De Vuono G., van Dijk D., Dieleman J., Numan S., Parke R., Raudkivi P., Gilder E., Dunning J., Termaat J., Mans G., Alderton J., Waugh D., Platt M.J., Pai A., Sevillano A., Lal A., Sinclair C., Kunst G., Knighton A., Cubas G.M., Saravanan P., Myles P.S., Smith J.A., Kasza J., Silbert B., Jayarajah M., Painter T., Cooper D.J., Marasco S., McNeil J., Bussieres J.S., McGuinness S., Byrne K., Chan M.T.V., Landoni G., Wallace S., Forbes A., Esmore D., Tonkin A., Buxton B., Heritier S., Merry A., Liew D., Meehan A., Galagher W., Farrington C., Ditoro A., Wutzlhofer L., Story D., Peyton P., Baulch S., Sidiropoulos S., Potgieter D., Baker R.A., Pesudovs B., O'Loughlin J Wells E., Coutts P., Bolsin S., Osborne C., Ives K., Hulley A., Christie-Taylor G., Lang S., Mackay H., Cokis C., March S., Bannon P.G., Wong C., Turner L., Scott D., Said S., Corcoran P., de Prinse L., Gagne N., Lamy A., Semelhago L., Underwood M., Choi G.S.Y., Fung B., Lembo R., Monaco F., Simeone F., Millner R., Vasudevan V., Patteril M., Lopez E., Basu R., and Lu J.

Abstract

Background: Tranexamic acid reduces blood loss and transfusion requirements in cardiac surgery but may increase the risk of coronary graft thrombosis. We previously reported the 30-day results of a trial evaluating tranexamic acid for coronary artery surgery. Here we report the 1-year clinical outcomes. Method(s): Using a factorial design, we randomly assigned patients undergoing coronary artery surgery to receive aspirin or placebo and tranexamic acid or placebo. The results of the tranexamic acid comparison are reported here. The primary 1-year outcome was death or severe disability, the latter defined as living with a modified Katz activities of daily living score of less than 8. Secondary outcomes included a composite of myocardial infarction, stroke, and death from any cause through to 1 year after surgery. Result(s): The rate of death or disability at 1 year was 3.8% in the tranexamic acid group and 4.4% in the placebo group (relative risk, 0.85; 95% confidence interval, 0.64-1.13; P =.27), and this did not significantly differ according to aspirin exposure at the time of surgery (interaction P =.073). The composite rate of myocardial infarction, stroke, and death up to 1 year after surgery was 14.3% in the tranexamic acid group and 16.4% in the placebo group (relative risk, 0.87; 95% CI, 0.76-1.00; P =.053). Conclusion(s): In this trial of patients having coronary artery surgery, tranexamic acid did not affect death or severe disability through to 1 year after surgery. Further work should be done to explore possible beneficial effects on late cardiovascular events.Copyright © 2018 The American Association for Thoracic Surgery

Published
2019

18. Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine initiative: clinical indicators

Author

Haller, Guy, Bampoe, Sohail, Cook, Tim, Fleisher, Lee A, Grocott, Michael PW, Neuman, Mark, Story, Davd, Myles, Paul S, Myles, P, Grocott, M, Biccard, B, Blazeby, J, Boney, O, Chan, M, Diouf, E, Fleisher, L, Kalkman, C, Kurz, A, Moonesinghe, R, Wijeysundera, D, Gan, TJ, Peyton, P, Sessler, D, Tramèr, M, Cyna, A, De Oliveira, GS, Wu, C, Jensen, M, Kehlet, H, Botti, Mari, Cook, T, Neuman, M, Story, D, Gruen, R, Evered, L, Scott, D, Silbert, B, van Dijk, D, Grocott, H, Eckenhoff, R, Rasmussen, L, Eriksson, L, Beattie, S, Landoni, G, Leslie, K, Howell, S, Nagele, P, Richards, T, Lamy, A, Lalu, M, Pearse, R, Mythen, M, Canet, J, Moller, A, Gin, T, Schultz, M, Pelosi, P, Gabreu, M, Futier, E, Creagh-Brown, B, Abbott, T, Klein, A, Corcoran, T, Jamie Cooper, D, Dieleman, S, McIlroy, D, Bellomo, R, Shaw, A, Prowle, J, Karkouti, K, Billings, J, Mazer, D, Jayarajah, M, Murphy, M, Bartoszko, J, Sneyd, R, Morris, S, George, R, Shulman, M, Lane-Fall, M, Nilsson, U, Stevenson, N, Cooper, JDJ, van Klei, W, Cabrini, L, Miller, T, Pace, N, Jackson, S, Buggy, D, Short, T, Riedel, B, Gottumukkala, V, Alkhaffaf, B, Johnson, M, Haller, Guy, Bampoe, Sohail, Cook, Tim, Fleisher, Lee A, Grocott, Michael PW, Neuman, Mark, Story, Davd, Myles, Paul S, Myles, P, Grocott, M, Biccard, B, Blazeby, J, Boney, O, Chan, M, Diouf, E, Fleisher, L, Kalkman, C, Kurz, A, Moonesinghe, R, Wijeysundera, D, Gan, TJ, Peyton, P, Sessler, D, Tramèr, M, Cyna, A, De Oliveira, GS, Wu, C, Jensen, M, Kehlet, H, Botti, Mari, Cook, T, Neuman, M, Story, D, Gruen, R, Evered, L, Scott, D, Silbert, B, van Dijk, D, Grocott, H, Eckenhoff, R, Rasmussen, L, Eriksson, L, Beattie, S, Landoni, G, Leslie, K, Howell, S, Nagele, P, Richards, T, Lamy, A, Lalu, M, Pearse, R, Mythen, M, Canet, J, Moller, A, Gin, T, Schultz, M, Pelosi, P, Gabreu, M, Futier, E, Creagh-Brown, B, Abbott, T, Klein, A, Corcoran, T, Jamie Cooper, D, Dieleman, S, McIlroy, D, Bellomo, R, Shaw, A, Prowle, J, Karkouti, K, Billings, J, Mazer, D, Jayarajah, M, Murphy, M, Bartoszko, J, Sneyd, R, Morris, S, George, R, Shulman, M, Lane-Fall, M, Nilsson, U, Stevenson, N, Cooper, JDJ, van Klei, W, Cabrini, L, Miller, T, Pace, N, Jackson, S, Buggy, D, Short, T, Riedel, B, Gottumukkala, V, Alkhaffaf, B, and Johnson, M

Published
2019

19. Systematic review and consensus definitions for standardised endpoints in perioperative medicine: postoperative cancer outcomes

Author

Buggy, D.J., primary, Freeman, J., additional, Johnson, M.Z., additional, Leslie, K., additional, Riedel, B., additional, Sessler, D.I., additional, Kurz, A., additional, Gottumukkala, V., additional, Short, T., additional, Pace, N., additional, Myles, P.S., additional, Gan, T.J., additional, Peyton, P., additional, Tramèr, M., additional, Cyna, A., additional, De Oliveira, G.S., additional, Wu, C., additional, Jensen, M., additional, Kehlet, H., additional, Botti, M., additional, Boney, O., additional, Haller, G., additional, Grocott, M., additional, Cook, T., additional, Fleisher, L., additional, Neuman, M., additional, Story, D., additional, Gruen, R., additional, Bampoe, S., additional, Evered, Lis, additional, Scott, D., additional, Silbert, B., additional, van Dijk, D., additional, Kalkman, C., additional, Chan, M., additional, Grocott, H., additional, Eckenhoff, R., additional, Rasmussen, L., additional, Eriksson, L., additional, Beattie, S., additional, Wijeysundera, D., additional, Landoni, G., additional, Biccard, B., additional, Howell, S., additional, Nagele, P., additional, Richards, T., additional, Lamy, A., additional, Lalu, M., additional, Pearse, R., additional, Mythen, M., additional, Canet, J., additional, Moller, A., additional, Gin, T., additional, Schultz, M., additional, Pelosi, P., additional, Gabreu, M., additional, Futier, E., additional, Creagh-Brown, B., additional, Abbott, T., additional, Klein, A., additional, Corcoran, T., additional, Jamie Cooper, D., additional, Dieleman, S., additional, Diouf, E., additional, McIlroy, D., additional, Bellomo, R., additional, Shaw, A., additional, Prowle, J., additional, Karkouti, K., additional, Billings, J., additional, Mazer, D., additional, Jayarajah, M., additional, Murphy, M., additional, Bartoszko, J., additional, Sneyd, R., additional, Morris, S., additional, George, R., additional, Moonesinghe, R., additional, Shulman, M., additional, Lane-Fall, M., additional, Nilsson, U., additional, Stevenson, N., additional, van Klei, W., additional, Cabrini, L., additional, Miller, T., additional, Jackson, S., additional, and Alkhaffaf, B., additional

Published
2018
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20. A systematic review and consensus definitions for standardised end-points in perioperative medicine: pulmonary complications

Author

Abbott, T.E.F., primary, Fowler, A.J., additional, Pelosi, P., additional, Gama de Abreu, M., additional, Møller, A.M., additional, Canet, J., additional, Creagh-Brown, B., additional, Mythen, M., additional, Gin, T., additional, Lalu, M.M., additional, Futier, E., additional, Grocott, M.P., additional, Schultz, M.J., additional, Pearse, R.M., additional, Myles, P., additional, Gan, T.J., additional, Kurz, A., additional, Peyton, P., additional, Sessler, D., additional, Tramèr, M., additional, Cyna, A., additional, De Oliveira, G.S., additional, Wu, C., additional, Jensen, M., additional, Kehlet, H., additional, Botti, M., additional, Boney, O., additional, Haller, G., additional, Grocott, M., additional, Cook, T., additional, Fleisher, L., additional, Neuman, M., additional, Story, D., additional, Gruen, R., additional, Bampoe, S., additional, Evered, Lis, additional, Scott, D., additional, Silbert, B., additional, van Dijk, D., additional, Kalkman, C., additional, Chan, M., additional, Grocott, H., additional, Eckenhoff, R., additional, Rasmussen, L., additional, Eriksson, L., additional, Beattie, S., additional, Wijeysundera, D., additional, Landoni, G., additional, Leslie, K., additional, Biccard, B., additional, Howell, S., additional, Nagele, P., additional, Richards, T., additional, Lamy, A., additional, Gabreu, M., additional, Klein, A., additional, Corcoran, T., additional, Jamie Cooper, D., additional, Dieleman, S., additional, Diouf, E., additional, McIlroy, D., additional, Bellomo, R., additional, Shaw, A., additional, Prowle, J., additional, Karkouti, K., additional, Billings, J., additional, Mazer, D., additional, Jayarajah, M., additional, Murphy, M., additional, Bartoszko, J., additional, Sneyd, R., additional, Morris, S., additional, George, R., additional, Moonesinghe, R., additional, Shulman, M., additional, Lane-Fall, M., additional, Nilsson, U., additional, Stevenson, N., additional, van Klei, W., additional, Cabrini, L., additional, Miller, T., additional, Pace, N., additional, Jackson, S., additional, Buggy, D., additional, Short, T., additional, Riedel, B., additional, Gottumukkala, V., additional, Alkhaffaf, B., additional, and Johnson, M., additional

Published
2018
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21. A systematic review and consensus definitions for standardised end-points in perioperative medicine: pulmonary complications

Author

Abbott, TEF, Fowler, AJ, Pelosi, P, Gama de Abreu, M, Møller, AM, Canet, J, Creagh-Brown, B, Mythen, M, Gin, T, Lalu, MM, Futier, E, Grocott, MP, Schultz, MJ, Pearse, RM, Myles, P, Gan, TJ, Kurz, A, Peyton, P, Sessler, D, Tramèr, M, Cyna, A, De Oliveira, GS, Wu, C, Jensen, M, Kehlet, H, Botti, Mari, Boney, O, Haller, G, Grocott, M, Cook, T, Fleisher, L, Neuman, M, Story, D, Gruen, R, Bampoe, S, Evered, L, Scott, D, Silbert, B, van Dijk, D, Kalkman, C, Chan, M, Grocott, H, Eckenhoff, R, Rasmussen, L, Eriksson, L, Beattie, S, Wijeysundera, D, Landoni, G, Leslie, K, Biccard, B, Howell, S, Nagele, P, Richards, T, Lamy, A, Gabreu, M, Klein, A, Corcoran, T, Jamie Cooper, D, Dieleman, S, Diouf, E, McIlroy, D, Bellomo, R, Shaw, A, Prowle, J, Karkouti, K, Billings, J, Mazer, D, Jayarajah, M, Murphy, M, Bartoszko, J, Sneyd, R, Morris, S, George, R, Moonesinghe, R, Shulman, M, Lane-Fall, M, Nilsson, U, Stevenson, N, van Klei, W, Cabrini, L, Miller, T, Pace, N, Jackson, S, Buggy, D, Short, T, Riedel, B, Gottumukkala, V, Alkhaffaf, B, Johnson, M, Abbott, TEF, Fowler, AJ, Pelosi, P, Gama de Abreu, M, Møller, AM, Canet, J, Creagh-Brown, B, Mythen, M, Gin, T, Lalu, MM, Futier, E, Grocott, MP, Schultz, MJ, Pearse, RM, Myles, P, Gan, TJ, Kurz, A, Peyton, P, Sessler, D, Tramèr, M, Cyna, A, De Oliveira, GS, Wu, C, Jensen, M, Kehlet, H, Botti, Mari, Boney, O, Haller, G, Grocott, M, Cook, T, Fleisher, L, Neuman, M, Story, D, Gruen, R, Bampoe, S, Evered, L, Scott, D, Silbert, B, van Dijk, D, Kalkman, C, Chan, M, Grocott, H, Eckenhoff, R, Rasmussen, L, Eriksson, L, Beattie, S, Wijeysundera, D, Landoni, G, Leslie, K, Biccard, B, Howell, S, Nagele, P, Richards, T, Lamy, A, Gabreu, M, Klein, A, Corcoran, T, Jamie Cooper, D, Dieleman, S, Diouf, E, McIlroy, D, Bellomo, R, Shaw, A, Prowle, J, Karkouti, K, Billings, J, Mazer, D, Jayarajah, M, Murphy, M, Bartoszko, J, Sneyd, R, Morris, S, George, R, Moonesinghe, R, Shulman, M, Lane-Fall, M, Nilsson, U, Stevenson, N, van Klei, W, Cabrini, L, Miller, T, Pace, N, Jackson, S, Buggy, D, Short, T, Riedel, B, Gottumukkala, V, Alkhaffaf, B, and Johnson, M

Published
2018

22. A systematic review and consensus definitions for standardised end-points in perioperative medicine:pulmonary complications

Author

Abbott, T. E.F., Fowler, A. J., Pelosi, P., Gama de Abreu, M., Møller, A. M., Canet, J., Creagh-Brown, B., Mythen, M., Gin, T., Lalu, M. M., Futier, E., Grocott, M. P., Schultz, M. J., Pearse, R. M., Myles, P., Gan, T. J., Kurz, A., Peyton, P., Sessler, D., Tramèr, M., Cyna, A., De Oliveira, G. S., Wu, C., Jensen, M., Kehlet, H., Botti, M., Boney, O., Haller, G., Cook, T., Fleisher, L., Neuman, M., Story, D., Gruen, R., Bampoe, S., Evered, Lis, Scott, D., Silbert, B., van Dijk, D., Kalkman, C., Chan, M., Grocott, H., Eckenhoff, R., Rasmussen, L., Eriksson, L., Beattie, S., Wijeysundera, D., Landoni, G., Leslie, K., Biccard, B., Howell, S., Nagele, P., Richards, T., Lamy, A., Gabreu, M., Klein, A., Corcoran, T., Jamie Cooper, D., Dieleman, S., Diouf, E., McIlroy, D., Bellomo, R., Shaw, A., Prowle, J., Karkouti, K., Billings, J., Mazer, D., Jayarajah, M., Murphy, M., Bartoszko, J., Sneyd, R., Morris, S., George, R., Moonesinghe, R., Shulman, M., Lane-Fall, M., Nilsson, U., Stevenson, N., van Klei, W., Cabrini, L., Miller, T., Pace, N., Jackson, S., Buggy, D., Short, T., Riedel, B., Gottumukkala, V., Alkhaffaf, B., Johnson, M., Abbott, T. E.F., Fowler, A. J., Pelosi, P., Gama de Abreu, M., Møller, A. M., Canet, J., Creagh-Brown, B., Mythen, M., Gin, T., Lalu, M. M., Futier, E., Grocott, M. P., Schultz, M. J., Pearse, R. M., Myles, P., Gan, T. J., Kurz, A., Peyton, P., Sessler, D., Tramèr, M., Cyna, A., De Oliveira, G. S., Wu, C., Jensen, M., Kehlet, H., Botti, M., Boney, O., Haller, G., Cook, T., Fleisher, L., Neuman, M., Story, D., Gruen, R., Bampoe, S., Evered, Lis, Scott, D., Silbert, B., van Dijk, D., Kalkman, C., Chan, M., Grocott, H., Eckenhoff, R., Rasmussen, L., Eriksson, L., Beattie, S., Wijeysundera, D., Landoni, G., Leslie, K., Biccard, B., Howell, S., Nagele, P., Richards, T., Lamy, A., Gabreu, M., Klein, A., Corcoran, T., Jamie Cooper, D., Dieleman, S., Diouf, E., McIlroy, D., Bellomo, R., Shaw, A., Prowle, J., Karkouti, K., Billings, J., Mazer, D., Jayarajah, M., Murphy, M., Bartoszko, J., Sneyd, R., Morris, S., George, R., Moonesinghe, R., Shulman, M., Lane-Fall, M., Nilsson, U., Stevenson, N., van Klei, W., Cabrini, L., Miller, T., Pace, N., Jackson, S., Buggy, D., Short, T., Riedel, B., Gottumukkala, V., Alkhaffaf, B., and Johnson, M.

Abstract

Background: There is a need for robust, clearly defined, patient-relevant outcome measures for use in randomised trials in perioperative medicine. Our objective was to establish standard outcome measures for postoperative pulmonary complications research. Methods: A systematic literature search was conducted using MEDLINE, Web of Science, SciELO, and the Korean Journal Database. Definitions were extracted from included manuscripts. We then conducted a three-stage Delphi consensus process to select the optimal outcome measures in terms of methodological quality and overall suitability for perioperative trials. Results: From 2358 records, the full texts of 81 manuscripts were retrieved, of which 45 met the inclusion criteria. We identified three main categories of outcome measure specific to perioperative pulmonary outcomes: (i) composite outcome measures of multiple pulmonary outcomes (27 definitions); (ii) pneumonia (12 definitions); and (iii) respiratory failure (six definitions). These were rated by the group according to suitability for routine use. The majority of definitions were given a low score, and many were imprecise, difficult to apply consistently, or both, in large patient populations. A small number of highly rated definitions were identified as appropriate for widespread use. The group then recommended four outcome measures for future use, including one new definition. Conclusions: A large number of postoperative pulmonary outcome measures have been used, but most are poorly defined. Our four recommended outcome measures include a new definition of postoperative pulmonary complications, incorporating an assessment of severity. These definitions will meet the needs of most clinical effectiveness trials of treatments to improve postoperative pulmonary outcomes.

Published
2018

23. Stopping vs. Continuing Aspirin before Coronary Artery Surgery

Author

ANZCA Clinical Trials Network, Myles, PS, Painter, TW, Silbert, BS, Smith, JA, Forbes, A, Silbert, B, Jayarajah, M, Painter, T, Cooper, DJ, Marasco, S, McNeil, J, Bussières, JS, Wallace, S, ATACAS Investigators of the ANZCA Clinical Trials Network, ANZCA Clinical Trials Network, Myles, PS, Painter, TW, Silbert, BS, Smith, JA, Forbes, A, Silbert, B, Jayarajah, M, Painter, T, Cooper, DJ, Marasco, S, McNeil, J, Bussières, JS, Wallace, S, and ATACAS Investigators of the ANZCA Clinical Trials Network

Abstract

BACKGROUND: Most patients with coronary artery disease receive aspirin for primary or secondary prevention of myocardial infarction, stroke, and death. Aspirin poses a risk of bleeding in patients undergoing surgery, but it is unclear whether aspirin should be stopped before coronary artery surgery. METHODS: We used a 2-by-2 factorial trial design to randomly assign patients who were scheduled to undergo coronary artery surgery and were at risk for perioperative complications to receive aspirin or placebo and tranexamic acid or placebo. The results of the aspirin trial are reported here. Patients were randomly assigned to receive 100 mg of aspirin or matched placebo preoperatively. The primary outcome was a composite of death and thrombotic complications (nonfatal myocardial infarction, stroke, pulmonary embolism, renal failure, or bowel infarction) within 30 days after surgery. RESULTS: Among 5784 eligible patients, 2100 were enrolled; 1047 were randomly assigned to receive aspirin and 1053 to receive placebo. A primary outcome event occurred in 202 patients in the aspirin group (19.3%) and in 215 patients in the placebo group (20.4%) (relative risk, 0.94; 95% confidence interval, 0.80 to 1.12; P=0.55). Major hemorrhage leading to reoperation occurred in 1.8% of patients in the aspirin group and in 2.1% of patients in the placebo group (P=0.75), and cardiac tamponade occurred at rates of 1.1% and 0.4%, respectively (P=0.08). CONCLUSIONS: Among patients undergoing coronary artery surgery, the administration of preoperative aspirin resulted in neither a lower risk of death or thrombotic complications nor a higher risk of bleeding than that with placebo. (Funded by the Australian National Health and Medical Research Council and others; Australia New Zealand Clinical Trials Registry number, ACTRN12605000557639.).

Published
2016

26. Systematic review and consensus definitions for the Standardized Endpoints in Perioperative Medicine (StEP) initiative: cardiovascular outcomes

Author

W. Scott Beattie, Manoj Lalu, Matthew Bocock, Simon Feng, Duminda N. Wijeysundera, Peter Nagele, Lee A. Fleisher, Andrea Kurz, Bruce Biccard, Kate Leslie, Simon Howell, Giovanni Landoni, Hilary Grocott, Andre Lamy, Toby Richards, Paul Myles, T.J. Gan, Phil Peyton, Dan Sessler, Martin Tramèr, Alan Cyna, Gildasio S. De Oliveira, Christopher Wu, Mark Jensen, Henrik Kehlet, Mari Botti, Oliver Boney, Guy Haller, Mike Grocott, Tim Cook, Lee Fleisher, Mark Neuman, David Story, Russell Gruen, Sam Bampoe, Lis Evered, David Scott, Brendan Silbert, Diederik van Dijk, Cor Kalkman, Matthew Chan, Rod Eckenhoff, Lars Rasmussen, Lars Eriksson, Scott Beattie, Duminda Wijeysundera, Richard J. Bartlett, Robert McMonnies, Jacob Gerstl, Mohammad Jay, David Kishlyansky, Matthew Machina, Matthew Bobcock, Rupert Pearse, Monty Mythen, Jaume Canet, Ann Moller, Tony Gin, Marcus Schultz, Paolo Pelosi, Marcelo Gabreu, Emmanuel Futier, Ben Creagh-Brown, Tom Abbott, Andy Klein, Tomas Corcoran, D. Jamie Cooper, Stefan Dieleman, Elisabeth Diouf, David McIlroy, Rinaldo Bellomo, Andrew Shaw, John Prowle, Keyvan Karkouti, Josh Billings, David Mazer, Mohindas Jayarajah, Michael Murphy, Justyna Bartoszko, Rob Sneyd, Steve Morris, Ron George, Ramani Moonesinghe, Mark Shulman, Meghan Lane-Fall, Ulrica Nilsson, Nathalie Stevenson, Jamie (DJ) Cooper, Wilton van Klei, Luca Cabrini, Tim Miller, Nathan Pace, Sandy Jackson, Donal Buggy, Tim Short, Bernhard Riedel, Vijay Gottumukkala, Bilal Alkhaffaf, Mark Johnson, Beattie, W. S., Lalu, M., Bocock, M., Feng, S., Wijeysundera, D. N., Nagele, P., Fleisher, L. A., Kurz, A., Biccard, B., Leslie, K., Howell, S., Landoni, G., Grocott, H., Lamy, A., Richards, T., Myles, P., Cooper, D. J., Gan, T. J., Peyton, P., Sessler, D., Tramer, M., Cyna, A., De Oliveira, G. S., Wu, C., Jensen, M., Kehlet, H., Botti, M., Boney, O., Haller, G., Grocott, M., Cook, T., Fleisher, L., Neuman, M., Story, D., Gruen, R., Bampoe, S., Evered, L., Scott, D., Silbert, B., van Dijk, D., Kalkman, C., Chan, M., Eckenhoff, R., Rasmussen, L., Eriksson, L., Beattie, S., Wijeysundera, D., Bartlett, R. J., Mcmonnies, R., Gerstl, J., Jay, M., Kishlyansky, D., Machina, M., Bobcock, M., Pearse, R., Mythen, M., Canet, J., Moller, A., Gin, T., Schultz, M., Pelosi, P., Gabreu, M., Futier, E., Creagh-Brown, B., Abbott, T., Klein, A., Corcoran, T., Dieleman, S., Diouf, E., Mcilroy, D., Bellomo, R., Shaw, A., Prowle, J., Karkouti, K., Billings, J., Mazer, D., Jayarajah, M., Murphy, M., Bartoszko, J., Sneyd, R., Morris, S., George, R., Moonesinghe, R., Shulman, M., Lane-Fall, M., Nilsson, U., Stevenson, N., Cooper, J. D., van Klei, W., Cabrini, L., Miller, T., Pace, N., Jackson, S., Buggy, D., Short, T., Riedel, B., Gottumukkala, V., Alkhaffaf, B., Johnson, M., Tramer, Martin, and Haller, Guy Serge Antoine

Subjects
medicine.medical_specialty, Consensus, Heart disease, Delphi Technique, Endpoint Determination, perioperative medicine, MACE, Cochrane Library, Perioperative Care, 03 medical and health sciences, Patient safety, cardiovascular events, outcome measures, 0302 clinical medicine, Postoperative Complications, 030202 anesthesiology, Anesthesiology, medicine, Humans, clinical trials, myocardial infarction, standardised endpoint, Intensive care medicine, Adverse effect, Clinical Trials as Topic, Perioperative medicine, ddc:617, business.industry, Cardiovascular Diseases, Perioperative Medicine, Research Design, Perioperative, medicine.disease, Clinical trial, Anesthesiology and Pain Medicine, business
Abstract

Background: Adverse cardiovascular events are a leading cause of perioperative morbidity and mortality. The definitions of perioperative cardiovascular adverse events are heterogeneous. As part of the international Standardized Endpoints in Perioperative Medicine initiative, this study aimed to find consensus amongst clinical trialists on a set of standardised and valid cardiovascular outcomes for use in future perioperative clinical trials.Methods: We identified currently used perioperative cardiovascular outcomes by a systematic review of the anaesthesia and perioperative medicine literature (PubMed/Ovid, Embase, and Cochrane Library). We performed a three-stage Delphi consensus-gaining process that involved 55 clinician researchers worldwide. Cardiovascular outcomes were first shortlisted and the most suitable definitions determined. These cardiovascular outcomes were then assessed for validity, reliability, feasibility, and clarity.Results: We identified 18 cardiovascular outcomes. Participation in the three Delphi rounds was 100% (n=19), 71% (n=55), and 89% (n=17), respectively. A final list of nine cardiovascular outcomes was elicited from the consensus: myocardial infarction, myocardial injury, cardiovascular death, non-fatal cardiac arrest, coronary revascularisation, major adverse cardiac events, pulmonary embolism, deep vein thrombosis, and atrial fibrillation. These nine cardiovascular outcomes were rated by the majority of experts as valid, reliable, feasible, and clearly defined.Conclusions: These nine consensus cardiovascular outcomes can be confidently used as endpoints in clinical trials designed to evaluate perioperative interventions with the goal of improving perioperative outcomes.

Published
2021

27. Tranexamic Acid in Patients Undergoing Coronary-Artery Surgery

Author

Paul S. Myles, Julian A. Smith, Andrew Forbes, Brendan Silbert, Mohandas Jayarajah, Thomas Painter, D. James Cooper, Silvana Marasco, John McNeil, Jean S. Bussières, Shay McGuinness, Kelly Byrne, Matthew T.V. Chan, Giovanni Landoni, Sophie Wallace, Myles, P, Smith, Ja, Forbes, A, Silbert, B, Jayarajah, M, Painter, T, Cooper, Dj, Marasco, S, Mcneil, J, Bussières, J, Mcguinness, S, Byrne, K, Chan, Mt, Landoni, G, and Wallace, S

Subjects
Aspirin, medicine.medical_specialty, business.industry, General Medicine, Perioperative, 030204 cardiovascular system & hematology, medicine.disease, Placebo, Surgery, Coronary artery disease, 03 medical and health sciences, 0302 clinical medicine, 030202 anesthesiology, Anesthesia, medicine, Platelet aggregation inhibitor, Myocardial infarction, business, Stroke, Tranexamic acid, medicine.drug
Abstract

Background Tranexamic acid reduces the risk of bleeding among patients undergoing cardiac surgery, but it is unclear whether this leads to improved outcomes. Furthermore, there are concerns that tranexamic acid may have prothrombotic and proconvulsant effects. Methods In a trial with a 2-by-2 factorial design, we randomly assigned patients who were scheduled to undergo coronary-artery surgery and were at risk for perioperative complications to receive aspirin or placebo and tranexamic acid or placebo. The results of the tranexamic acid comparison are reported here. The primary outcome was a composite of death and thrombotic complications (nonfatal myocardial infarction, stroke, pulmonary embolism, renal failure, or bowel infarction) within 30 days after surgery. Results Of the 4662 patients who were enrolled and provided consent, 4631 underwent surgery and had available outcomes data; 2311 were assigned to the tranexamic acid group and 2320 to the placebo group. A primary outcome event occurred in 386 patients (16.7%) in the tranexamic acid group and in 420 patients (18.1%) in the placebo group (relative risk, 0.92; 95% confidence interval, 0.81 to 1.05; P=0.22). The total number of units of blood products that were transfused during hospitalization was 4331 in the tranexamic acid group and 7994 in the placebo group (P

Published
2017
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28. Aspirin in coronary artery surgery: 1-year results of the Aspirin and Tranexamic Acid for Coronary Artery Surgery trial.

Author

Myles PS, Smith JA, Kasza J, Silbert B, Jayarajah M, Painter T, Cooper DJ, Marasco S, McNeil J, Bussières JS, McGuinness S, Chan MTV, Wallace S, and Forbes A

Subjects
Aged, Antifibrinolytic Agents adverse effects, Aspirin adverse effects, Coronary Artery Disease diagnostic imaging, Coronary Artery Disease mortality, Coronary Thrombosis etiology, Coronary Thrombosis mortality, Coronary Thrombosis prevention & control, Disability Evaluation, Double-Blind Method, Female, Fibrinolytic Agents adverse effects, Hemorrhage chemically induced, Hemorrhage mortality, Hemorrhage prevention & control, Humans, Male, Middle Aged, Myocardial Infarction etiology, Myocardial Infarction mortality, Myocardial Infarction prevention & control, Progression-Free Survival, Risk Factors, Time Factors, Tranexamic Acid adverse effects, Antifibrinolytic Agents administration & dosage, Aspirin administration & dosage, Coronary Artery Bypass adverse effects, Coronary Artery Bypass mortality, Coronary Artery Disease surgery, Fibrinolytic Agents administration & dosage, Tranexamic Acid administration & dosage
Abstract

Background: Aspirin may reduce the risk of vascular graft thrombosis after cardiovascular surgery. We previously reported the 30-day results of a trial evaluating aspirin use before coronary artery surgery. Here we report the 1-year outcomes evaluating late thrombotic events and disability-free survival., Methods: Using a factorial design, we randomly assigned patients undergoing coronary artery surgery to receive aspirin or placebo and tranexamic acid or placebo. The results of the aspirin comparison are reported here. The primary 1-year outcome was death or severe disability, the latter defined as living with a modified Katz activities of daily living score < 8. Secondary outcomes included a composite of myocardial infarction, stroke and death from any cause through to 1 year after surgery., Results: Patients were randomly assigned to aspirin (1059 patients) or placebo (1068 patients). The rate of death or severe disability was 4.1% in the aspirin group and 3.5% in the placebo group (relative risk, 1.17; 95% confidence interval, 0.76-1.81; P = .48). There was no significant difference in the rates of myocardial infarction (P = .11), stroke (P = .086), or death (P = .24), or a composite of these cardiovascular end points (P = .68). With the exception of those with a low European System for Cardiac Operative Risk Evaluation score (P = .03), there were no interaction effects on these outcomes with tranexamic acid (all tests of interaction P > .10)., Conclusions: In patients undergoing coronary artery surgery, preoperative aspirin did not reduce death or severe disability, or thrombotic events through to 1 year after surgery., (Copyright © 2018 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Published
2019
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29. Defining clinically important perioperative blood loss and transfusion for the Standardised Endpoints for Perioperative Medicine (StEP) collaborative: a protocol for a scoping review.

Author

Bartoszko J, Vorobeichik L, Jayarajah M, Karkouti K, Klein AA, Lamy A, Mazer CD, Murphy M, Richards T, Englesakis M, Myles PS, and Wijeysundera DN

Subjects
Humans, Research Design, Scoping Reviews As Topic, Blood Loss, Surgical, Blood Transfusion standards, Perioperative Period standards, Reference Standards
Abstract

Introduction: 'Standardised Endpoints for Perioperative Medicine' (StEP) is an international collaboration undertaking development of consensus-based consistent definitions for endpoints in perioperative clinical trials. Inconsistency in endpoint definitions can make interpretation of trial results more difficult, especially if conflicting evidence is present. Furthermore, this inconsistency impedes evidence synthesis and meta-analyses. The goals of StEP are to harmonise definitions for clinically meaningful endpoints and specify standards for endpoint reporting in clinical trials. To help inform this endeavour, we aim to conduct a scoping review to systematically characterise the definitions of clinically important endpoints in the existing published literature on perioperative blood loss and transfusion., Methods and Analysis: The scoping review will be conducted using the widely adopted framework developed by Arksey and O'Malley, with modifications from Levac. We refined our methods with guidance from research librarians as well as researchers and clinicians with content expertise. The electronic literature search will involve several databases including Medline, PubMed-not-Medline and Embase. Our review has three objectives, namely to (1) identify definitions of significant blood loss and transfusion used in previously published large perioperative randomised trials; (2) identify previously developed consensus-based definitions for significant blood loss and transfusion in perioperative medicine and related fields; and (3) describe the association between different magnitudes of blood loss and transfusion with postoperative outcomes. The multistage review process for each question will involve two reviewers screening abstracts, reading full-text articles and performing data extraction. The abstracted data will be organised and subsequently analysed in an iterative process., Ethics and Dissemination: This scoping review of the previously published literature does not require research ethics approval. The results will be used to inform a consensus-based process to develop definitions of clinically important perioperative blood loss and transfusion. The results of the scoping review will be published in a peer-reviewed scientific journal., Competing Interests: Competing interests: AAK has received support for research and/or honoraria from Pharmacosmos, Vifor Pharma, CSL Behring, Brightwake Ltd and Fisher Paykel. TR has received support for research and/or honoraria from Pharmocosmos, Vifor Pharma, Acelity and Libresse/Bodyform. TR is a director of the Iron Clinic Ltd (London, UK), director of Veincare London Ltd (London, UK) and Vascular Surgery lead for 18 Week Support Ltd (London, UK). The remaining authors have no competing interests or conflicts to declare., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Published
2017
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30. Tranexamic Acid in Patients Undergoing Coronary-Artery Surgery.

Author

Myles PS, Smith JA, Forbes A, Silbert B, Jayarajah M, Painter T, Cooper DJ, Marasco S, McNeil J, Bussières JS, McGuinness S, Byrne K, Chan MT, Landoni G, and Wallace S

Subjects
Aged, Aged, 80 and over, Antifibrinolytic Agents adverse effects, Aspirin therapeutic use, Blood Transfusion statistics & numerical data, Coronary Artery Disease mortality, Coronary Artery Disease surgery, Double-Blind Method, Female, Heart Valves surgery, Hemorrhage chemically induced, Humans, Male, Middle Aged, Platelet Aggregation Inhibitors therapeutic use, Postoperative Complications chemically induced, Reoperation statistics & numerical data, Seizures chemically induced, Thrombosis chemically induced, Tranexamic Acid adverse effects, Antifibrinolytic Agents therapeutic use, Coronary Artery Bypass, Hemorrhage prevention & control, Intraoperative Complications prevention & control, Tranexamic Acid therapeutic use
Abstract

Background: Tranexamic acid reduces the risk of bleeding among patients undergoing cardiac surgery, but it is unclear whether this leads to improved outcomes. Furthermore, there are concerns that tranexamic acid may have prothrombotic and proconvulsant effects., Methods: In a trial with a 2-by-2 factorial design, we randomly assigned patients who were scheduled to undergo coronary-artery surgery and were at risk for perioperative complications to receive aspirin or placebo and tranexamic acid or placebo. The results of the tranexamic acid comparison are reported here. The primary outcome was a composite of death and thrombotic complications (nonfatal myocardial infarction, stroke, pulmonary embolism, renal failure, or bowel infarction) within 30 days after surgery., Results: Of the 4662 patients who were enrolled and provided consent, 4631 underwent surgery and had available outcomes data; 2311 were assigned to the tranexamic acid group and 2320 to the placebo group. A primary outcome event occurred in 386 patients (16.7%) in the tranexamic acid group and in 420 patients (18.1%) in the placebo group (relative risk, 0.92; 95% confidence interval, 0.81 to 1.05; P=0.22). The total number of units of blood products that were transfused during hospitalization was 4331 in the tranexamic acid group and 7994 in the placebo group (P<0.001). Major hemorrhage or cardiac tamponade leading to reoperation occurred in 1.4% of the patients in the tranexamic acid group and in 2.8% of the patients in the placebo group (P=0.001), and seizures occurred in 0.7% and 0.1%, respectively (P=0.002 by Fisher's exact test)., Conclusions: Among patients undergoing coronary-artery surgery, tranexamic acid was associated with a lower risk of bleeding than was placebo, without a higher risk of death or thrombotic complications within 30 days after surgery. Tranexamic acid was associated with a higher risk of postoperative seizures. (Funded by the Australian National Health and Medical Research Council and others; ATACAS Australia New Zealand Clinical Trials Registry number, ACTRN12605000557639 .).

Published
2017
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31. An audit to assess the impact of new directives about the use of aprotinin on re-exploration rates and blood product usage after adult cardiac surgery.

Author

Khan SA, Jayarajah M, and Ahlijah B

Subjects
Adult, Blood Component Transfusion trends, Cardiac Surgical Procedures trends, Humans, Medical Audit trends, Postoperative Hemorrhage drug therapy, Postoperative Hemorrhage etiology, Postoperative Hemorrhage prevention & control, Practice Guidelines as Topic, Reoperation trends, Aprotinin administration & dosage, Blood Component Transfusion statistics & numerical data, Cardiac Surgical Procedures adverse effects, Medical Audit methods, Reoperation statistics & numerical data
Published
2009
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32. Severe coronary artery disease with coarctation of the aorta: role of off-pump coronary artery bypass grafting.

Author

Balakrishnan KR, Thanikachalam S, Murthy JS, Saldanha R, and Jayarajah M

Subjects
Angina Pectoris etiology, Aortic Coarctation complications, Blood Vessel Prosthesis Implantation, Coronary Disease complications, Female, Humans, Hypertension complications, Male, Middle Aged, Thoracotomy methods, Treatment Outcome, Ventricular Dysfunction, Left etiology, Ventricular Dysfunction, Left surgery, Aortic Coarctation surgery, Coronary Artery Bypass, Off-Pump methods, Coronary Disease surgery
Abstract

Severe coronary artery disease with coarctation of the aorta is an unusual and challenging clinical problem. We encountered three adults with severe coronary artery disease and tight coarctation of the aorta. Since angina was the dominant symptom in all, off-pump coronary artery bypass grafting (OPCABG) was done as a first stage. All survived the operation. After a gap of 3 weeks, coarctation repair has been done in 1 patient. We believe that OPCABG offers some unique advantages in this difficult situation.

Published
2005
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33. Evaluation of neuromuscular effects and antagonism of rocuronium bromide: a preliminary report.

Author

Davis L, Jayarajah MJ, Toner CC, and Flynn PJ

Subjects
Adolescent, Adult, Androstanols administration & dosage, Androstanols antagonists & inhibitors, Anesthesia, Cholinesterase Inhibitors pharmacology, Double-Blind Method, Edrophonium pharmacology, Humans, Middle Aged, Muscle Relaxation drug effects, Neostigmine pharmacology, Neuromuscular Nondepolarizing Agents administration & dosage, Neuromuscular Nondepolarizing Agents antagonists & inhibitors, Rocuronium, Time Factors, Androstanols pharmacology, Neuromuscular Nondepolarizing Agents pharmacology
Abstract

Twenty ASA I-II patients received either 2 or 3 x ED95 doses of rocuronium bromide during nitrous oxide, oxygen, propofol, fentanyl-based anaesthesia. The mean times to maximum block were 98 s and 74 s and the mean duration of clinical relaxation (recovery to 25% T1) was 35 min and 46 min following 620 micrograms kg-1 and 930 micrograms kg-1, respectively. Neuromuscular blockade was antagonized with either neostigmine or edrophonium from a twitch height of 25%. Although there was no significant difference between the recovery times neostigmine appeared to give more consistent antagonism of rocuronium-induced blockade.

Published
1995

34. Hazard of reinforced tracheal tubes.

Author

Jayarajah MJ and Cole PJ

Subjects
Adult, Anesthesia, General, Equipment Design, Equipment Failure, Female, Humans, Laryngoscopy, Airway Obstruction etiology, Intubation, Intratracheal adverse effects
Published
1994
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