Restrictive or Liberal Red-Cell Transfusion for Cardiac Surgery
C David Mazer, Richard P Whitlock, Dean A Fergusson, Judith Hall, Emilie Belley-Cote, Katherine Connolly, Boris Khanykin, Alexander J Gregory, Étienne de Médicis, Shay McGuinness, Alistair Royse, François M Carrier, Paul J Young, Juan C Villar, Hilary P Grocott, Manfred D Seeberger, Stephen Fremes, François Lellouche, Summer Syed, Kelly Byrne, Sean M Bagshaw, Nian C Hwang, Chirag Mehta, Thomas W Painter, Colin Royse, Subodh Verma, Gregory M T Hare, Ashley Cohen, Kevin E Thorpe, Peter Jüni, Nadine Shehata, TRICS Investigators and Perioperative Anesthesia Clinical Trials Group, Charlie MacAdams, J Carson, D Cook, R Cook, H Nathan, R Roberts, M Krahn, G Growe, R Baskett, D Bainbridge, G Djaiani, M Eaton, A Garg, Y Zhou, B Dai, C Du, S Schulman, J Ingemann, M Chasse, W Kuebler, M Gofeld, S Novoshinov, W Popescu, M Contreras, C Gomez-Builes, R Bittencourt, F Papa, Jodi Shim, Alice Dang, Christopher Ducharme, Devin McCaskell, Isabelle Laksono, Leslie Louvelle, Pamela DeVerno, Kosma Wysocki, Maria Naydenova, Nikhil Mistry, Jonathan Wu, M H Masse, J Marchand, C MacAdams, D Seal, A Ferland, I Ali, K Maier, T Creary, L Tittley, J Spence, I Jaffer, S Brodutch, J Bussières, F Dagenais, P Lizotte, N Gagné, H Tremblay, C Breton, P Bouchard, T Bentall, F Béïque, S Ramachandran, A Rochon, M Vervais, S Grenier, H Kashani, E Ambrose, J McVagh, C Crescini, S Yagnik, A Slabiak, K Han, R Karkhanis, N Baig, S Sidhu, R MacArthur, K Reid, S Boehnke, C Hudson, F D Rubens, D Winch, R Klein, R Grey, K Teoh, W Wiley, C Darby, A Ho, T Saha, D DuMerton Shore, J Shelley, Y Lamarche, C Sirois, C D Brown, C Dube, K Holden, L Roy, B Rolfe, S Brown, N Badner, R Saczkowski, W Senner, N Noiseux, P Hebert, F Benettaib, A Ghamraoui, M Lebrasseur, W S Beattie, J Carroll, H Poonawala, G Zbitnew, S Howells, R Mawhinney, S Sampson, C Yegappan, R Schroeder, S Perfect, M Jones, J Leff, S Nair, K A Moncada, C Joco, M Harrison, P Greilich, K Landgraf, R S Kramer, B Gallant, M Fontes, K Stavris, T Rosengart, S Omer, K Coffey, E Broussard, E Tseng, M J London, K M Stanley, L Casson, M Julien, P Myles, S Wallace, W Galagher, A Ditoro, Z Williams, L Tivendale, N Dong, S Judelman, J Leyden, E Yarad, M Doane, C Player, D A Scott, B Slater, P Corcoran, R Hu, S Sidiropoulos, S Baulch, D Brewster, S Simpson, J Smith, A Hulley, L de Prinse, P Bannon, L Turner, L Beattie, A Eslick, L Cope, B Sanderson, R A Baker, B Pesudovs, J S Bennetts, D Dimovski, N Duggan, K Ives, C Yap, G Mans, J Termaat, E Ridgeon, S Reddy, S Hurford, D Mackle, T Baker, A Hunt, R Cruz, S Henderson, J Mehrtens, R Parke, E Gilder, K Cowdrey, J Dalton, M Butler, S Long, A Lammert, A Blakemore, C Walker, D France, R Hutchison, S Xue, J Gu, X Chen, A Fan, S Suraya, N Raja, I Yusnida, T Azura, T Saibon, M Tze Bing, R S Tan, F Ang, T T Chin, A Jain, P Sharma, R Shah, P Shaikh, M Kanchi, A Sigamani, K Anusha, P Johansson, T Anderson, L Olesen, N Lilleør, S Rasmussen, A Fenger, S Treskatsch, V Mezger, E Falk, M Habicher, M Sander, F Edinger, C Koch, A Boening, I Oswald, S Bulat-Genc, D Bolliger, J Fassl, E Seeberger, B Eberle, J Takala, M Stucki, E Mateo, J Moreno, T Gabaldon, I Cobo, J J Peña, C Ferrer, P Carmona, I Zarragoikoetxea, J Galan, G Urrutia, M Martínez, M Rivilla, V Cegarra, R Acosta, L Gajate-Martin, A Candela-Toha, G I Tagarakis, V Simopoulos, D Karangelis, D Filipescu, A Paunescu, H Fawzy, W Mawlana, S Preisman, E Raanani, D Kogan, I Matot, A Cattan, H Artsi, C Galhardo, S Olival, R Toledo, E Hernandez, F R Montes, E Váquiro, C Garavito, M Abello, E J Manrique, S M Vásquez, L A Aguilar, M Coral, H Rodríguez, J C Tellez, C Martinez, B M Biccard, C S Alphonsus, B D Spiess, R Hall, B Kent, A Denault, A Deschamps, C David Mazer, Richard P Whitlock, Dean A Fergusson, Judith Hall, Emilie Belley-Cote, Katherine Connolly, Boris Khanykin, Alexander J Gregory, Étienne de Médicis, Shay McGuinness, Alistair Royse, François M Carrier, Paul J Young, Juan C Villar, Hilary P Grocott, Manfred D Seeberger, Stephen Fremes, François Lellouche, Summer Syed, Kelly Byrne, Sean M Bagshaw, Nian C Hwang, Chirag Mehta, Thomas W Painter, Colin Royse, Subodh Verma, Gregory M T Hare, Ashley Cohen, Kevin E Thorpe, Peter Jüni, Nadine Shehata, TRICS Investigators and Perioperative Anesthesia Clinical Trials Group, Charlie MacAdams, J Carson, D Cook, R Cook, H Nathan, R Roberts, M Krahn, G Growe, R Baskett, D Bainbridge, G Djaiani, M Eaton, A Garg, Y Zhou, B Dai, C Du, S Schulman, J Ingemann, M Chasse, W Kuebler, M Gofeld, S Novoshinov, W Popescu, M Contreras, C Gomez-Builes, R Bittencourt, F Papa, Jodi Shim, Alice Dang, Christopher Ducharme, Devin McCaskell, Isabelle Laksono, Leslie Louvelle, Pamela DeVerno, Kosma Wysocki, Maria Naydenova, Nikhil Mistry, Jonathan Wu, M H Masse, J Marchand, C MacAdams, D Seal, A Ferland, I Ali, K Maier, T Creary, L Tittley, J Spence, I Jaffer, S Brodutch, J Bussières, F Dagenais, P Lizotte, N Gagné, H Tremblay, C Breton, P Bouchard, T Bentall, F Béïque, S Ramachandran, A Rochon, M Vervais, S Grenier, H Kashani, E Ambrose, J McVagh, C Crescini, S Yagnik, A Slabiak, K Han, R Karkhanis, N Baig, S Sidhu, R MacArthur, K Reid, S Boehnke, C Hudson, F D Rubens, D Winch, R Klein, R Grey, K Teoh, W Wiley, C Darby, A Ho, T Saha, D DuMerton Shore, J Shelley, Y Lamarche, C Sirois, C D Brown, C Dube, K Holden, L Roy, B Rolfe, S Brown, N Badner, R Saczkowski, W Senner, N Noiseux, P Hebert, F Benettaib, A Ghamraoui, M Lebrasseur, W S Beattie, J Carroll, H Poonawala, G Zbitnew, S Howells, R Mawhinney, S Sampson, C Yegappan, R Schroeder, S Perfect, M Jones, J Leff, S Nair, K A Moncada, C Joco, M Harrison, P Greilich, K Landgraf, R S Kramer, B Gallant, M Fontes, K Stavris, T Rosengart, S Omer, K Coffey, E Broussard, E Tseng, M J London, K M Stanley, L Casson, M Julien, P Myles, S Wallace, W Galagher, A Ditoro, Z Williams, L Tivendale, N Dong, S Judelman, J Leyden, E Yarad, M Doane, C Player, D A Scott, B Slater, P Corcoran, R Hu, S Sidiropoulos, S Baulch, D Brewster, S Simpson, J Smith, A Hulley, L de Prinse, P Bannon, L Turner, L Beattie, A Eslick, L Cope, B Sanderson, R A Baker, B Pesudovs, J S Bennetts, D Dimovski, N Duggan, K Ives, C Yap, G Mans, J Termaat, E Ridgeon, S Reddy, S Hurford, D Mackle, T Baker, A Hunt, R Cruz, S Henderson, J Mehrtens, R Parke, E Gilder, K Cowdrey, J Dalton, M Butler, S Long, A Lammert, A Blakemore, C Walker, D France, R Hutchison, S Xue, J Gu, X Chen, A Fan, S Suraya, N Raja, I Yusnida, T Azura, T Saibon, M Tze Bing, R S Tan, F Ang, T T Chin, A Jain, P Sharma, R Shah, P Shaikh, M Kanchi, A Sigamani, K Anusha, P Johansson, T Anderson, L Olesen, N Lilleør, S Rasmussen, A Fenger, S Treskatsch, V Mezger, E Falk, M Habicher, M Sander, F Edinger, C Koch, A Boening, I Oswald, S Bulat-Genc, D Bolliger, J Fassl, E Seeberger, B Eberle, J Takala, M Stucki, E Mateo, J Moreno, T Gabaldon, I Cobo, J J Peña, C Ferrer, P Carmona, I Zarragoikoetxea, J Galan, G Urrutia, M Martínez, M Rivilla, V Cegarra, R Acosta, L Gajate-Martin, A Candela-Toha, G I Tagarakis, V Simopoulos, D Karangelis, D Filipescu, A Paunescu, H Fawzy, W Mawlana, S Preisman, E Raanani, D Kogan, I Matot, A Cattan, H Artsi, C Galhardo, S Olival, R Toledo, E Hernandez, F R Montes, E Váquiro, C Garavito, M Abello, E J Manrique, S M Vásquez, L A Aguilar, M Coral, H Rodríguez, J C Tellez, C Martinez, B M Biccard, C S Alphonsus, B D Spiess, R Hall, B Kent, A Denault, A Deschamps
Abstract
Background: The effect of a restrictive versus liberal red-cell transfusion strategy on clinical outcomes in patients undergoing cardiac surgery remains unclear.
Methods: In this multicenter, open-label, noninferiority trial, we randomly assigned 5243 adults undergoing cardiac surgery who had a European System for Cardiac Operative Risk Evaluation (EuroSCORE) I of 6 or more (on a scale from 0 to 47, with higher scores indicating a higher risk of death after cardiac surgery) to a restrictive red-cell transfusion threshold (transfuse if hemoglobin level was <7.5 g per deciliter, starting from induction of anesthesia) or a liberal red-cell transfusion threshold (transfuse if hemoglobin level was <9.5 g per deciliter in the operating room or intensive care unit [ICU] or was <8.5 g per deciliter in the non-ICU ward). The primary composite outcome was death from any cause, myocardial infarction, stroke, or new-onset renal failure with dialysis by hospital discharge or by day 28, whichever came first. Secondary outcomes included red-cell transfusion and other clinical outcomes.
Results: The primary outcome occurred in 11.4% of the patients in the restrictive-threshold group, as compared with 12.5% of those in the liberal-threshold group (absolute risk difference, -1.11 percentage points; 95% confidence interval [CI], -2.93 to 0.72; odds ratio, 0.90; 95% CI, 0.76 to 1.07; P<0.001 for noninferiority). Mortality was 3.0% in the restrictive-threshold group and 3.6% in the liberal-threshold group (odds ratio, 0.85; 95% CI, 0.62 to 1.16). Red-cell transfusion occurred in 52.3% of the patients in the restrictive-threshold group, as compared with 72.6% of those in the liberal-threshold group (odds ratio, 0.41; 95% CI, 0.37 to 0.47). There were no significant between-group differences with regard to the other secondary outcomes.
Conclusions: In patients undergoing cardiac surgery who were at moderate-to-high risk for death, a restrictive strategy regarding red-cell transfusion was noninferior to a liberal strategy with respect to the composite outcome of death from any cause, myocardial infarction, stroke, or new-onset renal failure with dialysis, with less blood transfused. (Funded by the Canadian Institutes of Health Research and others; TRICS III ClinicalTrials.gov number, NCT02042898 .).
Source: PubMed