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N Engl J Med. 2008 May 29;358(22):2319-31. doi: 10.1056/NEJMoa0802395. Epub 2008 May 14.

A comparison of aprotinin and lysine analogues in high-risk cardiac surgery.

Collaborators (364)

Hébert PC, Fergusson DA, Mazer CD, Fremes S, MacAdams C, Murkin JM, Teoh K, Duke PC, Arellano R, Blajchman MA, Bussières JS, Côté D, Karski J, Martineau R, Robblee JA, Rodger M, Wells G, Pretorius R, Fergusson DA, Hébert PC, Mazer CD, Fremes S, MacAdams C, Murkin JM, Teoh K, Duke PC, Hébert PC, Arellano R, Denault A, Fremes S, MacAdams C, Martin R, MacAdams C, Robblee JA, Coté D, Bussières J, Denault A, Rochon A, Martineau R, Cain JP, Murkin JM, Béïque F, Arellano R, Hirsch G, Mazer CD, Mathur S, Fremes S, Karski J, Finegan B, Ansley D, Townsend GE, Teoh K, Duke PC, Friesen R, Lee TW, Hudson R, Laupacis A, Hardy JF, Pelletier C, Roberts R, Clinch J, Bérard D, Coutu S, de Médicis E, Greentree D, Mueller X, Martin M, Seal D, Maitland A, Bands C, Caton B, Chun R, Haigh J, Ha D, Hopper G, Kowalewski R, Mansell W, Sirounis D, Tang T, Appoo J, Bayes A, Burgess J, Fedak P, Kidd W, Prystai G, MacDonald B, Nathan H, Mesana T, Beauvais M, Blackburn S, Duperey D, Laflamme P, Marcotte D, Martineau A, Ouellet JM, Parent F, St-Onge S, St Pierre A, Villeneuve J, Rheault M, Bélisle S, Blain R, Taillefer J, Couture P, Cogan J, Hemmings G, Ayoub C, Lebon JS, Qizilbash B, Deschamps A, Pellerin M, Arellano R, Cummings M, Fleming M, Henry R, Milne B, Parlow J, Saha T, Shelley S, Wang L, Bainbridge D, Novick R, McKenzie N, Menkis A, Quantz M, Badner N, Cheng D, Dain S, Dobkowski W, Granton J, Harle C, Iglesias I, Kutt J, Mezon B, Ralley F, St Amand M, Teneja R, Vannelli A, Morin JF, Langlois Y, Ma F, Kent B, Allen C, Barker R, Glenn J, Hirsch K, Kolysher P, Vlatten A, Rapchuk I, Hall R, DiQuinzio C, Dicklieson A, Baskett R, Stewart K, Sullivan J, Legare JF, Ali I, O'Blenes S, Hancock-Friesen C, Wood J, Ali I, Hare G, Abrahamson S, Baker J, Bonneau D, Bowry R, Chen R, Darrah W, Dickson J, Errett L, Houston P, Joo H, Kataoka M, Lambert S, Latter D, Leclerc Y, Leung P, Levene R, Lin K, Loffelmann C, McKnight D, McLean J, Naik V, Noble W, Tousignant C, Verma S, Wassermann J, Cohen G, Christakis G, O'Blenes S, Goldman B, Djaiani G, Fedorko L, Cheng D, Yau T, Cusimano R, Feindel C, Brister S, David T, Rao V, Scully H, Ralph-Edwards A, Kruger M, Modry D, Wang S, Gelfand E, Mullen J, Koshal A, Ross D, Lampa M, Allison J, Fenje N, Wollach G, Willms S, Van Der Wal M, Moll G, Dutton J, Brownlee RT, Ofeish J, Perchinsky M, Abouzahr L, Chu FV, Cybulsky IJ, Lamy A, Semelhago LC, Muirhead B, DeBrouwere R, Enns J, Kowalski S, Maguire D, Raabe M, Lindsay W, Thomson I, Peters D, MacKenzie S, Scatliff J, Young S, Maguire D, Jacobsohn E, Enns J, Zivot J, Grocott H, Kowalski S, DeBrouwere R, Christodoulou C, Laroche L, Croteau S, Gagnon V, Maier K, Finlay S, Winch D, Auclaire L, Ferland MC, Dugas H, Mercier L, Gagné N, Doucet M, Soucy J, Roy M, Shore DD, Orr B, Adams S, Irwin B, Squire S, Pardy E, Crecca M, Chamoun P, Rossiter M, McIsaac J, Sikich N, Michaud D, Gauthier B, Chrapchynski V, Vehkala K, Whissel J, Poirier RA, Gee F, Dion C, Jamil M, Piekos A, Vallieres M, Fountas N, Vincent J, Yang Y, Poonawala H, Carroll J, Wilkinson V, Bryden C, Hsu N, Fox R, Reimer L, Blackall MH, Kenny S, Darroch G, Gerstein R, Cloutier S, Herrick J, Matthes P, Threinen C, Kayll-Peters A, Taichman J, Chateauvert N, Grenier T, Robitaille M, Raymond AN, Gray C, Psutka P, Alexander M, Martin M, Cohen E, Roy J, Snow D, Parsons L, Proceviat J, Gibb L, Hatzifilalithis K, Quinton I, Iazzetta J, Yi T, Wang D, Blake J, Pon R, Lau J, Carey N, Naumann T, Campbell L, Ng T, Day T, Lambert N, Smith R, Sobi G, Biljan M, Kozak B, Swatzky D, Bergeron C, Harrington A, Mattu K, Szick S, Baird D, Pretorius R, Bleskie D, Bleskie D, Kabir MJ, Bordeleau C, Tran ML, Rhubab M, McCue I, Doucette S, Cotê J, Domingo S, Aziz A, Stassen M, Vetter D, Coady A, Maier K, Roy M, Ferland MC, Watpool I, Cleary N, Nowakowska E, Roy L, Webb L, Routh T, Piché C.

Erratum in

  • N Engl J Med. 2010 Sep 23;363(13):1290.

Abstract

BACKGROUND:

Antifibrinolytic agents are commonly used during cardiac surgery to minimize bleeding and to reduce exposure to blood products. We sought to determine whether aprotinin was superior to either tranexamic acid or aminocaproic acid in decreasing massive postoperative bleeding and other clinically important consequences.

METHODS:

In this multicenter, blinded trial, we randomly assigned 2331 high-risk cardiac surgical patients to one of three groups: 781 received aprotinin, 770 received tranexamic acid, and 780 received aminocaproic acid. The primary outcome was massive postoperative bleeding. Secondary outcomes included death from any cause at 30 days.

RESULTS:

The trial was terminated early because of a higher rate of death in patients receiving aprotinin. A total of 74 patients (9.5%) in the aprotinin group had massive bleeding, as compared with 93 (12.1%) in the tranexamic acid group and 94 (12.1%) in the aminocaproic acid group (relative risk in the aprotinin group for both comparisons, 0.79; 95% confidence interval [CI], 0.59 to 1.05). At 30 days, the rate of death from any cause was 6.0% in the aprotinin group, as compared with 3.9% in the tranexamic acid group (relative risk, 1.55; 95% CI, 0.99 to 2.42) and 4.0% in the aminocaproic acid group (relative risk, 1.52; 95% CI, 0.98 to 2.36). The relative risk of death in the aprotinin group, as compared with that in both groups receiving lysine analogues, was 1.53 (95% CI, 1.06 to 2.22).

CONCLUSIONS:

Despite the possibility of a modest reduction in the risk of massive bleeding, the strong and consistent negative mortality trend associated with aprotinin, as compared with the lysine analogues, precludes its use in high-risk cardiac surgery. (Current Controlled Trials number, ISRCTN15166455 [controlled-trials.com].).

Copyright 2008 Massachusetts Medical Society.

PMID:
18480196
[PubMed - indexed for MEDLINE]
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