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. 2014 Dec 9;186(18):1379-86.
doi: 10.1503/cmaj.131582. Epub 2014 Sep 29.

Regulatory decisions pertaining to aprotinin may be putting patients at risk

Collaborators, Affiliations

Regulatory decisions pertaining to aprotinin may be putting patients at risk

Paul C Hébert et al. CMAJ. .
No abstract available

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Figures

Figure 1:
Figure 1:
Sensitivity analyses comparing aprotinin with lysine analogues in all patients who underwent randomization in the BART. CI = confidence interval, RR = risk ratio. *Excluded only those patients for whom outcome assessment was not possible because of withdrawal of consent or loss to follow-up.
Figure 2:
Figure 2:
(A) Cumulative comparison of 30-day mortality (aprotinin v. lysine analogues). Data presented summarize the risk ratio comparing aprotinin with the lysine analogues as additional patients are incorporated into the analysis over time. (B) Cumulative comparison of massive bleeding (aprotinin v. lysine analogues). Data presented summarize the risk ratio comparing aprotinin with the lysine analogues as additional patients are incorporated into the analysis over time. CI = confidence interval, RR = risk ratio.
Figure 3:
Figure 3:
Comparison of 30-day mortality (aprotinin v. lysine analogues), stratified by heparin dose. The adjusted analyses were done using multivariable logistic regression and accounted for the effects of age, sex, surgical procedure, total bypass duration and cross-clamp duration. CI = confidence interval, OR = odds ratio.

References

    1. FDA requests marketing suspension of Trasylol [press release]. Silver Spring (MD): US Food and Drug Administration; 2007. Nov. 5 Available: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm109021.htm (accessed 2012 July 9).
    1. Laupacis A, Fergusson D. Drugs to minimize perioperative blood loss in cardiac surgery: meta-analyses using perioperative blood transfusion as the outcome. The International Study of Peri-operative Transfusion (ISPOT) Investigators. Anesth Analg 1997;85:1258–67. - PubMed
    1. Carless PA, Moxey AJ, Stokes BJ, et al. Are antifibrinolytic drugs equivalent in reducing blood loss and transfusion in cardiac surgery? A meta-analysis of randomized head-to-head trials. BMC Cardiovasc Disord 2005;5:19. - PMC - PubMed
    1. Fremes SE, Wong BI, Lee E, et al. Metaanalysis of prophylactic drug treatment in the prevention of postoperative bleeding. Ann Thorac Surg 1994;58:1580–8. - PubMed
    1. Fergusson D, Glass KC, Hutton B, et al. Randomized controlled trials of aprotinin in cardiac surgery: Could clinical equipoise have stopped the bleeding? Clin Trials 2005;2:218–29. - PubMed