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Does aprotinin increase the risk of renal failure in cardiac surgery patients?

Does aprotinin increase the risk of renal failure in cardiac surgery patients?. Anthony P. Furnary, MD, FAHA YingXing Wu, MD Loren F. Hiratzka, MD, FAHA Gary L. Grunkemeier, PhD U. Scott Page, MD. Providence Health Systems, Portland , OR

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Does aprotinin increase the risk of renal failure in cardiac surgery patients?

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  1. Does aprotinin increase the risk of renal failure in cardiac surgery patients? Anthony P. Furnary, MD, FAHA YingXing Wu, MD Loren F. Hiratzka, MD, FAHA Gary L. Grunkemeier, PhD U. Scott Page, MD Providence Health Systems, Portland , OR Health Data Research /Merged Cardiac Registry, Portland, OR TriHealth Systems, Cincinatti, OH

  2. Does Aprotinin Increase the Risk of Renal Failure in Cardiac Surgery Patients? Furnary AP, Wu YX, Hiratzka LF, Grunkemeier GL, Page US AHA Presentation AHA annual Scientific Sessions 2006; Oral Presentation: Chicago, IL November 15, 2006 Publication Circulation. September 11, 2007; 116(suppl I): I-127--I-133 DisclosureInformation FINANCIAL DISCLOSURE: NONE UNLABELED/UNAPPROVED USES DISCLOSURE: NONE

  3. Does aprotinin increase the risk of renal failure in cardiac surgery patients? Non-Randomized Retrospective Multicenter Observational study 66 centers / 16 countries 1374 Patients “Control” / 1295 Patients Aprotinin Increased risk of “Renal Event” by 2.3 - 2.6 times; p < 0.001 Conclusion: “Continued use [of Aprotinin] is not prudent”

  4. Hypothesis Aprotinin (Trasylol)is an independent risk factor for new onset, dialysis-dependent renal failure (ARF) following open heart surgery.

  5. Assessment of Pre-op ARF Risk: CCF Risk Model Thakar, et al:J AM Soc Nephrol 16:162-8, 2005 31,677 OHS patients: 1992 - 2002 C-Index = 0.82 • Gender • CHF • LVEF < 35% • Preop IABP • COPD • IDDM • Redo OHS • Emergency Surgery • Surgery type • Preop Creatinine

  6. Methods: Database • Merged Cardiac Registry • Locally validated, prospective perioperative data entry • January 2001 - Feb 2006 23,105 patients 12 centers Validated Aprotinin Usage Data

  7. Methods: Patient Population 23,105 OHS patients 12 centers 7931 pts incomplete CCF ARF data 15,174 patients 11 centers Validate CCF ARF Risk model 3976 pts missing transfusion (PRBC) data 11,198 patients 10 centers Aprotinin CCF ARF PRBC

  8. ROC of CCF ARF Risk model Sensitivity (%) 1 - Specificity (%)

  9. Renal Failure by Aprotinin Use P < 0.0001

  10. Demographics CCF Risk Variable for ARF

  11. Observed ARFvs CCF Expected P < 0.001 P < 0.001 No Aprotinin Aprotinin

  12. Multivariable Analysis of Renal Failure CCF Model + Aprotinin VariableP valueOdds Ratio CCF Risk score < 0.001 2.4 (12 variables) Aprotinin0.008 1.5 Area under the ROC curve = 0.817 n = 15,174

  13. Renal Failure vs. #PRBC P < 0.0001

  14. PRBC Utilization by Aprotinin Use P < 0.0001 No Aprotinin Aprotinin

  15. Transfusions (# PRBC) P < 0.001 No Aprotinin Aprotinin

  16. Multivariable Analysis of Renal Failure CCF Model +#PRBC - (Aprotinin) VariableP valueOdds Ratio CCF Risk score < 0.001 1.9 (12 variables) # PRBC < 0.001 1.2 Aprotinin.231 Area under the ROC curve = 0.910 n = 11,198

  17. Nontransfused Patients 23,105 OHS patients 12 centers 15,174 patients 11 centers Aprotinin No PRBC 1372 11,198 patients 10 centers Aprotinin CCF ARF PRBC No Aprotinin No PRBC 4357

  18. CCF Expected vs Observed ARFNon-transfused subgroup No Aprotinin Aprotinin

  19. Multivariable Analysis of Renal Failure CCF Model - (Aprotinin) Non-transfused subgroup VariableP valueOdds Ratio CCF Risk score < 0.001 3.8 (12 variables) Aprotinin0.654 n = 5729

  20. Aprotinin as a Risk Factor for ARF Key: U = Univariate;M = Multivariable AP CCF + AP CCF + PRBC CCF (No PRBC)

  21. Summary Aprotinin does NOT independently increase the risk of postoperative ARF Following CT surgery. Increasing PRBC use is independently related to an increased risk of postoperative ARF Aprotinin lowers predicted PRBC requirements CCF risk model for ARF was validated, but further postoperative ARF risk assessment could be enhanced with the addition of #PRBC data to the model

  22. Conclusions The implication of aprotinin as a causal factor for postoperative ARF was incorrect and premature. Previously published results were likely faulty due to the absence of PRBC data in the Magnano study. All efforts to minimize PRBC usage should be undertaken to prevent higher occurrence rates of ARF. All subsequent analyses of postoperative ARF should adjust for PRBC usage, as this is a highly significant risk factor for the subsequent development of ARF. The FDA should consider withdrawal of aprotinin advisory warnings based on these data.

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