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Welcome Ask The Experts March 24-27, 2007 New Orleans, LA

Welcome Ask The Experts March 24-27, 2007 New Orleans, LA. Steven V. Manoukian, MD, FACC Director of Interventional Cardiology Assistant Professor of Medicine Emory University School of Medicine.

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Welcome Ask The Experts March 24-27, 2007 New Orleans, LA

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  1. Welcome Ask The Experts March 24-27, 2007 New Orleans, LA

  2. Steven V. Manoukian, MD, FACCDirector of Interventional CardiologyAssistant Professor of MedicineEmory University School of Medicine Prognostic Implicationsof Bleeding and TransfusionsinAcute Coronary SyndromesandPercutaneous Coronary Intervention

  3. Prognostic Implicationsof Bleeding and TransfusionsinAcute Coronary SyndromesandPercutaneous Coronary InterventionSteven V. Manoukian, M.D., F.A.C.C., F.S.C.A.I.Director, Interventional Cardiology,Emory Crawford Long HospitalEmory University School of MedicineAtlanta, Georgia

  4. Prognostic Implicationsof Bleeding and Transfusions • Incidence • Impact • Risks • Predictors of bleeding • Predictors of mortality

  5. Washington Hospital Center (N=10,974):Rates of Bleeding in PCI Kinnaird TD et al. Am J Cardiol 2003;92:930-935.

  6. The REPLACE-2 Trial (N=6,010):Rates of Major Bleeding in PCI(Overall 3.2%) 4.0% 4.1% p=0.0021 p=0.0251 2.5% 2.2% Major Bleeding REPLACE-2 • Intracranial, retroperitoneal • Observed bleed with fall in Hgb 3g/dL • No observed bleed with fall in Hgb 4g/dL • Transfusion 2 units PRBC or whole blood Voeltz MD, Lincoff AM, Feit F, Manoukian SV. Circulation 2005;112(17):II-737.

  7. The REPLACE-2 Trial (N=6,010):Major Bleeding and Mortality in PCI Feit F, Voeltz MD, Attubato MA, et al. Unpublished.

  8. The GRACE Registry (N=24,045):Rates of Major Bleeding in ACS Major Bleeding GRACE • Life-threatening with transfusion 2 units • Life-threatening with decrease in HCT >10% • Resulting in death • Hemorrhagic, subdural hematoma Moscucci M et al. Eur Heart J 2003;24:1815-23.

  9. The GRACE Registry (N=24,045):Major Bleeding and Mortality in ACS P<0.001 Mortality (%) Overall Unstable NSTEMI STEMI ACS Angina Major Bleeding GRACE • Life-threatening with transfusion 2 units • Life-threatening with decrease in HCT >10% • Resulting in death • Hemorrhagic, subdural hematoma Moscucci M et al. Eur Heart J 2003;24:1815-23.

  10. OASIS Registry, OASIS-2, and CURE (N=34,146):Major Bleeding and Mortality in ACS Eikelboom JW et al. Circulation 2006;114:774-782.

  11. The ACUITY Trial (N=13,819) Rates of Major Bleeding in ACS PSup=0.31 PSup<.001 PSup=0.38 PSup<0.0001 Stone GW et al. N Engl J Med 2006;355:2203-16.

  12. The ACUITY Trial (N=13,819)Major Bleeding and Events in ACS P<0.0001 for all Manoukian SV, Feit F, Mehran R, et al. J Am Coll Cardiol 2007;49:1362-8.

  13. Severity of Bleeding and Mortality in ACS Kaplan Meier Curves for 30-Day Death, Stratified by Bleed Severity Rao SV, et al. Am J Cardiol. 2005.

  14. Decreased Risk Increased Risk Bleeding Definition and Events in ACS 30-Day Death/MI, N=15,858 Rao SV, et al. JACC 2006.

  15. The ACUITY Trial (N=13,819)Major Bleeding and Baseline Characteristics Manoukian SV, Feit F, Mehran R, et al. J Am Coll Cardiol 2007;49:1362-8.

  16. The ACUITY Trial (N=13,819)Predictors of Major Bleeding in ACS Odds ratio ±95% CI OR (95% CI) P-value *Anemia was defined as baseline hemoglobin <13 g/dL in men and <12 g/dL in women. †Renal insufficiency was defined as a creatinine clearance <60 ml/minute as calculated by the Cockcroft-Gault equation. ‡Unfractionated heparin or enoxaparin. Manoukian SV, Feit F, Mehran R, et al. J Am Coll Cardiol 2007;49:1362-8.

  17. The REPLACE-2 Trial (N=6,010):Predictors of Major Bleeding in PCI Feit F, Voeltz MD, Attubato MA, et al. Unpublished.

  18. The REPLACE-2 Trial (N=6,010):Bleeding and Chronic Kidney Disease in PCI Creatinine Clearance Chew DP, Lincoff AM, Gurm H, et al. Am J Cardiol 2005;95:581–585.

  19. The REPLACE-2 Trial (N=6,010):Major Bleeding and Anemia in PCI Overall REPLACE-2 Major bleeding = 3.2% 4.9% P=0.0001 Protocol definition: >3g/dL drop in HgB, intracranial, retroperitoneal, 2U transfusion 2.8% Major Bleeding Voeltz MD, Attubato MJ, Feit F, et al. J Am Coll Cardiol 2005;45(3)[Suppl A]:1037-12-31A.

  20. 3.77 (3.14, 4.52) Adjusted for transfusion propensity 3.54 (2.96, 4.23) Adjusted for baseline characteristics Adjusted for baseline Characteristics, bleeding propensity, transfusion Propensity, & nadir HCT 3.94 (3.26, 4.75) -4.0 1.0 10 PRBC Transfusion in ACSCox model for 30-day Death (N=24,111) *Transfusion as a time-dependent covariate Rao SV, et. al., JAMA 2004

  21. = Not Elderly, <75 = Elderly, >75 The REPLACE-2 Trial (N=6,010):Bleeding and Transfusion in Elderly PCI More: female, Caucasian, prior CVD, risk factors. Lower: BMI, Hgb, CrCl, tobacco. Ischemic outcomes did not differ between elderly and younger patients. p<0.0001 p=0.0001 Voeltz MD, Lincoff AM, Feit F, Manoukian SV. Circulation 2005;112(17):II-613.

  22. = No = Yes The REPLACE-2 Trial (N=6,010):Mortality, Bleeding, Transfusion in Elderly PCI More: female, Caucasian, prior CVD, risk factors. Lower: BMI, Hgb, CrCl, tobacco. Ischemic outcomes did not differ between elderly and younger patients. p<0.0001 p=0.0001 30-Day Mortality Voeltz MD, Lincoff AM, Feit F, Manoukian SV. Circulation 2005;112(17):II-613.

  23. CRT 2005 The REPLACE-2 Trial (N=6,010):Mortality with Transfusion in PCI Non-transfused Transfused *p<0.0001 Manoukian SV, Voeltz MD, Attubato MJ, Bittl JA, Feit F, Lincoff AM. CRT 2005.

  24. Results: The ACUITY Trial (N=13,819)Transfusion and Events in ACS P<0.0001 for all Manoukian SV, Voeltz MD, Feit F et al. TCT 2006.

  25. The REPLACE-2 Trial (N=6,010):Predictors of One-Year Mortality in PCI Major Bleeding REPLACE-2 • Intracranial, retroperitoneal • Observed bleed with fall in Hgb 3g/dL • No observed bleed with fall in Hgb 4g/dL • Transfusion 2 units PRBC or whole blood Voeltz MD, Patel AD, Feit F, et al. Am J Cardiol, June 2007, in press.

  26. The ACUITY Trial (N=13,819)Predictors of 30-Day Mortality in ACS Odds ratio ±95% CI OR (95% CI) P-value Manoukian SV, Feit F, Mehran R, et al. J Am Coll Cardiol 2007;49:1362-8.

  27. Conclusion:Prognostic Implications of Bleeding and Transfusions • Frequent complication of PCI and ACS. • Associated with increased mortality and ischemic event rates. • Rivals risk attributed to the ischemic complication of MI. • Factors often associated with increased risk: • baseline factors: age, female, renal disease, anemia; • presentation factors: high-risk ACS presentation; • treatment factors: heparin(s) + GPI, procedure/sheath time. • Knowledge of these factors is important in assessment of the: • hemorrhagic risk of, • ischemic risk of, and • subsequent decision-making for an individual patient.

  28. Question & Answer

  29. Thank You! Please make sure to hand in your evaluation and pick up a ClinicalTrialResults.org flash drive

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