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Michael A. Nelson, MD 1 Michele D. Voeltz, MD 1 Frederick Feit, MD 2 A. Michael Lincoff, MD 3

Elderly Patients with Major Bleeding or Need for Transfusion Complicating Percutaneous Coronary Intervention Have an Increased Risk of 30-Day and 1-Year Mortality. Michael A. Nelson, MD 1 Michele D. Voeltz, MD 1 Frederick Feit, MD 2 A. Michael Lincoff, MD 3 Steven V. Manoukian, MD 1

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Michael A. Nelson, MD 1 Michele D. Voeltz, MD 1 Frederick Feit, MD 2 A. Michael Lincoff, MD 3

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  1. Elderly Patientswith Major Bleeding or Need for Transfusion Complicating Percutaneous Coronary Intervention Have an Increased Risk of30-Day and 1-Year Mortality Michael A. Nelson, MD1 Michele D. Voeltz, MD1 Frederick Feit, MD 2 A. Michael Lincoff, MD 3 Steven V. Manoukian, MD1 1Emory University School of Medicine 2 New York University School of Medicine 3 Cleveland Clinic Foundation

  2. Presenter Disclosure Information • Michael A. Nelson: None • Michele D. Voeltz: None • Frederick Feit: The Medicines Co.-Consultant (significant) • A. Michael Lincoff: The Medicines Co.-Research Support (significant), Honoraria (modest) • Steven V. Manoukian: The Medicines Co.-Research Support, Consultant, Speaker (modest), sanofi-aventis/BMS: Consultant (modest)

  3. Elderly Patients with Major Bleeding or Transfusion:Background • Elderly patients have an increased risk of major bleeding and transfusion when undergoing percutaneous coronary intervention (PCI). • Despite these risks, the effect of major bleeding and transfusion on mortality in the elderly is unknown. • We evaluated outcomes in elderly patients undergoing PCI from the REPLACE-2 Trial.

  4. Background: The REPLACE-2 TrialTrial Design 6010 Urgent or elective PCI patients Aspirin Clopidogrel Stent Bivalirudin Provisional GPIIb/IIIa Endpoints 30-day Death MI Revasc Hemorrhage Economics 6, 12m follow up 2999 Heparin 65 U/kg Abciximab or Eptifibatide 3011 Lincoff AM, et al. JAMA 2003; 289: 853-863.

  5. Background: The REPLACE-2 TrialPrimary Endpoint at 30 Days p = 0.324 p = 0.255 p = 0.430 p = 0.435 p < 0.001 % of patients Major bleeding • Intracranial, intraocular, or 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 Lincoff AM, et al. JAMA 2003; 289: 853-863.

  6. = Not Elderly, <75 (N=5196) = Elderly, >75 (N=805) Background: The REPLACE-2 TrialMortality by Age p<0.0001 p<0.0001 p=0.0001 Mortality Voeltz MD, et al. Circulation 2005;112(17):II-613.

  7. = Not Elderly, <75 (N=5196) = Elderly, >75 (N=805) Background: The REPLACE-2 TrialBleeding and Transfusion by Age p<0.0001 p<0.0001 Voeltz MD. et al. Circulation 2005;112(17):II-613.

  8. Elderly Patients with Major Bleeding or Transfusion:Hypothesis • Elderly patients with major bleeding or transfusion complicating PCI have an increased risk of mortality.

  9. Elderly Patients with Major Bleeding or Transfusion:Methods • We reviewed the REPLACE-2 Trial in order to evaluate the impact of major bleeding and transfusion on the risk of 30-day, 6-month and 1-year mortality in elderly patients undergoing PCI. • Elderly patients were defined as > 75 years of age. • Major Bleeding (30-Days) was defined as: • Intracranial, intraocular, or retroperitoneal hemorrhage • Overt blood loss with drop in Hgb >3g/dL • Any decrease in Hgb >4g/dL • Transfusion of >2 pRBC’s or whole blood • Transfusion (30-Days) was defined as any transfusion of pRBC’s or whole blood.

  10. Results:Baseline Characteristics by Age

  11. = Not Elderly, <75 (N=139) = Elderly, >75 (N=54) Results:Mortality with Major Bleeding by Age p<0.01 p<0.01 p<0.02 Mortality Nelson MA, et al. AHA 2006.

  12. = Not Elderly, <75 (N=86) = Elderly, >75 (N=40) Results:Mortality with Transfusion by Age p<0.02 p<0.02 p<0.02 Mortality Nelson MA, et al. AHA 2006.

  13. = Elderly, No Major Bleed (N=751) = Elderly, Major Bleed (N=54) Results:Mortality Among Elderly by Bleeding Status p<0.01 p<0.01 p<0.01 Mortality Nelson MA, et al. AHA 2006.

  14. = Elderly, No Transfusion (N=765) = Elderly, Transfusion (N=40) Results:Mortality Among Elderly by Transfusion Status p<0.0001 p<0.0001 p<0.0001 Mortality Nelson MA, et al. AHA 2006.

  15. Results:Baseline Characteristics Among Elderly by Bleeding Status

  16. Elderly Patients with Major Bleeding or Transfusion:Conclusions • Elderly patients undergoing PCI have an increased risk of major bleeding, transfusion, and mortality, compared to younger patients. • Among patients with major bleeding or transfusion, the elderly have an increased risk of mortality. • Among the elderly, major bleeding or transfusion is associated with an increased risk of mortality. • Knowledge of these findings is important in the care of elderly patients undergoing PCI. Nelson MA, et al. AHA 2006.

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