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Relevant Conflict of Interest Statement

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Relevant Conflict of Interest Statement

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  1. Transfusion is Associated with Increased 30-Day Mortality and Ischemic Complications in Non-ST Elevation Acute Coronary Syndromes:The ACUITY TrialSteven V. Manoukian1, Michele D. Voeltz1, Frederick Feit2, Roxana Mehran3, George D. Dangas3, Eugenia Nikolsky3, A. Michael Lincoff4, Spencer B. King5, III, E. Magnus Ohman6, Gregg W. Stone31Emory University School of Medicine, Atlanta, GA2New York University School of Medicine, New York, NY3Columbia University Medical Center, New York, NY4The Cleveland Clinic, Cleveland, OH5Fuqua Heart Center, Atlanta, GA6Duke University Medical Center, Durham, NC

  2. Relevant Conflict of Interest Statement Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Steven V. Manoukian, MD, FACC The Medicines Co. Research Support Consultant Speaker sanofi aventis/BMS Consultant

  3. Background:Transfusion in ACS and PCI • Blood product transfusion is an important complication in acute coronary syndromes (ACS) and percutaneous coronary intervention (PCI) patients treated with potent antithrombotic and antiplatelet agents. • Recent data suggest that transfusion is associated with an increase in adverse outcomes in ACS and PCI, including mortality. • We assessed the impact of transfusion on mortality and ischemic events in patients with ACS from the ACUITY Trial. Manoukian SV, Voeltz MD, Feit F et al. TCT 2006.

  4. Background: The REPLACE-2 TrialTransfusion and Major Bleeding areMore Frequent in Elderly PatientsUndergoing PCI 806 patients (13.4%) classified as elderly, >75 years of age. p<0.0001 p=0.0001 = Not Elderly, <75 = Elderly, >75 Voeltz MD, Lincoff AM, Feit F, Manoukian SV. Circulation 2005;112(17):II-613.

  5. Background: The REPLACE-2 TrialTransfusion and Mortality in PCI Non-transfused Transfused *p<0.0001 Manoukian SV, Voeltz MD, Attubato MJ, Bittl JA, Feit F, Lincoff AM. CRT 2005.

  6. = No = Yes Background: The REPLACE-2 TrialTransfusion is Associated withIncreased Mortality inElderly Patients Undergoing PCI 806 patients (13.4%) classified as elderly, >75 years of age. p<0.0001 p=0.0001 30-Day Mortality Voeltz MD, Lincoff AM, Feit F, Manoukian SV. Circulation 2005;112(17):II-613.

  7. Background: GUSTO IIb, PURSUIT, PARAGON BTransfusion and 30-Day Mortality in ACS (N=24111) Rao SV et al. JAMA 2004;292:1555-1562.

  8. 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 Background: GUSTO IIb, PURSUIT, PARAGON BTransfusion and 30-Day Mortality in ACS (N=24111) *Transfusion as a time-dependent covariate Rao SV et al. JAMA 2004;292:1555-1562.

  9. Methods: The ACUITY TrialStudy Design and Definitions • The ACUITY Trial compared: heparin or enoxaparin + glycoprotein inhibition (H+GPI), bivalirudin + glycoprotein inhibition (BIV+GPI), and bivalirudin monotherapy (BIV) in 13819 patients with moderate and high-risk NSTE-ACS. • We evaluated outcomes in patients who received transfusion (non-CABG-related) within 30 days of randomization. Manoukian SV, Voeltz MD, Feit F et al. TCT 2006.

  10. Medical management UFH or Enoxaparin + GP IIb/IIIa PCI Bivalirudin + GP IIb/IIIa Angiography within 72h R* Bivalirudin Alone CABG Methods: The ACUITY Trial (N=13819)First Randomization Moderate and high-risk unstable angina or NSTEMI undergoing an invasive strategy Moderate- high risk ACS Aspirin in all Clopidogrel dosing and timing per local practice *Stratified by pre-angiography thienopyridine use or administration ACUITY Design. Stone GW et al. AHJ 2004;148:764–75.

  11. P (log rank) Estimate UFH/Enoxaparin + IIb/IIIa (N=4603) 11.7% 0.89 Bivalirudin + IIb/IIIa (N=4604) 11.8% 0.014 Bivalirudin alone (N=4612) 10.1% Methods: The ACUITY Trial (N=13819) Overall Net Clinical OutcomeComposite Endpoint 15 UFH/Enoxaparin + GPI vs. Bivalirudin + GPI vs. Bivalirudin Alone 10 Cumulative Events (%) 5 0 0 5 10 15 20 25 30 35 Days from Randomization ACUITY Trial. Stone GW. ACC 2006.

  12. PSup = 0.32 PSup = 0.34 PSup = 0.35 PSup = 0.78 Methods: The ACUITY Trial (N=13819) Overall Ischemic Endpoints ACUITY Trial. Stone GW. ACC 2006.

  13. Methods: The ACUITY Trial (N=13819)Overall Bleeding Endpoints PSup=0.31 PSup<.001 PSup=0.38 PSup<0.0001 ACUITY Trial. Stone GW. ACC 2006.

  14. UFH or Enoxaparin Medical management Routine upstream GPI in all pts GPI started in CCL for PCI only PCI Bivalirudin Routine upstream GPI in all pts R R GPI started in CCL for PCI only Bivalirudin Alone CABG Methods: The ACUITY Trial (N=13819) Second Randomization Moderate and high-risk unstable angina or NSTEMI undergoing an invasive strategy Moderate- high risk ACS Angiography within 72h Aspirin in all Clopidogrel dosing and timing per local practice Stone GW et al. AHJ 2004;148:764–75.

  15. Methods: The ACUITY Trial (N=13819)Overall Primary Endpoint Measures for Upstream vs. Deferred IIb/IIIa PNI <0.0001 PSup = 0.93 PNI = 0.044 PSup = 0.13 PNI < 0.0001 PSup = 0.009 ACUITY Trial. Stone GW. ACC 2006.

  16. Results: The ACUITY Trial (N=13819)Transfusion (non-CABG-related) in ACS • 319 (2.3%) of 13819 patients had transfusion by 30 days. • Patients with transfusion were (p<0.05): • older, female, non-smokers, and had lower body weight, diabetes, hypertension, impaired creatinine clearance, elevated biomarkers, and high-risk (ST-changes or elevated biomarkers). • more likely to receive pre-treatment with a thienopyridine. • more likely to have a >4h randomization to angiography time. • Transfusion was less frequent for: • Bivalirudin vs. Heparin(s) + GPI (1.6% vs. 2.7%, p<0.0001), • Bivalirudin vs. Bivalirudin + GPI (1.6% vs. 2.6%, p<0.0001). • Transfusion was associated with higher 30-day mortality and ischemic event rates. Manoukian SV, Voeltz MD, Feit F et al. TCT 2006.

  17. Results: The ACUITY Trial (N=13819)Transfusion and Baseline Characteristics Manoukian SV, Voeltz MD, Feit F et al. TCT 2006.

  18. Results: The ACUITY Trial (N=13819)Transfusion by Treatment Strategy P<0.001 P=ns ACUITY Trial. Stone GW. ACC 2006.

  19. Results: The ACUITY Trial (N=13819)Transfusion, Ischemic Endpoints, and Mortality P<0.0001 for all Manoukian SV, Voeltz MD, Feit F et al. TCT 2006.

  20. Results: The ACUITY Trial (N=13819)Transfusion and Myocardial Infarction P<0.0001 for all Manoukian SV, Voeltz MD, Feit F et al. TCT 2006.

  21. Results: The ACUITY Trial (N=13819)Transfusion, Ischemic Endpoints, and Mortality Manoukian SV, Voeltz MD, Feit F et al. TCT 2006.

  22. Results: The ACUITY TrialPredictors of Transfusion Risk ratio ± 95% CI RR (95% CI) P-value Manoukian SV, Voeltz MD, Feit F et al. TCT 2006.

  23. Conclusion: The ACUITY Trial (N=13819)Transfusion in Patients with ACS • Transfusion is associated with increased 30-day mortality and ischemic event rates in patients with ACS undergoing an invasive strategy. • Bivalirudin results in lower transfusion rates compared to GPI-based strategies. • Factors associated with an increase in the risk of transfusion: • age, female gender, diabetes, hypertension, chronic kidney disease, anemia; • high-risk presentation; • treatment with heparin(s) + GPI. • Knowledge of these factors is important in the assessment of the transfusion risk of, and decision-making for an individual patient. • Minimizing transfusion risk is paramount in order to optimize outcomes in this setting. Manoukian SV, Voeltz MD, Feit F et al. TCT 2006.

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