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Blood Management in the Cath Lab

Blood Management in the Cath Lab. Sunil V. Rao MD Associate Professor of Medicine Duke University Medical Center Durham VA Medical Center Duke Clinical Research Institute. Disclosures. Consultant Sanofi-Aventis, Bristol Myers Squibb The Medicines Company Astra Zeneca

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Blood Management in the Cath Lab

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  1. Blood Management in the Cath Lab Sunil V. Rao MD Associate Professor of Medicine Duke University Medical Center Durham VA Medical Center Duke Clinical Research Institute

  2. Disclosures • Consultant • Sanofi-Aventis, Bristol Myers Squibb • The Medicines Company • Astra Zeneca • Terumo Corporation • Research funding • Cordis Corporation • Ikaria • Off-label uses of drugs/devices may be discussed

  3. Improving PCI outcomes • Why talk about blood transfusion in the cath lab? • Drivers of transfusion in cath patients • Data on transfusion and outcomes in patients with CAD • Reducing bleeding risk – risk assessment, drug therapy, vascular access

  4. Plateletaggregation Plateletactivation ADP Collagen TXA2 Fibrinogen Fibrin Thrombin THROMBUS PlasmaClottingcascade TissueFactor Prothrombin Thrombus formation Thrombin plays a central role among tissue injury, coagulation, and platelet response.

  5. Twenty-five year trends in PCI outcomesN=24,410 procedures at the Mayo Clinic Singh M., et. al. Circulation 2007

  6. In Hospital PCI Mortality & Bleeding Peterson ED ACC 2007 Mehta SR ACC 2007

  7. Bleeding & OutcomesN=26,452 pts from PURSUIT, GUSTO IIb, PARAGON A & B Kaplan Meier Curves for 30-Day Death, Stratified by Bleed Severity log rank p-value for all four categories <0.0001 log-rank p-value for no bleeding vs. mild bleeding = 0.02 log-rank p-value for mild vs. moderate bleeding <0.0001 log-rank p-value for moderate vs. severe <0.001 Rao SV, et al. Am J Cardiol. 2005

  8. Bleeding and Outcomes 26,452 patients from PURSUIT, PARAGON A, PARAGON B, GUSTO IIb NST Bleeding severity and adjusted hazard of death *p<0.0001 Rao SV, et. al. AJC 2005

  9. Bleeding and Outcomes 26,452 patients from PURSUIT, PARAGON A, PARAGON B, GUSTO IIb NST Adjusted hazard ratios for 30d Death Stratified by Procedure and Non-procedure related bleeds *p<0.0001 Rao SV, et. al. AJC 2005

  10. Bleeding and resource usePredictors of total costsN=1235 pts from GUSTO IIb Mod/sev bleed Per patient cost - $530 Transfusion - $2080, P < 0.01 Per patient cost - $287 Rao SV, et. al. AHJ 2008 Model C-index=0.87 Adjusted for patient characteristics

  11. Risk versus benefit Thrombosis BleedingTransfusion

  12. Bleeding – Mechanisms of harm • Severe bleeding • Hypotension • Reversal of antithrombotic therapy • Mild or Moderate bleeding • Cessation of antithrombotic therapy • Blood transfusion

  13. Bleeding and Evidence-based TherapiesN=2498 ACS patients from the PREMIER Registry Discharge ASA and thienopyridine Pts. with bleeding vs. pts. without bleeding Thienopyridine OR (95% CI) Aspirin OR (95% CI) 0.62 (0.42, 0.91) 0.45 (0.31, 0.64) Discharge 1 Month 6 Months 1 Year 0.68 (0.50, 0.92) 0.83 (0.59, 1.17) 1.06 (0.78, 1.45) 0.63 (0.46, 0.87) 1.12 (0.81, 1.55) 0.94 (0.66, 1.34) 0.5 1.0 2.0 0.5 1.0 2.0 Wang TY, et. al. Circulation 2008

  14. Evidence for and against the “10/30” Rule • 1996 -- No  ischemia Hgb < 10 • 1996 -- No mortality until Hgb < 6 • 1998 -- No  ischemia Hgb < 10 • 1999 -- No ∆ Hgb 9 vs 7 • 2004 -  mortality for Tx at HCT >25% • 2009 – No  MACE for Sx-driven Tx • 1945 -- C.O. • 1970 -- mortality Hgb < 10 • 1998 -- ischemia HCT < 28 • 2001 – mortality HCT < 33 12 million units of blood transfused annually

  15. Geographic variation in transfusion relative to U.S. N=24,112 0.24 (0.19 – 0.30) Unadjusted Adjusted for baseline characteristics 0.19 (0.15 – 0.25) Adjusted for baseline characteristics and procedures 0.69 (0.54 – 0.88) Adjusted for baseline characteristics, procedures, and bleeding 0.76 (0.59 – 1.00) Less than US More than US 1.0 Rao SV, et. al. AJC 2008

  16. Variations in Transfusion Rates for NSTE ACS Across Hospitals Non-CABG Overall Percentage of Hospitals (%) Percentage of Patients Receiving Blood Transfusions (%) Yang X, et. al. JACC 2005

  17. HCT< 33 % Cooperative Cardiovascular Project30 day death by transfusion and Hct Odds ratio for 30 day mortality Higher • 78,974 pts > 65 years with confirmed MI • Grouped into categories of admission hematocrit • Excluded pts with bleeding and those with CABG • Primary endpoint: 30-day mortality Lower Wu W, NEJM 2001

  18. Transfusion in ACSN=24,111 pts from PURSUIT, PARAGON B, GUSTO IIb Rao SV, et. al., JAMA 2004

  19. 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 Among NSTE ACS Patients:Cox model for 30-day Death (N=24,111) *Transfusion as a time-dependent covariate Rao SV, et. al., JAMA 2004

  20. Cochrane Collaboration Systematic Review30-day mortality by strategy Carless P, et. al. Cochrane Database of Systematic Reviews 2010

  21. Transfusion for Hgb < 10 g/dl Post-op Hip Fx CV disease Hgb < 10 g/dl Functional Recovery At 60 days Transfusion for Sx or Hgb < 8 g/dl FOCUS Trial N=2600 Secondary endpoints: Transfusion errors, cardiac ischemia www.clinicaltrials.gov

  22. FOCUS TrialN=2013 Reported MI rate: Liberal 2.3% vs. Restrictive 3.8%, P=NS Carson JL, AHA 2009

  23. NSTEMI Hct ≤ 0.30 within 72 hrs of admission N=45 Maintain Hct 0.24 - 0.27 Transfuse if Hct < 0.24 Maintain Hct 0.30 - 0.33 Transfuse if Hct < 0.30 In-hospital Death, MI, or CHF CRIT Pilot Trial 13% P=0.046 38% Cooper HA, et. al. AJC 2011

  24. Properties of PRBCs • Low 2,3 DPG* • High O2 affinity* • Depleted of Nitric Oxide • NO plays a fundamental role in O2 exchange† *Welch HG, et. al. Ann Int Med 1992 †Stamler JS, et. al. Science 1997

  25. Lungs Capillary SNO FeNO SH FeNO SH FeO2 SNO O2 R T T NO/SNO O2 Artery Vein Vein Nitric Oxide Stamler JS, et. al. Science 1997

  26. Effects of Transfusion • Packed red cells • Depleted of NO • Function as NO “sinks” • Lead to vasoconstriction • Platelet aggregation • Ineffective O2 delivery • Associated with increases in CRP and IL6* *Fransen E, et. al. Chest 1999

  27. MINT Trial Planned N=200 patients with ACS or CAD + Hgb < 10 g/dl STEMI, NSTEMI, or Sig. CAD/PCI Hgb < 10 g/dl Liberal Restrictive Tx for symptoms Or Hgb < 8 g/dl Tx to keep Hgb ≥ 10 g/dl 30-day Death, MI, Urgent Revasc 6-month Mortality

  28. Strategies to deal with bleeding and transfusion risks • Prevention is KEY • Pharmacological strategies • Dosing • Newer agents • Vascular access

  29. Excessive Dosing of Anticoagulants by Age Alexander KP, et. al. JAMA 2005

  30. Overall 1.46 (1.22, 1.73) Women 1.72 (1.30, 2.28) Men 1.27 (0.97, 1.66) 1.0 1.5 2.0 2.5 0.5 Excess Dosing More Likely to Bleed Excess dosing of Gp IIb/IIIa and bleeding in womenN=32,601 patients from CRUSADE Alexander KP, et. al. Circulation 2006

  31. REPLACE-2 ACUITY HORIZONS Bivalirudin STEEPLE IV enoxaparin OASIS 5 Fondaparinux PLATO ticagrelor STEEPLE Investigators. NEJM 2006 OASIS Investigators. NEJM 2006 Lincoff AM, et. al. JAMA 2003 Stone GW. ACC 2006

  32. Bleeding in PCI Trials: Frequency and site* Among bleeders *All transfemoral access Rao SV, et. al., JACC 2010 (in press)

  33. Risk for 1 year mortality • Combined REPLACE-2, ACUITY, HORIZONS-AMI (n=17,393) • 1-year mortality risk of non-access site bleeding vs access site = HR 2.27 (95%CI 1.42-3.64), p=0.0007 No Bleed TIMI Major + Minor Bleed VerheugtJACC Cardio Interv2011;4:191-7:

  34. PCI-related complications and costsN=335,477 Medicare pts undergoing PCI in 2002 Kugelmass A, et. al. AJC 2006

  35. Updated meta-analysis including RIVAL Jolly SS, et. al. Lancet 2011

  36. Radial access and 1-year mortalityN=38,872 procedures Chase AJ, et. al. BMJ 2008

  37. Prevalence of radial approach in the US N = 593,094 PCI procedures 2004-2007 606 sites 1.3% of all PCI procedures Google stock 106% growth 2009-2010 8.5% of diagnostics, 7.8% of PCIs at end of 2010 (118% growth 2009-2010) Rao SV, et. al. JACC: CI 2008

  38. Blood management in the cath labSummary (1) • Patients with acute ischemic heart disease and those undergoing cath/intervention are at high risk for bleeding/transfusion • Antithrombotic therapy to reduce complications • Arteriotomy • Bleeding and transfusions have emerged as an important events that are associated with increased morbidity, mortality, and costs

  39. Blood management in the cath labSummary (2) • Reducing ischemic events while minimizing bleeding and transfusion risk is a clinical priority • Strategies that achieve this balance are associated with improved survival • The optimal transfusion strategy is not known…but prevention is the best approach • Appropriate choice/dosing of antithrombotics • Radial approach

  40. Duke Univ. Medical Center Duke Clinical Research Institute

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