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Evidence-Based Medicine Therapies in ACS: From Principles to Practice

E. Magnus Ohman, MB, FRCPI, FESC, FACC Professor of Cardiovascular Medicine Director, Program for Advanced Coronary Disease Duke University Medical Center Duke Clinical Research Institute Durham, North Carolina. Evidence-Based Medicine Therapies in ACS: From Principles to Practice.

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Evidence-Based Medicine Therapies in ACS: From Principles to Practice

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  1. E. Magnus Ohman, MB, FRCPI, FESC, FACCProfessor of Cardiovascular MedicineDirector, Program for Advanced Coronary DiseaseDuke University Medical CenterDuke Clinical Research InstituteDurham, North Carolina Evidence-Based Medicine Therapies in ACS: From Principles to Practice

  2. Evidence-Based Medicine Therapies in ACS; From Principles to Practice • Conflict of interest: • Research grants - • Berlex, Sanofi-Aventis, Schering-Plough, The Medicine Company, Bristol Meyer Squibb, CVT Therapeutics, and Eli Lilly • Stock ownership - • Medtronic, Savacor • Consultant - • Northpointe Domain, Liposcience, Abiomed, Datascope, and Inovise Medical

  3. Provider-centered Price-driven Care decisions widely varying Fragmented care Little quality measurement Persistent escalating costs Patient-centered Value-driven Evidence-based care Coordinated care Ubiquitous quality measurement Overall cost decline Changes in Health Care Systems: Moving From the 20th to the 21st Century 21st Century 20th Century National Committee for Quality Health Care 2003

  4. Quality of Care Incorporated in the “Drugs for the Elderly” Medicare Bill Passed by Congress in 2003 Program Description Pay for performance IOM to develop a strategy for aligning quality and payment Hospital to report on Hospitals that report will get performance 0.4% larger payments Changing MD’s practice MD that participate will get higher pay Improving access for Develop demonstration chronic illness (CHF) programs IT provision Grants for electronic prescribing

  5. Improvement in Performance Scores Pilot trial of Medicare Population: 270 Hospitals – 400,000 Patients Source: Centers for Medicare and Medicaid Services

  6. Evolution of Guidelines for ACS 2004 2007 1990 1992 1994 1996 1998 2000 2002 1990ACC/AHAAMI R. Gunnar 1994AHCPR/NHLBIUA E. Braunwald 1996 1999Rev Upd ACC/AHA AMI T. Ryan 2000 2002 2007 Rev UpdRev ACC/AHA UA/NSTEMI E. Braunwald J. Anderson Figure 1. Evolution of Guidelines for Management of Patients with AMI The first guideline published by the ACC/AHA described the management of patients with acute myocardial infarction (AMI). The subsequent three documents were the Agency for Healthcare and Quality/National Heart, Lung and Blood Institute sponsored guideline on management of unstable angina (UA), the revised/updated ACC/AHA guideline on AMI, and the revised/updated ACC/AHA guideline on unstable angina/non-ST segment myocardial infarction (UA/NSTEMI). The present guideline is a revision and deals strictly with the management of patients presenting with ST segment elevation myocardial infarction (STEMI). The names of the chairs of the writing committees for each of the guidelines are shown at the bottom of each box. Rev, Revised; Upd, Update 2004 2007 Rev Upd ACC/AHA STEMI E. Antman

  7. CRUSADE National Quality Improvement Initiative • Academic collaboration between cardiology and emergency medicine specialties started in 2001 • Multiple industry sponsors • Millennium-Schering Plough • Bristol-Myers-Squibb • Sanofi-Aventis • Merck-Schering • PDL Pharma • Goal: Improve adherence to ACC/AHA ACS guidelines • UA and NSTEMI  STEMI added in 2004

  8. Aspirin Clopidogrel Beta Blocker Heparin (UFH or LMWH) GP IIb-IIIa Inhibitor All receiving cath/PCI Aspirin Clopidogrel Beta Blocker ACE Inhibitor Statin/Lipid Lowering Smoking Cessation Cardiac Rehabilitation Goals for CRUSADE: Improve Adherence to ACC/AHA Guidelines forPatients with Unstable Angina/Non-STEMI Discharge Therapies Acute Therapies • Evaluating the Process of Care • An adherence score is applied to each patient. incorporating the components of process of care. • The score from each patient then combined for all patients at each hospital. Typical scores ranged from 50 to 95%. • All 400 hospital adherence scores then ranked in quartiles - best to worst. Circulation, JACC 2002 - ACC/AHA Guidelines update

  9. CRUSADE Site Distribution Total sites = 568 (Active sites = 409) WA (7) VT (1) ME (0) MT (0) ND (1) MI NH (2) MN (4) NY (37) OR (5) MA (11) WI (5) SD (2) ID (0) RI (1) MI (22) WY (0) CT (8) PA (37) IA (5) NJ (10) NE (4) OH (30) IN (7) DE (3) NV (1) IL (14) WV (3) UT (1) MD (13) VA (16) CO (8) KY (8) MO (12) KS (3) DC (1) CA (35) NC (15) TN (11) SC (6) OK (9) AZ (9) AR (3) NM (2) GA (15) AL (11) MS (6) LA (8) TX (17) FL (33) AK (0) 205,528 patients included as of January 2007 HI (1)

  10. Acute CoronaryTreatmentand InterventionOutcomes Network National ACS Surveillance System Assess characteristics, treatments, and outcomes of ACS patients Focuses on NSTEMI and STEMI Optimize ACS management and outcomes Implement evidence-based guideline recommendations in clinical practice Improve quality and safety of ACS care Investigate novel QI methods Follow Guidelines Adherence, Medication Dosing, and Outcomes with the ACC-ACTION Registry

  11. CRUSADE Lessons Learned • Complex patient population • Variations in use of medications • Disparities in use of invasive procedures • Rapid changes in revascularization procedures • Transfusions and bleeding are common • Importance of proper medication dosing • Comprehensive guidelines adherence saves lives • Academic output critical to success

  12. CRUSADE Lessons Learned • Complex patient population • Variations in use of medications • Disparities in use of invasive procedures • Rapid changes in revascularization procedures • Transfusions and bleeding are common • Importance of proper medication dosing • Comprehensive guidelines adherence saves lives • Academic output critical to success

  13. CRUSADE  ACTION – NSTEMI PatientsInvasive Procedures in Cath-Eligible Population* * Excludes ~25% of patients with cath contraindications ACTION/CRUSADE: April, 2006 – May, 2007

  14. Early Cath (<48h) Use by Risk Status 75.5 18% 64.1 63.2 53.5 32.2 26.6 21% - Tricoci et al AHA 2005

  15. Procedure Use as a Function of Age - Alexander, JACC 2005

  16. Rates of Cardiac Catheterization According to Predictive Risk of Severe CAD (L-Main or 3 Vessel) in ACS Patients n = 97,004 - Cohen, et al AHA 2005

  17. Risk – Treatment Paradox Cath, p=0.0002; PCI, p=0.03; CABG, p=0.01 53.6 38.0 24.6 16.0 5.8 5.4 GRACE Risk Score (Deciles)

  18. Discharge Medication Use by Invasive Care –UA/NSTEMI Patients from CRUSADE Percentage Use Bhatt DL, JAMA 2004;292:2096-104.

  19. CRUSADE Lessons Learned • Complex patient population • Variations in use of medications • Disparities in use of invasive procedures • Rapid changes in revascularization procedures • Transfusions and bleeding are common • Importance of proper medication dosing • Comprehensive guidelines adherence saves lives • Academic output critical to success

  20. 0.5 1 1.5 2 Independent Predictors of Early Cath Cardiology Care Age (per 10 yrs) Prior CHF Renal Insufficiency Signs of CHF Caucasian Race Female Sex Adjusted Odds Ratio Bhatt et al, JAMA 2004

  21. A Reduction in the Use of Medical Strategy Alone in ACS Patients After Introduction of DES - Gogo et al, ACC 2006

  22. More PCI for 3-Vessel CAD After Introduction of DES - Gogo et al, ACC 2006

  23. Trends for DES Use for UA/NSTEMI – CRUSADE to ACTION:July 2006 - March 2007

  24. The Use of Medical Therapy Alone in Patients With 3-Vessel CAD Has Been Constant Over Time - Gogo et al, ACC 2006

  25. CRUSADE Lessons Learned • Complex patient population • Variations in use of medications • Disparities in use of invasive procedures • Rapid changes in revascularization procedures • Transfusions and bleeding are common • Importance of proper medication dosing • Comprehensive guidelines adherence saves lives • Academic output critical to success

  26. Use of Blood Transfusions in CRUSADE Yang X, JACC 2005;46:1490-5.

  27. CRUSADE Lessons Learned • Complex patient population • Variations in use of medications • Disparities in use of invasive procedures • Rapid changes in revascularization procedures • Transfusions and bleeding are common • Importance of proper medication dosing • Comprehensive guidelines adherence saves lives • Academic output critical to success

  28. Excessive Dosing of Anticoagulants by Age 42% of patients got excess -- Alexander JAMA 2005;294:3108-3116

  29. Dosing Combinations and Transfusions: Heparin + GP IIb-IIIa Inhibitors* * Among patients receiving both Heparin (UFH or LMWH) and GP IIb-IIIa Inhibitors -- Alexander JAMA 2005;294:3108-3116

  30. CRUSADE RBC Transfusions by Excess Dosing RBC Transfusion (%) Alexander KA, JAMA 2005;294:3108-16.

  31. Impact of Overdosing Reporting in CRUSADE Overdosing (%)

  32. CRUSADE Lessons Learned • Complex patient population • Variations in use of medications • Disparities in use of invasive procedures • Rapid changes in revascularization procedures • Transfusions and bleeding are common • Importance of proper medication dosing • Comprehensive guidelines adherence saves lives • Academic output critical to success

  33. Link Between Overall ACC/AHA Guidelines Adherence and Mortality Every 10%  in guidelines adherence  11%  in mortality Peterson et al, ACC 2004

  34. Change in Mortality by Hospital Performance Improvement Peterson et al, AHA 2004

  35. Hospital Mortality According to How Consistently Hospitals Follow Trial Evidence Quartiles of Hospital Composite of Medication Core Measures Granger Am J Med. 2005;118:858-65

  36. Proportion of Patients Receiving 100% of All Guidelines-Recommended Therapies* *In patients without contraindications Mehta et al, AHA 2005

  37. CRUSADE Lessons Learned: Conclusions • Disparities in use of invasive procedures • The highest risk patients frequently do not undergo an invasive management in ACS • Rapid changes in revascularization procedures • Substantial changes in DES and CABG use during the last year highlights physician uncertainty on safety • Transfusions and bleeding are common • Importance of proper medication dosing • Appropriate dosing of therapies need to be emphasized before and after interventions

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