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What is GRACE?

Global Registry of Acute Coronary Events Assessing Today’s Practice Patterns to Enhance Tomorrow’s Care. Supported by an unrestricted educational grant from sanofi-aventis to the Center for Outcomes Research University of Massachusetts Medical School. What is GRACE?.

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What is GRACE?

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  1. Global Registry of Acute Coronary EventsAssessing Today’s Practice Patterns to Enhance Tomorrow’s Care Supported by an unrestricted educational grant from sanofi-aventis to the Center for Outcomes Research University of Massachusetts Medical School

  2. What is GRACE? Global Registry of Acute Coronary Events • Largest multinational registry covering the full spectrum of ACS • Generalizable patient inclusion criteria • In-hospital and 6-month follow-up • Representative of the catchment population: (clusters of hospitals) • Full spectrum of hospitals and facilities • Training, audit and quality control

  3. International Scientific Advisory Committee International Advisory Committee ‘Americas’ clusters Chair: JM Gore ‘European’ clusters Chair: KAA Fox 8 advisors 8 advisors 40 subsite cardiologists 40 subsite cardiologists

  4. Scientific Advisory Committee Co-Chairs Keith AA Fox, UK Joel M Gore, USA Publications Kim A Eagle, USA Co-ChairsPh Gabriel Steg, France Study Co-ordination Fred Anderson, University of Massachusetts Argentina Enrique Gurfinkel Australia/New Zealand David Brieger Austria Georg Gaul Belgium Frans J Van de Werf Brazil Álvaro Avezum Canada Shaun Goodman Germany Dietrich C Gulba Italy Giancarlo Agnelli France Gilles Montalescot Ph Gabriel Steg Poland Andrzej Budaj Spain José López-Sendón United Kingdom Keith AA Fox Marcus Flather United States Frederick A Anderson Kim A Eagle Robert J Goldberg Joel M Gore Christopher B Granger Brian M Kennelly

  5. Objectives of GRACE • Identify opportunities to improve the quality of care for patients with ACS • Describe diagnostic & treatment strategies, & hospital & post-discharge outcomes • Develop hypotheses for future clinical research • Disseminate findings to a wider audience

  6. Core GRACE Study Design • ~100 hospitals in 14 countries • Europe, North & South America, Australia, New Zealand • Population-based clusters with community hospitals and referral centres • First 10-20 consecutive cases per centre/month: qualifying symptoms PLUS evidence of CAD • Random audit of all centres: 3 year cycle

  7. Cluster Strategy for Study Sites: Population-Based Design 2 1 3 18 advisory committee members ~100 hospitals ~10,000 ACS patients/year 4 6 5

  8. Multinational Site Network Argentina6 sites Australia7 sites Austria 6 site Belgium 6 sites Brazil 7 sites Canada 6 sites France 6 sites Germany 5 sites Italy 5 sites New Zealand 2 sites Poland 6 sites Spain 4 sites UK 5 sites USA 18 sites

  9. 89 Active Core Study Sites: 17 Clusters in 14 Countries

  10. Status of 17 Core Clusters • 70,359 cases enrolled • 85% six-month follow-up Q4-2007

  11. GRACE Core Substudy 1 Substudy 3 Substudy 2 The “Big Picture”Core GRACE & GRACE2 GRACE2 31,982 patients 158 hospitals 23 countries GRACE Core 70,359 patients 89 hospitals 14 countries

  12. 247 Core GRACE & GRACE2 Study Sites in 30 Countries* *30 countries = 16 GRACE2 + 7 core GRACE + 7 both

  13. Status: December 31, 200789 Core & 158 Expanded Sites • 30 countries • 247 hospitals • 102,341 cases Q4-2007

  14. Internet Websitewww.outcomes.org/grace

  15. Hospital CharacteristicsQ4-2001 vs. Current Quarter Q4-2001 Q4-2007 Number of Hospitals 109 89 Coronary care unit 94% 98% Emergency department 86% 88% Cardiac catheterization laboratory 65% 72% Open heart surgery 43% 45% Hospital beds (mean) 416 523 Coronary care unit beds (mean) 10 11 ACS admissions (mean, per year) 487 585 Q4-2007

  16. 70,359 Cases Enrolledas of December 31, 2007 Q4-2007

  17. Classification of Cases Q4-2007

  18. Hospital Discharge Status STEMI NSTEMI UA Death 7% 4% 3% Home 77% 78% 87% Transfer * 10% 12% 9% Other 6% 6% 2% *Transfer to another acute care hospital. Q4-2007

  19. MI N=4100 (36%) UA N=4999 (44%) ‘Rule-out’ MI N=957 (9%) Unspecified chest pain N=745 (7%) Other cardiac N=381 (3%) Non-cardiac N=125 (1%) STEMI N=3419 (30%) Non-STEMI N=2893 (25%) Unstable angina N=4397 (38%) Other cardiac N=508 (4%) Non-cardiac N=326 (3%) Admission versus Final Diagnosis *Missing diagnosis in 236 patients Admission diagnoses versus final diagnoses (derived from discharge diagnosis, electrocardiographic changes and cardiac enzymes) in 11,543 patients with acute coronary syndromes. Figures expressed as percentage of total ACS. Fox KAA et al.Eur Heart J 2002;23:1177-89.

  20. Baseline Characteristics • STEMI NSTEMI UA(n = 13,862) (11,316) (12,509) • Median age (years) 65 68 66 • Male (%) 70 66 64 • Prior history (%) • Angina 43 56 78 • Myocardial infarction 20 32 41 • PCI/CABG 8/5 15/14 25/19 • Smoking 62 57 55 • Diabetes mellitus 21 28 26 • Hypertension 52 62 66 • Hyperlipidemia 38 47 54 • Participant in clin trial (%) 11 7 7

  21. Hospital Treatment According to Admission Diagnosis MI UA ? MI Chest pain n 16,304 15,266 3,474 3,266 %% % % ACE inhibitors 69 56 56 55 Aspirin 94 92 92 92 -blockers 83 81 81 79 Ca2+ blockers 15 34 30 29 Gp IIb/IIIa: no PCI 5 4 7 7 Gp IIb/IIIa with PCI 26 11 15 18 LMWH 52 64 40 40 UFH 59 43 51 51 Thrombolytic agents 35 2 3 3

  22. Diagnostic Procedures

  23. Hospital Cardiac Interventions According to Final Diagnosis Intervention STEMI NSTEMI UA n 13,862 11,316 12,509 %% % Cardiac catheterization 62 57 49 PCI 45 31 23 CABG 4 7 6

  24. Treatments at Discharge STEMI NSTEMI UA n 13,862 11,316 12,509 %% % ACE inhibitors 67 56 52 Aspirin 92 89 88 -blockers 78 76 72 Ca2+ blockers 10 20 31 Statins 63 59 57 Warfarin 8 7 7

  25. Hospital Outcome by Final Diagnosis

  26. Hospital Outcomes <0.0001 10.7 <0.0001 5.6 5.6 4.0 Lankes W et al.Eur Heart J 2002;23(Abstr Suppl):502.

  27. What proportion of eligible patients receive reperfusion therapy?

  28. Practice variation and missed opportunities for reperfusion in ST-segment-elevation myocardial infarction: findings from the Global Registry of Acute Coronary Events (GRACE) Kim A. Eagle, Shaun G. Goodman, Álvaro Avezum, Andrzej Budaj, Cynthia M. Sullivan, José López-Sendón, for the GRACE Investigators Lancet 2002;359:373-77

  29. Missed Opportunities for Reperfusion ST ↑ or LBBB, <12 hrs from onset, no contraindications ANC (%) US (%) AB (%) EUR (%) n 269 327 339 739 PCI alone 1.1 17.7 13.9 16.2 Lytic alone 66.9 30.6 53.1 49.4 Both 2.2 18.7 5.0 4.9 Neither 29.7 33.0 28.0 29.5 AB, Argentina/Brazil; ANC, Australia/New Zealand/Canada; EUR, Europe; US, United States Eagle KA et al. Lancet 2002;359:373-7.

  30. Independent Predictors of No Reperfusion Variable OR (95% CI) Prior CABG 2.28(1.35 - 3.87) History of diabetes 1.46(1.11 -1.94) History of congestive heart failure 2.92(1.84 - 4.67) Presentation without chest pain 2.23(2.13 - 4.89) *Age 75 years2.37(1.82 - 3.08) *As compared to the <55 years age group Eagle KA et al. Lancet 2002;359:373-7.

  31. Geographical Variation: Admission to Hospitals with/without Access to Cath Lab ANC, Australia/New Zealand/Canada; AB, Argentina/Brazil

  32. Global patterns of use of antithrombotic and antiplatelet therapies in patients with acute coronary syndromes: Insights from the Global Registry of Acute Coronary Events (GRACE) Andrzej Budaj, David Brieger, Ph Gabriel Steg, Shaun G. Goodman, Omar H. Dabbous, Keith A. A. Fox, Álvaro Avezum, Christopher P. Cannon, Tomasz Mazurek, Marcus D. Flather, and Frans Van De Werf, for the GRACE Investigators Am Heart J 2003;146:999-1006.

  33. Geographic Practice Variation Budaj A et al. Am Heart J 2003;146:999-1006.

  34. Antithrombotic Rx Used Cannon CP et al.Eur Heart J 2001;22(Abstr Suppl):592.

  35. Incidence of Major Bleeding Cannon CP et al.Eur Heart J 2001;22(Abstr Suppl):592.

  36. Multivariate Adjusted Odds of Major Hemorrhage Major hem 3.9% 2.4% 8.3% 2.9% UFH LMWH UFH +IIb/IIIa LMWH + IIb/IIIa OR=0.55 P<0.001 OR=2.26 0 0.5 1 2 3 Lower Higher Cannon CP et al.Eur Heart J 2001;22(Abstr Suppl):592.

  37. Safety Events  Cannon CP et al.Eur Heart J 2001;22(Abstr Suppl):592.

  38. Major Cardiac Events Cannon CP et al.Eur Heart J 2001;22(Abstr Suppl):592.

  39. Predictors of major bleeding in acute coronary syndromes: the Global Registry of Acute Coronary Events (GRACE) M. Moscucci, K.A.A. Fox, Christopher P. Cannon, W. Klein, José López-Sendón, G. Montalescot, K. White, R.J. Goldberg, for the GRACE Investigators European Heart Journal 2003;24:1815-1823

  40. Incidence of Major Bleeding Moscucci Met al.Eur Heart J 2003;24:1815-23.

  41. Predictors of Major Bleed Variables Overall UA STEMI NSTEMI Age (per 10 year ↑) x x x x Female gender x x x History of renal insufficiency x x x History of bleeding x x x x Killip Class IV xMAP (per 20 mmHg ↓) x x IV Inotropics x x x x Other vasodilatorsx x Thrombolytics x x Diuretics x x x x Unfractionated heparin x x IIb/IIIa receptor blockers x x x PA catheters x x x x PCI x x x Thrombolytics and IIb/IIIa inhib x x x Moscucci Met al.Eur Heart J 2003;24:1815-23.

  42. In-Hospital Mortality Rates ** ** ** ** **P<0.001 Moscucci Met al.Eur Heart J 2003;24:1815-23.

  43. Outcome of “Low-risk” Patients with ACS • Presentation with UA in the absence of dynamic ECG changes, no troponin elevation, no arrhythmia nor hypotension • Abnormal ECG in 38%, • 27% stress test, 37% echo, 52% angio • 6 month outcome: • 23% readmission • 12% revascularized • 3% deaths • “Low-risk” is not no risk Devlinet al.Eur Heart J 2001;22(Abstr Suppl):525.

  44. Evidence Based Medicine Total Population = 9,980 ST  MI Non-ST  MI UA % of pts who are Therapy (n=2,501) (n=2,504) (n=3,631) eligible ASA X X X B blocker X X ACE-I X X Reperfusion X GP IIb/IIIa/LMWH X X Granger CBet al. J Am Coll Cardiol 2001;37(2 Suppl A):503A.

  45. GRACE: Use of EBM in “Eligible” Patients 14% PTCA 14% IIb/IIIa 56% lytics 48% LMWH n=5,373 n=4,480 n=3,254 n=1,963 n=4112 Granger CBet al. J Am Coll Cardiol 2001;37(2 Suppl A):503A.

  46. Management of acute coronary syndromes. variations in practice and outcome: Findings from the Global Registry of Acute Coronary Events (GRACE) K.A.A. Fox, S.G. Goodman, W. Klein, D. Brieger, P.G. Steg, O. Dabbous and Á. Avezum for the GRACE Investigators Eur Heart J 2002;23:1177-1189

  47. Geographic Practice Variation:Discharge Medication **P<0.01 AT/AC, antithrombin or anticoagulant Fox KAAet al. Eur Heart J 2002;23:1177-89.

  48. n=3420 of 8213 with CK, CK-MB & troponin measurements ³ ³ ³ Increase in Diagnosis of MI Utilizing Troponin Goodman SGet al. J Am Coll Cardiol 2001;37(2 Suppl A):358A.

  49. In-Hospital Mortality OR & 95% CI n=1111 * (3.3 - 10.1) n=900 n=124 * (1.6 - 5.7) (0.6 - 7.4) £ £ Goodman SGet al. J Am Coll Cardiol 2001;37(2 Suppl A):358A. *p<0.05

  50. Impact of Aspirin on Presentation and Hospital Outcomes in Patients with Acute Coronary Syndromes (The Global Registry of Acute Coronary Events [GRACE]) Frederick A. Spencer, Jose J. Santopinto, Joel M. Gore, Robert J. Goldberg, Keith A.A. Fox, Mauro Moscucci, Kami White, and Enrique P. Gurfinkel Am J Cardiol 2002;90:1056-1061

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