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Global Registry of Acute Coronary Events Assessing Todays Practice Patterns to Enhance Tomorrows Care Supported by an unrestricted educational grant from.

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Presentation on theme: "Global Registry of Acute Coronary Events Assessing Todays Practice Patterns to Enhance Tomorrows Care Supported by an unrestricted educational grant from."— Presentation transcript:

1 Global Registry of Acute Coronary Events Assessing Todays Practice Patterns to Enhance Tomorrows 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 Largest multinational registry covering the full spectrum of ACS Generalizable patient inclusion criteria Generalizable patient inclusion criteria In-hospital and 6-month follow-up In-hospital and 6-month follow-up Representative of the catchment population: (clusters of hospitals) Representative of the catchment population: (clusters of hospitals) Full spectrum of hospitals and facilities Full spectrum of hospitals and facilities Training, audit and quality control Training, audit and quality control

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

4 Scientific Advisory Committee 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 Co-ChairsKeith AA Fox, UK Joel M Gore, USA Publications Kim A Eagle, USA Co-Chairs Ph Gabriel Steg, France Study Co-ordination Fred Anderson, University of Massachusetts

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

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

7 Cluster Strategy for Study Sites: Population-Based Design ~ 100 hospitals ~ 10,000 ACS patients/year 18 advisory committee members 18 advisory committee members

8 Multinational Site Network Argentina 6 sites Australia 7 sites Austria 6 site Belgium6 sites Brazil7 sites Canada6 sites France6 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 70,359 cases enrolled 85% six-month follow-up 85% six-month follow-up Q4-2007

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

12 247 Core GRACE & GRACE 2 Study Sites in 30 Countries* *30 countries = 16 GRACE core GRACE + 7 both

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

14 Internet Website

15 Hospital Characteristics Q vs. Current Quarter Q Q Q Q Number of Hospitals Number of Hospitals Coronary care unit94% 98% Coronary care unit94% 98% Emergency department86% 88% Emergency department86% 88% Cardiac catheterization laboratory 65% 72% Cardiac catheterization laboratory 65% 72% Open heart surgery 43% 45% Open heart surgery 43% 45% Hospital beds (mean) Hospital beds (mean) Coronary care unit beds (mean) Coronary care unit beds (mean) ACS admissions (mean, per year) ACS admissions (mean, per year) Q4-2007

16 70,359 Cases Enrolled as of December 31, 2007 Q4-2007

17 Classification of Cases

18 Hospital Discharge Status STEMI NSTEMI UA STEMI NSTEMI UA Death7%4%3% Home77%78%87% Transfer * 10%12%9% Other6%6%2% * Transfer to another acute care hospital. Q4-2007

19 *Missing diagnosis in 236 patients 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%) MI N=4100 (36%) 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. Admission versus Final Diagnosis Fox KAA et al.Eur Heart J 2002;23:

20 Baseline Characteristics STEMI NSTEMI UA (n = 13,862) (11,316) (12,509) STEMI NSTEMI UA (n = 13,862) (11,316) (12,509) Median age (years) Male (%) Prior history (%) Angina435678Angina Myocardial infarction203241Myocardial infarction PCI/CABG8/515/1425/19PCI/CABG8/515/1425/19 Smoking625755Smoking Diabetes mellitus Diabetes mellitus Hypertension Hypertension Hyperlipidemia Hyperlipidemia Participant in clin trial (%) 1177

21 Hospital Treatment According to Admission Diagnosis MI UA ? MI Chest pain n 16,304 15,266 3,474 3,266 % % % % % % % ACE inhibitors Aspirin blockers blockers Ca 2+ blockers Gp IIb/IIIa: no PCI Gp IIb/IIIa with PCI LMWH UFH Thrombolytic agents

22 Diagnostic Procedures

23 Hospital Cardiac Interventions According to Final Diagnosis Intervention STEMI NSTEMI UA n 13,862 11,316 12,509 % % % % % Cardiac catheterization PCI CABG476

24 Treatments at Discharge STEMI NSTEMI UA n 13,862 11,316 12,509 % % % % % ACE inhibitors Aspirin blockers blockers Ca 2+ blockers Statins Warfarin 877

25 Hospital Outcome by Final Diagnosis

26 Hospital Outcomes < 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 PCI alone Lytic alone Both Neither 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 ( ) History of diabetes 1.46 ( ) History of congestive heart failure 2.92 ( ) Presentation without chest pain 2.23 ( ) *Age 75 years 2.37 ( ) *As compared to the <55 years age group Eagle KA et al. Lancet 2002;359:373-7.

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

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:

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

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 LowerHigher Major hem Major hem3.9%2.4%8.3%2.9% UFHLMWH UFH + IIb/IIIa LMWH + IIb/IIIa OR=0.55P<0.001 OR=2.26 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:

40 Incidence of Major Bleeding Moscucci Met al.Eur Heart J 2003;24: Moscucci M et al.Eur Heart J 2003;24:

41 Predictors of Major Bleed VariablesOverallUASTEMINSTEMI Age (per 10 year )xxxx Female genderxxx History of renal insufficiencyxxx History of bleedingxxxx Killip Class IVx MAP (per 20 mmHg )xx IV Inotropicsxxxx Other vasodilatorsxx Thrombolyticsxx Diureticsxxxx Unfractionated heparinxx IIb/IIIa receptor blockersxxx PA cathetersxxxx PCIxxx Thrombolytics and IIb/IIIa inhibxxx Moscucci Met al.Eur Heart J 2003;24: Moscucci M et al.Eur Heart J 2003;24:

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

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

44 Total Population = 9,980 Evidence Based Medicine ST MI Non- ST MIUA% of pts who are Therapy(n=2,501)(n=2,504)(n=3,631) eligible ASAXXX B blockerXX ACE-IXX ReperfusionX GP IIb/IIIa/LMWHXX et al. J Am Coll Cardiol 2001;37(2 Suppl A):503A. Granger CB et al. J Am Coll Cardiol 2001;37(2 Suppl A):503A.

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

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

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

49 In-Hospital Mortality ( ) ( ) ( ) * OR & 95% CI *p<0.05 n=900 n=124 * et al. J Am Coll Cardiol 2001;37(2 Suppl A):358A. Goodman SG et al. J Am Coll Cardiol 2001;37(2 Suppl A):358A. n=1111

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:

51 Impact of Prior ASA on ACS: GRACE

52 Type of ACS and Hospital Mortality in Patients with History of CAD Stratified By Prior ASA Impact of prior ASA on: Impact of prior ASA on: –STEMI 0.52 (0.44,0.61)* –Death 0.69 (0.5,0.95)** *Controlled for age, sex, medical hx, prior therapies, in hospital therapies **Controlled for above plus MI type

53 Type of ACS and Hospital Mortality in Patients without History of CAD Stratified By Prior ASA Impact of prior ASA on: Impact of prior ASA on: –STEMI 0.35 (0.30,0.40)* –Death 0.77 (0.55,1.07)** *Controlled for age, sex, medical hx, prior therapies, in hospital therapies ** Controlled for above plus MI type

54 Association of Statin Therapy with Outcomes of Acute Coronary Syndromes: The GRACE Study Frederick A. Spencer, Jeanna Allegrone, Robert J. Goldberg, Joel M. Gore, Keith A.A. Fox, Christopher B. Granger, Rajendra H. Mehta and David Brieger for the GRACE Investigators* Ann Intern Med 2004;140:

55 Patients Prior and Early Utilization of Statins in Patients with ACS: GRACE Ann. Intern Med. 2004;140:

56 Final Diagnosis of ACS Patients According to Previous Treatment with Statins *Multivariate analysis: Prior statin users less likely to present with STEMI -OR 0.79 (0.71,0.88) Ann. Intern Med. 2004;140:

57 Hospital Outcomes of ACS Patients Stratified by Statin Use OutcomePrior statins Prior & Hospital Hospital Statins Only Statin Only Death1.39 (0.91,2.14) 0.20 (0.16,0.25)0.38 (0.30,0.48) Recurrent MI0.69 (0.43,1.11) 0.90 (0.75,1.07)1.22 (1.08,1.37) Stroke1.08 (0.43,2.73) 0.68 (0.42, 1.12)0.80 (0.57, 1.14) Composite 1.02 (0.74,1.41) 0.66 (0.56,0.77) 0.87 (0.78,0.97) *Compared to patients never receiving statins Ann. Intern Med. 2004;140:

58 Comparison of Outcomes of Patients With Acute Coronary Syndromes With and Without Atrial Fibrillation Rajendra H. Mehta, Omar H. Dabbous, Christopher B. Granger, Polina Kuznetsova, Eva M. Kline-Rogers, Frederick A. Anderson, Jr., Keith A.A. Fox, Joel M. Gore, Robert J. Goldberg and Kim A. Eagle for the GRACE Investigators Ann J Cardiol 2003;92:

59 Adjusted ORs for Hospital Events in Patients with ACS and New-Onset Atrial Fibrillation Odds Ratio Major bleed Stroke Cardiac arrest Pulmonary edema Shock Death AF BetterAF Worse Am J Cardiol 2003;92(9):1031-6

60 Adjusted ORs for Hospital Events in Patients with ACS and Previous Atrial Fibrillation Odds Ratio Major bleed Stroke Cardiac arrest Pulmonary edema Shock Death AF BetterAF Worse Am J Cardiol 2003;92(9):1031-6

61 Determinants and Prognostic Impact of Heart Failure Complicating Acute Coronary Syndromes: Observations From the Global Registry of Acute Coronary Events (GRACE) Philippe Gabriel Steg, Omar H. Dabbous, Laurent J. Feldman, Alain Cohen-Solal, Marie-Claude Aumont, José López-Sendón, Andrzej Budaj, Robert J. Goldberg, Werner Klein, Frederick A. Anderson, Jr, for the Global Registry of Acute Coronary Events (GRACE) Investigators Circulation. 2004;109:

62 Impact of Heart Failure on Admission on Hospital Mortality >75 years years years <55 years 3.1 (2.4,3.9) 3.3 (2.3,4.8) 5.0 (2.9,8.3) 10.1 (5.3,19.2) Lower odds ratio for death Higher odds of death *Relative to patients without HF Circulation 2004;109:

63 Death Rates from Hospital Admission to 6-Month Follow-Up for Patients According to Timing of Heart Failure Circulation 2004;109:

64 Hospital Case-Fatality Rates According to Development of Heart Failure Group HF (+)HF (-) All patients 12.0% 2.9% STEMI 16.5% 4.1% Non-STEMI 10.3% 3.0% Unstable angina 6.7% 1.6% Circulation 2004;109:

65 Stenting and Glycoprotein IIb/IIIa Inhibition in Patients With Acute Myocardial Infarction Undergoing Percutaneous Coronary Intervention: Findings From the Global Registry of Acute Coronary Events (GRACE) Gilles Montalescot, Frans Van de Werf, Dietrich C. Gulba, Àlvaro Avezum, David Brieger, Brian M. Kennelly, Tomasz Mazurek, Frederick Spencer, Kami White, and Joel M. Gore for the GRACE Investigators Catheterization & Cardiovascular Interventions. 60: (2003)

66 Probability of Survival at 6 Months (all PCI) Death rates: +GP +stent 7.3%+GP –stent 12.8% -GP +stent 6.7%-GP – stent 14.4% et al.Catheter Cardiovasc Interv 2003;60: Montalescot G et al.Catheter Cardiovasc Interv 2003;60:360-7.

67 Probability of Survival at 6 Months (Primary PCI) Death rates: +GP +stent 7.7%+GP –stent 7.4% -GP +stent 8.7%-GP –stent 20.1% et al.Catheter Cardiovasc Interv 2003;60: Montalescot G et al.Catheter Cardiovasc Interv 2003;60:360-7.

68 Six-Month Outcomes in a Multinational Registry of Patients Hospitalized With an Acute Coronary Syndrome (The Global Registry of Acute Coronary Events [GRACE]) Robert J. Goldberg, Kristen Currie, Kami White, David Brieger, Phillippe Gabriel Steg, Shaun G. Goodman, Omar Dabbous, Keith A.A. Fox and Joel M. Gore for the GRACE Investigators Am J Cardiol 2004;93:

69 Six-Month Follow-Up* STEMI NSTEMI UA Death 5% (480/9414)6% (496/7977)4% (349/9357) Stroke 1% (110/9173)1% (103/7749)1% (79/9176) Rehospitalized 18% (1619/9147)19% (1501/7721)19% (1761/9150) *Excluding events that occurred in hospital oet al.Am J Cardiol 2004;93: Goldberg RJ et al.Am J Cardiol 2004;93:

70 Discharge to 6 Month Outcomes: Cardiac Interventions Scheduled and unscheduled procedures oet al.Am J Cardiol 2004;93: Goldberg RJ et al.Am J Cardiol 2004;93:

71 6 Month Follow-up Cannon CP et al.Eur Heart J 2001;22(Abstr Suppl):592.

72 Total Outcomes: Admission to 6 Months

73 Survival Rate 6 Months Post Discharge for STEMI, NSTEMI, and UA Patients oet al.Am J Cardiol 2004;93: Goldberg RJ et al.Am J Cardiol 2004;93:

74 Factors Associated With An Increased Risk of Post-Discharge Death Characteristic STEMINon-STEMI Age (yrs) HR 95% CI HR 95% CI > Medical history HF MI TIA/Stroke Hospital complications Cardiogenic shock HF Stroke oet al.Am J Cardiol 2004;93: Goldberg RJ et al.Am J Cardiol 2004;93:

75 Factors Associated with an Increased Risk of Post-Discharge Death in Patients with UA Characteristic Age (yrs) HR 95% CI Medical history HF MI PCI Hospital complications Cardiogenic shock HF oet al.Am J Cardiol 2004;93: Goldberg RJ et al.Am J Cardiol 2004;93:

76 From guidelines to clinical practice: the impact of hospital and geographical characteristics on temporal trends in the management of acute coronary syndromes: The Global Registry of Acute Coronary Events (GRACE ) Keith A.A. Fox, Shaun G. Goodman, Frederick A. Anderson Jr., Christopher B.Granger, Mauro Moscucci, Marcus D. Flather, Frederick Spencer, Andrzej Budaj, Omar H. Dabbous, Joel M. Gore on behalf of the GRACE Investigators European Heart Journal 2003;24:

77 Temporal Trends in ACS Diagnostic Categories

78 Temporal Trends STEMI: In-hospital Therapies Fox KAA et al. Eur Heart J 2003;24: *without PCI

79 Temporal Trends STEMI: Reperfusion Fox KAA et al. Eur Heart J 2003;24: *within 12 h

80 Temporal Trends NSTEMI: In-hospital Therapies Fox KAA et al. Eur Heart J 2003;24:

81 GRACE Palm Pilot Software In-hospital, 6-months Death, Death/MI Prediction Model

82

83 GRACE PDA Software

84

85 At Admission Risk Model

86 At Discharge Risk Model

87 GRACE Publications

88 Abstract Acceptance Rate (1999 to 2007) Number of abstracts accepted = 111

89 Manuscript Status

90 GRACE Quarterly Reports to Investigators

91 Quarterly Report Current Quarter vs. Overall

92 Quarterly Report Temporal Trends

93 Unique Features of GRACE Multi-national perspective Multi-national perspective Full spectrum of coronary syndromes Full spectrum of coronary syndromes Increased data on demographics, presentation, management and outcome Increased data on demographics, presentation, management and outcome Regular audits of data quality Regular audits of data quality Feedback to participating sites Feedback to participating sites 6-month follow-up 6-month follow-up


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