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Impact of Treatment Delays on Outcomes After Primary PCI for AMI: Implications for Patient Triage

Impact of Treatment Delays on Outcomes After Primary PCI for AMI: Implications for Patient Triage. Bruce R Brodie, MD LeBauer Cardiovascular Research Foundation Moses Cone Heart and Vascular Center Greensboro, NC Dartmouth-Hitchcock Medical Center Lebanon, NH April 29, 2004.

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Impact of Treatment Delays on Outcomes After Primary PCI for AMI: Implications for Patient Triage

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  1. Impact of Treatment Delays on Outcomes After Primary PCI for AMI:Implications for Patient Triage Bruce R Brodie, MD LeBauer Cardiovascular Research Foundation Moses Cone Heart and Vascular Center Greensboro, NC Dartmouth-Hitchcock Medical Center Lebanon, NH April 29, 2004

  2. The New York Times, November 16, 1988

  3. The New York Times April 17, 2002

  4. Short-term Clinical Outcomes: Primary PCI vs Thrombolytic Therapy Summary of 23 Randomized Trials(n=7739) PCI p<0.0001 OR=0.57 Lytic p<0.0001 p=0.0003 p=0.0004 Keeley Lancet 2003

  5. Traditional Paradigm for the Mechanism of Benefit of Reperfusion Therapy for AMI: • Early restoration of normal blood flow to the myocardium will result in myocardial salvage and better short and long-term survival

  6. Time to Treatment and Mortality with tPANRMI-2 2 (n=71,253) Adjusted Odds Ratio of In-hospital Death 1 <1 1-2 2-3 3-4 4-5 5-6 6-8 8-12 Time to Treatment (hrs) Goldberg RJ AJC 1998;82:259

  7. Time to Reperfusion and 30 Day Mortality Moses Cone Primary PCI Registry 9.5% 9.3% 9.0% (n=1,352) 30 Day Mortality % 4.3% 2-4 (n=581) 4-6 (n=332) >6 (n=275) <2 (n=164) Time to Reperfusion (hr) Brodie JACC 1998

  8. Time to Reperfusion and Late Cardiac Survival Moses Cone Primary PCI Registry 2 hrs Cardiac Survival % >2-4 hrs >6 hrs >4-6 hrs Years Brodie JACC 1998

  9. Time to Reperfusion and Late Cardiac Mortality Moses Cone Primary PCI Registry 1.80 1.53 Adjusted Hazard Ratio Late Cardiac Mortality 1.49 <2 2-4 4-6 >6 Time to Reperfusion (hrs) Brodie JACC 1998 (updated)

  10. Time to Reperfusion and One Year MortalityCADILLAC Trial (n=2002) 4.8 4.4 4.2 p=0.04 (<3 hrs vs >3 hrs) 2.6 2.6 One Year Mortality % 3-4 <2 4-6 6-12 2-3 (n=455) (n=121) (n=475) (n=513) (n=438) Time to Reperfusion (hrs) Brodie JAAC 2003

  11. Time to Reperfusion and One Year SurvivalCADILLAC Trial (n=2,002) p=0.14 (overall) p=0.04 (<3 vs. >3 hrs) Brodie JACC 2003

  12. Door-to-Balloon Time and In-Hospital MortalityNRMI-2 Registry 2.2 2 (n=27,080) 1.8 1.62 1.61 1.6 Adjusted OddsRatio 1.41 1.4 1.2 1.15 1.14 1 0.8 0.6 1.0-1.5 2.5-3.0 <1.0 1.5-2.0 2.0-2.5 >3.0 Door-to-BalloonTime (hrs) Cannon JAMA 2000;283:2941

  13. Door-to-Balloon Time and Late Cardiac Survival Moses Cone Primary PCI Registry p<0.0001 <1.5 hrs Cardiac Survival % >1.5-2.0 hrs >2.0-3.0 hrs >3.0 hrs (n=1959) Years Brodie ACC 2004

  14. Door-to-Balloon Time and Late Cardiac Mortality Moses Cone Primary PCI Registry 2.5 (n=1959) 2 1.51 1.5 1.41 Adjusted Hazard Ratio Late Cardiac Mortality 1.17 1 0.5 0 <1.5 1.5-2.0 >2.0-3.0 >3.0 Door-to-Balloon Time (hrs) Brodie ACC 2004

  15. Door-to-Balloon Time and Late Mortality InPatients with Early Presentation (< 2 hrs) Moses Cone Primary PCI Registry Brodie ACC 2004

  16. Door-to-Balloon Time and Late Cardiac Mortality In Patients with Early Presentation (< 2 hrs) Moses Cone Primary PCI Registry 1.65 1.58 Adjusted Hazard Ratio Late Cardiac Mortality 1.29 <1.5 1.5-2 >2-3 >3 Door-to-Balloon Time (hrs) Brodie ACC 2004

  17. Door-to-Balloon Time and Late Mortality In Patients with Late Presentation (> 2 hrs) Moses Cone Primary PCI Registry Brodie ACC 2004

  18. Door-to-Balloon Time and Late Cardiac Mortality In Patients with Late Presentation (> 2 hrs) Moses Cone Primary PCI Registry Adjusted Hazard Ratio Late Cardiac Mortality 1.28 1.09 1.03 <1.5 1.5-2 >2-3 >3 Door-to-Balloon Time (hrs) Brodie ACC 2004

  19. Door-to-Balloon Time and One Year Mortality Stratified by Time to Presentation CADILLAC Trial p=NS 5.1% 4.8% p=0.12 3.9% DB Time < 1.5 hrs DB Time > 1.5 hrs 1.9% <2 hrs >2 hrs Time To Presentation Brodie ACC 2003

  20. Importance of Time to Reperfusion: High Risk Patients vs. Low Risk Patients

  21. Time to Reperfusion and 6 Month Mortality In Low and High Risk Patients Florence, Italy Group 12.9% 11.5% High Risk 7.9% High Risk: Age > 70 yrs Anterior MI HR > 100 bpm 4.8% 1.6% 1.3% 1.3% 0% Low Risk <2 2-4 4-6 >6 Time to Reperfusion (hrs) Antoniucci AJC 2002;89:1248

  22. Time to Reperfusion and In-hospital Mortality In Shock and Non-shock Patients Moses Cone Primary PCI Registry 62% 50% Shock (n=138) 31% Non-shock (n=1705) 5.8% 4.6% 4.8% <3 3-<6 >6 Time to Reperfusion Brodie AHJ 2003;145:708

  23. Time to Reperfusion and One Year Mortality in Low and High Risk Patients CADILLAC Trial p=0.09 7.0% Reperfusion Time < 3 hrs Reperfusion Time > 3 hrs High Risk: Age > 70 yrs Killip Class 2 - 3 Anterior MI 4.1% One Year Mortality % p=0.77 1.7% 1.1% Low Risk High Risk Brodie ACC 2003

  24. Importance of Time to Reperfusion • Reinfarction • Microvascular Reperfusion • Myocardial Salvage

  25. Time to Reperfusion and Re-infarction Stent PAMI (6 Months) CADILLAC (One Year) 4.2% p=0.03 3.3% 3.0% 2.6% p=0.003 Re-infarction % 1.5% 1.4% 0% >6 <3 3-6 <2 2-4 4-6 >6 Time to Reperfusion (hrs) Brodie AJC 2001;88:1085 Brodie ACC 2003

  26. Time to Reperfusion and Myocardial Blush and ST-Segment Resolution CADILLAC Trial Grade 2-3 Myocardial Blush Complete (>70%) ST-Segment Resolution 68% 64% p=0.0002 p=0.007 55% Frequency % 53% 47% 44% <3 3-6 >6 >6 <3 3-6 Brodie ACC 2004

  27. Myocardial Salvage by Time to Reperfusion with Primary PCI Myocardial Salvage Index % Time to Reperfusion O’keefe J Nucl Cardiol 1995;2:35

  28. Recovery of LV Function by Time toReperfusion with Primary PCI Moses Cone Primary PCI Registry 59.5% (n=606) 55.8% 55.7% 6.9 54.8% 3.9 3.7 2.5 LV Ejection Fraction % 51.8 52.0 52.6 52.3 <2 2-4 >6 4-6 Time to Reperfusion (hrs) Brodie JACC 1998;32:1312

  29. Improvement in LV Ejection Fraction by Time to Reperfusion CADILLAC Trial 4.8% p=0.03 2.5% Improvement LVEF % (7 mos) -0.2% <3 3-6 >6 Time to Reperfusion (hrs) Brodie ACC 2003

  30. Why is the Impact of Time to Treatment Different with Primary PCI than with Thrombolytic Therapy?

  31. Effect of Time to Treatment on Reperfusion Rates with Thrombolytic Therapy 63% 62% 54% 50% TIMI Flow (2-3 or 3 %) 47% 45% 40% 35% 27% 17% 4-6 2-4 6 >6hrs >6hrs 2-4 4-6hrs <2 6 >6hrs rPA RAPID-2 (TIMI 3) SK TIMI 1 (TIMI 2-3) tPA RAPID-2 (TIMI 3) tPA GUSTO-1 (TIMI 3) Genetech GUSTO Database Bode C Circulation 1996;94:891 Chesebro JH Circulation 1987;76:142

  32. Effect of Time to Treatment on Reperfusion Rates with Primary PTCA 96 96 95 93 92 92 92 92 91 90 89 TIMI 3 Flow % <2 2-4 4-6 >6 <2 2-4 4-6 >6 <3 3-6 >6 Moses Cone CADILLAC STENT PAMI

  33. Time to Treatment with Fibrinolytic Therapy and Risk of Cardiac Rupture (GISSI) 2.0% 1.3% 1.2% Mortality from Cardiac Rupture % 0.7% 0-3 9-12 6-9 3-6 Time to Treatment Mauri F G lta Cardiol 1987;17:37

  34. Expanded Paradigm for the Mechanism of Benefit of Reperfusion Therapy with Primary PCI: Early reperfusion (< 2-3 hrs) will improve survival by enhancing myocardial salvage. This is a very time dependent process. Later reperfusion (> 2-3 hrs) improves survival through the benefits of an open infarct artery (by preventing remodeling and promoting electrical stability) rather than myocardial salvage. This process is not very time dependent.

  35. What are the clinical implications for triage of patients for Primary PCI?

  36. Moses Cone Heart and Vascular Center Greensboro, NC Eden Morehead Hospital Reidsville 34 miles Annie Penn Hospital 23 miles Burlington Greensboro Alamance Hospital Moses Cone Hospital 18 miles Wesley Long Hospital 30 miles Asheboro Randolph Hospital

  37. Additional Treatment Delay in Transferred Patients 54 minutes Treatment Delays in Transferred vs Non-transferred Patients Moses Cone Primary PCI Registry Symptoms to ED Door-to-Balloon Reperfusion Time 1.8 1.9 Non-Transferred (n=1161) 3.7 hrs 1.6 2.8 Transferred (n=680) 4.4 hrs Brodie AJC 2002

  38. Outcomes in Transferred vs Non-Transferred Patients Moses Cone Primary PCI Registry Brodie AJC 2002

  39. Multivariate Predictors of 30 Day MortalityMoses Cone Primary PCI Registry 13.9 Cardiogenic Shock 7.3 TIMI Flow  2 2.7 Age > 70 yrs 2.1 Diabetes 1.9 Anterior MI 1.7 3 Vessel CAD 1.3 Women 1.2 Transferred vs Non-transferred OR = 0.90 95% CI 0.59 – 1.36 Prior CABG 0.9 Prior MI 0.9 Transferred Adjusted Odds Ratio 30 Day Mortality (95% CI) Brodie AJC 2002

  40. Late Survival in Transferred vs Non-transferred Patients Moses Cone Primary PCI Registry Non-transferred (n=1,161) Transferred (n=680) Cardiac Survival % p=0.47 Late clinical follow-up in 98% Mean follow-up time 6.1 yrs Years Brodie AJC 2002

  41. Denmark DANAMI - 2 Anderson NEJM 2003

  42. DANAMI-2: Median Treatment Times (min) tPA (Local) 108 60 168 minutes Pre-hospital Door-needle PCI (Transported) 229 minutes 103 50 34 42 Pre-hospital In-door Out-door Door-Balloon Transport 61 minute treatment delay

  43. DANAMI-2:30 Day Outcomes Local tPA vs Transport for Primary PCI (n=1129) 14.2 tPA p=0.002 PCI (55 minute treatment delay) Incidence % 8.5 8.5 6.5 p<0.001 6.2 2.0 1.9 1.6 Death Re-infarction CVA MACE Anderson NEJM 2003

  44. PRAGUE-2

  45. Time intervals from pain onset to reperfusion 185 minutes 277 minutes 92 minute treatment delay

  46. Outcomes in AMI Treated with Local Lytic Therapy vs Transfer for Primary PCI PRAGUE 2 15.2% p=0.12 p=0.003 10.0% 30 Day Events 8.4% 6.8% p=0.15 p=0.03 3.1% 2.0% 1.4% 0.2% Composite Stroke Death Re-infarction Widimsky Eur Heart J 2003;24:94

  47. Mortality Benefit of Primary PCI vs Lytics by Time to Presentation PRAGUE 2 15.3% 30 Day Mortality 7.4% 7.3% 6.0% <3 hrs 3-12 hrs Time to Presentation Widimsky Eur Heart J 2003;24:94

  48. Facilitated PCI • Pharmacologic therapy (low dose thrombolytic therapy plus GP IIb/IIIa platelet inhibitors) given ASAP after the dx of AMI • Emergent transfer to interventional facilities for coronary intervention (facilitated PCI)

  49. Benefit of an Open Artery on Arrival at the Cath Lab Closed Artery Open Artery p value TIMI 0-1 TIMI 2-3 (n=1,214) (n=272) _________________________________________________________ Procedural Outcomes Procedural Success 94% 97% .02 Adverse Events 13.1% 5.0% <.001 Hospital Outcomes 30 Day Mortality 8.9% 4.8% .02 Peak CK(U/L) 2,790 1,328 <.001 LV Function Acute EF 51.6% 54.3% .05 6 Month EF 54.9% 59.2% .004 Brodie AJC 2000; 25:13

  50. Late Survival in Patients with Open vs Closed Artery on Arrival to Cath Lab TIMI 2-3 TIMI 0-1 Survival % p=0.009 Years Brodie AJC 2000;25:13

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