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Welcome Ask The Experts March 24-27, 2007

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Welcome Ask The Experts March 24-27, 2007

  1. 1. <ul><li>Welcome </li></ul><ul><li>Ask The Experts </li></ul><ul><li>March 24-27, 2007 </li></ul><ul><li>New Orleans, LA </li></ul>
  2. 2. Incorporating Patient Risk into Decisions Regarding the Optimal Reperfusion Strategy for ST Elevation MI Duane S. Pinto, MD Assistant Professor of Medicine Harvard Medical School Director, Cardiology Fellowship Training Program Beth Israel Deaconess Medical Center Boston, MA
  3. 3. PAMI (Grines et al. N Engl J Med 1993;328:673)
  4. 4. GUSTO IIb  29% (N Engl J Med 1997; 336: 1621)
  5. 5. PCI vs Fibrinolysis for STEMI: Short Term Clinical Outcomes PCI Frequency (%) P=0.0002 P=0.0003 P < 0.0001 P < 0.0001 P < 0.0001 P=0.0004 P=0.032 P < 0.0001 Death Death, no SHOCK data ReMI Rec. Ischemia Total Stroke Hem. Stroke Major Bleed Death MI CVA Fibrinolysis N = 7739 Keeley E. et al., Lancet 2003; 361:13-20.
  6. 6. Importance of Rapid Time to Treatment With Fibrinolysis in STEMI Time from onset of symptoms to treatment (hours) Absolute % difference in mortality at 35 days 3.5%  2.5%  1.8%   1.6%  0.5%  0.0 1.0 3.0 2.0 4.0 0 – 1 2 – 3 4 – 6 7 – 12 12 – 24 The Fibrinolytics Therapy Trialists’ collaborative group. Lancet . 1994; 343:311.
  7. 7. NRMI 2: Primary PCI Door-to-Balloon Time vs. Mortality Door-to-Balloon Time (minutes) MV Adjusted Odds of Death P=0.01 P=0.0007 P=0.0003 n = 2,230 5,734 6,616 4,461 2,627 5,412 Cannon CP, JAMA 2000
  8. 8. Symptom – balloon inflation (min) One-year mortality, % 6 RCTs of Primary PCI by Zwolle Group 1994 – 2001 N = 1791 RR = 1.08 for each 30 min delay ( P = 0.04) P < 0.0001 12 10 8 6 4 2 0 0 60 120 180 240 300 360 Symptom Onset-Balloon Time and Mortality in Primary PCI for STEMI DeLuca, Suryapranata, Circ 109:1223, 2004 The relative risk of 1-year mortality increases by 7.5% for each 30-minute delay
  9. 9. Time from Symptom Onset to Treatment Predicts One-year Mortality with PCI p = 0.006 <2 hrs 2-4 hrs 4-6 hrs p = 0.02 De Luca at al, JACC 2003 >6 hrs All Patients Low-Risk p = NS High-Risk
  10. 10. PCI-Related Time Delay vs Mortality Benefit in 22 Randomized Studies of PCI vs Fibrinolytic Therapy Nallamothu and Bates, AJC 2003 23 RCTs For every 10 min delay to PCI: 1 % reduction in Mortality Difference Between PCI & Lysis N= 7419 p=0.006
  11. 11. PCI-Related Time Delay vs Mortality Benefit in 21 Randomized Studies of PCI vs Fibrinolytic Therapy Betriu A, Massotti M. Am J Cardiol. 2005. 100-101 21 RCTs For every 10 min delay to PCI: 0.24 % reduction in Mortality Difference Between PCI & Lysis N= 7350
  12. 12. PCAT-2 Analysis <ul><li>Patient level data included in analysis of 22 trials (n=6,763) </li></ul><ul><li>PPCI was associated with a </li></ul><ul><ul><ul><li>67% reduction in odds of death at 30 days if PCI related delay was <35 minutes </li></ul></ul></ul><ul><ul><ul><li>Only 28% if >35 minutes (p=0.004) </li></ul></ul></ul>Boersma E. EHJ. 2006; 27: 779-788.
  13. 13. Advantage of PCI Compared With Fibrinolysis Decreases as PCI-Related Delay Increases Pinto DS, et al. Circulation . 2006;114:2019-2025. *Betriu A. Am J Cardiol. 2005; 95:100-101. Odds of Death With Fibrinolysis PCI-Related Delay (door-to-balloon–door-to-needle time), min PCI Better Fibrinolysis Better 2.0 1.5 1.25 1.0 0.8 0.5 60 75 90 105 114 135 150 165 180 Randomized Studies*
  14. 14. PCI Related Delay (DB-DN) Where PCI and Fibrinolytic Mortality Are Equal (Min) Stratified by Patient Characteristics PCI Related Delay (DB-DN) (Min) 68,716 123,793 125,737 66,772 69,331 123,178 115,293 77,141 192,509 <120 120+ ANT NonAnt 65+ <65 Prehospital Delay (min) Infarct Location Age (years) All Patients P<0.05 for all 2 way comparisons Pinto DS, et al. Circulation . 2006;114:2019-2025.
  15. 15. Meta-analysis of Transfer for PCI vs. Fibrinolysis Dalby M, et al. Circ 2003; 1809 2% beneficial survival rate with PPCI with PCI related time delay of 65 minutes
  16. 16. DANAMI-2: Primary Results Death/MI/Stroke (%) Lytic Primary PCI P =0.0003 Combined 0 4 12 16 8 14 8 RRR 45% Lytic Primary PCI P =0.002 Transfer Sites 0 4 12 16 8 14 9 RRR 40% Lytic Primary PCI P =0.048 Non-Transfer Sites 0 4 12 16 8 7 12 RRR 45%
  17. 17. Transportation= 32 min DANAMI-2 Invasive Referral Invasive Referral Minutes Hospitals Fibrinolysis PCI 26 min 0 60 120 180 240 Door-to-balloon Door-to-needle Door-to-balloon In-door-out-door Prehospital Prehospital Prehospital Door-to-needle Prehospital ↑ Randomization-balloon = 90 min Door-balloon = 93 min 45 min 50 min
  18. 18. Maybe Our Systems Are Not Completely Optimized in the US!
  19. 19. DANAMI vs US AMI: Are We As Quick in the US? Pinto DS, et al. Cardiovascular Reviews and Report. 2003;24:267-276. 0 Median Time (min) DANAMI On-Site Primary PCI DANAMI Transfer Primary PCI US AMI Transfer Primary PCI 90 110 185 50 100 150 200 225 25 75 125 175
  20. 20. Times in Randomized Trials vs. the “Real World” BK Nallamothu, ER Bates, HM Krumholz, et al. Circulation 2005; 761 Median Door to Balloon Time: 180 min Median Door to Door (Transfer) Time: 120 Min Median PCI Hospital DB time: 53 Min <5% of patients had Total DB time <90 Min if a transfer was involved Compare this to the randomized studies with: Total DB times of 90 min , Transport times of 30 min , and PCI hospital DB times of 25 min
  21. 21. PCI-Related Time Delay vs Mortality Benefit in 22 Randomized Studies of PCI vs Fibrinolytic Therapy Nallamothu and Bates, AJC 2003 23 RCTs For every 10 min delay to PCI: 1 % reduction in Mortality Difference Between PCI & Lysis N= 7419 p=0.006 DANAMI: on site PCI 90 DB – 50 DN = 40 min delay DANAMI: with transfer 110 DB – 50 DN = 60 min delay “ USA AMI” with transfer: 171 DB – 32 DN = 139 min delay
  22. 22. Prehospital Delay & Timing of Reperfusion Strategy Equivalence PCI Related Delay (DB-DN) Where PCI and Fibrinolytic Mortality Are Equal (Min) Prehospital Delay (min) 19,517 5,296 9,812 41,774 16,119 20,424 10,614 3,739
  23. 23. Gersh, B. J. et al. JAMA 2005;293:979-986. Hypothetical Construct of the Relationship Among the Duration of Symptoms of Acute MI Before Reperfusion Therapy, Mortality Reduction, and Extent of Myocardial Salvage
  24. 24. One Size Does Not Fit All!
  25. 25. Summary <ul><li>Simple rules: </li></ul><ul><ul><li>DB<90 min </li></ul></ul><ul><ul><li>DB-DN <60 min </li></ul></ul><ul><ul><li>DN <30 min </li></ul></ul><ul><ul><li>Transfer all for PCI, etc </li></ul></ul><ul><li>are not enough to determine the optimal reperfusion strategy for all patients in all situations </li></ul>
  26. 26. Summary <ul><li>The clinician must integrate: </li></ul><ul><ul><li>Prehospital Delay </li></ul></ul><ul><ul><li>Anticipated STEMI Risk (age, anterior, inferior, shock) </li></ul></ul><ul><ul><li>Anticipated Risk for ICH </li></ul></ul><ul><ul><li>Anticipated Transfer time/PCI related delay </li></ul></ul>
  27. 27. Summary <ul><li>Fibrinolysis is not unreasonable when </li></ul><ul><ul><li>PCI associated with unacceptable delay (Class I) </li></ul></ul><ul><ul><li>Short time from symptom onset (<1 hr) (Class I) </li></ul></ul><ul><li>Primary PCI is superior to Fibrinolysis in several clinical situations, particularly if: </li></ul><ul><ul><li>Competent personnel involved </li></ul></ul><ul><ul><li>DB times are <90 Min, PCI related Delay Acceptable </li></ul></ul><ul><ul><li>High Risk for Bleeding or Complication from MI </li></ul></ul><ul><ul><li>Late Presentation </li></ul></ul>
  28. 28. Summary <ul><li>The benefits and limitations of Primary PCI should be considered when developing regionalized transfer and community based PCI systems </li></ul><ul><li>Continued work is needed to develop pharmacologic strategies to rapidly, effectively, and safely open closed arteries thereby extending the benefit of PCI to a larger group of patients </li></ul>
  29. 29. <ul><li>Question </li></ul><ul><li>& </li></ul><ul><li>Answer </li></ul>
  30. 30. <ul><li>Thank You! </li></ul><ul><li>Please make sure to hand in your evaluation and pick up a ClinicalTrialResults.org flash drive </li></ul>

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