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Welcome Ask The Experts March 24-27, 2007 New Orleans, LA

Welcome Ask The Experts March 24-27, 2007 New Orleans, LA.

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Welcome Ask The Experts March 24-27, 2007 New Orleans, LA

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  1. Welcome Ask The Experts March 24-27, 2007 New Orleans, LA

  2. Incorporating Patient Risk into Decisions Regarding the Optimal Reperfusion Strategy for ST Elevation MIDuane S. Pinto, MDAssistant Professor of Medicine Harvard Medical SchoolDirector, Cardiology Fellowship Training ProgramBeth Israel Deaconess Medical CenterBoston, MA

  3. PAMI (Grines et al. N Engl J Med 1993;328:673)

  4. GUSTO IIb 29% (N Engl J Med 1997; 336: 1621)

  5. PCI vs Fibrinolysis for STEMI:Short Term Clinical Outcomes PCI Fibrinolysis P < 0.0001 Frequency (%) P < 0.0001 P=0.0002 P=0.032 P=0.0003 P < 0.0001 P=0.0004 P < 0.0001 Hem.Stroke Death Death, no SHOCKdata ReMI Rec.Ischemia Total Stroke Major Bleed DeathMICVA N = 7739 Keeley E. et al., Lancet 2003; 361:13-20.

  6. Importance of Rapid Time to Treatment With Fibrinolysis in STEMI 4.0 3.5% ¯ 3.0 2.5% ¯ Absolute % difference in mortality at 35 days 2.0 1.8%¯ 1.6% ¯ 1.0 0.5% ¯ 0.0 0 – 1 2 – 3 4 – 6 7 – 12 12 – 24 Time from onset of symptoms to treatment (hours) The Fibrinolytics Therapy Trialists’ collaborative group. Lancet. 1994; 343:311.

  7. NRMI 2: Primary PCI Door-to-Balloon Time vs. Mortality P=0.01 P=0.0007 P=0.0003 MV Adjusted Odds of Death n = 2,230 6,616 4,461 2,627 5,412 5,734 Door-to-Balloon Time (minutes) Cannon CP, JAMA 2000

  8. Symptom Onset-Balloon Time and Mortality in Primary PCI for STEMI 6 RCTs of Primary PCI by Zwolle Group 1994 – 2001N = 1791 12 10 8 6 4 2 0 P < 0.0001 One-year mortality, % RR = 1.08 for each 30 min delay(P = 0.04) 0 60 120 180 240 300 360 Symptom – balloon inflation (min) The relative risk of 1-year mortality increases by 7.5% for each 30-minute delay DeLuca, Suryapranata, Circ 109:1223, 2004

  9. Time from Symptom Onset to TreatmentPredicts One-year Mortality with PCI 4-6 hrs >6 hrs 2-4 hrs <2 hrs p = 0.006 p = NS p = 0.02 All Patients Low-Risk High-Risk De Luca at al, JACC 2003

  10. PCI-Related Time Delay vs Mortality Benefitin 22 Randomized Studies of PCI vs Fibrinolytic Therapy For every 10 min delay to PCI: 1 % reduction in Mortality Difference Between PCI & Lysis 23 RCTs N= 7419 p=0.006 Nallamothu and Bates, AJC 2003

  11. PCI-Related Time Delay vs Mortality Benefitin 21 Randomized Studies of PCI vs Fibrinolytic Therapy For every 10 min delay to PCI: 0.24 % reduction in Mortality Difference Between PCI & Lysis 21 RCTs N= 7350 Betriu A, Massotti M. Am J Cardiol. 2005. 100-101

  12. PCAT-2 Analysis • Patient level data included in analysis of 22 trials (n=6,763) • PPCI was associated with a • 67% reduction in odds of death at 30 days if PCI related delay was <35 minutes • Only 28% if >35 minutes (p=0.004) Boersma E. EHJ. 2006; 27: 779-788.

  13. Randomized Studies* Advantage of PCI Compared With Fibrinolysis Decreases as PCI-Related Delay Increases 2.0 Odds of Death With Fibrinolysis 1.5 PCI Better 1.25 1.0 0.8 Fibrinolysis Better 0.5 114 135 60 75 90 150 165 180 105 PCI-Related Delay (door-to-balloon–door-to-needle time), min Pinto DS, et al. Circulation. 2006;114:2019-2025. *Betriu A. Am J Cardiol. 2005; 95:100-101.

  14. PCI Related Delay (DB-DN) Where PCI and Fibrinolytic Mortality Are Equal (Min)Stratified by Patient Characteristics Prehospital Delay (min) Infarct Location Age (years) All Patients P<0.05 for all 2 way comparisons PCI Related Delay (DB-DN) (Min) <120 120+ ANT NonAnt 65+ <65 125,737 66,772 69,331 123,178 77,141 68,716 115,293 123,793 192,509 Pinto DS, et al. Circulation. 2006;114:2019-2025.

  15. Meta-analysis of Transfer for PCI vs. Fibrinolysis 2% beneficial survival rate with PPCI with PCI related time delay of 65 minutes Dalby M, et al. Circ 2003; 1809

  16. DANAMI-2: Primary Results Combined Transfer Sites Non-Transfer Sites P=0.0003 P=0.002 P=0.048 16 16 16 14 14 RRR45% RRR40% 12 12 12 12 RRR45% 9 8 Death/MI/Stroke (%) 8 8 8 7 4 4 4 0 0 0 Lytic Primary PCI Lytic Primary PCI Lytic Primary PCI

  17. DANAMI-2 Hospitals 45 min Prehospital Door-to-needle Referral Fibrinolysis 50 min 26 min Prehospital Door-to-needle Invasive Transportation= 32 min Door-to-balloon Prehospital Referral In-door-out-door PCI ↑ Randomization-balloon = 90 min Door-to-balloon Prehospital Invasive Door-balloon = 93 min 0 60 120 180 240 Minutes

  18. Maybe Our Systems Are Not Completely Optimized in the US!

  19. DANAMI vs US AMI: Are We As Quick in the US? 225 200 185 175 150 125 110 Median Time (min) 90 100 75 50 25 0 DANAMI On-Site Primary PCI DANAMI Transfer Primary PCI US AMI Transfer Primary PCI Pinto DS, et al. Cardiovascular Reviews and Report. 2003;24:267-276.

  20. Times in Randomized Trials vs. the “Real World” 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 BK Nallamothu, ER Bates, HM Krumholz, et al. Circulation 2005; 761

  21. PCI-Related Time Delay vs Mortality Benefitin 22 Randomized Studies of PCI vs Fibrinolytic Therapy 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 For every 10 min delay to PCI: 1 % reduction in Mortality Difference Between PCI & Lysis 23 RCTs N= 7419 p=0.006 Nallamothu and Bates, AJC 2003

  22. Prehospital Delay & Timing of Reperfusion Strategy Equivalence 10,614 20,424 3,739 PCI Related Delay (DB-DN) Where PCI and Fibrinolytic Mortality Are Equal (Min) 16,119 9,812 5,296 41,774 19,517 Prehospital Delay (min)

  23. Hypothetical Construct of the Relationship Among the Duration of Symptoms of Acute MI Before Reperfusion Therapy, Mortality Reduction, and Extent of Myocardial Salvage Gersh, B. J. et al. JAMA 2005;293:979-986.

  24. One Size Does Not Fit All!

  25. Summary Simple rules: • DB<90 min • DB-DN <60 min • DN <30 min • Transfer all for PCI, etc are not enough to determine the optimal reperfusion strategy for all patients in all situations

  26. Summary • The clinician must integrate: • Prehospital Delay • Anticipated STEMI Risk (age, anterior, inferior, shock) • Anticipated Risk for ICH • Anticipated Transfer time/PCI related delay

  27. Summary • Fibrinolysis is not unreasonable when • PCI associated with unacceptable delay (Class I) • Short time from symptom onset (<1 hr) (Class I) • Primary PCI is superior to Fibrinolysis in several clinical situations, particularly if: • Competent personnel involved • DB times are <90 Min, PCI related Delay Acceptable • High Risk for Bleeding or Complication from MI • Late Presentation

  28. Summary • The benefits and limitations of Primary PCI should be considered when developing regionalized transfer and community based PCI systems • 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

  29. Question & Answer

  30. Thank You! Please make sure to hand in your evaluation and pick up a ClinicalTrialResults.org flash drive

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