Fibrinolysis or Primary PCI: Does “One Size Fits All” for Acute Myocardial Infarction Patients? Luiz Alberto Mattos Instituto Dante Pazzanese de Cardiologia Sao Paulo, Brazil Reperfusion for Acute Myocardial Infarction Primary PCI is the “Gold-Standard” Treatment Circulation, November 14 Th, 2006 TIMI-3 Flow 100% Gradient of Benefit: Primary PCI vs. Lytics 30 day Mortality – Summary from RCT’s 75% 50% 47% vs STK 38% vs Lytic (>70-<80 yrs) 30% vs TNK 25% 24% vs Transfer 0 Time Delay for Primary PCI < 90 minutes > 90 minutes Reperfusion Therapy Evolution July 1999 / December 2005 – GRACE Registry JAMA 2007;297:1894 Reperfusion in Latin America Reperfusion for Acute MI (STEMI) Geographical Variances of Therapeutics Global Registry of Acute Coronary Events (GRACE) Predictors of “No Reperfusion” Strategy 94 Hospitals in 14 Countries Variable Odds Ratio p Age >75 yrs 2.28 (1,35-3,87) <0,001 No More Pain 3.23 (2,13-4,89) <0,001 Diabetics 1.46 (1,11-1,94) 0,001 Heart Failure 2.92 (1,84-4,67) <0,001 Previous CABG 2.28 (1,35-3,87) <0,001 Eagle KA, Lancet, February 2, 2002 Myocardial Reperfusion Strategies Primary PCI versus Fibrinolysis Variable Accessibility Delay for reperfusion Limitation Benefit Restricted Broad Higher for arriving Reduced to arriving Reduced to obtain Higher to obtain Failure of No-flow still is a Rescue PCI Reperfusion challenging scenario Future Directions for Primary PCI Which Will Be The Next Steps? MI ST Segment Elevation Logistics Improvements Reducing PCI Delay Transferring Acute MI Units Facilitated PCI Pre-Hospital Lytics Quality of Reperfusion Antiplatelets Agents Clopidogrel Rheolytic (Aspiration) Adenosine During DES Usage Pre 3-Challenging Priorities for Primary Coronary Intervention 1. Optimizing Logistical Intake – MI Hubs Multidisciplinary Approach Protocols 2. Speed Up Admittance and Transfer Better Quality-of-Care Process D2B Alliance is a vehicle to disseminate knowledge and promote improvement www.d2balliance.org More than 1,000 hospitals joined the effort The Use of Strategies Changed in D2B Alliance Hospitals Recommended Strategy* Baseline Follow-up EM activation Single call Cath team < 30 min Prompt data feedback Activate from PH ECG D2B Team 52% 31% 81% 61% 33% 64% 60% 37% 89% 79% 41% 85% * All differences are significant P< 0.001 Several Key Strategies Were Identified Harvard Medical School How to Optimize Reperfusion in Acute MI Problem Solution Longer Delay for Presentation Large Midia Education (symptom onset to presentation) Delay for Transportation (reception and guiding) Delay for Treatment (either lytics or PCI) Logistical Protocols In-Hospital Quality of Care 3-Challenging Priorities for Primary Coronary Intervention 1. Optimizing Logistical Intake – MI Hubs Multidisciplinary Approach Protocols Brazilian Scenario – Primary PCI 2. Speed Up Admittance and Transfer Better Quality-of-Care Process SBHCI – Brazilian Society of Interventional Cardiology 1) 33 years in Brazil, from diagnostic to interventional cardiology (1975-2008) – www.sbhci.org.br 2) Gather nearly 1,000 interventional cardiologists spread in 26 of 27 federative states 3) Strongly committed to board certification, medical education and quality of care in clinical practice 4) Open elections each 2-year period 200 million people 70.000 PCI’s year = 0,3/1,000 <30% DES Usage 5) Annual Scientific Meeting since 1976, that receive up to 1,000 health professionals Brazilian SAMU Emergency 192 System www.datasus.gov.br SAMU (Serviço de Atendimento Móvel de Urgência) Reintrodução no SUS Brasileiro – Abril de 2004 Disque 192 – Atendimento em até 12 minutos 452 ambulâncias UTI já entregues Sistema de Gestão Pública Mista 146 cidades atendidas = >100 milhões de pessoas 32 centrais telefônicas com médicos 24 horas Investimento inicial de 297 milhões de reais (150 milhões de dólares americanos) Reperfusion for Acute MI Expediting the Triage Process for the Treatment 1. EMS prompt activation of Invasive Cardiology Group 2. “Singe-call” activation of all professionals involved 3. Invasive Cardiology set-up in average of 30 minutes 4. Constant feed-back review of time to treatment and quality-of-care of the system 5. Central and Respected Managing 6. Multidisciplinary team effort 7. Pre hospital EKG analysis for speed up the process Percutaneous Coronary Intervention Brazil State-Owned Health System Year 2004 2005 2006 2007 2008 Total of PCI’s 16,484 35,880 41,730 43,210 46,266 Total of Stents 15,336 (93,0%) 33,739 (94,0%) 39,563 (94,8%) 41,144 (95,25) 44,123 (95,3%) Mortality 1,0% 1,0% 0,9% 1,1% 1,4% Total of Primary PCI 1,901 (11,7%) 5,400 (15,1%) 6,605 (15,8%) 7,551 (17,4%) 7,648 (16,5%) Mortality 7,9% 6,6% 6,9% 7,4% 6,7% Total of MI 45,023 48,749 47,024 45,505 51,350 (16,5%/PPCI) (14,9%/PPCI) 15,1% 15,9% (excl. AMI) (4,2%/PPCI) Mortality 16,4% (11,1%/ PPCI) (14,1%/PPCI) 16,1% 15,9% www.datasus.gov.br 3-Challenging Priorities for Primary Coronary Intervention 1. Optimizing Logistical Intake – MI Hubs Multidisciplinary Approach Protocols 2. Speed Up Admittance and Transfer Better Quality-of-Care Process 3. Increase Operator Expertise Continuous Medical Education Primary PCI in Brazil South (RGS) vs. Other States AIH’s – Year 2005 2006 2007 RS Brazil RS Brazil RS Brazil Total PCI’s 5,656 35,880 6,633 41,730 6,963 43,210 Mortality 1,1% 1,0% 0,8 0,9% 1,0 1,1% Total Primary PCI’s 296 (5,2%) 5,400 (15,1%) 637 (9.6%) 6,605 (15,8%) 936 (13,4%) 7,551 (17,4%) Mortality 11,1% 6,6% 6,1% 6,9% 7,8% 7,4% All Acute MI’s 4,422 48,749 4,612 47,024 4,604 45,505 (6,7%-ICP) Mortality 17,8% (13,8%-ICP) 16,1% 17,4% (20,3%-ICP) 15,9% 17,8% 16,1% Primary PCI in Brazil Rio de Janeiro vs. Sao Paulo State AIH’s – Year 2005 2006 2007 RJ SP RJ SP RJ SP Total Acute MI’s 5,039 13,072 5,389 13,937 5,663 14,241 Mortality 16,2% 16,9% 15,7% 15,9% 16,7% 16,1% Total Primary PCI 58 2,272 80 2,371 60 2,544 Mortality 6,9% 6,0% 12,5% 5,6% 20,0% 6,4% Continuous Update for Primary PCI Improving Operator Experience Logistic and Pharmacological Enforces Update Clopidogrel and beyond Bivalirudin and IIb/IIIa Inhibitors Mechanical and Intra-Procedural Strategies Direct Stenting: DES or BMS To aspirate or not aspirate all culprit AMI vessels Rheolytic strategies No/Slow Flow Prophylaxis Optimizing The Challenge of Reperfusion in AMI Increase the Number of MI Diagnosed and Treated Higher Rate of TIMI-3 Flow for the Culprit Vessel Primary Percutaneous Coronary Intervention Reduce Time to Balloon Optimize MI Primary Care Units Immediate MI Confirmation Selection for Transferring and Rescue Aspirin, Clopidogrel and Heparin (?) Facilitate Reperfusion (r-tpa & tnk) Increase MI Diagnose and Reperfusion Broad Spectrum of Treatment Fibrinolysis Estratégias de Reperfusão no IAM ST Supra STEMI <12 hrs of Symptom Onset Primary Care Facility On-Site Invasive Cardiology Transfer Feasible Yes No No Pain Duration <2 hrs Lytic Failure Primary PCI Pain Duration >2 hrs Rescue PCI Success PCI <24-72 hrs Myocardial Reperfusion and Delay for Lytic 30-day Mortality FTT (meta-analysis 9 RCT’s; n= 58,600): Fibrinolytics Lifes Saved/1000 p<0,01 p<0,01 p<0,01 p<0,01 39 30 27 21 p=NS 7 Lancet 1994 343:311 Selecting the Best Reperfusion Strategy Fibrinolysis and Primary PCI Fibrinolysis is not unreasonable when: PCI associated with unacceptable delay (Class I) Short time from symptom onset (<2 hr) (Class I) with anticipated door-to-balloon >2 hours 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 Selecting the Best Reperfusion Strategy Fibrinolysis and Primary PCI “ One Size, Definitely, Does Not Fit for All AMI’s… Logistics Sinergy is the way” The “Patient Size” Will Always Be #... Joint Efforts Are Mandatory !! Rio de Janeiro, March 7 Th 2008 www.sbhci.org.br Reperfusão no Infarto do Miocárdio Selecionando A Melhor Estratégia