Fibrinolysis or Primary PCI: Fibrinolysis or Primary PCI:

Does “One Size Fits All” for AcuteDoes “One Size Fits All” for Acute

Myocardial Infarction Patients?Myocardial Infarction Patients?

Luiz Alberto MattosLuiz Alberto MattosInstituto Dante Pazzanese de CardiologiaInstituto Dante Pazzanese de Cardiologia

Sao Paulo, Brazil Sao Paulo, Brazil

Fibrinolysis or Primary PCI: Fibrinolysis or Primary PCI:

Does “One Size Fits All” for AcuteDoes “One Size Fits All” for Acute

Myocardial Infarction Patients?Myocardial Infarction Patients?

Luiz Alberto MattosLuiz Alberto MattosInstituto Dante Pazzanese de CardiologiaInstituto Dante Pazzanese de Cardiologia

Sao Paulo, Brazil Sao Paulo, Brazil

Reperfusion for Acute Myocardial Reperfusion for Acute Myocardial InfarcInfarction tion

Primary PCI is the “Gold-Standard” TreatmentPrimary PCI is the “Gold-Standard” Treatment

Circulation, November 14 Th, 2006 Circulation, November 14 Th, 2006

Time Delay forPrimary PCI

Time Delay forPrimary PCI < 90 minutes< 90 minutes > 90 minutes> 90 minutes

00

100%100%

50%50%

Gradient of Benefit: Primary PCI vs. Lytics

30 day Mortality – Summary from RCT’s

Gradient of Benefit: Primary PCI vs. Lytics

30 day Mortality – Summary from RCT’s

47% vs STK47% vs STK

24% vs Transfer24% vs Transfer

25%25%

75%75%

30% vs TNK30% vs TNK38% vs Lytic(>70-<80 yrs)

38% vs Lytic(>70-<80 yrs)

TIMI-3 Flow

TIMI-3 Flow

Reperfusion Therapy Evolution Reperfusion Therapy Evolution July 1999 / December 2005 – GRACE RegistryJuly 1999 / December 2005 – GRACE Registry

JAMA 2007;297:1894JAMA 2007;297:1894

Reperfusion in Latin America

Reperfusion for Acute MI (STEMI)Reperfusion for Acute MI (STEMI)Geographical Variances of TherapeuticsGeographical Variances of Therapeutics Global Registry of Acute Coronary Events (GRACE) Global Registry of Acute Coronary Events (GRACE)

Reperfusion for Acute MI (STEMI)Reperfusion for Acute MI (STEMI)Geographical Variances of TherapeuticsGeographical Variances of Therapeutics Global Registry of Acute Coronary Events (GRACE) Global Registry of Acute Coronary Events (GRACE)

94 Hospitals in 14 Countries94 Hospitals in 14 Countries Eagle KA, Lancet, February 2, 2002Eagle KA, Lancet, February 2, 2002

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

Predictors of “No Reperfusion” Strategy Predictors of “No Reperfusion” Strategy

Myocardial Reperfusion StrategiesMyocardial Reperfusion Strategies

Primary PCI versus Fibrinolysis

Variable Limitation Benefit

Accessibility

Restricted Broad

Delay for reperfusion

Higher for arriving Reduced to obtain

Reduced to arriving Higher to obtain

Failure of Reperfusion

No-flow still is a challenging scenario

Rescue PCI

Future Directions for Primary PCIFuture Directions for Primary PCI Which Will Be The Next Steps?Which Will Be The Next Steps?

MI ST SegmentElevation

MI ST SegmentElevation

Logistics Improvements Reducing PCI Delay

Transferring Acute MI Units Facilitated PCI

Pre-Hospital Lytics

Logistics Improvements Reducing PCI Delay

Transferring Acute MI Units Facilitated PCI

Pre-Hospital Lytics

Quality of Reperfusion Antiplatelets Agents

Clopidogrel Rheolytic (Aspiration)

Adenosine DES Usage

Quality of Reperfusion Antiplatelets Agents

Clopidogrel Rheolytic (Aspiration)

Adenosine DES Usage

Pre

Pre

During

During

1.1. Optimizing Logistical Intake – MI Hubs Optimizing Logistical Intake – MI Hubs

Multidisciplinary Approach ProtocolsMultidisciplinary Approach Protocols

2.2. Speed Up Admittance and TransferSpeed Up Admittance and Transfer

Better Quality-of-Care ProcessBetter Quality-of-Care Process

3-Challenging Priorities for 3-Challenging Priorities for Primary Coronary InterventionPrimary Coronary Intervention

www.d2balliance.org

D2B Alliance is a vehicle to disseminate knowledge and

promote improvement

More than 1,000 hospitalsjoined the effort

Recommended Strategy* Baseline Follow-up

EM activation 52% 60%Single call 31% 37%Cath team < 30 min 81% 89%Prompt data feedback 61% 79%Activate from PH ECG 33% 41%D2B Team 64% 85%

* All differences are significant P< 0.001

The Use of Strategies Changedin D2B Alliance Hospitals

Harvard Medical School

Several Key Several Key Strategies Were IdentifiedStrategies Were Identified

Several Key Several Key Strategies Were IdentifiedStrategies Were Identified

How to Optimize Reperfusion in Acute MIHow to Optimize Reperfusion in Acute MI

ProblemProblemProblemProblem SolutionSolutionSolutionSolution

Longer Delay for PresentationLonger Delay for Presentation(symptom onset to presentation)(symptom onset to presentation)

Longer Delay for PresentationLonger Delay for Presentation(symptom onset to presentation)(symptom onset to presentation)

Large Midia Large Midia EducationEducation

Large Midia Large Midia EducationEducation

Delay for TransportationDelay for Transportation(reception and guiding)(reception and guiding)

Delay for TransportationDelay for Transportation(reception and guiding)(reception and guiding)

Logistical Logistical ProtocolsProtocolsLogistical Logistical ProtocolsProtocols

Delay for TreatmentDelay for Treatment(either lytics or PCI)(either lytics or PCI)

Delay for TreatmentDelay for Treatment(either lytics or PCI)(either lytics or PCI)

In-Hospital In-Hospital Quality of Quality of

CareCare

In-Hospital In-Hospital Quality of Quality of

CareCare

1.1. Optimizing Logistical Intake – MI Hubs Optimizing Logistical Intake – MI Hubs

Multidisciplinary Approach ProtocolsMultidisciplinary Approach Protocols

Brazilian Scenario – Primary PCIBrazilian Scenario – Primary PCI

2.2. Speed Up Admittance and TransferSpeed Up Admittance and Transfer

Better Quality-of-Care ProcessBetter Quality-of-Care Process

3-Challenging Priorities for 3-Challenging Priorities for Primary Coronary InterventionPrimary Coronary Intervention

1)1) 33 years in Brazil, from diagnostic 33 years in Brazil, from diagnostic

to interventional cardiology to interventional cardiology

(1975-2008) – (1975-2008) – www.sbhci.org.br

2)2) Gather nearly 1,000 interventional Gather nearly 1,000 interventional

cardiologists spread in 26 of 27 cardiologists spread in 26 of 27

federative statesfederative states

3)3) Strongly committed to board Strongly committed to board

certification, medical education and certification, medical education and

quality of care in clinical practicequality of care in clinical practice

4)4) Open elections each 2-year periodOpen elections each 2-year period

5)5) Annual Scientific Meeting since Annual Scientific Meeting since

1976, that receive up to 1,000 health 1976, that receive up to 1,000 health

professionals professionals

SBHCI – Brazilian Society SBHCI – Brazilian Society of Interventional Cardiologyof Interventional Cardiology

200 million people 70.000 PCI’s year =

0,3/1,000 <30% DES Usage

Brazilian SAMU Emergency 192 SystemBrazilian SAMU Emergency 192 System

www.datasus.gov.brwww.datasus.gov.brwww.datasus.gov.brwww.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)

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 MIReperfusion for Acute MIExpediting the Triage Process for the Treatment 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

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 InterventionPercutaneous Coronary InterventionBrazil State-Owned Health System 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 (excl. AMI)

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 (4,2%/PPCI)

48,749(11,1%/ PPCI)

47,024 (14,1%/PPCI)

45,505 (16,5%/PPCI)

51,350 (14,9%/PPCI)

Mortality 16,4% 16,1% 15,9% 15,1% 15,9%

www.datasus.gov.brwww.datasus.gov.brwww.datasus.gov.brwww.datasus.gov.br

1.1. Optimizing Logistical Intake – MI Hubs Optimizing Logistical Intake – MI Hubs

Multidisciplinary Approach ProtocolsMultidisciplinary Approach Protocols

2.2. Speed Up Admittance and TransferSpeed Up Admittance and Transfer

Better Quality-of-Care ProcessBetter Quality-of-Care Process

3.3. Increase Operator ExpertiseIncrease Operator Expertise

Continuous Medical Education Continuous Medical Education

3-Challenging Priorities for 3-Challenging Priorities for Primary Coronary InterventionPrimary Coronary Intervention

Primary PCI in BrazilPrimary PCI in BrazilSouth (RGS) vs. Other States South (RGS) vs. Other States

AIH’s – Year 2005 2006 2007RS 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 (6,7%-ICP)

48,749 4,612 (13,8%-ICP)

47,024 4,604 (20,3%-ICP)

45,505

Mortality 17,8% 16,1% 17,4% 15,9% 17,8% 16,1%

Primary PCI in BrazilPrimary PCI in BrazilRio de Janeiro vs. Sao Paulo State 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 Continuous Update for Primary PCI Improving Operator Experience Improving Operator Experience

Logistic and Pharmacological Enforces UpdateLogistic and Pharmacological Enforces Update Clopidogrel and beyondClopidogrel and beyond

Bivalirudin and IIb/IIIa Inhibitors Bivalirudin and IIb/IIIa Inhibitors

Mechanical and Intra-Procedural StrategiesMechanical and Intra-Procedural Strategies Direct Stenting: DES or BMSDirect Stenting: DES or BMS

To aspirate or not aspirate all culprit AMI vessels To aspirate or not aspirate all culprit AMI vessels

Rheolytic strategiesRheolytic strategies

No/Slow Flow ProphylaxisNo/Slow Flow Prophylaxis

Increase the Number of MI Diagnosed and Treated

Optimizing The Challenge of Reperfusion in AMIOptimizing The Challenge of Reperfusion in AMI

Higher Rate ofTIMI-3 Flow for the

Culprit Vessel

Primary PercutaneousCoronary Intervention

FibrinolysisBroad Spectrum

of Treatment

Optimize MI Primary Care Units

Immediate MI ConfirmationSelection for Transferring and Rescue

Aspirin, Clopidogrel and Heparin(?) Facilitate Reperfusion (r-tpa & tnk)

Increase MI Diagnose and Reperfusion

Reduce Time to Balloon

Estratégias de Reperfusão no IAM ST SupraEstratégias de Reperfusão no IAM ST Supra

STEMI <12 hrs of Symptom OnsetSTEMI <12 hrs of Symptom OnsetSTEMI <12 hrs of Symptom OnsetSTEMI <12 hrs of Symptom Onset

On-Site Invasive CardiologyOn-Site Invasive CardiologyOn-Site Invasive CardiologyOn-Site Invasive Cardiology

Primary PCIPrimary PCIPrimary PCIPrimary PCI

Primary Care FacilityPrimary Care Facility

Transfer FeasibleTransfer FeasibleTransfer FeasibleTransfer Feasible

YesYesYesYes NoNo

LyticLytic

FailureFailure SuccessSuccessSuccessSuccess

PCIPCI <24-72 hrs<24-72 hrs

PCIPCI <24-72 hrs<24-72 hrs

Rescue Rescue PCIPCI

Rescue Rescue PCIPCI

Tran

sfer

Tran

sfer

D2bal

loon

<2

hrs

D2bal

loon

<2

hrs

Pain Duration

>2 hrs

Pain Duration

>2 hrs

NoNoNoNo

Pain Duration

<2 hrs

Pain Duration

<2 hrs

FTT (meta-analysis 9 RCT’s; n= 58,600): FibrinolyticsFTT (meta-analysis 9 RCT’s; n= 58,600): Fibrinolytics

Lancet 1994343:311

Lancet 1994343:311

p<0,01 p<0,01p<0,01 p<0,01 p=NS

Lifes Saved/1000

Lifes Saved/1000 3939 3030 2727 2121 77

Myocardial Reperfusion and Delay for LyticMyocardial Reperfusion and Delay for Lytic30-day Mortality30-day Mortality

Selecting the Best Reperfusion Strategy Selecting the Best Reperfusion Strategy Fibrinolysis and Primary PCIFibrinolysis and Primary PCI

Fibrinolysis is not unreasonable when:Fibrinolysis is not unreasonable when: PCI associated with unacceptable delay (Class I)PCI associated with unacceptable delay (Class I)

Short time from symptom onset (<2 hr) (Class I) with anticipated Short time from symptom onset (<2 hr) (Class I) with anticipated

door-to-balloon >2 hoursdoor-to-balloon >2 hours

Primary PCI is superior to Fibrinolysis in several Primary PCI is superior to Fibrinolysis in several clinical situations, particularly if:clinical situations, particularly if:

Competent personnel involvedCompetent personnel involved

DB times are <90 Min, PCI related Delay AcceptableDB times are <90 Min, PCI related Delay Acceptable

High Risk for Bleeding or Complication from MIHigh Risk for Bleeding or Complication from MI

Late PresentationLate Presentation

Selecting the Best Reperfusion Strategy Selecting the Best Reperfusion Strategy Fibrinolysis and Primary PCIFibrinolysis and Primary PCI

“ “ One Size, Definitely, One Size, Definitely,

Does Not Fit for All AMI’s… Does Not Fit for All AMI’s…

Logistics Sinergy is the way”Logistics Sinergy is the way”

The “Patient Size” Will Always Be #...The “Patient Size” Will Always Be #...Joint Efforts Are Mandatory !! Joint Efforts Are Mandatory !!

Rio de Janeiro, March 7 Th 2008

www.sbhci.org.br

Rio de Janeiro, March 7 Th 2008

www.sbhci.org.br

Reperfusão no Infarto do MiocárdioReperfusão no Infarto do MiocárdioSelecionando A Melhor EstratégiaSelecionando A Melhor Estratégia