acs web version

8/6/2019 ACS Web Version

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Charles V. Pollack Jr, MA, MD, FACEP, FAAEMCharles V. Pollack Jr, MA, MD, FACEP, FAAEM

Program ChairmanProgram ChairmanChairman, Department of Emergency MedicineChairman, Department of Emergency Medicine

Pennsylvania HospitalPennsylvania Hospital

Professor of Emergency MedicineProfessor of Emergency Medicine

University of PennsylvaniaUniversity of Pennsylvania

School of MedicineSchool of Medicine

Philadelphia, PennsylvaniaPhiladelphia, Pennsylvania








Cardiovascular EmergenciesCardiovascular EmergenciesNew Dimensions andNew Dimensions and

Critical Practice AdvancesCritical Practice Advances

Cardiovascular EmergenciesCardiovascular EmergenciesNew Dimensions andNew Dimensions and

Critical Practice AdvancesCritical Practice Advances

Evidence-Based Management of Acute Coronary Syndromes:Evidence-Based Management of Acute Coronary Syndromes:Optimizing Patient Outcomes in the Complex and Challenging SpherOptimizing Patient Outcomes in the Complex and Challenging Sphere

of Cardiovascular Emergency Careof Cardiovascular Emergency Care

Evidence-Based Management of Acute Coronary Syndromes:Evidence-Based Management of Acute Coronary Syndromes:Optimizing Patient Outcomes in the Complex and Challenging SphereOptimizing Patient Outcomes in the Complex and Challenging Sphere

of Cardiovascular Emergency Careof Cardiovascular Emergency Care

Getting in the Stream of ThingsGetting in the Stream of ThingsGetting in the Stream of ThingsGetting in the Stream of Things


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CME-accredited symposiumCME-accredited symposium jointly sponsored by the University ofjointly sponsored by the University ofMassachusetts Medical School and CMEducation Resources, LLCMassachusetts Medical School and CMEducation Resources, LLC

Commercial Support:Commercial Support: Sponsored by an independent educationalSponsored by an independent educational

grant from The Medicines Companygrant from The Medicines Company

Mission statement:Mission statement: Improve patient care through evidence-basedImprove patient care through evidence-based

education, expert analysis, and case study-based managementeducation, expert analysis, and case study-based management

Processes:Processes: Strives for fair balance and clinical relevance; stressesStrives for fair balance and clinical relevance; stresses

on-label indications for agents discussed, and emerging evidenceon-label indications for agents discussed, and emerging evidence

and information from recent studiesand information from recent studies

COI:COI: Full faculty disclosures provided in syllabus and at theFull faculty disclosures provided in syllabus and at the

beginning of the programbeginning of the program

Welcome and Program OverviewWelcome and Program Overview


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Program Educational ObjectivesProgram Educational ObjectivesProgram Educational ObjectivesProgram Educational Objectives

As a result of this session, emergency physicians will:As a result of this session, emergency physicians will:

Learn to identify signs, symptoms, and prognostic features of acuteLearn to identify signs, symptoms, and prognostic features of acute

coronary syndromes and related cardiovascular emergencies.coronary syndromes and related cardiovascular emergencies.

Learn to assess and implement optimal pharmacologicLearn to assess and implement optimal pharmacologic

interventions, especially antithrombotic therapy in the upstreaminterventions, especially antithrombotic therapy in the upstreamsetting, for patients presenting with manifestations of ACS andsetting, for patients presenting with manifestations of ACS and

related cardiovascular disease emergencies.related cardiovascular disease emergencies.

Learn to characterize, identify, and evaluate the safety, efficacy, andLearn to characterize, identify, and evaluate the safety, efficacy, and

side effects of myriad therapeutic options used for acute ischemicside effects of myriad therapeutic options used for acute ischemiccoronary syndromes including, aspirin, antiplatelet agents, directcoronary syndromes including, aspirin, antiplatelet agents, direct

thrombin inhibitors, UFH, LMWHs, and factor Xa inhibitors with athrombin inhibitors, UFH, LMWHs, and factor Xa inhibitors with a

focus on new 2007 ACC/AHA UA/NSTEMI Guidelinesfocus on new 2007 ACC/AHA UA/NSTEMI Guidelines

As a result of this session, emergency physicians will:As a result of this session, emergency physicians will:

Learn to identify signs, symptoms, and prognostic features of acuteLearn to identify signs, symptoms, and prognostic features of acute

coronary syndromes and related cardiovascular emergencies.coronary syndromes and related cardiovascular emergencies.

Learn to assess and implement optimal pharmacologicLearn to assess and implement optimal pharmacologic

interventions, especially antithrombotic therapy in the upstreaminterventions, especially antithrombotic therapy in the upstreamsetting, for patients presenting with manifestations of ACS andsetting, for patients presenting with manifestations of ACS and

related cardiovascular disease emergencies.related cardiovascular disease emergencies.

Learn to characterize, identify, and evaluate the safety, efficacy, andLearn to characterize, identify, and evaluate the safety, efficacy, and

side effects of myriad therapeutic options used for acute ischemicside effects of myriad therapeutic options used for acute ischemiccoronary syndromes including, aspirin, antiplatelet agents, directcoronary syndromes including, aspirin, antiplatelet agents, direct

thrombin inhibitors, UFH, LMWHs, and factor Xa inhibitors with athrombin inhibitors, UFH, LMWHs, and factor Xa inhibitors with a

focus on new 2007 ACC/AHA UA/NSTEMI Guidelinesfocus on new 2007 ACC/AHA UA/NSTEMI Guidelines


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Program FacultyProgram Faculty

Program ChairmanProgram Chairman

Charles V. Pollack Jr, MA,Charles V. Pollack Jr, MA,

MD, FACEP, FAAEMMD, FACEP, FAAEMChairman, Department ofChairman, Department of

Emergency MedicineEmergency MedicinePennsylvania HospitalPennsylvania Hospital


University of Pennsylvania SchoolUniversity of Pennsylvania School

of Medicineof Medicine


Program ChairmanProgram Chairman

Charles V. Pollack Jr, MA,Charles V. Pollack Jr, MA,

MD, FACEP, FAAEMMD, FACEP, FAAEMChairman, Department ofChairman, Department of

Emergency MedicineEmergency MedicinePennsylvania HospitalPennsylvania Hospital


University of Pennsylvania SchoolUniversity of Pennsylvania School

of Medicineof Medicine


Distinguished PresentersDistinguished Presenters

Judd E. Hollander, MDJudd E. Hollander, MDProfessor and Clinical Research DirectorProfessor and Clinical Research Director

Department of Emergency MedicineDepartment of Emergency Medicine



Sunil Rao, MD, FACCSunil Rao, MD, FACCDirector of Interventional CardiologyDirector of Interventional Cardiology

Veterans Administration Medical CenterVeterans Administration Medical CenterAssistant ProfessorAssistant Professor

Division of Cardiovascular MedicineDivision of Cardiovascular Medicine

Duke University Medical CenterDuke University Medical Center

Durham, North CarolinaDurham, North Carolina

Distinguished PresentersDistinguished Presenters





Sunil Rao, MD, FACCSunil Rao, MD, FACCDirector of Interventional CardiologyDirector of Interventional Cardiology

Veterans Administration Medical CenterVeterans Administration Medical CenterAssistant ProfessorAssistant Professor

Division of Cardiovascular MedicineDivision of Cardiovascular Medicine

Duke University Medical CenterDuke University Medical Center

Durham, North CarolinaDurham, North Carolina


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COI Faculty DisclosuresCOI Faculty Disclosures

Charles V. Pollack Jr, MA, MD, FACEP, FAAEMCharles V. Pollack Jr, MA, MD, FACEP, FAAEMGrant/Research Support: GlaxoSmithKlineConsultant: The Medicines Co., Schering-Plough, Sanofi-Aventis, BMS, GenentechSpeakers Bureau: Schering-Plough, Sanofi-Aventis, BMS, Genentech

Judd E. Hollander, MDJudd E. Hollander, MDGrant/Research Support: Sanofi-Aventis, Biosite, Scios, The Medicines CompanyGrant/Research Support: Sanofi-Aventis, Biosite, Scios, The Medicines Company

Consultant: Sanofi-Aventis, Biosite, Scios, The Medicines CompanyConsultant: Sanofi-Aventis, Biosite, Scios, The Medicines Company

Speakers Bureau: Sanofi-Aventis, Biosite, Scios, The Medicines CompanySpeakers Bureau: Sanofi-Aventis, Biosite, Scios, The Medicines Company

Sunil Rao, MD, FACCSunil Rao, MD, FACCGrant/Research Support: CordisGrant/Research Support: Cordis

Consultant: Sanofi-Aventis, The Medicines CompanyConsultant: Sanofi-Aventis, The Medicines Company

Speakers Bureau: Sanofi-Aventis, The Medicines Company, CordisSpeakers Bureau: Sanofi-Aventis, The Medicines Company, Cordis

Charles V. Pollack Jr, MA, MD, FACEP, FAAEMCharles V. Pollack Jr, MA, MD, FACEP, FAAEMGrant/Research Support: GlaxoSmithKlineConsultant: The Medicines Co., Schering-Plough, Sanofi-Aventis, BMS, GenentechSpeakers Bureau: Schering-Plough, Sanofi-Aventis, BMS, Genentech

Judd E. Hollander, MDJudd E. Hollander, MDGrant/Research Support: Sanofi-Aventis, Biosite, Scios, The Medicines CompanyGrant/Research Support: Sanofi-Aventis, Biosite, Scios, The Medicines Company

Consultant: Sanofi-Aventis, Biosite, Scios, The Medicines CompanyConsultant: Sanofi-Aventis, Biosite, Scios, The Medicines Company

Speakers Bureau: Sanofi-Aventis, Biosite, Scios, The Medicines CompanySpeakers Bureau: Sanofi-Aventis, Biosite, Scios, The Medicines Company

Sunil Rao, MD, FACCSunil Rao, MD, FACCGrant/Research Support: CordisGrant/Research Support: Cordis

Consultant: Sanofi-Aventis, The Medicines CompanyConsultant: Sanofi-Aventis, The Medicines Company

Speakers Bureau: Sanofi-Aventis, The Medicines Company, CordisSpeakers Bureau: Sanofi-Aventis, The Medicines Company, Cordis


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Acute Coronary SyndromeAcute Coronary SyndromeThe 2007 ACC/AHA UA/NSTEMI GuidelinesThe 2007 ACC/AHA UA/NSTEMI Guidelines

From the ED to CCU and Cath Lab From the ED to CCU and Cath Lab

Adherence Yields Better OutcomesAdherence Yields Better Outcomes

Acute Coronary SyndromeAcute Coronary SyndromeThe 2007 ACC/AHA UA/NSTEMI GuidelinesThe 2007 ACC/AHA UA/NSTEMI Guidelines

From the ED to CCU and Cath Lab From the ED to CCU and Cath Lab

Adherence Yields Better OutcomesAdherence Yields Better Outcomes








Getting in the (Up)Stream of ThingsGetting in the (Up)Stream of ThingsGetting in the (Up)Stream of ThingsGetting in the (Up)Stream of Things


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Changing the CalculationChanging the CalculationAssessing Adherence to GuidelinesAssessing Adherence to Guidelines

Changing the CalculationChanging the CalculationAssessing Adherence to GuidelinesAssessing Adherence to Guidelines

Anderson HV, Bach RG, J Am Coll Cardiol2005;46:1488-9.

We need to invert the current equationWe need to invert the current equation

to calculate an opportunity score for ACSto calculate an opportunity score for ACS

patients rather than a risk score. Patientspatients rather than a risk score. Patients

with higher baseline risks, such as thewith higher baseline risks, such as the

elderly, would have higher opportunityelderly, would have higher opportunity

scores for benefit, even allowing forscores for benefit, even allowing for

some of the greater risks from thesome of the greater risks from the

treatment.treatment.

We need to invert the current equationWe need to invert the current equation

to calculate an opportunity score for ACSto calculate an opportunity score for ACS

patients rather than a risk score. Patientspatients rather than a risk score. Patients

with higher baseline risks, such as thewith higher baseline risks, such as the

elderly, would have higher opportunityelderly, would have higher opportunity

scores for benefit, even allowing forscores for benefit, even allowing for

some of the greater risks from thesome of the greater risks from the

treatment.treatment.


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++++

Ischemic Discomfortat Rest

Ischemic Discomfortat Rest

No ST-segmentElevation

No ST-segmentElevation

Non-Q-wave MIUnstable

Angina

Q-wave MI

ST-segmentElevation

ST-segmentElevation

++ ++

( : positive cardiac biomarker)

EmergencyEmergencyDepartmentDepartment

In-hospitalIn-hospital

6-24hrs6-24hrs

PresentationPresentation

Acute Coronary SyndromesAcute Coronary SyndromesClinical Spectrum and PresentationClinical Spectrum and Presentation

Acute Coronary SyndromesAcute Coronary SyndromesClinical Spectrum and PresentationClinical Spectrum and Presentation

NSTEMINSTEMI


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SYNERGY

LMWHLMWH

ESSENCEESSENCE

19941994 1995199519961996 19971997 1998199819991999 20002000 20022002 200200

3320042004 20052005 2006200620012001

CURECURE

ClopidogrelClopidogrel

Bleeding riskBleeding risk

Ischemic riskIschemic risk

GP IIb/IIIaGP IIb/IIIa

blockersblockers

PRISM-PLUSPRISM-PLUS

PURSUITPURSUIT

ACUITYTACTICS TIMI-18TACTICS TIMI-18

Early invasiveEarly invasive

PCIPCI ~ 5% stents~ 5% stents ~85% stents~85% stents Drug-eluting stentsDrug-eluting stents

ISAR-REACT 2

Milestones in ACS Management

OASIS-5

[ Fondaparinux ][ Fondaparinux ]

Anti-Thrombin RxAnti-Thrombin Rx

Anti-Platelet RxAnti-Platelet Rx

Treatment StrategyTreatment Strategy

HeparinHeparin

AspirinAspirin

ConservativeConservative

ICTUS

BivalirudinBivalirudin

REPLACE 2REPLACE 2

Ada ted from and with the courtes of Steven Manoukian MDAdapted from and with the courtesy of Steven Manoukian, MDAdapted from and with the courtesy of Steven Manoukian, MDAdapted from and with the courtesy of Steven Manoukian, MD


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We Must Risk Stratify PatientsWe Must Risk Stratify Patients

with Chest Painwith Chest Pain

Three levels of risk stratification are pertinentThree levels of risk stratification are pertinentto Emergency Department Managementto Emergency Department Management

LowLow, intermediate, or high risk, intermediate, or high risk that ischemic symptoms arethat ischemic symptoms are

a result of CADa result of CAD

Low, intermediateLow, intermediate, or, orhigh riskhigh risk of short-term death orof short-term death or

nonfatal MI from ACSnonfatal MI from ACS

Dynamic, ongoing risk-oriented evaluationDynamic, ongoing risk-oriented evaluation of low- orof low- orintermediate-risk patients for conversion to high-riskintermediate-risk patients for conversion to high-risk

statusstatus that is linked to intensity of treatmentthat is linked to intensity of treatment

Three levels of risk stratification are pertinentThree levels of risk stratification are pertinentto Emergency Department Managementto Emergency Department Management

LowLow, intermediate, or high risk, intermediate, or high risk that ischemic symptoms arethat ischemic symptoms are

a result of CADa result of CAD

Low, intermediateLow, intermediate, or, orhigh riskhigh risk of short-term death orof short-term death ornonfatal MI from ACSnonfatal MI from ACS

Dynamic, ongoing risk-oriented evaluationDynamic, ongoing risk-oriented evaluation of low- orof low- orintermediate-risk patients for conversion to high-riskintermediate-risk patients for conversion to high-risk

statusstatus that is linked to intensity of treatmentthat is linked to intensity of treatment


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Dynamic Risk Stratification ToolsDynamic Risk Stratification ToolsDynamic Risk Stratification ToolsDynamic Risk Stratification Tools

History and PhysicalHistory and Physical Standard EKG and non-standard EKG leadsStandard EKG and non-standard EKG leads

15-lead ECGs should, perhaps, be standard in all but very-15-lead ECGs should, perhaps, be standard in all but very-

low-risk patientslow-risk patients

BiomarkersBiomarkers CPK-MB, Troponins I and T, MyoglobinCPK-MB, Troponins I and T, Myoglobin

Ischemia-Modified AlbuminIschemia-Modified Albumin

Non-Invasive ImagingNon-Invasive Imaging

EchocardiogramEchocardiogram Stress testingStress testing

Technetium-99m-sestamibiTechnetium-99m-sestamibi

Predictive Indices/SchemesPredictive Indices/Schemes

Better as research tools than for real-time clinical decision-Better as research tools than for real-time clinical decision-makingmaking

History and PhysicalHistory and Physical Standard EKG and non-standard EKG leadsStandard EKG and non-standard EKG leads

15-lead ECGs should, perhaps, be standard in all but very-15-lead ECGs should, perhaps, be standard in all but very-low-risk patientslow-risk patients

BiomarkersBiomarkers CPK-MB, Troponins I and T, MyoglobinCPK-MB, Troponins I and T, Myoglobin

Ischemia-Modified AlbuminIschemia-Modified Albumin

Non-Invasive ImagingNon-Invasive Imaging

EchocardiogramEchocardiogram Stress testingStress testing

Technetium-99m-sestamibiTechnetium-99m-sestamibi

Predictive Indices/SchemesPredictive Indices/Schemes

Better as research tools than for real-time clinical decision-Better as research tools than for real-time clinical decision-

makingmaking


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Braunwald E, Antman EM, Beasley JW, et al: ACC/AHABraunwald E, Antman EM, Beasley JW, et al: ACC/AHAguidelines for the management of patients with unstableguidelines for the management of patients with unstable

angina and non-ST-segment elevation myocardial infarction:angina and non-ST-segment elevation myocardial infarction:

a report of the American College of Cardiology/Americana report of the American College of Cardiology/American

Heart Association Task Force on Practice GuidelinesHeart Association Task Force on Practice Guidelines

(Committee on the Management of Patients with Unstable(Committee on the Management of Patients with Unstable

Angina).Angina). J Am Coll CardiolJ Am Coll Cardiol2000;36:970-1062 (2002 update2000;36:970-1062 (2002 update

atat www.acc.orgwww.acc.org; summary in; summary in CirculationCirculation 2002;106:1893-2002;106:1893-

1900)1900)

Pollack CV, Roe MT, Peterson ED: 2002 Update to thePollack CV, Roe MT, Peterson ED: 2002 Update to the

ACC/AHA guidelines for the management of patients withACC/AHA guidelines for the management of patients with

unstable angina and non-ST-segment elevation myocardialunstable angina and non-ST-segment elevation myocardial

infarction: Implications for emergency department practice.infarction: Implications for emergency department practice.

Ann Emerg MedAnn EmergMed2003;41:355-692003;41:355-69

Braunwald E, Antman EM, Beasley JW, et al: ACC/AHABraunwald E, Antman EM, Beasley JW, et al: ACC/AHAguidelines for the management of patients with unstableguidelines for the management of patients with unstable

angina and non-ST-segment elevation myocardial infarction:angina and non-ST-segment elevation myocardial infarction:

a report of the American College of Cardiology/Americana report of the American College of Cardiology/American

Heart Association Task Force on Practice GuidelinesHeart Association Task Force on Practice Guidelines

(Committee on the Management of Patients with Unstable(Committee on the Management of Patients with UnstableAngina).Angina). J Am Coll CardiolJ Am Coll Cardiol2000;36:970-1062 (2002 update2000;36:970-1062 (2002 update

atat www.acc.orgwww.acc.org; summary in; summary in CirculationCirculation 2002;106:1893-2002;106:1893-

1900)1900)

Pollack CV, Roe MT, Peterson ED: 2002 Update to thePollack CV, Roe MT, Peterson ED: 2002 Update to the

ACC/AHA guidelines for the management of patients withACC/AHA guidelines for the management of patients with

unstable angina and non-ST-segment elevation myocardialunstable angina and non-ST-segment elevation myocardial

infarction: Implications for emergency department practice.infarction: Implications for emergency department practice.

Ann Emerg MedAnn EmergMed2003;41:355-692003;41:355-69

NSTE ACS Optimal Therapy: 2002NSTE ACS Optimal Therapy: 2002NSTE ACS Optimal Therapy: 2002NSTE ACS Optimal Therapy: 2002
http://www.pbase.com/es839145/animated_waterhttp://www.pbase.com/es839145/animated_waterhttp://www.pbase.com/es839145/animated_waterhttp://www.pbase.com/es839145/animated_waterhttp://www.pbase.com/es839145/animated_waterhttp://www.pbase.com/es839145/animated_waterhttp://www.pbase.com/es839145/animated_water


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II IIaIIa IIbIIb IIIIII

The GuidelinesThe GuidelinesClasses of RecommendationsClasses of Recommendations

The GuidelinesThe GuidelinesClasses of RecommendationsClasses of Recommendations

Intervention is useful and effectiveIntervention is useful and effective

Evidence supportive; awaitingEvidence supportive; awaiting

confirming dataconfirming data

Evidence conflicts/opinions differ;Evidence conflicts/opinions differ;

neutral statementneutral statement

Intervention is not useful/effective andIntervention is not useful/effective andmay be harmfulmay be harmful

Intervention is useful and effectiveIntervention is useful and effective

Evidence supportive; awaitingEvidence supportive; awaiting

confirming dataconfirming data

Evidence conflicts/opinions differ;Evidence conflicts/opinions differ;

neutral statementneutral statement

Intervention is not useful/effective andIntervention is not useful/effective andmay be harmfulmay be harmful

E id B d A h ACSE id B d A h t ACS


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Evidence-Based Approach to ACSEvidence-Based Approach to ACSWeighing the EvidenceWeighing the Evidence

Class I:Class I: Benefit > > RiskBenefit > > Risk

Class IIa:Class IIa: Benefit > RiskBenefit > Risk

Class IIb:Class IIb: BenefitBenefit >> RiskRisk

Class III:Class III: RiskRisk >> BenefitBenefit

Class I:Class I: Benefit > > RiskBenefit > > Risk

Class IIa:Class IIa: Benefit > RiskBenefit > Risk

Class IIb:Class IIb: BenefitBenefit >> RiskRisk

Class III:Class III: RiskRisk >> BenefitBenefit

Th G id li Th G id li


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The GuidelinesThe GuidelinesWeighing the EvidenceWeighing the Evidence

Weight of Evidence GradesWeight of Evidence Grades

= Data from many large, randomized= Data from many large, randomized

trialstrials

== Data from fewer, smaller randomizedData from fewer, smaller randomized

trials, careful analyses oftrials, careful analyses of

nonrandomized studies,nonrandomized studies,

observational registriesobservational registries

== Expert consensusExpert consensus

GWh t D Th G id li MWh t D Th G id li M


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What Do The Guidelines MeanWhat Do The Guidelines Mean

for Emergency Medicine Practice?for Emergency Medicine Practice?



Objective approach to risk stratification andObjective approach to risk stratification and

treatmenttreatment

Driven by risk, not patient geographyDriven by risk, not patient geography

MultidisciplinaryMultidisciplinary

Provides a foundation for communication,Provides a foundation for communication,

collaboration, and continuum of care from EDcollaboration, and continuum of care from ED

to cardiology serviceto cardiology service

2007 Guidelines push for that continuum to be2007 Guidelines push for that continuum to be

compressed in durationcompressed in duration

Objective approach to risk stratification andObjective approach to risk stratification and

treatmenttreatment

Driven by risk, not patient geographyDriven by risk, not patient geography

MultidisciplinaryMultidisciplinary

Provides a foundation for communication,Provides a foundation for communication,

collaboration, and continuum of care from EDcollaboration, and continuum of care from ED

to cardiology serviceto cardiology service

2007 Guidelines push for that continuum to be2007 Guidelines push for that continuum to be

compressed in durationcompressed in duration

Wh t D Th G id li MWh t D Th G id li M


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AcuteAcute

CoronaryCoronary

SyndromeSyndrome

AcuteAcute

CoronaryCoronary

SyndromeSyndrome



GWh t D Th G id li MWh t D Th G id li MWh t D Th G id li M


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AcuteAcute

ControversyControversy

SyndromeSyndrome

AcuteAcute

ControversyControversy

SyndromeSyndrome





Wh t D Th G id li MWh t D Th G id li M


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AcuteAcute

ConfusionalConfusional

SyndromeSyndrome

AcuteAcute

ConfusionalConfusional

SyndromeSyndrome




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Acute Confounded SyndromeAcute Confounded Syndrome

The Writing Committee believes thatThe Writing Committee believes that inadequateinadequateunconfounded, comparative information is availableunconfounded, comparative information is available toto

recommend a preferred [anticoagulation] regimen whenrecommend a preferred [anticoagulation] regimen whenan early, invasive strategy is used for UA/NSTEMI, andan early, invasive strategy is used for UA/NSTEMI, and

physician and health care system preference, togetherphysician and health care system preference, together

with individualized patient application, is advised.with individualized patient application, is advised.

Acute Confounded SyndromeAcute Confounded Syndrome

The Writing Committee believes thatThe Writing Committee believes that inadequateinadequate

unconfounded, comparative information is availableunconfounded, comparative information is available toto

recommend a preferred [anticoagulation] regimen whenrecommend a preferred [anticoagulation] regimen whenan early, invasive strategy is used for UA/NSTEMI, andan early, invasive strategy is used for UA/NSTEMI, and

physician and health care system preference, togetherphysician and health care system preference, together

with individualized patient application, is advised.with individualized patient application, is advised.

UA/NSTEMI Strategy OverviewUA/NSTEMI Strategy OverviewUA/NSTEMI Strategy OverviewUA/NSTEMI Strategy Overview

ACC/AHA 2007 Guidelines for the Management of UA/NSTEMI. August 6, 2007, Circulation.ACC/AHA 2007 Guidelines for the Management of UA/NSTEMI. August 6, 2007, Circulation.

Wh t D Th G id li MWh t D Th G id li MWh t D Th G id li MWhat Do The Guidelines Mean


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AcuteAcute

ContentiousnessContentiousness

SyndromeSyndrome

AcuteAcute

ContentiousnessContentiousness

SyndromeSyndrome





Wh t D Th G id li MWh t D Th G id li MWh t D Th G id li MWhat Do The Guidelines Mean


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AcuteAcute

CollaborationCollaboration

SyndromeSyndrome

AcuteAcute

CollaborationCollaboration

SyndromeSyndrome






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Big Picture: Early Invasive Vs.Big Picture: Early Invasive Vs.

Initial Conservative TherapyInitial Conservative Therapy

An early invasive strategy (i.e., diagnostic angiography with intent toAn early invasive strategy (i.e., diagnostic angiography with intent to

perform revascularization) is indicated in initially stabilized UA/NSTEMIperform revascularization) is indicated in initially stabilized UA/NSTEMI

patients (without serious comorbidities or contraindications to suchpatients (without serious comorbidities or contraindications to such

procedures)procedures) who have an elevated risk for clinical eventswho have an elevated risk for clinical events..

In initially stabilized patients, anIn initially stabilized patients, an initially conservative (i.e., a selectivelyinitially conservative (i.e., a selectively

invasive) strategy may be consideredinvasive) strategy may be considered as a treatment strategy foras a treatment strategy for

UA/NSTEMI patients (without serious comorbidities or contraindicationsUA/NSTEMI patients (without serious comorbidities or contraindications

to such procedures) who have an elevated risk for clinical events,to such procedures) who have an elevated risk for clinical events,

including those who are troponin positiveincluding those who are troponin positive..

The decision to implement an initial conservative (vs. initial invasive)The decision to implement an initial conservative (vs. initial invasive)

strategy in these patients may be made bystrategy in these patients may be made by considering physician andconsidering physician and

patient preferencepatient preference..

Big Picture: Early Invasive Vs.Big Picture: Early Invasive Vs.

Initial Conservative TherapyInitial Conservative Therapy

An early invasive strategy (i.e., diagnostic angiography with intent toAn early invasive strategy (i.e., diagnostic angiography with intent to

perform revascularization) is indicated in initially stabilized UA/NSTEMIperform revascularization) is indicated in initially stabilized UA/NSTEMI

patients (without serious comorbidities or contraindications to suchpatients (without serious comorbidities or contraindications to such

procedures)procedures) who have an elevated risk for clinical eventswho have an elevated risk for clinical events..

In initially stabilized patients, anIn initially stabilized patients, an initially conservative (i.e., a selectivelyinitially conservative (i.e., a selectively

invasive) strategy may be consideredinvasive) strategy may be considered as a treatment strategy foras a treatment strategy for

UA/NSTEMI patients (without serious comorbidities or contraindicationsUA/NSTEMI patients (without serious comorbidities or contraindications

to such procedures) who have an elevated risk for clinical events,to such procedures) who have an elevated risk for clinical events,

including those who are troponin positiveincluding those who are troponin positive..

The decision to implement an initial conservative (vs. initial invasive)The decision to implement an initial conservative (vs. initial invasive)

strategy in these patients may be made bystrategy in these patients may be made by considering physician andconsidering physician and

patient preferencepatient preference..

UA/NSTEMI Strategy OverviewUA/NSTEMI Strategy OverviewUA/NSTEMI Strategy OverviewUA/NSTEMI Strategy Overview

ACC/AHA 2007 Guidelines for the Management of UA/NSTEMI. August 6, 2007,ACC/AHA 2007 Guidelines for the Management of UA/NSTEMI. August 6, 2007, Circulation.Circulation.ACC/AHA 2007 Guidelines for the Management of UA/NSTEMI. August 6, 2007,ACC/AHA 2007 Guidelines for the Management of UA/NSTEMI. August 6, 2007, Circulation.Circulation.

Al ith f E l ti d M t fAl ith f E l ti d M t f


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Algorithm for Evaluation and Management ofAlgorithm for Evaluation and Management of

Patients Suspected of Having ACSPatients Suspected of Having ACS

ACC/AHA 2007 Guidelines for the Management of UA/NSTEMI. August 6, 2007, Circulation.

AASymptoms Suggestive ofSymptoms Suggestive of

ACSACS

Symptoms Suggestive ofSymptoms Suggestive of

ACSACS

NoncardiacNoncardiac

DiagnosisDiagnosis

NoncardiacNoncardiac

DiagnosisDiagnosis

UnstableUnstable

AnginaAngina

UnstableUnstable

AnginaAngina

Treatment asTreatment as

indicated byindicated by

alternativealternative

diagnosisdiagnosis

Treatment asTreatment as

indicated byindicated by

alternativealternative

diagnosisdiagnosis

See ACC/AHASee ACC/AHA

Guidelines forGuidelines for

Chronic StableChronic Stable

AnginaAngina

See ACC/AHASee ACC/AHA

Guidelines forGuidelines for

Chronic StableChronic Stable

AnginaAngina

BIBI B2B2

PossiblePossible

ACSACS

PossiblePossible

ACSACS

DefiniteDefinite

ACSACS

DefiniteDefinite

ACSACS

B3B3 B4B4



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Possible ACSPossible ACSPossible ACSPossible ACS

Nondiagnostic ECGNondiagnostic ECG

Normal initial serum cardiac biomarkersNormal initial serum cardiac biomarkers

Nondiagnostic ECGNondiagnostic ECG

Normal initial serum cardiac biomarkersNormal initial serum cardiac biomarkers

OBSERVEOBSERVE

12 hours or more from12 hours or more fromsymptom onsetsymptom onset

OBSERVEOBSERVE

12 hours or more from12 hours or more fromsymptom onsetsymptom onset

No recurrent pain,No recurrent pain,

negative follow-upnegative follow-up

studiesstudies

No recurrent pain,No recurrent pain,

negative follow-upnegative follow-up

studiesstudies

Recurrent pain, positiveRecurrent pain, positive

follow-up studiesfollow-up studies

Diagnosis OF ACSDiagnosis OF ACS

confirmedconfirmed

Recurrent pain, positiveRecurrent pain, positive

follow-up studiesfollow-up studies

Diagnosis OF ACSDiagnosis OF ACS

confirmedconfirmed

Admit to hospitalAdmit to hospital

Manage via acuteManage via acute

ischemia pathwayischemia pathway

Admit to hospitalAdmit to hospital

Manage via acuteManage via acute

ischemia pathwayischemia pathway

Stress study to provoke ischemiaStress study to provoke ischemia

Consider evaluation of LV function ifConsider evaluation of LV function if

ischemia is present (tests may beischemia is present (tests may be

performed either prior to discharge or asperformed either prior to discharge or as

outpatientoutpatient


Consider evaluation of LV function ifConsider evaluation of LV function if

ischemia is present (tests may beischemia is present (tests may be



D1D1

E1E1

F2F2F1F1

G1G1

H3H3




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PositivePositive

Diagnosis of ACSDiagnosis of ACS

confirmed or highlyconfirmed or highly

likelylikely

PositivePositive

Diagnosis of ACSDiagnosis of ACS

confirmed or highlyconfirmed or highly

likelylikely

Admin to hospitalAdmin to hospital

Manage viaManage via

acute ischemia pathwayacute ischemia pathway

Admin to hospitalAdmin to hospital

Manage viaManage via

acute ischemia pathwayacute ischemia pathway

H2H2 H3H3


Consider evaluation of LV function ifConsider evaluation of LV function ifischemia is present (tests may beischemia is present (tests may be




Consider evaluation of LV function ifConsider evaluation of LV function ifischemia is present (tests may beischemia is present (tests may be



G1G1

NegativeNegativePotential diagnoses:Potential diagnoses:

Nonischemic discomfort;Nonischemic discomfort;

low-risk ACSlow-risk ACS

NegativeNegativePotential diagnoses:Potential diagnoses:

Nonischemic discomfort;Nonischemic discomfort;

low-risk ACSlow-risk ACS

Arrangements forArrangements for

outpatient follow-upoutpatient follow-up

Arrangements forArrangements for

outpatient follow-upoutpatient follow-up

H1H1

I1I1



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Specific Recommendations, ClassSpecific Recommendations, Class

Designation, and Levels OfDesignation, and Levels Of

EvidenceEvidence

Initial Invasive Strategy: Whats New?Initial Invasive Strategy: Whats New?

Specific Recommendations, ClassSpecific Recommendations, Class

Designation, and Levels OfDesignation, and Levels Of

EvidenceEvidence

Initial Invasive Strategy: Whats New?Initial Invasive Strategy: Whats New?

UA/NSTEMI Strategy OverviewUA/NSTEMI Strategy Overview


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New Strategies: AnticoagulantsNew Strategies: Anticoagulants

Two new anticoagulants,Two new anticoagulants, fondaparinux andfondaparinux andbivalirudinbivalirudin, have undergone, have undergone favorable testing infavorable testing in

clinical trials and are recommendedclinical trials and are recommended as alternativesas alternatives

to unfractionated heparin (UFH) and low-molecular-to unfractionated heparin (UFH) and low-molecular-

weight heparins (LMWHs) for specific or moreweight heparins (LMWHs) for specific or more

general applications.general applications.

New Strategies: AnticoagulantsNew Strategies: Anticoagulants

Two new anticoagulants,Two new anticoagulants, fondaparinux andfondaparinux andbivalirudinbivalirudin, have undergone, have undergone favorable testing infavorable testing in

clinical trials and are recommendedclinical trials and are recommended as alternativesas alternatives

to unfractionated heparin (UFH) and low-molecular-to unfractionated heparin (UFH) and low-molecular-

weight heparins (LMWHs) for specific or moreweight heparins (LMWHs) for specific or more

general applications.general applications.

UA/NSTEMI Strategy OverviewUA/NSTEMI Strategy Overview


Al ith f P ti t With UA/NSTEMIAlgorithm for Patients With UA/NSTEMI


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Algorithm for Patients With UA/NSTEMIAlgorithm for Patients With UA/NSTEMI

Managed by an Initial Invasive StrategyManaged by an Initial Invasive Strategy

Diagnosis of UA/NSTEMI is Likely or DefiniteDiagnosis of UA/NSTEMI is Likely or DefiniteDiagnosis of UA/NSTEMI is Likely or DefiniteDiagnosis of UA/NSTEMI is Likely or Definite

ASA (Class I, LOE:A)*ASA (Class I, LOE:A)*

Clopidogrel if ASA intolerant (Class I, LOE: A)Clopidogrel if ASA intolerant (Class I, LOE: A)

ASA (Class I, LOE:A)*ASA (Class I, LOE:A)*

Clopidogrel if ASA intolerant (Class I, LOE: A)Clopidogrel if ASA intolerant (Class I, LOE: A)

Select Management StrategySelect Management StrategySelect Management StrategySelect Management Strategy

Invasive StrategyInvasive Strategy

Initiate anticoagulant therapy (Class I, LOE: A):Initiate anticoagulant therapy (Class I, LOE: A):

Acceptable options*: enoxaparin or UFH (Class I,Acceptable options*: enoxaparin or UFH (Class I,LOE: A), bivalirudin or fondaparinux are preferableLOE: A), bivalirudin or fondaparinux are preferable

(Class I, LOE: B)(Class I, LOE: B)

Invasive StrategyInvasive Strategy

Initiate anticoagulant therapy (Class I, LOE: A):Initiate anticoagulant therapy (Class I, LOE: A):

Acceptable options*: enoxaparin or UFH (Class I,Acceptable options*: enoxaparin or UFH (Class I,

LOE: A), bivalirudin or fondaparinux are preferableLOE: A), bivalirudin or fondaparinux are preferable

(Class I, LOE: B)(Class I, LOE: B)

InitialInitial


StrategyStrategy

InitialInitial


StrategyStrategy

AAAA

B1B1B1B1


Al ith f P ti t With UA/NSTEMIAlgorithm for Patients With UA/NSTEMI


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Algorithm for Patients With UA/NSTEMIAlgorithm for Patients With UA/NSTEMI

Managed by an Initial Invasive StrategyManaged by an Initial Invasive Strategy

Prior to AngiographyPrior to Angiography

Initiate at least one (Class I, LOE: A) orInitiate at least one (Class I, LOE: A) or

Both (Class IIa, LOE: B) of the following:Both (Class IIa, LOE: B) of the following:

Clopidogrel*Clopidogrel*

IV GP IIb/IIIa inhibitor*IV GP IIb/IIIa inhibitor*

Factors favoring administration of both clopidogrelFactors favoring administration of both clopidogrel

and GP IIb/IIIa inhibitor include:and GP IIb/IIIa inhibitor include:

Delay to angiographyDelay to angiography

High risk featuresHigh risk featuresEarly recurrent ischemic discomfortEarly recurrent ischemic discomfort

Prior to AngiographyPrior to Angiography

Initiate at least one (Class I, LOE: A) orInitiate at least one (Class I, LOE: A) or

Both (Class IIa, LOE: B) of the following:Both (Class IIa, LOE: B) of the following:

Clopidogrel*Clopidogrel*

IV GP IIb/IIIa inhibitor*IV GP IIb/IIIa inhibitor*

Factors favoring administration of both clopidogrelFactors favoring administration of both clopidogrel

and GP IIb/IIIa inhibitor include:and GP IIb/IIIa inhibitor include:

Delay to angiographyDelay to angiography

High risk featuresHigh risk featuresEarly recurrent ischemic discomfortEarly recurrent ischemic discomfort

Diagnostic AngiographyDiagnostic AngiographyDiagnostic AngiographyDiagnostic Angiography

B2B2B2B2



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Welcome To This Program!Welcome To This Program!

Move from confusion, controversy, andMove from confusion, controversy, and

contentiousness tocontentiousness to collaboration andcollaboration and

more evidence-based caremore evidence-based care

Give emergency physicians familiarityGive emergency physicians familiarity

they need with ACC/AHA 2007 UA/NSTEMIthey need with ACC/AHA 2007 UA/NSTEMI

Guidelines in order to:Guidelines in order to:q (1) Treat patients optimally and;(1) Treat patients optimally and;

q (2) Work effectively and collegially with their(2) Work effectively and collegially with their

cardiology consultantscardiology consultants

Move from confusion, controversy, andMove from confusion, controversy, and

contentiousness tocontentiousness to collaboration andcollaboration and

more evidence-based caremore evidence-based care

Give emergency physicians familiarityGive emergency physicians familiarity

they need with ACC/AHA 2007 UA/NSTEMIthey need with ACC/AHA 2007 UA/NSTEMI

Guidelines in order to:Guidelines in order to:q (1) Treat patients optimally and;(1) Treat patients optimally and;

q (2) Work effectively and collegially with their(2) Work effectively and collegially with their

cardiology consultantscardiology consultants


33/217

Recent Clinical Trials in STEMIRecent Clinical Trials in STEMI

and NSTEMIand NSTEMIWhat New Evidence Tells Us and ImplicationsWhat New Evidence Tells Us and Implications

for ED Cardiovascular Managementfor ED Cardiovascular Management

Recent Clinical Trials in STEMIRecent Clinical Trials in STEMI

and NSTEMIand NSTEMIWhat New Evidence Tells Us and ImplicationsWhat New Evidence Tells Us and Implications

for ED Cardiovascular Managementfor ED Cardiovascular Management




Getting in the Stream of ThingsGetting in the Stream of Things


34/217

ACS: Recent Clinical Trials inACS: Recent Clinical Trials in

STEMISTEMI and NSTEMIand NSTEMI

ACS: Recent Clinical Trials inACS: Recent Clinical Trials in

STEMISTEMI and NSTEMIand NSTEMI

Getting in the (Up)Stream of ThingsGetting in the (Up)Stream of Things

PCIPCI versusversus FibrinolysisFibrinolysis


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8.57.3 7.2

22.0

2.0

7.2

4.92.8

6.8

1.0

0.0

5.0

10.0

15.0

20.0

25.0

Death Death

SHOCK

excl.

Reinfarction Recurrent

ischemia

Stroke

Percent(%)

Lysis

PCI

PCIPCI versusversus FibrinolysisFibrinolysis

Systematic OverviewSystematic Overview

Short term (4-6 weeks)

Keeley EC, Boura JA, Grines CL. Lancet. 2003.

P=0.0002P=0.0002P=0.0003P=0.0003 P


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5.9%

2.2%

3.7%

5.7%

0%

2%

4%

6%

8%

10%

2 Hrs

(n=374)

30-daymort

ality

Pre-hosp tPA

PCI

7.4%

15.3%

7.3%6.0%

0%

5%

10%

15%

20%

3 Hrs

(n=299)

30-daymort

ality

Lytic (SK)

Transfer for PCI

Early Presenting Patients Early Presenting Patients Primary PCIPrimary PCI versusversus FibrinolyticsFibrinolytics

Early Presenting Patients Early Presenting Patients Primary PCIPrimary PCI versusversus FibrinolyticsFibrinolytics

p=0.058p=0.058 p=0.47p=0.47

CAPTIMCAPTIM

p


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Mortality Rates with Primary PCI as aMortality Rates with Primary PCI as a

Function of PCI Time DelayFunction of PCI Time Delay

Mortality Rates with Primary PCI as aMortality Rates with Primary PCI as aFunction of PCI Time DelayFunction of PCI Time Delay

PP=.006=.006

Circle sizes =Circle sizes = sample size of the studysample size of the study

Solid line = weighted metaregressionSolid line = weighted metaregression

Nallamothu BK, Bates ER.Am J Cardiol. 2003;92:824-826.

62 min62 minBenefitBenefit

Favors PCIFavors PCI

HarmHarm

Favors LysisFavors Lysis

For every 10 min delay to PCI: 1% reduction in mortality difference towards lyticsFor every 10 min delay to PCI: 1% reduction in mortality difference towards lytics

55

1010

1515

00

Abs

oluteriskd

iffere

nceinde

ath(%

)

Abs

oluteriskd

iffere

nceinde

ath(%

)

5500 2020 4040 6060 8080 100100

PCI-related time delay (door to balloon - door to needle)PCI-related time delay (door to balloon - door to needle)


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Can We Improve STEMI CareCan We Improve STEMI Care

With Fibrinolysis?With Fibrinolysis?

Can We Improve STEMI CareCan We Improve STEMI CareWith Fibrinolysis?With Fibrinolysis?

Optimizing STEMI OutcomesOptimizing STEMI Outcomes

Adjunctive MedicationsAdjunctive Medications


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Adjunctive Medications Adjunctive Medications

No Effect in STEMINo Effect in STEMI

Double-bolus t-PADouble-bolus t-PA TNKTNK

rPArPA

nPAnPA

GP IIb/IIIa inhibitionGP IIb/IIIa inhibition

+lytic+lytic

Oral GP IIb/IIIaOral GP IIb/IIIa

Double-bolus t-PADouble-bolus t-PA TNKTNK

rPArPA

nPAnPA

GP IIb/IIIa inhibitionGP IIb/IIIa inhibition+lytic+lytic

Oral GP IIb/IIIaOral GP IIb/IIIa

HirudinHirudin PexulizamabPexulizamab

MagnesiumMagnesium

AdenosineAdenosine

PSGLPSGL

GIKGIK

HirudinHirudin PexulizamabPexulizamab

MagnesiumMagnesium

AdenosineAdenosine

PSGLPSGL

GIKGIK

USEFUL ADJUNCTSUSEFUL ADJUNCTS

Aspirin

Enoxaparin

Clopidogrel

USEFUL ADJUNCTSUSEFUL ADJUNCTS

Aspirin

Enoxaparin

Clopidogrel


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CLARITYTIMI 28CLARITYTIMI 28CLARITYTIMI 28CLARITYTIMI 28

Double-blind, randomized, placebo-controlled trial inDouble-blind, randomized, placebo-controlled trial in

3491 Patients, aged 183491 Patients, aged 1875 yr, with STEMI


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PlaceboClopidogrel

PP=.001=.001

Odds Ratio: 0.64Odds Ratio: 0.64(95% CI, 0.53-0.76)(95% CI, 0.53-0.76)

1.00.4 0.6 0.8 1.2 1.6

ClopidogrelBetter

PlaceboBetter

n=1752 n=1739

36%Odds Reduction

15.0

21.7

Occlude

dArter y

o

rDeath/MI

(%)

0

5

10

15

20

25

Sabatine MS, et al. N Engl J Med. 2005;352:1179-1189.

CLARITYTIMI 28CLARITYTIMI 28

CV Death MI and UrgentCV Death MI and UrgentCV Death MI and UrgentCV Death MI and Urgent


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CV Death, MI, and UrgentCV Death, MI, and Urgent

RevascularizationRevascularization

CV Death, MI, and UrgentCV Death, MI, and Urgent

RevascularizationRevascularization

Days

Endpoint(

%)

0

5

10

15

0 5 10 15 20 25 30

PlaceboPlacebo

ClopidogrelClopidogrel

Odds Ratio: 0.80Odds Ratio: 0.80

(95% CI, 0.65(95% CI, 0.650.97)0.97)

PP=.03=.03

20%20%


CLARITY TIMI 28 Bl di


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CLARITYTIMI 28: BleedingCLARITYTIMI 28: BleedingCLARITYTIMI 28: BleedingCLARITYTIMI 28: Bleeding

NSNS7.27.27.57.5In those undergoing CABGIn those undergoing CABGNSNS7.97.99.19.1CABG w/in 5 d of study medCABG w/in 5 d of study med

0.90.9

1.71.7

0.70.7

0.50.5

1.11.1

PlaceboPlacebo(%)(%)PlaceboPlacebo(%)(%)

NSNS

NSNS

NSNS

NSNS

NSNS

PPPP

1.91.9TIMI majorTIMI major

1.61.6

0.50.5

1.01.0

1.31.3

ClopidogrelClopidogrel(%)(%)ClopidogrelClopidogrel(%)(%)

TIMI minorTIMI minor

ICHICH

Through 30 daysThrough 30 days

TIMI minorTIMI minor

TIMI majorTIMI major

Through angiographyThrough angiography

OutcomeOutcomeOutcomeOutcome



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STEMI < 6 hoursSTEMI < 6 hours

Lytic eligibleLytic eligibleLytic choice by MDLytic choice by MD

(TNK, tPA, rPA, SK)(TNK, tPA, rPA, SK)

ENOXAPARIN< 75 y: 30 mg IV bolus

SC 1.0 mg / kg q 12 h (Hosp DC)

75 y: No bolus

SC 0.75 mg / kg q 12 h (Hosp DC)

CrCl < 30: 1.0 mg / kg q 24h

Double-blind, double-dummyDouble-blind, double-dummy

ASAASA

Day 30Day 30

11 Efficacy Endpoint: Death or Nonfatal MIEfficacy Endpoint: Death or Nonfatal MI

1 Safety Endpoint: TIMI Major Hemorrhage1 Safety Endpoint: TIMI Major Hemorrhage

EXTRACT: TIMI 25EXTRACT: TIMI 25EXTRACT: TIMI 25EXTRACT: TIMI 25

UFH60 U / kg bolus (4000 U)

Inf 12 U / kg / h (1000 U / h)

Duration: at least 48 h

Contd at MD discretion

Primary End Point (ITT) Primary End Point (ITT) Primary End Point (ITT) Primary End Point (ITT)


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Primary End Point (ITT) Primary End Point (ITT) Death or Nonfatal MIDeath or Nonfatal MI

Primary End Point (ITT) Primary End Point (ITT) Death or Nonfatal MIDeath or Nonfatal MI

0

3

6

9

12

15

0 5 10 15 20 25 30

P

rimaryEnd

Point( %

)

P

rimar y

EndPoint( %

)

ENOX

UFH

Relative RiskRelative Risk

0.83 (0.77 to 0.90)0.83 (0.77 to 0.90)

P


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Death or Nonfatal MI Day 30Death or Nonfatal MI Day 30

Medical Therapy vs Any PCIMedical Therapy vs Any PCIDeath or Nonfatal MI Day 30Death or Nonfatal MI Day 30

Medical Therapy vs Any PCIMedical Therapy vs Any PCI

0.00040.00040.0010.001

%%

Event

s

Event s

0

5

10

15

Any PCI Medical RxN = 15,223 (75%)N = 4,676 (23%)

P ValueP Value

9.79.7

RRRRRR

16%16%

11.411.413.813.8

10.710.7

RRRRRR

23%23%

EnoxaparinEnoxaparin

UFHUFH


UFHUFH

Antman EM, et al.Antman EM, et al. NEJMNEJM354:1477-1488354:1477-1488Antman EM, et al.Antman EM, et al. NEJMNEJM354:1477-1488354:1477-1488

Death or Nonfatal MI Day 30Death or Nonfatal MI Day 30Death or Nonfatal MI Day 30Death or Nonfatal MI Day 30


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Death or Nonfatal MI Day 30Death or Nonfatal MI Day 30

Clopidogrel UseClopidogrel Use

Death or Nonfatal MI Day 30Death or Nonfatal MI Day 30Clopidogrel UseClopidogrel Use

0.00050.0005 0.00060.0006

%%

Event s

Event s

0

5

10

15

No Clopidogrel Clopidogrel Use*N = 14,752 (78%) N = 5,727 (28%)

P ValueP Value

10.410.4

RRRRRR

15%15%

12.212.211.411.4

8.78.7

RRRRRR

24%24%

* 2546 clopidogrel treated patients did not undergo PCI


UFHUFH


UFHUFH

Antman EM, et al.Antman EM, et al. NEJMNEJM354:1477-1488354:1477-1488Antman EM, et al.Antman EM, et al. NEJMNEJM354:1477-1488354:1477-1488


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Net Clinical Benefit at 30 DaysNet Clinical Benefit at 30 DaysNet Clinical Benefit at 30 DaysNet Clinical Benefit at 30 Days

11 1.251.250.90.90.80.8

Death or Nonfatal MI orDeath or Nonfatal MI or

Nonfatal ICHNonfatal ICH


Nonfatal Major BleedNonfatal Major Bleed


Nonfatal Disabl. StrokeNonfatal Disabl. Stroke

ENOX BetterENOX Better UFH BetterUFH BetterRRRR

UFH (%)UFH (%) ENOX (%)ENOX (%) RRR (%RRR (%

12.312.3 10.110.1 1818

12.812.8 11.011.0 1414

12.212.2 10.110.1 1717

Prespecified DefinitionsPrespecified Definitions

P


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ppPCI vs Lysis for STEMIPCI vs Lysis for STEMI

7

2.2

3.4

0

2

4

6

8

10

%

Eve

nts

%

Eve

nts

(30-42

Days)

(30-42Days)

ReinfarctionReinfarction

Lytic

Arms

(UFH) PCI

ArmsENOX

Overview of 23 RCTsOverview of 23 RCTsOverview of 23 RCTsOverview of 23 RCTs

The advance in adjunctive therapy with enoxaparin has narrowed the gapThe advance in adjunctive therapy with enoxaparin has narrowed the gap

between PCI and Lysis as reperfusion for STEMIbetween PCI and Lysis as reperfusion for STEMIThe advance in adjunctive therapy with enoxaparin has narrowed the gapThe advance in adjunctive therapy with enoxaparin has narrowed the gap

between PCI and Lysis as reperfusion for STEMIbetween PCI and Lysis as reperfusion for STEMI


Study Design: Randomized, Double Blind,Study Design: Randomized, Double Blind,


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12,000 Patients with STEMI < 12 h of symptom onset

Inclusion: ST 2 mm prec leads or 1 mm limb leadsExclusion: Contraindicated. For anticoagulant, INR > 1.8, pregnancy, ICH


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y yy yDeath/MI at 30 DaysDeath/MI at 30 Days

DaysDays

C

umu

lative

H

azard

C

umu

lative H

azard

0.0

0.0

0.0

2

0.0

2

0.04

0.04

0.06

0.06

0.08

0.08

0.10

0.10

0.12

0.12

00 33 66 99 1212 1515 1818 2121 2424 2727 3030

UFH/PlaceboUFH/Placebo

FondaparinuxFondaparinux

HR 0.86HR 0.86

95% CI 0.77-95% CI 0.77-0.960.96

P=0.008P=0.008


Efficacy of Fondaparinux by StrataEfficacy of Fondaparinux by Strata


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y p yy p yon Death/MIon Death/MI

0.760.76--1.021.020.880.8811.211.212.712.7Stratum II (n = 6434)Stratum II (n = 6434)

(Fonda vs. UFH)(Fonda vs. UFH)

0.760.76

--0.990.99

0.870.87

15.915.9

17.317.3

Stratum I (n = 5658)Stratum I (n = 5658)

(Fonda vs. Placebo)(Fonda vs. Placebo)

95% CI95% CIHRHRFondaFondaControlControl

No. of Events (%)No. of Events (%)

Interaction P=0.88Interaction P=0.88


STEMI C l iSTEMI C l i


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STEMI ConclusionsSTEMI Conclusions

There is still a role for fibrinolyticThere is still a role for fibrinolytictherapy in STEMItherapy in STEMI

Adjuvant clopidogrel and/orAdjuvant clopidogrel and/or

enoxaparin improve outcomes inenoxaparin improve outcomes incombination with fibrinolyticscombination with fibrinolytics

Fondaparinux improves outcomesFondaparinux improves outcomesrelative to placeborelative to placebo

G tti i th (U ) St f ThiGetting in the (Up) Stream of Things


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ACS: Recent Clinical Trials in

STEMI and NSTEMI

ACS: Recent Clinical Trials in

STEMI and NSTEMI

Getting in the (Up) Stream of ThingsGetting in the (Up) Stream of Things

The Link Between GuidelineThe Link Between GuidelineThe Link Between GuidelineThe Link Between Guideline


55/217

5.955.956.336.33

5.165.16 5.075.07 4.974.974.634.63

4.164.16 4.174.17

0

1

22

33

44

55

66

7

Hospital Composite Quality Quartiles

%

In-hosp

italMo

rtality

Every 10%Every 10% in guidelines adherence =in guidelines adherence =11%11% in mortality (OR=0.89, 95% CI, 0.81-0.98)in mortality (OR=0.89, 95% CI, 0.81-0.98)

Peterson ED et al. J Am Coll Cardiol. 2004;43(suppl A):406A. Abstract 1077-71.

Implementation and Mortality Is ClearImplementation and Mortality Is ClearImplementation and Mortality Is ClearImplementation and Mortality Is Clear

25% 25%50% 50%75% 75%

Adjusted

UnadjustedUnadjusted

Antithrombotic and AntiplateletAntithrombotic and AntiplateletAntithrombotic and AntiplateletAntithrombotic and Antiplatelet


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pp

Therapy in ACSTherapy in ACSpp

Therapy in ACSTherapy in ACS

ACC/AHA Guideline Update for UA and NSTEMI. 2002.

CURE:CURE: CClopidogrel inlopidogrel in UUnstable Angina tonstable Angina to


57/217

PreventPrevent RRecurrentecurrent EEventsvents

CURE: Primary End Point:CURE: Primary End Point:


58/217

yy

MI/Stroke/CV Death (N=12,562*)MI/Stroke/CV Death (N=12,562*)

CURE S f tCURE S f tCURE S f tCURE S f t


59/217

CURE SafetyCURE SafetyCURE SafetyCURE Safety

SYNERGY D iSYNERGY Design


60/217

SYNERGY DesignSYNERGY Design

At least 2 of 3 required:

Age 60 ST (transient) or

(+) CK-MB or troponin

Primary endpoint: Death or MI at 30 days

High-riskHigh-risk

ACS PatientsACS Patients

Early invasive strategyOther therapy per ACC/AHA guidelines

(ASA, -blocker, ACE, clopidogrel, GP IIb/IIIa)

Enoxaparin IV UFH

RandomizeRandomize

(n = 10,000)(n = 10,000)

60 U/kg60 U/kg 12 U/kg/h12 U/kg/h(aPTT 50 70 sec)(aPTT 50 70 sec)1 mg/kg SC Q12 h

1 mg/kg SC Q12 h

SYNERGY Trial Investigators. JAMA 2004;292:45-54SYNERGY Trial Investigators. JAMA 2004;292:45-54

D th d MI t 30 DD th d MI t 30 DD th d MI t 30 DD th d MI t 30 D


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Death and MI at 30 DaysDeath and MI at 30 DaysDeath and MI at 30 DaysDeath and MI at 30 Days

1

Hazard Ratio (95% CI)

Enoxaparin UFH

Better Better

30-day Death/MI30-day Death/MI

0.8 1.0

1.2

HR 0.96 (0.86

1.06)

HR 0.96 (0.86

1.06)

1.11.1

0 5 10 15 20 25 300.8

0.9

0.95

1.0

Freedo

m

fromD

eat h

/MI

Days from Randomization

0.85Enoxaparin

UFH

Enoxaparin

UFH


6-Month Survival Death/MI6-Month Survival Death/MI


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(Intention-to-Treat)(Intention-to-Treat)

HR (95% CI) = 0.978 (0.891, 1.075)HR (95% CI) = 0.978 (0.891, 1.075)

0 3030 6060 9090 120120 150150 1801800.7

0.750.75

0.80.8

0.850.85

0.90.9

0.950.95

1

Freedo

m

from

De a

th/M

Iat6M

on

ths


UFHUFH



Bl di E tBl di E tBl di E tBleeding Events


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Bleeding EventsBleeding EventsBleeding EventsBleeding Events

GUSTO severe 2.7 2.2 0.08

TIMI major (clinical): 9.1 7.6 0.008

CABG-related 6.8 5.9 0.08Non-CABG-related 2.4 1.8 0.03

Hb/HCT drop (algorithm) 15.2 12.5 < 0.001

Any RBC transfusion 17.0 16.0 0.16

ICH < 0.1 < 0.1 NS

EnoxaparinEnoxaparin UFHUFH P valueP value(n = 4,993)(n = 4,993) (n = 4,985)(n = 4,985)

%%


SYNERGY C l i /C tSYNERGY C l i /C t


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Enoxaparin was not superior to unfractionated heparinEnoxaparin was not superior to unfractionated heparinbut was noninferior for nonST-segment elevation ACSbut was noninferior for nonST-segment elevation ACS

More bleeding was observed with enoxaparinMore bleeding was observed with enoxaparin

Enoxaparin was an alternative to unfractionatedEnoxaparin was an alternative to unfractionatedheparin for nonST-segment elevation ACS in high-riskheparin for nonST-segment elevation ACS in high-risk

patients being managed with a rapid transition topatients being managed with a rapid transition tointerventionintervention

Do not change fromDo not change fromq UFH to Enoxaparin, orUFH to Enoxaparin, or

q Enoxaparin to UFHEnoxaparin to UFH Stay with the agent initiated in the EDStay with the agent initiated in the ED

q CollaborationCollaboration

q PathwaysPathways

q Bivalirudin may be exceptionBivalirudin may be exception

SYNERGY: Conclusions/CaveatsSYNERGY: Conclusions/Caveats

OASIS 5 St d D iOASIS 5 Study DesignOASIS 5 Study DesignOASIS 5 Study Design


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OASIS-5 Study DesignOASIS-5 Study DesignOASIS-5 Study DesignOASIS-5 Study Design

Yusuf S, et al. N Engl J Med. 2006;354(14):1464-76Yusuf S, et al. N Engl J Med. 2006;354(14):1464-76

Patients w/ NSTE ACSPatients w/ NSTE ACS Chest pain < 24 hours2/3:

Age > 60ST-segment

cardiac markers

Chest pain < 24 hours

2/3:

Age > 60ST-segment

cardiac markers

ASA, clopidogrel, IIb/IIIa,

planned cath per local

practice

ASA, clopidogrel, IIb/IIIa,

planned cath per local

practice

Exclude

Age < 21

Contraindication to enoxHemorrhagic stroke < 12 mo

Creat > 3 mg/dL (265 umol/L)

Exclude

Age < 21

Contraindication to enoxHemorrhagic stroke < 12 mo

Creat > 3 mg/dL (265 umol/L)

RandomizeRandomize

n = 20,000n = 20,000

Fondaparinux

2.5 mg sc qd

Fondaparinux2.5 mg sc qd

Enoxaparin

1 mg/kg sc bid

Enoxaparin1 mg/kg sc bid

PCI < 6 h: IV fondaparinux2.5 mg w/o IIb/IIIa, 0 w/ IIb/IIIa

PCI > 6h: IV fondaparinux

5 mg w/o IIb/IIIa, 2.5 mg w/ IIb/IIIa

PCI < 6 h: IV fondaparinux2.5 mg w/o IIb/IIIa, 0 w/ IIb/IIIa

PCI > 6h: IV fondaparinux

5 mg w/o IIb/IIIa, 2.5 mg w/ IIb/IIIa

Primary Efficacy: Death, MI, refractory ischemia at 9 daysSafety: Major bleeding at 9 days

Risk/Benefit: Death, MI, refractory ischemia and major bleeding at 9 days

Secondary Above and each component separately at day 30 and 6 months

Primary Efficacy: Death, MI, refractory ischemia at 9 daysSafety: Major bleeding at 9 days

Risk/Benefit: Death, MI, refractory ischemia and major bleeding at 9 days

Secondary Above and each component separately at day 30 and 6 months

PCI < 6 h: no UFH

PCI > 6h: IV UFH

100 U/kg w/o IIb/IIIa

60 U/kg w/ IIb/IIIa

PCI < 6 h: no UFH

PCI > 6h: IV UFH

100 U/kg w/o IIb/IIIa

60 U/kg w/ IIb/IIIaOutcomesOutcomes

OASIS 5: Efficacy at Day 9OASIS 5: Efficacy at Day 9


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OASIS5: Efficacy at Day 9OASIS5: Efficacy at Day 9EnoxEnox FondaFonda

%%

Death/MI/RIDeath/MI/RI 5.85.8 5.95.9

Death/MIDeath/MI 4.14.1 4.14.1

DeathDeath 1.91.9 1.81.8

MIMI 2.72.7 2.72.7

Refract IschRefract Isch 1.91.9 2.052.05

0.80.8 11 1.21.2

Non-inferiorityNon-inferiority

Margin = 1.185Margin = 1.185

Hazard RatioHazard Ratio

Fonda BetterFonda Better Enox BetterEnox Better


OASIS 5 Bl di R t t D 9OASIS 5: Bleeding Rates at Day 9OASIS 5: Bleeding Rates at Day 9OASIS 5: Bleeding Rates at Day 9


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OASIS5: Bleeding Rates at Day 9OASIS5: Bleeding Rates at Day 9OASIS5: Bleeding Rates at Day 9OASIS5: Bleeding Rates at Day 9

OutcomeOutcome EnoxEnox FondaFonda HR (95% CI)HR (95% CI) PP

No. RandomizedNo. Randomized 10,02110,021 10,05710,057

Total Bleed (%)Total Bleed (%) 7.07.0 3.23.2 0.44 (0.39 0.51)0.44 (0.39 0.51) < 0.0001< 0.0001

Major Bleed (%)Major Bleed (%) 4.04.0 2.12.1 0.53 (0.45 0.62)0.53 (0.45 0.62) < 0.0001< 0.0001

TIMI Major Bleed (%)TIMI Major Bleed (%) 1.31.3 0.70.7 0.54 (0.41 0.73)0.54 (0.41 0.73) < 0.0001< 0.0001

Minor Bleed (%)Minor Bleed (%) 3.13.1 1.11.1 0.35 (0.28 0.43)0.35 (0.28 0.43) < 0.0001< 0.0001


Efficacy End Points at 6 MonthsEfficacy End Points at 6 Months


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Efficacy End Points at 6 MonthsEfficacy End Points at 6 Months

End pointEnd point EnoxaparinEnoxaparin FondaparinuxFondaparinux P valueP value

Death/MI/ refractory ischemiaDeath/MI/ refractory ischemia 13.2%13.2% 12.3%12.3% 0.060.06

Death/MIDeath/MI 11.4%11.4% 10.5%10.5% 0.050.05

DeathDeath 6.5%6.5% 5.8%5.8% 0.050.05

MIMI 6.6%6.6% 6.3%6.3% NSNS

StrokeStroke 1.7%1.7% 1.3%1.3% 0.040.04

Death/MI/stroke*Death/MI/stroke* 12.5%12.5% 11.3%11.3% 0.0070.007


PCI Procedural ComplicationsPCI Procedural ComplicationsPCI Procedural ComplicationsPCI Procedural Complications


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PCI Procedural ComplicationsPCI Procedural ComplicationsPCI Procedural ComplicationsPCI Procedural Complications

Events (30 Days)Events (30 Days) EnoxaparinEnoxaparin

n=3089n=3089

FondaparinuxFondaparinux

n=3118n=3118

P valueP value

Any UFH during PCIAny UFH during PCI 53.8%53.8% 18.8%18.8%

Any proceduralAny proceduralcomplicationcomplication

8.6%8.6% 9.6%9.6% 0.180.18

Abrupt closureAbrupt closure 1.1%1.1% 1.5%1.5% 0.200.20

Catheter thrombusCatheter thrombus 0.5%0.5% 1.3%1.3% 0.0010.001

Vascular accessVascular access 8.1%8.1% 3.3%3.3%


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Moderate-

high risk

ACS

First RandomizationFirst Randomization

Moderate-high risk unstable angina or NSTEMIundergoing an invasive strategy (N = 13,819)


Ang

iog

raphywithin

72h

Aspirin in allAspirin in allClopidogrelClopidogrel

dosing and timingdosing and timing

per local practiceper local practice

UFH orEnoxaparin+ GP IIb/IIIa

Bivalirudin+ GP IIb/IIIa

BivalirudinAlone

R*

ACUITY Design. Stone GW et al. AHJ 2004;148:76475

Medical

management

PCI

CABG

Primary endpoint: Net Clinical Composite

Death, MI, TVR, Bleeding

Primary endpoint: Net Clinical Composite

Death, MI, TVR, Bleeding

ACUITY Study Design S d R d i tiACUITY Study Design S d R d i ti


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Moderate-

high risk

ACS

Second RandomizationSecond Randomization



Ang

iog

raphywithin

72h

ACUITY Design. Stone GW et al. AHJ 2004;148:76475

Aspirin in allClopidogrel

dosing and timing

per local practice

Medical

management

PCI

CABG

BivalirudinAlone

UFH or Enoxaparin

Routine upstream

GPI in all pts

GPI started in CCL

for PCI only

R

Bivalirudin

R

Routine upstream

GPI in all pts

GPI started in CCL

for PCI only

3 Primary Endpoints (at 30 Days)3 Primary Endpoints (at 30 Days)


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1. Composite net clinical benefit =

2. Ischemic composite

or

3. Major bleeding

3 Primary Endpoints (at 30 Days)y p ( y )

Death from any cause

Myocardial infarction- During medical Rx: Any biomarker elevation >ULN- Post PCI: CKMB >ULN with new Q waves or >3x ULN w/o Q waves

- Post CABG: CKMB >5x ULN with new Q waves, >10x ULN w/o Q waves

Unplanned revascularization for ischemia

Stone GW, McLaurin BT. NEJM. 2006 Nov 23;355(21):2203-16.Stone GW, McLaurin BT. NEJM. 2006 Nov 23;355(21):2203-16.



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1. Composite net clinical benefit =

2. Ischemic composite

or

3. Major bleeding


Non CABG related bleeding

Intracranial bleeding or intraocular bleedingIntracranial bleeding or intraocular bleeding

Retroperitoneal bleedingRetroperitoneal bleeding

Access site bleed requiring intervention/surgeryAccess site bleed requiring intervention/surgery

Hematoma 5 cmHematoma 5 cm

HgbHgb 3g/dL with an overt source or3g/dL with an overt source or4g/dL w/o overt source4g/dL w/o overt source

Blood product transfusionBlood product transfusion

-- Reoperation for bleedingReoperation for bleeding


Ischemic Composite EndpointIschemic Composite EndpointIschemic Composite EndpointIschemic Composite Endpoint


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Ischemic Composite EndpointIschemic Composite EndpointIschemic Composite EndpointIschemic Composite Endpoint

0

5

10

15

0 5 10 15 20 25 30 35

CumulativeEv

ents(%)


EstimateEstimate PP

(log rank)(log rank)7.3%7.3%UFH/Enoxaparin + IIb/IIIa (N=4603)UFH/Enoxaparin + IIb/IIIa (N=4603)

Bivalirudin + IIb/IIIa (N=4604)Bivalirudin + IIb/IIIa (N=4604) 0.370.377.7%7.7%

Bivalirudin alone (N=4612)Bivalirudin alone (N=4612) 0.300.307.8%7.8%


Major Bleeding EndpointMajor Bleeding EndpointMajor Bleeding EndpointMajor Bleeding Endpoint


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Major Bleeding EndpointMajor Bleeding EndpointMajor Bleeding EndpointMajor Bleeding Endpoint

0

5

10

15

0 5 10 15 20 25 30 35

CumulativeEv

ents(%)


EstimateEstimate PP



Bivalirudin alone (N=4612)Bivalirudin alone (N=4612)


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Net Clinical OutcomeNet Clinical OutcomeNet Clinical OutcomeNet Clinical Outcome

0

5

10

15

0 5 10 15 20 25 30 35

Cumula

tiveEvents(%

)


EstimateEstimate PP



Bivalirudin alone (N=4612)Bivalirudin alone (N=4612) 0.0140.01410.1%10.1%


ACUITY Mortality at 1 yearACUITY Mortality at 1 yearACUITY Mortality at 1-yearACUITY Mortality at 1-year


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0 30 60 90 120 150 180 210 240 270 300 330 360 3900

4

5

Mortalit

y(%)


2

1

ACUITY Mortality at 1-yearACUITY Mortality at 1-yearACUITY Mortality at 1-yearACUITY Mortality at 1-year

UFH/Enoxaparin + IIb/IIIa

Bivalirudin + IIb/IIIa

Bivalirudin alone

Estimate

P(log rank)

1.4%

0.531.6%

0.391.6%

Estimate

P(log rank)

4.4%

0.934.2%

0.663.8%

1 year

p=0.90

Bivalirudin+GPI vs. Hep+GPI

HR [95% CI] = 0.99 (0.80-1.22)

30 day

3

Bivalirudin alone vs. Hep+GPI

HR [95% CI] = 0.95 (0.77-1.18)


ACUITY ConclusionsACUITY ConclusionsACUITY ConclusionsACUITY Conclusions


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Bivalirudin plus IIb/IIIa had similar ischemicBivalirudin plus IIb/IIIa had similar ischemicoutcomes, similar bleeding, and similar netoutcomes, similar bleeding, and similar net

clinical benefit to heparin plus IIb/IIIaclinical benefit to heparin plus IIb/IIIa

Bivalirudin alone (with provisional IIb/IIIa use)Bivalirudin alone (with provisional IIb/IIIa use)had similar ischemic outcomes, less bleeding,had similar ischemic outcomes, less bleeding,

and superior net clinical benefit to heparin plusand superior net clinical benefit to heparin plus

IIb/IIIaIIb/IIIa

Whether or not reductions in bleeding willWhether or not reductions in bleeding will

translate into longer-term reductions in mortalitytranslate into longer-term reductions in mortality

is yet to be determinedis yet to be determined

Bivalirudin plus IIb/IIIa had similar ischemicBivalirudin plus IIb/IIIa had similar ischemicoutcomes, similar bleeding, and similar netoutcomes, similar bleeding, and similar net

clinical benefit to heparin plus IIb/IIIaclinical benefit to heparin plus IIb/IIIa

Bivalirudin alone (with provisional IIb/IIIa use)Bivalirudin alone (with provisional IIb/IIIa use)had similar ischemic outcomes, less bleeding,had similar ischemic outcomes, less bleeding,

and superior net clinical benefit to heparin plusand superior net clinical benefit to heparin plus

IIb/IIIaIIb/IIIa

Whether or not reductions in bleeding willWhether or not reductions in bleeding will

translate into longer-term reductions in mortalitytranslate into longer-term reductions in mortality

is yet to be determinedis yet to be determined

ACUITY ConclusionsACUITY ConclusionsACUITY ConclusionsACUITY Conclusions

NSTEMI ConclusionsNSTEMI ConclusionsNSTEMI ConclusionsNSTEMI Conclusions


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NSTEMI ConclusionsNSTEMI ConclusionsNSTEMI ConclusionsNSTEMI Conclusions

Old and new options for ACSOld and new options for ACSq UFH or EnoxaparinUFH or Enoxaparinq BivalirudinBivalirudinq Fondaparinux (not tested adequately in cath lab)Fondaparinux (not tested adequately in cath lab)

Balance ischemic efficacy and safetyBalance ischemic efficacy and safetyq Customize approach for patient and institutionCustomize approach for patient and institution

Many choicesMany choicesq

Collaborate with IC and CARD on clinical pathwaysCollaborate with IC and CARD on clinical pathways

Adapt ACC/AHA 2007 Guidelines to ClinicalAdapt ACC/AHA 2007 Guidelines to ClinicalPractice in ED (Endorsed by SAEM)Practice in ED (Endorsed by SAEM)

Old and new options for ACSOld and new options for ACSq UFH or EnoxaparinUFH or Enoxaparinq BivalirudinBivalirudinq Fondaparinux (not tested adequately in cath lab)Fondaparinux (not tested adequately in cath lab)

Balance ischemic efficacy and safetyBalance ischemic efficacy and safetyq Customize approach for patient and institutionCustomize approach for patient and institution

Many choicesMany choicesq Collaborate with IC and CARD on clinical pathwaysCollaborate with IC and CARD on clinical pathways

Adapt ACC/AHA 2007 Guidelines to ClinicalAdapt ACC/AHA 2007 Guidelines to ClinicalPractice in ED (Endorsed by SAEM)Practice in ED (Endorsed by SAEM)



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Acute Coronary SyndromeAcute Coronary SyndromeThe 2007 ACC/AHA UA/NSTEMI Guidelines The 2007 ACC/AHA UA/NSTEMI Guidelines

From the ED to the CCU and Cath LabFrom the ED to the CCU and Cath Lab

Adherence as the Road to Better OutcomesAdherence as the Road to Better Outcomes

Acute Coronary SyndromeAcute Coronary SyndromeThe 2007 ACC/AHA UA/NSTEMI Guidelines The 2007 ACC/AHA UA/NSTEMI Guidelines From the ED to the CCU and Cath LabFrom the ED to the CCU and Cath Lab

Adherence as the Road to Better OutcomesAdherence as the Road to Better Outcomes


Charles V. Pollack Jr, MA, MD, FACEP, FAAEMCharles V. Pollack Jr, MA, MD, FACEP, FAAEMChairman, Department of Emergency MedicineChairman, Department of Emergency Medicine

Pennsylvania HospitalPennsylvania HospitalProfessor of Emergency MedicineProfessor of Emergency Medicine




Charles V. Pollack Jr, MA, MD, FACEP, FAAEMCharles V. Pollack Jr, MA, MD, FACEP, FAAEMChairman, Department of Emergency MedicineChairman, Department of Emergency Medicine

Pennsylvania HospitalPennsylvania HospitalProfessor of Emergency MedicineProfessor of Emergency Medicine




Evolution of Guidelines for ACSEvolution of Guidelines for ACSEvolution of Guidelines for ACSEvolution of Guidelines for ACS


81/217

19901990

19921992

19941994

19961996

19981998

20002000

20022002

19901990

ACC/AHAACC/AHA

AMIAMI

R. GunnarR. Gunnar

19941994

AHCPR/NHLBIAHCPR/NHLBI

UAUA

E. BraunwaldE. Braunwald19961996 19991999

RevisedRevised UpdatedUpdated

ACC/AHA AMIACC/AHA AMIT. RyanT. Ryan

2004 20072004 2007

Revised UpdatedRevised UpdatedACC/AHA STEMIACC/AHA STEMI

E. AntmanE. Antman

2004 20072004 2007

Revised UpdatedRevised UpdatedACC/AHA STEMIACC/AHA STEMI

E. AntmanE. Antman

2000 20022000 2002 20072007

Revised UpdatedRevised Updated RevisedRevised

ACC/AHA UA/NSTEMIACC/AHA UA/NSTEMI

E. Braunwald J. AndersonE. Braunwald J. Anderson

2000 20022000 2002 20072007

Revised UpdatedRevised Updated RevisedRevised

ACC/AHA UA/NSTEMIACC/AHA UA/NSTEMI

E. Braunwald J. AndersonE. Braunwald J. Anderson

20042004 20072007

Sea and Stream Changes in ACSSea and Stream Changes in ACSSea and Stream Changes in ACSSea and Stream Changes in ACS


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Sea and Stream Changes in ACSSea and Stream Changes in ACSSea and Stream Changes in ACSSea and Stream Changes in ACS

The 2007 Guidelines have created a SeaThe 2007 Guidelines have created a SeaChange in theChange in the EDED andand ICIC TTherapeuticherapeuticapproach to care of patients with UA/NSTEMIapproach to care of patients with UA/NSTEMI

New Streams of care, with newNew Streams of care, with new

anticoagulants, are in playanticoagulants, are in play Clopidogrel use has been liberalizedClopidogrel use has been liberalized Bleeding end points play a more importantBleeding end points play a more important

role in drug selectionrole in drug selection

Dogmatism is out, customization is inDogmatism is out, customization is in Collaboration is emphasizedCollaboration is emphasized

Applying Classification ofApplying Classification of

R d tiR d ti

Applying Classification ofApplying Classification of

R d tiR d ti


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Class I

Benefit >>> Risk

Procedure/ TreatmentSHOULD be performed/administered

Class IIa

Benefit >> RiskAdditional studies withfocused objectivesneeded

IT IS REASONABLE toperformprocedure/administer

treatment

Class IIb

Benefit RiskAdditional studies withbroad objectives needed;Additional registry datawould be helpful

Procedure/TreatmentMAY BE CONSIDERED

Class III

Risk BenefitNo additional studiesneeded

Procedure/Treatmentshould NOT beperformed/administeredSINCE IT IS NOT

HELPFUL AND MAY BEHARMFUL

ShouldShouldIs recommendedIs recommendedIs indicatedIs indicated

Is useful/effective/Is useful/effective/beneficialbeneficial

Is reasonableIs reasonableCan be useful/effective/Can be useful/effective/

beneficialbeneficial

Is probably recommendedIs probably recommendedor indicatedor indicated

May/might be consideredMay/might be consideredMay/might be reasonableMay/might be reasonableUsefulness/Usefulness/

effectiveness iseffectiveness isunknown/unclear/unknown/unclear/uncertain or not welluncertain or not wellestablishedestablished

Is not recommendedIs not recommende

acs web version

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