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Page 1: Acute Coronary Syndromes: Different Continents, Different .../media/Non-Clinical/Files-PDFs-Excel-MS-Word … · Merck, Novartis, Portola, sanofi-aventis, TMC •Consulting/Advisory:
Page 2: Acute Coronary Syndromes: Different Continents, Different .../media/Non-Clinical/Files-PDFs-Excel-MS-Word … · Merck, Novartis, Portola, sanofi-aventis, TMC •Consulting/Advisory:

Acute Coronary Syndromes: Different Continents, Different Guidelines?

Robert A. Harrington MD, MACC, FAHA, FESCArthur L. Bloomfield Professor of MedicineChair, Department of MedicineStanford UniversityTwitter: @HeartBobH

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Disclosure Statement of Financial Interest

• Research grants/contracts:– NHLBI, PCORI, Duke, Harvard, Astra, CSL, GSK, Janssen,

Merck, Novartis, Portola, sanofi-aventis, TMC

• Consulting/Advisory:– Adverse Events, Amgen, Element Science, Gilead, Merck,

MyoKardia, TMC, Vida Health, WebMD

• Board of Directors– AHA, SHC, Scanadu (mobile health), SignalPath (software)

Within the past 12 months, I have had a financial interest/arrangement

or affiliation with the organization(s) listed below.

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4-Global Burden of Disease Project, Lancet 2012

Leading Causes of Global Death and Disability (1990-2010)

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US ACS Hospitalizations

Acute Coronary

Syndromes*

1.57 Million Hospital Admissions - ACS

UA/NSTEMI† STEMI

1.24 million

Admissions per

year

0.33 million

Admissions per

year*Primary and secondary diagnoses. †About 0.57 million NSTEMI and 0.67 million UA.

Heart Disease and Stroke Statistics – 2007 Update. Circulation 2007; 115:69–171.

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Link Between Overall Guidelines

Adherence and Mortality

-Peterson E et al. JAMA 2006

5.95

5.16 4.97

4.16

5.074.63

4.17

6.33

0

1

2

3

4

5

6

7

<=25% 25 - 50% 50 - 75% >=75%

Hospital Composite Quality Quartiles

% In

-Ho

sp

Mo

rta

lity

Adjusted Unadjusted

Every 10% in guidelines adherence

11% in mortality (OR=0.89, 95% CI: 0.81-0.98)

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Top 10 NSTE ACS Advances (~25+ yrs)

1. Categorizing by ECG: STE and NSTE ACS

2. Practice guidelines

3. Risk stratification and risk scores

4. ASA and UFH as foundational therapies

5. Troponin to risk stratify AND predict treatment response

6. Glycoprotein IIb/IIIa inhibitors

7. Platelet ADP blockers and other receptor inhibitors

8. Early invasive approach

9. Risk post hospitalization

10. Global academic collaborations

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First “Unstable Angina” Guidelines

at STANFORD UNIVERSITY MEDICAL CE on April 13, 2014http://circ.ahajournals.org/Downloaded from

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Page 10: Acute Coronary Syndromes: Different Continents, Different .../media/Non-Clinical/Files-PDFs-Excel-MS-Word … · Merck, Novartis, Portola, sanofi-aventis, TMC •Consulting/Advisory:
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Guideline Authoring Principles

• Evidence-based (see COR/LOE slide)

– Abstracts are discouraged - must be published within 2 years and cannot be basis for a recommendation

– Late Breaking Clinical Trials (LBCT) - Should not be used for development of recommendations until published in peer-reviewed journals (limited text reference acceptable)

• Transparent - all relationships with industry are considered during the writing process and published in the final document

• Collaborative - other organizations are invited as partners, collaborators, authors, endorsers

• Concordant - guidelines should be consistent across topics unless there is new published evidence to justify a change. When there is overlap, recommendations in disease-based guidelines supersede recommendations in procedure guidelines.

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Class I

Benefit >>> Risk

Procedure/

Treatment SHOULD

be performed/

administered

Class IIa

Benefit >> Risk

Additional studies with

focused objectives

needed

IT IS REASONABLE

to perform

procedure/administer

treatment

Class IIb

Benefit ≥ Risk

Additional studies with

broad objectives

needed; Additional

registry data would be

helpful

Procedure/Treatment

MAY BE

CONSIDERED

Class III

Risk ≥ Benefit

No additional studies

needed

Procedure/Treatment

should NOT be

performed/administere

d SINCE IT IS NOT

HELPFUL AND MAY

BE HARMFUL

Applying Classification of

Recommendations and Level of Evidence

Level A: Recommendation based on evidence from multiple randomized trials or meta-analyses

Multiple (3-5) population risk strata evaluated; General consistency of direction and magnitude of

effect

Level B: Recommendation based on evidence from a single randomized trial or non-randomized studies

Limited (2-3) population risk strata evaluated

Level C: Recommendation based on expert opinion, case studies, or standard-of-care

Very limited (1-2) population risk strata evaluated

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2014 AHA/ACC Guideline for the

Management of Patients With

Non–ST-Elevation Acute

Coronary SyndromesDeveloped in Collaboration with the Society of Thoracic Surgeons and Society for

Cardiovascular Angiography and Interventions

Endorsed by the American Association for Clinical Chemistry

© American College of Cardiology Foundation and American Heart Association

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Prognosis: Early Risk Stratification (cont’d)

Recommendations COR LOE

Additional troponin levels should be obtained beyond 6

hours after symptom onset (see Section 3.4, Class I, #3

recommendation if time of symptom onset is unclear) in

patients with normal troponin levels on serial examination

when changes on ECG and/or clinical presentation confer

an intermediate or high index of suspicion for ACS.

I A

Risk scores should be used to assess prognosis in patients

with NSTE-ACS. I A

Risk-stratification models can be useful in management. IIa B

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Anti-Ischemic and Analgesic Medications:

Beta-Adrenergic Blockers

Recommendations COR LOE

Oral beta-blocker therapy should be initiated within the first

24 hours in patients who do not have any of the following:

1) signs of HF, 2) evidence of low-output state, 3) increased

risk for cardiogenic shock, or 4) other contraindications to

beta blockade (e.g., PR interval >0.24 second, second- or

third-degree heart block without a cardiac pacemaker,

active asthma, or reactive airway disease).

I A

In patients with concomitant NSTE-ACS, stabilized HF, and

reduced systolic function, it is recommended to continue

beta-blocker therapy with 1 of the 3 drugs proven to reduce

mortality in patients with HF: sustained-release metoprolol

succinate, carvedilol, or bisoprolol.

I C

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Anti-Ischemic and Analgesic Medications:

Beta-Adrenergic Blockers (cont’d)

Recommendations COR LOE

Patients with documented contraindications to beta blockers

in the first 24 hours of NSTE-ACS should be re-evaluated to

determine their subsequent eligibility. I C

It is reasonable to continue beta-blocker therapy in patients

with normal LV function with NSTE-ACS. IIa C

Administration of intravenous beta blockers is potentially

harmful in patients with NSTE-ACS who have risk factors

for shock.

III:

HarmB

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Anti-Ischemic and Analgesic Medications:

Cholesterol Management

Recommendations COR LOE

High-intensity statin therapy should be initiated or continued

in all patients with NSTE-ACS and no contraindications to

its use. I A

It is reasonable to obtain a fasting lipid profile in patients

with NSTE-ACS, preferably within 24 hours of presentation. IIa C

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Factors Associated With Appropriate Selection of Early Invasive

Strategy or Ischemia-Guided Strategy in Patients With NSTE-ACS

Immediate

invasive

(within 2 h)

Refractory angina

Signs or symptoms of HF or new or worsening mitral regurgitation

Hemodynamic instability

Recurrent angina or ischemia at rest or with low-level activities despite

intensive medical therapy

Sustained VT or VF

Ischemia-

guided

strategy

Low-risk score (e.g., TIMI [0 or 1], GRACE [<109])

Low-risk Tn-negative female patients

Patient or clinician preference in the absence of high-risk features

Early

invasive

(within 24 h)

None of the above, but GRACE risk score >140

Temporal change in Tn (Section 3.4)

New or presumably new ST depression

Delayed

invasive

(within

2572 h)

None of the above but diabetes mellitus

Renal insufficiency (GFR <60 mL/min/1.73 m²)

Reduced LV systolic function (EF <0.40)

Early postinfarction angina

PCI within 6 mo

Prior CABG

GRACE risk score 109–140; TIMI score ≥2

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Initial Antiplatelet/Anticoagulant Therapy in

Patients With Definite or Likely NSTE-ACS

Early Hospital Care

Come to our Session on Antithrombotic Therapies in ACS and CAD at 1145AM!

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Recommendation COR LOE

Participation in a standardized quality-of-care

data registry designed to track and measure

outcomes, complications, and performance

measures can be beneficial in improving the

quality of NSTE-ACS care.IIa B

Quality of Care and Outcomes for ACS-Use of

Performance Measures and Registries

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Thanks for the Opportunity to Visit