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CONVENTION DELLA CARDIOLOGIA LOMBARDA Sindromi Coronariche Acute Induno Olona (VA), Villa Porro Pirelli 27-28 Marzo 2015 Leonardo De Luca, MD, PhD, FACC, FESC Department of Cardiovascular Sciences Interventional Cardiology Unit European Hospital Rome, Italy [email protected] Quello che le Linee Guida Non Dicono

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CONVENTION DELLA

CARDIOLOGIA LOMBARDA

Sindromi Coronariche Acute

Induno Olona (VA), Villa Porro Pirelli

27-28 Marzo 2015

Leonardo De Luca, MD, PhD, FACC, FESC

Department of Cardiovascular Sciences

Interventional Cardiology Unit

European Hospital

Rome, Italy [email protected]

Quello che le Linee Guida

Non Dicono

1. It is carried out in a

high plane

2.There is lots of noise

and trumpeting

3.Nothing comes out of it

for 2 years

’80-’90

Research in ACS

& Sexual Behaviour in Animals

1. It is carried out in a

high plane

2.There is lots of noise

and trumpeting

3.Nothing comes out of it

for 2 years

’80-’90

1. It is carried out in a low

plane

2.Repetitive and

redundant

3.Often unproductive

Today

Research in ACS

& Sexual Behaviour in Animals

What

Guidelines Are and Are Not..

• Are the result of the scientific analysis of the available

data

• Refer only to a part of the patients – due to the usually

strict inclusion/exclusion criteria of the RCT

• Do not analyze local cost/effectiveness considerations

• Do not replace medical experience

• Provide a stronger scientific foundation for clinical

work, to achieve consistency, efficiency, effectiveness,

quality, and safety in medical care

Clinical Practice Guidelines

and Derivative Products

Antman EM, Peterson ED Circulation 2009; 119:1180

CLINICAL PRACTICE

GUIDELINES

EXPERT

CONSENSUS

PERF

MEASURES

APPROPRIATE

USE

CRITERIA

1. Increase use of Effective Therapies

2. Decrease Use of Inappropriate, Unnecessary,

Potentially Harmful Therapies

Improve Patient Outcomes

Reduce Costs of Healthcare Delivery

EVIDENCE

(RCTs, Registries)

Clinical

Experience

Different Ways to Look

at Guidelines

• Fanatic

The Good

of Guidelines

ACC/AHA 2009 Joint STEMI/PCI Guidelines Focused Update

Le Guide…

ACC/AHA 2009 Joint STEMI/PCI Guidelines Focused Update

Different Ways to Look

at Guidelines

• Fanatic

• Accountants

Classes of

Recommendations

Tricoci P, et al. JAMA 2009;301:831

Scientific Evidence Underlying the ACC/AHA

Clinical Practice Guidelines

Change in Class of Recommendations

Between First Guideline Version and Current Version

Class I Class II Class III Class I Class II Class III

Overall Guidelines PCI Guidelines

%

Bivalirudin (0.75 mg/kg bolus, followed by 1.75 mg/kg/hour for up to 4 hours after the procedure) is recommended as alternative to UFH plus GP IIb/IIIa receptor inhibitor during PCI.

I A Bivalirudin 0.75 mg/kg i.v. bolus followed by i.v. infusion of 1.75 mg/kg/h for up to 4 hours after the procedure

IIa A

Bivalirudin plus provisional GP IIb/IIIa receptor inhibitors are recommended as an alternative to UFH plus GP IIb/IIIa receptor inhibitors in patients with an intended invasive strategy, particularly in patients with a high risk of bleeding.

I B

Hamm CW, et al. Eur Heart J 2011;32:2999

Windecker S, et al. Eur Heart J 2014;35:2541

ESC Guidelines on NSTE-ACS

ESC Guidelines on Revascularization ESC Guidelines on Revascularization

Windecker S, et al. Eur Heart J 2014;35:2541

Bivalirudin (with use of GP IIb/IIIa blocker restricted to bailout) is recommended over unfractionated heparin and a GP IIb/IIIa blocker.

I B

ESC Guidelines on STEMI

Steg G, et al. Eur Heart J 2012;33:2569

How Bivalirudin Indications

are Moving

Different Ways to Look

at Guidelines

• Fanatic

• Accountants

• Lawyers

If you don’t Follow the Guidelines,

You May…

From 1985 to 2009, the Physician

Insurers Association of America registry documented 1,361 closed

coronary angiography claims.

Medicolegal Characteristics of Cardiac

Catheterization Litigation in the United States

Kim C, et al. Am J Cardiol 2013;112:1662

Different Ways to Look

at Guidelines

• Fanatic

• Accountants

• Lawyers

• Conspiracy

Relationships Between Authors of Clinical

Guidelines and the Pharmaceutical Industry

Choudhry NK, et al. JAMA 2002;287:612

Cross-sectional survey of 192 authors of 44 CPGs endorsed by

North American and European societies on common adult

diseases published between 1991 and July 1999

Different Ways to Look

at Guidelines

• Fanatic

• Accountants

• Lawyers

• Conspiracy

• Xenophile

Clopidogrel loading dose followed by daily maintenance dose in patients unable to take aspirin

I B

P2Y12 inhibitor, in addition to aspirin, for up to 12 mo for patients treated initially with either an early invasive or initial ischemia-guided strategy:−Clopidogrel−Ticagrelor

I B

Ticagrelor in preference to clopidogrel for patients treated with an early invasive or ischemia-guided strategy

IIa B

2014 AHA/ACC Guideline for the Management of

Patients With Non–ST-Elevation ACS

Amsterdam EA, et al. J Am Coll Cardiol. 2014;64(24):e139

Summary of Recommendations for Initial

Antiplatelet/Anticoagulant Therapy in Patients With Definite

or Likely NSTE-ACS and PCI

Different Ways to Look

at Guidelines

• Fanatic

• Accountants

• Lawyers

• Conspiracy

• Xenophile

• Skeptical

Medicine is an “art” and EBM threatens to bring about

stagnation and bland uniformity, and may also result in a

lower standard of safety by deskilling practitioners.

I could have done it better…

The Art of

Medicine

Pre-hospital and In-hospital Management

and Reperfusion Strategies within 24 h of FMC

Should Local Factors Modify

Recommendations?

Important Delays and

Treatment Goals

Should Local Factors Modify

Recommendations?

In-hospital mortality in 96,738 patients undergoing pPCI from July 2005 through June 2009

at 515 hospitals participating in the CathPCI Registry.

Menees DS, et al. N Engl J Med 2013;369:901

Door-to-Balloon Time and Mortality

among Patients Undergoing pPCI

Different Ways to Look

at Guidelines

• Fanatic

• Accountants

• Lawyers

• Conspiracy

• Xenophile

• Skeptical

• Bigot

Upstream pharmacotherapy

ASA upstream

Anticoagulant upstream

GP IIb/IIIa upstream

P2Y12 antag. upstream

Permutations: 3 x 5 x 4 x 5= 300

InLab pharmacotherapy

ASA in lab

Anticoagulant in lab

GP IIb/IIIa in lab

P2Y12 antag. in lab

Permutations: 3 x 4 x 4 x 5= 240

Post procedure pharmacotherapy

ASA post

GP IIb/IIIa post

P2Y12 antag. post

Permutations: 6 x 8 x 6= 288

1. High

1. UFH

1. Epti

1. Clop 600

2. Low

2. Bival

2. Tirof.

2. Clop 300

3. None

3. Enox

3. Abcix

3. Ticagrelor

4. Fonda

4. None

4. Prasugrel

5. None

5. None

1. High

1. UFH

1. Epti

1. Clop 600

2. Low

2. Bival

2. Tirof.

2. Clop 300

3. None

3. Enox

3. Abcix

3. Ticagrelor

4. None

4. None

4. Prasugrel

5. None

1. High 1 mo.

6. Low chronic

1. Epti none

6. Tir. 18 h

1. Clopi 150

6. None

2. High 1 y

2. Epti short

7. Abc. none

2. Clop 75

3. High chronic

3. Epti 18 h

8. Abc. infuse

3. Ticagrelor

4. Low after 1 mo.

4. Tir. None

4. Prasugrel 5

5. Low 1 y

5. Tir short

5. Prasu 10

20,736,000 Permutations in

Antiplatelet/Anticoagulant Rx

Aspirin (81-325 mg)

Clopidogrel → Novel P2Y12 inhibitors

LMWH → UFH → Bivalirudin

GP IIb/IIIa inhibitors

Routine post-PCI LMWH

Chronic oral anticoagulation

Stacking:

An Unappreciated Enemy

Different Ways to Look

at Guidelines

• Fanatic

• Accountants

• Lawyers

• Conspiracy

• Xenophile

• Skeptical

• Bigot