quello che le linee guida non dicono - · pdf filechange in class of recommendations between...
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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
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
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
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
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?
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