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Appropriatezza clinica nella diagnosi e terapia della Cardiopatia Ischemica
Cronica
G. Casolo
UOC Cardiologia Ospedale della VersiliaConsiglio Direttivo Nazionale ANMCO
Tigullio CardiologiaSanta Margherita Ligure, 7/8 aprile 2016
Cardiopatia IschemicaCardiopatia Ischemica
Appropriatezza
La miglior scelta per lo stato di salute del nostro paziente compatibilmentecon le risorse disponibili e con un progetto di cura che abbia un reale valore
Diagnostica
Prescrittiva
Terapeutica
Economica
Professionale
Organizzativa
Concetto molto utilizzato, di difficiledeclinazione, soggettivo, non universale,non costante nel tempo, applicato a dimensioni differenti, in genere a fini di contenimento di spesa
Outline
• Cosa intendiamo per cardiopatia ischemica cronica?
• Il paziente come raggiunge questa diagnosi?
• Quali strumenti diagnostico-terapeutici devono essere impiegati nel singolo paziente?
• Cosa deve o dovrebbe guidare la scelta e il tipo di trattamento?
Diagnosi e terapia della Cardiopatia Ischemica Cronica
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Clinical Conditions associated with the definition of Chronic CAD
• Chronic stable angina• Post-myocardial infarction• Post-revascularization CAD• Obstructive CAD• CAD with demonstration of ischemia• CAD with demonstration of viability• Left ventricular dysfunction and CAD
Clinical Patterns of Stable Coronary Artery Disease
Steg et Al. JAMA Intern Med. 2014
REGISTRO CLARIFY
Prospective Observational Longitudinal Registry of Patients With Stable Coronary Artery Disease
32 105 outpatients
20 291 (63.2%) had undergone a noninvasive test
Observed prevalence of angiographically confirmed 50% stenotic CAD
Cheng et Al. Circulation. 2011
Observed prevalence of angiographically confirmed 50% stenotic CAD
Cheng et Al. Circulation. 2011
Linee Guida ESC
• Quanto è appropriato non fare diagnosi di malattia ma solo di prognosi?
• La prognosi è una malattia?
• Siamo sicuri di conoscere quali sono i determinanti prognostici al punto di evitare di conoscere l’anatomia coronarica oggi?
Outcome of Stable Coronary Artery Disease (Registro Clarify)
Steg et Al. JAMA Intern Med. 2014 82278
Primary Outcome and Various Composite Outcomes for Patient Groups
Steg et Al. JAMA Intern Med. 2014
Annual Event Rates Stratified by Cardiac Computed Tomography Angiography Result
Hulten et al. JACC, 2011
• Diagnostica– Non invasiva (stress eco, SPECT,MDCT)– Invasiva (ICA - FFR - IVUS)
• Terapeutica– Terapia medica– Terapia interventistica e chirurgica
Appropriatezza diagnostica e terapeutica nel paziente con CAD cronica
Lin GA et Al. BMJ 2008
Rate ratio of stress testing prior to PCI in USA
Lin GA et Al. BMJ 2008
44% in media di stresstest prima di PCI
Proporzione di test non invasivi svolti in 2700 Ospedali
549.078 patients at 224 hospitalsAdmissions for suspected ischemia
Safavi et Al. JAMA Int Med 2014
Premier database includes administrative, operational, and some clinical data from 2700 hospitals in the United States.
Rapporto tra test di ischemia e coronarografie e rivascolarizzazioni
Safavi et Al. JAMA Int Med 2014 549.078 patients at 224 hospitalsAdmissions for suspected ischemia
Relazione tra test di ischemia e angiografia, rivascolarizzazioni e reingressi
Safavi et Al. JAMA Int Med 2014
L’inappropriatezza genera inappropriatezza
National Cardiovascular Data Registry
398,978 patients x 663 Hospitals
Patients without known coronary artery disease who were undergoing elective catheterization
37.6% had obstructive coronary artery disease
Patel et al. N Engl J Med 2010;362:886-95
2012 ACCF/AHA/ACP/AATS/PCNA/SCAI/STS Guidelinefor the Diagnosis and Management of Patients WithStable Ischemic Heart Disease
Variation in Hospital rate of asymptomatic patients at angiography
Bradley et Al. JAMA Int Med 2014
Relazione tra ICA eseguita in pazienti asintomatici e PCI inappropriate
Bradley et Al. JAMA Int Med 2014
Data from patients who underwent CABG surgery and PCI without acute coronary syndrome or previous CABG surgery in New York in 2009 and 2010
Rating Cases as Appropriatefor Revascularization According to
ACC/AHA Appropriate Use Criteria Patients
Hannah et Al. JACC 2012
JAMA Int Med 2014
Rita F. Redberg
Sham Controls in Medical Device Trials
N ENGL J MED September 4, 2014
PCI, a widely used procedure for treating stable coronary artery disease, has never been investigated in a blinded trial. Some nonblinded RCTs have shown that PCI has a beneficial effect on anginal symptoms, but there appears to be no difference between PCI and medical therapy in rates of the objective end points of nonfatal myocardial infarction and death due to cardiac causes. It is possible, therefore, that the perceived symptomatic benefit is actually a placebo effect and not attributable to PCI. Although a blinded trial would be relatively straightforward if two groups of patients were randomly assigned to a cardiac catheterization procedure, as was done for renal-artery denervation, such a study has yet to be performed, and the important question of PCI's actual clinical benefit therefore remains unanswered
Revascularisation versus medical treatment in patientswith stable coronary artery disease: network
meta-analysis
Windeker et Al. BMJ 2014
E-ZES=zotarolimus eluting (Endeavor) stent; R-ZES=zotarolimus eluting (Resolute) stent; EES=everolimus eluting stent
Revascularisation versus medical treatment in patientswith stable coronary artery disease: network
meta-analysis
Windeker et Al. BMJ 2014
E-ZES=zotarolimus eluting (Endeavor) stent; R-ZES=zotarolimus eluting (Resolute) stent; EES=everolimus eluting stent
Metanalisi effetto PCI in pazienti con CAD stabile e ischemia
Stergiopoulos et l. JAMA Intern Med 2014
Metanalisi effetto PCI in pazienti con CAD stabile e ischemia
Stergiopoulos et l. JAMA Intern Med 2014
Morte IMA non fatale
Revasc Unplanned Angina in FU
Freedom From Death, MI, or NSTE-ACS by Percent of Ischemic Myocardium or by
Anatomic Burden
Mancini et Al. Jacc Interv 2014
Proportion of Patients With Death, Myocardial Infarction or Non–ST-Segment Elevation Acute Coronary Syndrome by Ischemic Myocardium
and Atherosclerotic Burden of Disease
Mancini et Al. Jacc Interv 2014
Hiroo Onoda remained on an island in the Philippines until 1974 (29 years)
Declines in Rates of Death from Major Noncommunicable Diseases in the United States, 1950
to 2010
Hunter et Al. NEJMed 2013
Cardiovascular disease mortality trends for males and females (United States: 1979–2013).
Mozaffarian et al. Heart and Stroke Statistics 2016. Circulation 2016
US age-standardized death rates attributable to CV disesases, 2000 to 2013
Mozaffarian et al. Heart and Stroke Statistics 2016. Circulation 2016
-46%
Cardiovascular disease in Europe epidemiological update 2015
European Heart Journal Advance Access published August 25, 2015
Prevalence of CAD (2010)
Prevalence of coronary heart disease by age and sex
Mozaffarian D et al. Circulation. 2015;131:e29-e322
Prevalence of angina pectoris by age and sex (National Health and Nutrition Examination Survey:
2009–2012)
Mozaffarian et al. Heart and Stroke Statistics 2016. Circulation 2016
Incidence of angina pectoris (deemed uncomplicated on the basis of physician interview of patient) by age
and sex (Framingham Heart Study 1986–2009)
Mozaffarian et al. Heart and Stroke Statistics 2016. Circulation 2016
Secular trends in age-and sex-standardized prevalence rates of angina for adults aged ≥40
years in the United States
Mozaffarian et al. Heart and Stroke Statistics 2016. Circulation 2016
Temporal Trends in the Frequency of InducibleMyocardial Ischemia During Cardiac Stress Testing
Rozansky et Al. JACC 2013
Accuracy of a Test of Ischemia
All’aumentare della prevalenza si riducono i falsi positivi e i falsi negativi
???
30 day and 31–365 day mortality after first time hospitalisation for myocardial infarction between 1984 and 2008,
according to comorbidity category
Schmidt M et Al. BMJ 2012
Years after PCI
36%
64%
Spoon et Al, Circulation 2014
• 10 US academic and community hospitals performing percutaneous coronary interventions between 2009 and 2011
• 991 patients with stable coronary artery disease undergoing elective percutaneous coronary intervention.
Variation in patients’ perceptions of electivepercutaneous coronary intervention in stable coronary
artery disease
Kureshi et Al. BMJ 2014
Kureshi et Al. BMJ 2014
Variation in patients’ perceptions of electivepercutaneous coronary intervention in stable coronary
artery disease
Reasons for performing and beliefs about PCI
Rothberg et Al. Ann Intern Med. 2010
Year: 2000 2000 2002 2003 2004 2007
Appropriatezza Clinica
• Evidenze scientifiche datate• Popolazioni differenti e più anziane• Prognosi di popolazione in miglioramento• Ruolo dell’Ischemia moderato-severa in
discussione • Terapie (anche farmacologiche) sempre più
efficaci (non sempre prive di effetti indesiderati)
• Peso delle comorbidità crescente
Conclusioni
• L’appropriatezza è un argomento complesso e difficile da declinare in modo univoco o condiviso
• Le basi su cui poggiano le nostre idee di appropriatezza sono deboli e spesso non “appropriate” per il nostro singolo paziente
• L’appropriatezza clinica non può sottrarsi da una impostazione Professionale ispirata ai più elevati ideali etici, dalla esperienza, dal buon senso e da un confronto col paziente
• Dal costo, l’appropriatezza Clinica giunge alla dimensione del Valore dell’Atto Clinico. Tale valore non ha prezzo
