! ! ! ! 3"La ottobre" 2015" ischemica cronica oggi: cosa sta cambiando? cardiopatia ! AULA!A! 15.00!)16.30! ! La"Cardiopatia"ischemica"cronica"oggi":"cosa"sta"cambiando?" Moderatori!:!Fiscella!Antonio!)!Gambino!Pietro!–!Mossuti!Ernesto!)!!Spicola!Luigi! Discussant!:!Scordato!Francesca!)!Portale!Anna!!!!! !!!!!!!!! · I!percorsi!nel!postacuto:!Dalle!Linee!Guida!al!Documento!ANMCO/!GICR)IAPCR/GISE!! Gabriele"Michele" G. Di Guardo · Le!metodiche!diagnostiche!non!invasive:!utilità!–!limiti!–!costi! Cardiologia ARNAS Garibaldi-Nesima. Catania Di"Guardo"Giuseppe" Le metodiche diagnostiche non-invasive: utilità – limiti – costi 2013 ESC guidelines on the management of stable coronary artery disease The Task Force on t he m anagem ent of st able coronar y ar t er y disease of t he Eur opean Societ y of Car diology ESC Com m it t ee for Pr act ice Guidelines (CPG): Jose Luis Zam or ano (Chair per son) (Spain), St ephan Achenbach (Ger m any), Helm ut Baum gar t ner (Ger m any), Jer oen J. Bax (N et her lands), Héct or Bueno (Spain), Ver onica Dean (Fr ance), Chr ist i Deat on (UK), Cet in Er ol (Tur key), Rober t Fagar d (Belgium ), Rober t o Fer r ar i (It aly), David Hasdai (Isr ael ), Arno W . Hoes(N ether lands), PaulusKirchhof (Ger m any/UK), Juhani Knuut i (Finland), Philippe Kolh (Belgium), Patr izio Lancellot t i (Belgium), AlesLinhart (Czech Republic), Pet rosN ihoyannopoulos(UK), Massimo F. Piepoli (It aly), Piot r Ponikowski (Poland), Per Ant on Sir nes (N orway), Juan Luis Tam ar go (Spain), Michal Tendera (Poland), Adam Torbicki (Poland), W illiam W ijns (Belgium), Stephan W indecker (Swit zerland). Docum ent Reviewer s: Juhani Knuut i (CPG Review Coor dinat or ) (Finland), Mar co Valgim igli (Review Coor dinat or ) (It aly), Héct or Bueno (Spain), Mar c J. Claeys (Belgium ), N or ber t Donner -Banzhoff (Ger m any), Cet in Er ol (Tur key), Her ber t Fr ank (Aust r ia), Chr ist ian Funck-Br ent ano (Fr ance), Oliver Gaem per li (Swit zer land), José R. Gonzalez-Juanat ey (Spain), Michalis Ham ilos (Gr eece), David Hasdai (Isr ael ), St een Hust ed (Denm ar k), St efan K. Jam es (Sweden), Kar i Ker vinen (Finland), Philippe Kolh (Belgium ), St een Dalby Kr ist ensen (Denm ar k), Pat r izio Lancellot t i (Belgium ), Aldo Piet r o Maggioni (It aly), Massim o F. Piepoli (It aly), Axel R. Pr ies (Ger m any), * Correspondingauthors. The two chairmen contributed equally to the documents. Chairman, France: Professor GillesMontalescot, Institut de Cardiologie, Pitie-Salpetriere University Hospital, Bureau 2-236, 47-83 Boulevard de l’Hopital, 75013 Paris, France. Tel: + 33 1 42 16 30 06, Fax: + 33 1 42 16 29 31. Email: [email protected]. Chairman, Germany: Professor Udo Sechtem, Abteilungfür Kardiologie, Robert Bosch Krankenhaus, Auerbachstr.110,DE-70376 Stuttgart,Germany.Tel: + 497118101 3456,Fax: + 497118101 3795,Email: [email protected] Entities having participated in the development of this document: ESC Associations: Acute Cardiovascular Care Association (ACCA), European Association of Cardiovascular Imaging (EACVI), European Association for Cardiovascular Prevention & Downloaded from by guest on June 30, 2015 Task For ce Mem ber s: Gilles Mont alescot * (Chair per son) (Fr ance), Udo Secht em * (Chair per son) (Ger m any), St ephan Achenbach (Ger m any), Felicit a Andr eot t i (It aly), Chr is Ar den (UK), Andr zej Budaj (Poland), Raffaele Bugiar dini (It aly), Filippo Cr ea (It aly), Thom as Cuisset (Fr ance), Car lo Di Mar io (UK), J. Rafael Fer r eir a (Por t ugal ), Ber nar d J. Ger sh (USA), Anselm K. Git t (Ger m any), Jean-Sebast ien Hulot (Fr ance), N ikolaus Mar x (Ger m any), Lionel H. Opie (Sout h Afr ica), Mat t hias Pfist er er (Swit zer land), Eva Pr escot t (Denm ar k), Fr ank Ruschit zka (Swit zer land), Manel Sabat é (Spain), Roxy Senior (UK), David Paul Taggar t (UK), Er nst E. van der W all (N et her lands), Chr ist iaan J.M. Vr int s (Belgium ). Characteristics of tests commonly used to diagnose the presence of CAD Diagnosis of CAD Sensitivity (%) Specificity (%) Exercise ECG 45-50 85-90 Exercise stress echocardiography 80-85 80-88 Exercise stress SPECT 73-92 63-87 Dobutamine stress echocardiography 79-83 82-86 Dobutamine stress MRI 79-88 81-91 Vasodilatator stress echocardiography 72-79 92-95 Vasodilatator stress SPECT 90-91 75-84 Vasodilatator stress MRI 67-94 61-85 Coronary CTA 95-99 64-83 Vasodilatator stress PET 81-97 74-91 Eur Heart J 2013; 34:2949-3003 Ruolo dei test non invasivi • Chiarire la diagnosi • Presenza di CAD • Assenza di CAD • Identificare i pazienti che beneficeranno di un approccio invasivo • Identificare i pazienti per i quali la CVG rappresenta un rischio non necessario Test non invasivi: un uso crescente Ladapo JA et al Ann Intern Med. 2014 October 7; 161(7):482-490 Noninvasive testing was performed in 83.9% of the patients At catheterization 149,739 patients (37.6%) had obstructive coronary artery disease. No coronary artery disease was reported in 39.2% of the patients Utilità dei Test non invasivi Patients with Obstructive Coronary Artery Disease, According to Noninvasive Test Result Patel MR et al. N Engl J Med 2010: 362:886-895 Test non invasivi: un ruolo da ripensare • L’imaging cardiaco è rimasto uno dei pochi settori della cardiologia immune dalla tendenza di farsi guidare dalla medicina basata sulla evidenza, sottraendosi alla verifica dei suoi risultati in studi prospettici e randomizzati • Portandosi dietro, come corollario, una dilagante inappropriatezza nell’utilizzo delle metodiche assieme ad una crescente preoccupazione sulla lievitazione della spesa sanitaria Gaibazzi N. G Ital Cardiol 2015; 16(9) 462-468 Evaluation of integrated Cardiac Imaging for the Detection and Characterization of Ischemic Heart Disease E’ il primo studio che valuta simultaneamente, in modo prospettico, in una singola popolazione, le capacità diagnostiche di diverse modalità di imaging (anatomiche e funzionali) nell’identificare pazienti con CAD significativa alla CVG. EVINCI Evaluation of Integrated Cardiac Imaging for the Detection and Characterization of Ischemic Heart Disease EVINCI: Enrolment & investigation EVINCI: Imaging Performance to Detect CAD As a field, we must move beyond exclusively examining the necessary, but insufficient, metric of diagnostic accuracy and focus instead on the allimportant goal of using noninvasive testing to improve patient outcomes. PROMISE Prospective Multicenter Imaging Study for Evaluation of Chest Pain • SCOPO Comparare l’outcome di pz con sospetta CAD, a seconda che ricevessero una valutazione anatomica (CTA) o funzionale. • IPOTESI Migliore outcome con l’impiego di test anatomici rispetto a quelli funzionali Douglas PS et al N Engl J Med 2015;372:1291-300 PROMISE Prospective Multicenter Imaging Study for Evaluation of Chest Pain • END POINT primario • morte, IMA, ricovero per angina instabile • complicazioni procedurali maggiori • END POINT secondario • lesioni non ostruttive alla CVG • dose cumulativa di radiazioni Douglas PS et al N Engl J Med 2015;372:1291-300 PROMISE study: flow-chart Douglas PS et al N Engl J Med 2015;372:1291-300 PROMISE study: results (3,3%) 3,0% Douglas PS et al N Engl J Med 2015;372:1291-300 PROMISE study: risultati 12,2% 8,1% Coronarografie, rivascolarizzazioni e outcome in base a test anatomico (CTA) vs funzionale Gaibazzi N et al G Ital Cardiol 2015; 16(9) 462-468 PROMISE study: results Douglas PS et al N Engl J Med 2015;372:1291-300 PROMISE: considerazioni economiche Costo della CTA $ 404 Costo test funzionali Test ergometrico ECO con test da sforzo stress farmacologico Test nucleare da sforzo Test nucleare con farmaco $ 174 $ 514 $ 501 $ 946 $ 1,132 Daniel B. Mark (Duke Clinical Research Center, Durham, NC) Medscape Cardiology http://www.medscape.org/viewarticle/843977 PROMISE: considerazioni economiche Nella gestione successiva agli esami, l'impiego dei test funzionali si associa ad un costo inferiore rispetto alla CTA, ma la differenza non risulta statisticamente significativa TEST FUNZIONALI < 279 $ a 3 mesi < 358 $ a 12 mesi < 388 $ a 2 anni ANGIO-TAC CORONARICA Daniel B. Mark (Duke Clinical Research Center, Durham, NC) Medscape Cardiology http://www.medscape.org/viewarticle/843977 Test non invasivi: costo/beneficio • Mentre le valutazioni cliniche rimangono il criterio chiave per le decisioni, c’è un crescente bisogno di capire le implicazioni economiche di tali decisioni Expert Review of Pharmacoeconomics & Outcomes Research Do For per Cost per quality adjusted lif e years The cost cost–ef –efffect ectiveness ivenessof of diagnost diagnostic ic cardiac cardiac imaging imaging f or st stable able coronary coronary art artery ery disease disease Expert Expert Rev. Rev.Pharmacoecon. Pharmacoecon.Outcomes OutcomesRes. Res.Early Earlyonline, online,1–9 1–9(2015) (2015) Cost per patient Cost per correct diagnosis Cost per life years gained Current economic evidence incoronary the field does not Early artery Early and and accurate accurate diagnosis diagnosisofof stable stablecoronary arterydisease disease(CAD) (CAD)isiscrucial crucialtotoreduce reduce morbidity, morbidity, mortality mortalityand andhealthcare healthcarecosts. costs.This Thiscritical criticalappraisal appraisalofofhealth-economic health-economicliterature literature provide sufficient information to guide the concerning diagnostic totosummarize current concerning non-invasive non-invasive diagnosticcardiac cardiacimaging imagingaims aims summarize currentapproaches approaches to to economic economic evaluation evaluation ofof diagnostic diagnostic cardiac cardiac imaging imaging and and associated associatedprocedural proceduralrisks, risks, inform cardiologists how to use economic analyses for decision-making, highlight areas choice among modalities inform different cardiologists how to use imaging economic analyses for decision-making, highlightor areas where where new new information information could could strengthen strengthen the the economic economic evaluation evaluationand andshed shedlight lightonon cost-effective approaches toto diagnose cost-effective approaches diagnose stable stable CAD. CAD. Economic Economic analysis analysis can can support support strategies for each patient. cardiologists’ decision-making. Current economic evidence in the field does not provide cardiologists’ decision-making. Current economic evidence in the field does not provide 1 Giuseppe Giuseppe Turchet Turchettt i* i* 1,, 2 M MA A Kroes Kroes2,, 11 Valent ina Lorenzoni ,, Valentina Lorenzoni 1 1 Leopoldo Leopoldo Triest Triestee ,, 3 3, Ann-M Ann-M arie arie Chapman Chapman , 4 4, Alison C Sw eet Alison C Sw eet4 , 4 and Geof Geof ff II Wilson Wilson5,6 and 5,6 Danilo Danilo Neglia Neglia 1 1Scuola Superiore Sant’Anna, Pisa, Italy Scuola Superiore Sant’Anna, Pisa, Italy 2 2Abacus International, Bicester, Abacus International, Bicester, Oxfordshire, UK Oxfordshire, UK 3 3BresMed Health Solutions LTD, North BresMed Health Solutions LTD, North Church House, Sheffield, UK Church House, Sheffield, UK 4 4GE Healthcare, Chalfont St. Giles, GE Healthcare, Chalfont St. Giles, Buckinghamshire, UK Buckinghamshire, UK 5 5CNR Institute of Clinical Physiology, CNR Institute of Clinical Physiology, Pisa, Italy Pisa, Italy 6 6Fondazione Toscana G. Monasterio, Fondazione Toscana G. Monasterio, Pisa, Italy Pisa, Italy Cost per reclassification of r isk Cost saving per year sufficient ororstrategies forfor sufficient information informationto toguide guidethe thechoice choiceamong amongdifferent differentimaging imagingmodalities modalities strategies each each patient. patient. Available Available economic economic analyses analysessuggest suggest that that computed computedtomography tomographycoronary coronary0 2 angiography (CTCA) is a cost-effective approach to rule out CAD prior to invasive coronary angiography (CTCA) is a cost-effective approach to rule out CAD prior to invasive coronary angiography angiographyininpatients patientswith withlow lowtotointermediate intermediatepre-test pre-testprobability probabilityofofdisease diseaseand andthat thatstress stress imaging imagingmodalities modalitiesmay maybe becost-effective cost-effectiveatatvariable variablepre-test pre-testprobabilities. probabilities. Figure 2. Outcome measures reported i KKEYWORDS : coronary heart disease . diagnostic cardiac imaging . economic analysis . procedural risk . systematic EYWORDS: coronary heart disease . diagnostic cardiac imaging . economic analysis . procedural risk . systematic review review Coronary Coronary artery artery disease disease (CAD) (CAD) isisthe thesingle single doi: 10.1586/14737167.2015.1051037 The 2013 The 2013European EuropeanSociety SocietyofofCardiology Cardiology SCOT-HEART Scottish Computed Tomography of the HEART End-point primario la proporzione di pz con diagnosi di angina a 6 settimane Valutazione iniziale 36% diagnosi di angina Risultati a 6 settimane diagnosi di angina modificata nel 23% gruppo CTA nell’1% gruppo S.C. www.thelancet.com Vol 385 June 13, 2015 SCOT-HEART Scottish Computed Tomography of the HEART La CTA consentì la riclassificazione della diagnosi di angina in 1 ogni 4 pazienti ed un consistente mutamento nelle successive indagini e nel trattamento terapeutico www.thelancet.com Vol 385 June 13, 2015 SCOT-HEART Scottish Computed Tomography of the HEART La CTA consentì la riclassificazione della diagnosi di angina in 1 ogni 4 pazienti ed un consistente mutamento nelle successive indagini e nel trattamento terapeutico www.thelancet.com Vol 385 June 13, 2015 SCOT-HEART Scottish Computed Tomography of the HEART CTA Riduzione del 38% eventi a F.U. di 1.7 anni www.thelancet.com Vol 385 June 13, 2015 PLATFORM study Prospective Longitudinal Trial of FFRCT Outcomes and Resource Impacts Un test in grado di fornire insieme dati anatomici e funzionali (CTA/FFR) aumenta l’efficienza diagnostica e la sicurezza per il paziente? PLATFORM study Prospective Longitudinal Trial of FFRCT Outcomes and Resource Impacts European Heart Journal Ad European Heart Journal doi:10.1093/eurheartj/ehv444 PLATFORM study Prospective Longitudinal Trial of FFRCT Outcomes and Resource Impacts Riduzione CVG del 61% European Heart Journal Ad European Heart Journal doi:10.1093/eurheartj/ehv444 PLATFORM study Prospective Longitudinal Trial of FFRCT Outcomes and Resource Impacts Una strategia CTA/FFR guidata • rispetto ad un approccio direttamente invasivo riduce il numero delle CVG riduce la diagnosi di CAD non ostruttiva rende più efficiente il triage delle rivascolarizzazioni • non risulta più efficace dei test funzionali nel ridurre le CAD non ostruttive alla CVG European Heart Journal Ad European Heart Journal doi:10.1093/eurheartj/ehv444 Conclusioni • I test non invasivi lasciano finalmente le aride tabelle di sensibilità e specificità ed affrontano il mare aperto degli studi clinici randomizzati • I risultati di trial clinici recenti confermano tuttavia le indicazioni delle attuali linee-guida sulla gestione del dolore toracico stabile • I test funzionali non perdono, a confronto con le più recenti metodiche anatomiche, la loro tradizionale utilità nella stratificazione dei pazienti Conclusioni • Una strategia combinata di test anatomici e funzionali può migliorare il rapporto fra costo e beneficio sia per il paziente che per la società Conclusioni Ulteriori cliniche, osservazioni outcome- oriented, sono tuttavia necessarie per un più appropriato uso delle tecnologie e delle risorse economiche PLATFORM study Prospective Longitudinal Trial of FFRCT Outcomes and Resource Impacts European Heart Jour European Heart Journal doi:10.1093/eurheartj/ehv444 SCOT-HEART Scottish Computed Tomography of the HEART Conclusioni in pz con sospetta angina, l’aggiunta della CTA • chiarisce la diagnosi • riduce il bisogno di ulteriori test • incrementa il ricorso alla CVG (ed alla rivascolarizzazione) • può ridurre il rischio di infarto miocardico www.thelancet.com Vol 385 June 13, 2015 SCOT-HEART Scottish Computed Tomography of the HEART CTA Incremento rivascolarizzazioni a F.U. di 1.7 anni (p=0.0611) www.thelancet.com Vol 385 June 13, 2015 Expert Review of Pharmacoeconomics & Outcomes Research Do For per Cost per quality adjusted lif e years The cost cost–ef –efffect ectiveness ivenessof of diagnost diagnostic ic cardiac cardiac imaging imaging f or st stable able coronary coronary art artery ery disease disease Expert Expert Rev. Rev.Pharmacoecon. Pharmacoecon.Outcomes OutcomesRes. Res.Early Earlyonline, online,1–9 1–9(2015) (2015) 1 Giuseppe Giuseppe Turchet Turchettt i* i* 1,, 2 M MA A Kroes Kroes2,, 11 Valent ina Lorenzoni ,, Valentina Lorenzoni 1 1 Leopoldo Leopoldo Triest Triestee ,, 3 3, Ann-M Ann-M arie arie Chapman Chapman , 4 4, Alison C Sw eet Alison C Sw eet4 , 4 and Geof Geof ff II Wilson Wilson5,6 and 5,6 Danilo Danilo Neglia Neglia 1 1Scuola Superiore Sant’Anna, Pisa, Italy Scuola Superiore Sant’Anna, Pisa, Italy 2 2Abacus International, Bicester, Abacus International, Bicester, Oxfordshire, UK Oxfordshire, UK 3 3BresMed Health Solutions LTD, North BresMed Health Solutions LTD, North Church House, Sheffield, UK Church House, Sheffield, UK 4 4GE Healthcare, Chalfont St. Giles, GE Healthcare, Chalfont St. Giles, Buckinghamshire, UK Buckinghamshire, UK 5 5CNR Institute of Clinical Physiology, CNR Institute of Clinical Physiology, Pisa, Italy Pisa, Italy 6 6Fondazione Toscana G. Monasterio, Fondazione Toscana G. Monasterio, Pisa, Italy Pisa, Italy Cost per patient Cost per correct diagnosis Cost per life years gained Early Early and and accurate accurate diagnosis diagnosisofof stable stablecoronary coronaryartery arterydisease disease(CAD) (CAD)isiscrucial crucialtotoreduce reduce morbidity, morbidity, mortality mortalityand andhealthcare healthcarecosts. costs.This Thiscritical criticalappraisal appraisalofofhealth-economic health-economicliterature literature Cost percurrent reclassification of r isk concerning concerning non-invasive non-invasive diagnostic diagnosticcardiac cardiacimaging imagingaims aimstotosummarize summarize currentapproaches approaches to to economic economic evaluation evaluation ofof diagnostic diagnostic cardiac cardiac imaging imaging and and associated associatedprocedural proceduralrisks, risks, inform cardiologists how to use economic analyses for decision-making, highlight areas inform cardiologists how to use economic analyses for decision-making, highlight areas where where new new information information could could strengthen strengthen the the economic economic evaluation evaluationand andshed shedlight lightonon cost-effective can cost-effective approaches approaches toto diagnose diagnose stable stable CAD. CAD. Economic Economic analysis analysis can support support Cost saving per year cardiologists’ decision-making. Current economic evidence in the field does not provide cardiologists’ decision-making. Current economic evidence in the field does not provide sufficient ororstrategies forfor sufficient information informationto toguide guidethe thechoice choiceamong amongdifferent differentimaging imagingmodalities modalities strategies each each patient. patient. Available Available economic economic analyses analysessuggest suggest that that computed computedtomography tomographycoronary coronary0 2 angiography (CTCA) is a cost-effective approach to rule out CAD prior to invasive coronary angiography (CTCA) is a cost-effective approach to rule out CAD prior to invasive coronary angiography angiographyininpatients patientswith withlow lowtotointermediate intermediatepre-test pre-testprobability probabilityofofdisease diseaseand andthat thatstress stress imaging imagingmodalities modalitiesmay maybe becost-effective cost-effectiveatatvariable variablepre-test pre-testprobabilities. probabilities. Figure 2. Outcome measures reported i KKEYWORDS : coronary heart disease . diagnostic cardiac imaging . economic analysis . procedural risk . systematic EYWORDS: coronary heart disease . diagnostic cardiac imaging . economic analysis . procedural risk . systematic review review Coronary Coronary artery artery disease disease (CAD) (CAD) isisthe thesingle single doi: 10.1586/14737167.2015.1051037 The 2013 The 2013European EuropeanSociety SocietyofofCardiology Cardiology EVINCI study: considerazioni • Riconoscere una CAD ostruttiva con CTA è più utile che identificare o escludere una stenosi funzionalmente significativa con stress-imaging ? • La stenosi angiografica come gold standard deve essere considerato un parametro imperfetto, in assenza di documentate alterazioni funzionali. • Se l'end-point fosse stato la rivascolarizzazione i risultati sarebbero stati identici nei due gruppi (54% con CTA e del 50% con WMI) PROMISE: considerazioni economiche " On the whole, CTA might not be the holy grail it was once hoped to be - that being the complete solution for diagnostic testing - but its more liberal use following the PROMISE standards will definitely improve some aspects of care without causing the economic Armageddon in the healthcare system." Daniel B. Mark (Duke Clinical Research Center, Durham, NC) Medscape Cardiology http://www.medscape.org/viewarticle/843977 A total of 398,978 patients were included in the study. Noninvasive testing was performed in 83.9% of the patients At catheterization 149,739 patients (37.6%) had obstructive coronary artery disease. No coronary artery disease was reported in 39.2% of the patients PLATFORM study Prospective Longitudinal Trial of FFRCT Outcomes and Resource Impacts End-Point primario • Confronto CAD non ostruttiva fra gruppo CVG programmata/gruppo FFRCT End-Point secondario • Confronto CAD non ostruttiva fra gruppo test non invasivi/gruppo FFRCT MACE ed esposizione radiologica a 90 giorni European Heart Journal Ad European Heart Journal doi:10.1093/eurheartj/ehv444