Presentazione di PowerPoint - ANMCO · At catheterization 149,739 patients (37.6%) had obstructive coronary artery disease. No coronary artery disease was reported in 39.2% of the

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3"ottobre"2015"!

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"

· Le!metodiche!diagnostiche!non!invasive:!utilità!–!limiti!–!costi!Di"Guardo"Giuseppe"

· Il!punto!di!vista!dell’!emodinamista!alla!luce!delle!nuove!indagini!funzionali!e!di!imaging!!!Tomasello"Davide"

· Trattamento!della!CTO:!indicazioni!e!risultati!Galassi"Alfredo"

· Il!nuovo!ruolo!della!Ranolazina!ed!Ivabradina!alla!luce!delle!recenti!linee!guida!Bonura"Francesca"!Discussione!

!!!!!!!

La cardiopatia ischemica cronica oggi: cosa sta cambiando?

Le metodiche diagnostiche non-invasive: utilità – limiti – costi

G. Di Guardo Cardiologia ARNAS Garibaldi-Nesima. Catania

ESC GUIDELINES

2013 ESC guidelineson the management

of stable coronary artery disease

The Task Force on the management of stable coronary ar tery disease

of the European Society of Cardiology

Task Force Members: Gilles Montalescot * (Chairperson) (France), Udo Sechtem *

(Chairperson) (Germany), Stephan Achenbach (Germany), Felicita Andreot t i (Italy),

Chr is Arden (UK), Andrzej Budaj (Poland), Raffaele Bugiar dini (Italy), Filippo Crea

(Italy), Thomas Cuisset (France), Car lo Di Mar io (UK), J. Rafael Ferreira (Portugal ),

Bernard J. Gersh (USA), Anselm K. Git t (Germany), Jean-Sebast ien Hulot (France),

Nikolaus Marx (Germany), Lionel H. Opie (South Afr ica), Mat thiasPfisterer

(Switzer land), EvaPrescot t (Denmark), Frank Ruschitzka (Switzer land), Manel Sabat e

(Spain), Roxy Senior (UK), David Paul Taggart (UK), Ernst E. van der W all

(Nether lands), Chr ist iaan J.M. Vr ints (Belgium).

ESC Commit tee for Pract ice Guidelines (CPG): Jose Luis Zamorano (Chair person) (Spain), Stephan Achenbach

(Germany), Helmut Baumgartner (Germany), Jeroen J. Bax (Nether lands), Hector Bueno (Spain), Veronica Dean

(France), Chr ist i Deaton (UK), Cet in Erol (Turkey), Rober t Fagard (Belgium), Roberto Ferrar i (Italy), David Hasdai

(Israel ), Arno W . Hoes(Nether lands), PaulusKirchhof (Germany/UK), Juhani Knuut i (Finland), PhilippeKolh (Belgium),

Patr izio Lancellot t i (Belgium), AlesLinhart (Czech Republic), PetrosNihoyannopoulos(UK), Massimo F. Piepoli (Italy),

Piot r Ponikowski (Poland), Per Anton Sirnes (Norway), Juan LuisTamargo (Spain), Michal Tendera (Poland),

Adam Torbicki (Poland), W illiam W ijns (Belgium), Stephan W indecker (Switzer land).

Document Reviewers: Juhani Knuut i (CPG Review Coordinator) (Finland), Marco Valgimigli (Review Coordinator)

(Italy), Hector Bueno (Spain), Marc J. Claeys (Belgium), Norbert Donner-Banzhoff (Germany), Cet in Erol (Turkey),

Herbert Frank (Aust r ia), Chr ist ian Funck-Brentano (France), Oliver Gaemper li (Switzer land),

Jose R. Gonzalez-Juanatey (Spain), Michalis Hamilos (Greece), David Hasdai (Israel ), Steen Husted (Denmark),

Stefan K. James (Sweden), Kar i Kervinen (Finland), Philippe Kolh (Belgium), Steen Dalby Kr ist ensen (Denmark),

Pat r izio Lancellot t i (Belgium), Aldo Piet ro Maggioni (Italy), Massimo F. Piepoli (Italy), Axel R. Pr ies (Germ any),

* Correspondingauthors. Thetwo chairmen contributed equally to thedocuments. Chairman, France: Professor GillesMontalescot, Institut deCardiologie,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], Germany:

Professor UdoSechtem,Abteilungfur Kardiologie,Robert BoschKrankenhaus, Auerbachstr.110,DE-70376Stuttgart,Germany.Tel:+ 4971181013456,Fax:+ 4971181013795,Email:

[email protected]

Entities havingparticipated in the development of thisdocument:

ESC Associations: Acute Cardiovascular Care Association (ACCA), European Association of Cardiovascular Imaging (EACVI), European Association for Cardiovascular Prevention &

Rehabilitation (EACPR), European Association of Percutaneous Cardiovascular Interventions (EAPCI), Heart Failure Association (HFA)

ESC WorkingGroups: Cardiovascular Pharmacology and DrugTherapy,Cardiovascular Surgery, Coronary Pathophysiology and Microcirculation, Nuclear Cardiology and Cardiac CT,

Thrombosis, Cardiovascular Magnetic Resonance

ESC Councils: Cardiology Practice, Primary Cardiovascular Care

Thecontent of these European Society of Cardiology (ESC) Guidelineshasbeen published for personal and educational use only. No commercial use isauthorized.No part of the ESC

Guidelinesmaybetranslatedor reproduced inanyformwithout writtenpermission fromtheESC.Permission canbeobtaineduponsubmissionofawrittenrequest to OxfordUniversity

Press, the publisher of the European Heart Journal and the party authorized to handle such permissions on behalf of the ESC.

Disclaimer .The ESC Guidelines represent the viewsof theESC and werearrived at after careful consideration of the available evidence at the time they werewritten. Health profes-

sionalsare encouraged to take them fully into account when exercising their clinical judgement. The Guidelines do not, however, override the individual responsibility of health profes-

sionalstomakeappropriatedecisionsinthecircumstancesof theindividual patients, inconsultationwiththat patient andwhereappropriateandnecessary thepatient’sguardian or carer. It

isalso the health professional’s responsibility to verify the rulesand regulationsapplicable to drugs and devicesat the time of prescription.

& The European Society of Cardiology 2013. All rights reserved. For permissionsplease email: [email protected]

European Heart Journal (2013) 34, 2949–3003

doi:10.1093/eurheartj/eht296

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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

Patients with Obstructive Coronary Artery Disease, According to Noninvasive Test Result

Patel MR et al. N Engl J Med 2010: 362:886-895

Utilità dei Test non invasivi

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

Enrolment & investigation EVINCI:

Imaging Performance to Detect CAD EVINCI:

As a field, we must move beyond exclusively

examining the necessary, but insufficient, metric of

diagnostic accuracy and focus instead on the all-

important goal of using noninvasive testing to

improve patient outcomes.

• 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

Prospective Multicenter Imaging Study for Evaluation of Chest Pain PROMISE

Douglas PS et al N Engl J Med 2015;372:1291-300

• END POINT primario • morte, IMA, ricovero per angina instabile • complicazioni procedurali maggiori

• END POINT secondario

• lesioni non ostruttive alla CVG • dose cumulativa di radiazioni


Prospective Multicenter Imaging Study for Evaluation of Chest Pain PROMISE


PROMISE study: flow-chart

PROMISE study: results


(3,3%) 3,0%

Gaibazzi N et al G Ital Cardiol 2015; 16(9) 462-468

Coronarografie, rivascolarizzazioni e outcome in base a test anatomico (CTA) vs funzionale

12,2%

8,1%

PROMISE study: risultati


PROMISE study: results

Costo della CTA $ 404 Costo test funzionali Test ergometrico $ 174 ECO con test da sforzo $ 514 stress farmacologico $ 501 Test nucleare da sforzo $ 946 Test nucleare con farmaco $ 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

ANGIO-TAC CORONARICA

< 279 $ a 3 mesi < 358 $ a 12 mesi < 388 $ a 2 anni

• Mentre le valutazioni cliniche rimangono il criterio chiave per le decisioni, c’è un crescente bisogno di capire le implicazioni economiche di tali decisioni

Test non invasivi: costo/beneficio

The cost–effect iveness of

diagnost ic cardiac imaging

for stable coronary artery

diseaseExpert Rev. Pharmacoecon. Outcomes Res. Early online, 1–9 (2015)

Giuseppe Turchett i* 1,

MA Kroes2,

Valent ina Lorenzoni1,

Leopoldo Trieste1,

Ann-Marie Chapman3,

Alison C Sweet4,

Geoff I Wilson4 and

Danilo Neglia5,6

1Scuola Superiore Sant’Anna, Pisa, Italy2Abacus International, Bicester,

Oxfordshire, UK3BresMed Health Solutions LTD, North

Church House, Sheffield, UK4GE Healthcare, Chalfont St. Giles,

Buckinghamshire, UK5CNR Institute of Clinical Physiology,

Pisa, Italy6Fondazione Toscana G. Monasterio,

Pisa, Italy

* Author for correspondence:

Tel.: +39 0 5088 3808

[email protected]

Early and accurate diagnosis of stable coronary artery disease (CAD) is crucial to reduce

morbidity, mortality and healthcare costs. This critical appraisal of health-economic literature

concerning non-invasive diagnostic cardiac imaging aims to summarize current approaches

to economic evaluation of diagnostic cardiac imaging and associated procedural risks,

inform cardiologists how to use economic analyses for decision-making, highlight areas

where new information could strengthen the economic evaluation and shed light on

cost-effective approaches to diagnose stable CAD. Economic analysis can support

cardiologists’ decision-making. Current economic evidence in the field does not provide

sufficient information to guide the choice among different imaging modalities or strategies for

each patient. Available economic analyses suggest that computed tomography coronary

angiography (CTCA) is a cost-effective approach to rule out CAD prior to invasive coronary

angiography in patients with low to intermediate pre-test probability of disease and that stress

imaging modalitiesmay be cost-effective at variable pre-test probabilities.

KEYWORDS: coronary heart disease . diagnostic cardiac imaging . economic analysis . procedural risk . systematic

review

Coronary artery disease (CAD) is the single

most common cause of health-related death in

the EU, accounting for at least 681,000 deaths

each year, 15% among men and 13% among

women [1]. CAD costs the EU economy

almost e 38 billion a year: healthcare-related

costs account for about e 20 billion, produc-

tivity losses due to mortality cost e 12 billion

and productivity losses due to morbidity cost

e 5.5 billion, with an additional e 23 billion

spent on informal care [1]. Early and accurate

diagnosis in patients with symptoms suspected

for stable CAD is crucial to reduce the burden

of disease [2–4]. Invasive coronary angiography

(ICA) is the current gold standard for estab-

lishing the presence, location and severity of

disease. However, the technique is costly and

associated with a small risk of morbidity and

mortality [5]. Significant improvements in non-

invasive imaging have driven increased interest

to use these procedures more routinely in the

diagnostic algorithm for patients with sus-

pected CAD [6].

The 2013 European Society of Cardiology

(ESC) Guidelines for the management of sta-

ble CAD recommend diagnostic tests based on

a patient’s pre-test probability (PTP) of CAD

determined from age, gender and symptoms.

For patients with intermediate PTP (15–

85%), a functional stress test is recommended,

chosen from echocardiography (ECHO), car-

diac magnetic resonance (MRI) and nuclear

myocardial perfusion imaging, while computed

tomography coronary angiography (CTCA) is

a valid alternative for patients with lower PTP

(15–50%) [7]. The 2013 Appropriateness Cri-

teria from the American College of Radiology

(ACR) reviewed the evidence base for non-

invasive diagnostic techniques and consider

single photon emission computed tomography

(SPECT), ECHO, CTCA, MRI and positron

emission tomography (PET) to have similar

merit [8]. These guidelines provide an assess-

ment of the quality and value of clinical evi-

dence for different tests, but do not provide

specific guidance on when one test is more

informahealthcare.com 10.1586/14737167.2015.1051037 Ó 2015 Informa UK Ltd ISSN 1473-7167 1

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Finally, outcome measures varied considerably, even for the

same type of economic analysis. Less than half of CEA studies

(n = 9, 27%) of CEA studies (n = 14, 45%) used diagnostic

performance of tests as the measure of effectiveness mainly

expressing incremental cost–effectiveness ratios in terms of costs

per correctly identified CAD patient. Fourteen (42%) CEA

studies reported costs per quality-adjusted life-year (QALY).

The remaining studies reported cost per cardiac event detected

or prevented, or cost per hospitalization avoided (FIGURE 2).

Further quality assessment using the Drummond 10-point

checklist (TABLE 2) highlighted three common areas of concern:

effectiveness, costs and the way in which costs were measured

(including the sources of costs). Twenty-six studies (79%) were

judged either unclear (n = 12, 36%) or insufficient (n = 14,

42%) with regard to reporting effectiveness input data. Costs

reporting was considered insufficient for 20 studies (61%) and

a further 11 (33%) studies did not clearly report cost input.

Measurement of costs was either insufficient (n = 15, 45%) or

unclear (n = 16, 48%) in the majority of

studies.

In general, studies were judged posi-

tively with respect to the definition of

the study question and presenting results

as incremental analysis (n = 24, 73% for

both) as well as with regard to the inter-

pretation and discussion of results

(n = 20, 61%).

Direct comparison between study

results is therefore difficult due to the

different alternatives considered in the

economic evaluations. Thus, a brief sum-

mary of the evidence is reported, limited

to studies comparing non-invasive tests

versus ICA.

In particular, 12 studies, where a

CTCA strategy has been compared with

an ICA strategy, found the CTCA strat-

egy to be generally cost-effective com-

pared with the ICA strategy in patients

with low and low-to-intermediate PTP of

CAD [17,19–23,29,31,34,40,45,49]. The cost–

effectivenessof aCTCA strategy isdepen-

dent on anumber of factors, but thePTP

of disease is a key driver. The PTPs were

not reported, or expressed as prevalence

of CAD, in two publications [40,49].

A further study reported PTP as low to

Table 1. Number of studies performed by diagnost ic procedures evaluated.

ECHO CTCA SPECT MRI PET ICA

CUA n = 3

[30,46]* ,[42]

n = 8

[23,24,30,49]* ,[17,29,34,38]

n = 10

[26,30,37,46,47]* ,[18,33,34,38,42]

n = 3

[46]* ,[40,47]

n = 0 n = 12

[17,23,26,29,30,34,37,46,47,49]* ,

[38,42]

CEA n = 6

[20,22]* ,[31,32,35,43]

n = 7

[19–22,27,45]* ,[39]

n = 5

[22,27]* ,[25,28,43]

n = 4

[20,36]* ,[28,41]

n = 2

[27]* ,[44]

n = 7

[20–22,36,41,45]* ,

[19,41]

CCA n = 1

CCA [48]

n = 1

CCA [40]*

n = 0 n = 0 n = 0 n = 2

CCA [40,48]

N 10 16 15 7 2 21

* Studies reporting evaluation of risk associated with diagnostic procedure.Note: Numbers shown include duplicates, reflecting the comparison of two or more procedures in some publications.CCA: Cost-consequence analysis; CEA: Cost–effectiveness analysis; CTCA: Computed tomography coronary angiography; CUA: Cost–utility analysis; ECHO: Echocardiog-raphy; ICA: Invasive coronary angiography; SPECT: Single photon emission computed tomography.

0 2 4 6 8 10 12 14 16

Cost saving per year

Cost per reclassification of r isk

Cost per life years gained

Cost per correct diagnosis

Cost per patient

Cost per quality adjusted lif e years

Number of studies

Figure 2. Outcome measures reported in selected publications.

Review Turchetti, Kroes, Lorenzoni et al.

doi: 10.1586/14737167.2015.1051037 Expert Rev. Pharmacoecon. OutcomesRes.

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MA Kroes2,


Leopoldo Trieste1,

Ann-Marie Chapman3,

Alison C Sweet4,

Geoff I Wilson4 and

Danilo Neglia5,6






Pisa, Italy


Tel.: +39 0 5088 3808

[email protected]















review























pected CAD [6].

























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Current economic evidence in the field does not provide sufficient information to guide the choice among different imaging modalities or strategies for each patient.

SCOT-HEART

End-point primario la proporzione di pz con diagnosi di angina a 6 settimane

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

Valutazione iniziale 36% diagnosi di angina

Scottish Computed Tomography of the HEART

http://www.thelancet.com


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

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




CTA

Riduzione del 38% eventi a F.U. di 1.7 anni



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?

.....................................................................................................................................................................................

ESC Hot Line

Clinical outcomes of fract ional flow reserve by

computed tomographic angiography-guided

diagnost ic strategies vs. usual care in patients

with suspected coronary artery disease: the

prospective longitudinal tr ial of FFRct: outcome

and resource impacts study

Pamela S. Douglas1*, Gianluca Pontone2, Mark A. Hlatky3, Manesh R. Patel1,

Bjarne L. Norgaard4, Robert A. Byrne5, Nick Curzen6, Ian Purcell7,

Mat thias Gutber let 8, Gilles Rioufol9, Ulr ich Hink10, Herwig W alter Schuchlenz11,

Gudrun Feuchtner 12, Mart ine Gilard13, Daniele Andreini2, Jesper M. Jensen4,

Mart in Hadamitzky5, Karen Chiswell1, Derek Cyr 1, Alan W ilk14, Furong W ang14,

Campbell Rogers14, and Bernard De Bruyne15, On Behalf of the PLATFORM

Invest igators†

1DukeClinical Research Institute, Duke University School of Medicine,7022 North Pavilion DUMC,PO Box 17969, Durham, NC 27715,USA; 2Centro Cardiologico Monzino, IRCCS,

University of Milan,Milan, Italy; 3Department of Health Research and Policy,Stanford University School of Medicine,Stanford, CA,USA; 4Department of Cardiology, AarhusUniversity

Hospital, Aarhus Skejby, Denmark; 5Deutsches Herzzentrum Munchen, Technische Universitat Munchen, Munich, Germany; 6University Hospital Southampton NHSTrust,

Southampton, UK;7Freeman Hospital,Newcastle upon Tyne, UK; 8University of LeipzigHeart Centre,Leipzig, Germany; 9HospicesCivilsdeLyon and CARMEN INSERM 1060, Lyon,

France; 10Department of Cardiology, Johannes Gutenberg University Hospital, Mainz, Germany; 11LKH Graz West, Graz, Austria; 12Department of Radiology, Innsbruck Medical

University, Innsbruck, Austria; 13Department of Cardiology, Cavale Blanche Hospital, Brest, France; 14HeartFlow, Redwood City, CA, USA; and 15Cardiovascular Centre Aalst, Aalst,

Belgium

Received 6 July 2015; revised 6 August 2015; accepted 12 August 2015

A im s In symptomatic patients with suspected coronary artery disease (CAD), computed tomographic angiography (CTA)

improves patient selection for invasive coronary angiography (ICA) compared with functional testing. The impact of

measuring fractional flow reserve by CTA (FFRCT) is unknown.

Met hods

and r esult s

At 11sites,584patientswithnew onset chest painwereprospectivelyassigned to receiveeither usual testing(n¼ 287)

or CTA/FFRCT(n¼ 297). Test interpretation and caredecisionsweremadeby theclinical care team.Theprimaryend-

point was the percentage of those with planned ICA in whom no significant obstructive CAD (no stenosis ≥ 50%by

core laboratory quantitative analysis or invasive FFR, 0.80) was found at ICA within 90 days. Secondary endpoints

including death, myocardial infarction, and unplanned revascularization were independently and blindly adjudicated.

Subjects averaged 61+ 11 years of age, 40%were female, and the mean pre-test probability of obstructive CAD

was 49+ 17%. Among those with intended ICA (FFRCT-guided ¼ 193; usual care¼ 187), no obstructive CAD was

found at ICA in 24 (12%) in the CTA/FFRCT arm and 137 (73%) in the usual care arm (risk difference 61%, 95%

confidence interval 53–69, P, 0.0001), with similar mean cumulative radiation exposure (9.9 vs. 9.4 mSv,

* Corresponding author. Tel: + 1 919 681 2690, Fax: + 1 919 668 7059, Email: [email protected]

†Members are listed in Appendix.

& The Author 2015. Published by Oxford University Press on behalf of the European Society of Cardiology.

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which

permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact

[email protected]

European Heart Journal

doi:10.1093/eurheartj/ehv444

European Heart Journal Advance Access published September 1, 2015

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Belgium





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Riduzione CVG del 61%

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

.....................................................................................................................................................................................

ESC Hot Line













Invest igators†







Belgium





Met hods

and r esult s















[email protected]




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• 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 osservazioni cliniche, outcome-oriented, sono tuttavia necessarie per un più appropriato uso delle tecnologie e delle risorse economiche

Conclusioni

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ESC Hot Line













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Belgium





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PLATFORM study



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




Incremento rivascolarizzazioni a F.U. di 1.7 anni (p=0.0611)

CTA








MA Kroes2,


Leopoldo Trieste1,

Ann-Marie Chapman3,

Alison C Sweet4,

Geoff I Wilson4 and

Danilo Neglia5,6






Pisa, Italy


Tel.: +39 0 5088 3808

[email protected]















review























pected CAD [6].

























Review

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Finally, outcome measures varied considerably, even for the

same type of economic analysis. Less than half of CEA studies

(n = 9, 27%) of CEA studies (n = 14, 45%) used diagnostic

performance of tests as the measure of effectiveness mainly

expressing incremental cost–effectiveness ratios in terms of costs

per correctly identified CAD patient. Fourteen (42%) CEA

studies reported costs per quality-adjusted life-year (QALY).

The remaining studies reported cost per cardiac event detected

or prevented, or cost per hospitalization avoided (FIGURE 2).

Further quality assessment using the Drummond 10-point

checklist (TABLE 2) highlighted three common areas of concern:

effectiveness, costs and the way in which costs were measured

(including the sources of costs). Twenty-six studies (79%) were

judged either unclear (n = 12, 36%) or insufficient (n = 14,

42%) with regard to reporting effectiveness input data. Costs

reporting was considered insufficient for 20 studies (61%) and

a further 11 (33%) studies did not clearly report cost input.

Measurement of costs was either insufficient (n = 15, 45%) or

unclear (n = 16, 48%) in the majority of

studies.

In general, studies were judged posi-

tively with respect to the definition of

the study question and presenting results

as incremental analysis (n = 24, 73% for

both) as well as with regard to the inter-

pretation and discussion of results

(n = 20, 61%).

Direct comparison between study

results is therefore difficult due to the

different alternatives considered in the

economic evaluations. Thus, a brief sum-

mary of the evidence is reported, limited

to studies comparing non-invasive tests

versus ICA.

In particular, 12 studies, where a

CTCA strategy has been compared with

an ICA strategy, found the CTCA strat-

egy to be generally cost-effective com-

pared with the ICA strategy in patients

with low and low-to-intermediate PTP of

CAD [17,19–23,29,31,34,40,45,49]. The cost–

effectivenessof aCTCA strategy isdepen-

dent on anumber of factors, but thePTP

of disease is a key driver. The PTPs were

not reported, or expressed as prevalence

of CAD, in two publications [40,49].

A further study reported PTP as low to

Table 1. Number of studies performed by diagnost ic procedures evaluated.

ECHO CTCA SPECT MRI PET ICA

CUA n = 3

[30,46]* ,[42]

n = 8

[23,24,30,49]* ,[17,29,34,38]

n = 10

[26,30,37,46,47]* ,[18,33,34,38,42]

n = 3

[46]* ,[40,47]

n = 0 n = 12

[17,23,26,29,30,34,37,46,47,49]* ,

[38,42]

CEA n = 6

[20,22]* ,[31,32,35,43]

n = 7

[19–22,27,45]* ,[39]

n = 5

[22,27]* ,[25,28,43]

n = 4

[20,36]* ,[28,41]

n = 2

[27]* ,[44]

n = 7

[20–22,36,41,45]* ,

[19,41]

CCA n = 1

CCA [48]

n = 1

CCA [40]*

n = 0 n = 0 n = 0 n = 2

CCA [40,48]

N 10 16 15 7 2 21

* Studies reporting evaluation of risk associated with diagnostic procedure.Note: Numbers shown include duplicates, reflecting the comparison of two or more procedures in some publications.CCA: Cost-consequence analysis; CEA: Cost–effectiveness analysis; CTCA: Computed tomography coronary angiography; CUA: Cost–utility analysis; ECHO: Echocardiog-raphy; ICA: Invasive coronary angiography; SPECT: Single photon emission computed tomography.

0 2 4 6 8 10 12 14 16

Cost saving per year

Cost per reclassification of r isk

Cost per life years gained

Cost per correct diagnosis

Cost per patient

Cost per quality adjusted lif e years

Number of studies

Figure 2. Outcome measures reported in selected publications.

Review Turchetti, Kroes, Lorenzoni et al.

doi: 10.1586/14737167.2015.1051037 Expert Rev. Pharmacoecon. OutcomesRes.

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MA Kroes2,


Leopoldo Trieste1,

Ann-Marie Chapman3,

Alison C Sweet4,

Geoff I Wilson4 and

Danilo Neglia5,6






Pisa, Italy


Tel.: +39 0 5088 3808

[email protected]















review























pected CAD [6].

























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• 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)

EVINCI study: considerazioni



" 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."


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

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

.....................................................................................................................................................................................

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Invest igators†







Belgium





Met hods

and r esult s















[email protected]




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PLATFORM study


Documents

Presentazione di PowerPoint - ANMCO · At catheterization 149,739 patients (37.6%) had obstructive coronary artery disease. No coronary artery disease was reported in 39.2% of the