attualità in tema di infarto miocardico acuto stemi - … oltrona heartline... · attualità in...

Luigi Oltrona Visconti

Divisione di Cardiologia

IRCCS Fondazione Policlinico S. Matteo

Pavia

Attualità in tema di

Infarto Miocardico Acuto STEMI

Heartline 2016

Genova 11 – 12 Novembre 2016

LOV 2016

• Reperfusion and outcome

• New therapeutic solutions (?)

• Drugs

• Follow-up management



ACC/AHA 2009 Joint STEMI/PCI Guidelines Focused Update

21

86

7,53,9

0

20

40

60

80

100

% Treated Patients % Mortality

BLITZ (2001)

EYESHOT (2013)

STEMI patients treated with primary PCI and related in-hospital

mortality in 2 Italian Registries (year 2001 – year 2013/2014 )

5

≥600 PPCI/mill/year 400-<600 PPCI/mill/year 200-<400 PPCI/mill/year <200 PPCI/mill/year Data unknown SE

FI

UK IRL

ES PT

BE

DK

PL

CZ

AT

IT

GR

SLO HU

U

RO

MK

BA BG TR

CY

LV

MT

CH HR

AZ

GE

Numbers of Primary PCI per million inhabitants 2010/2011 in 37 ESC member countries,

grouped

E SAU IS

NE

SK

GE

SM

FR

SRB

Number of Catherization laboratories with 24 hour service seven days a week (24/7).

Development from 2007 to 2011 in SFL countries

Countries

Catherization laboratories 24/7

2007 2011

Bulgaria 9 33

Egypt NA 14

France 200 210

Greece 10 18

•Italy 164 211

Portugal 9 21

Romania 0 11

Serbia 1 5

Spain 56 78

Turkey 35 15*

Bucholz EM et al. NEJM 2016;375:1332-1342

LOV 2016

New therapeutic solutions (?)

• Cardioprotective strategies

Remote Ischemic - Post-conditioning - Drugs

• Regenerative therapy

BMC - GCSF - Mesenchymal - Other cells

• Vagal stimulation



• ♂ 52 aa, no-DM, • Sintomi-balloon 165 min • IVA prox, mono-vasale • PCI + stent, flusso finale TIMI 3

• ♂ 42 aa, no-DM, • Sintomi-balloon 179 min • IVA prox, mono-vasale • PCI + stent, flusso finale TIMI 3

Trova le differenze…

Yellon DM, Hausenloy DJ. Myocardial Reperfusion Injury. N Engl J Med, 2007;357:1121-1135.

= Flusso TIMI 3 ≠ Riperfusione

Crimi G. et al., JACC Cardiovasc Interv. 2013 Oct;6(10):1055-63..

Remote Post-Conditioning

Relative Reduction: 20%; 95% CI 0.2% - 28.7%

p=0.043

Standard Error


Crimi G. et al., JACC Cardiovasc Interv. 2013 Oct;6(10):1055-63..

ICE spiral

Pressure bag filled

with 4C saline

Microcatheter tip

0.014’’ guidewire for PTCA and stenting

Microcatheter connection

Thrombus

Hypothermic perfusion

100 pts enrolled

Transcoronary hypothermia

pPCI

pPCI

Cardiac MRI (3-5 days)

Cardiac MRI (3-5 days)

RNDM 1:1

Randomized, open label Blinded evaluation of endpoint

FROST Study

LOV 2016

New therapeutic solutions (?)

• Cardioprotective strategies

Remote Ischemic - Post-conditioning - Drugs

• Regenerative therapy

BMC - GCSF - Mesenchymal - Other cells

• Vagal stimulation



19

(B) Large infarct (MI) in a cytokine-

treated mouse; forming myocardium

(arrowheads) at higher magnification (adjacent panel).

(C) MI in a nontreated mouse.

Healing comprises the entire infarct

(arrowheads). Scarring at higher

magnification (adjacent panel).

EXPERIMENTAL EVIDENCE: 1

20

ENDOGENOUS STRATEGY

G-CSF TRIALS IN STEMI

21 Achilli F. et Al. Heart 2014

http://www.google.it/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&docid=HUVA000QJcU0QM&tbnid=UhC2dcB_D58qhM:&ved=0CAUQjRw&url=http://www.ptca.org/news/2009/0728_RADIAL.html&ei=Bt14U77tKYbuOrWlgbAJ&bvm=bv.66917471,d.d2k&psig=AFQjCNGwgB1hg8IbtXCtd0E5IslQCDQvhg&ust=1400516193914187

22

“The final verdict on G-CSF therapy

will emerge not from meta-analyses, but from adequately

powered randomized controlled trials with optimized study

parameters, i.e., dose, duration, timing, patient

population, and outcome parameters”.

G-CSF TREATMENT IN AMI: FUTURE PERSPECTIVE

23

22/11/2016 23

PHASE III ongoing CT of Cell Therapy

STEM-AMI OUTCOME

1530 Patients with anterior STEMI (LVEF <45%) >3h <12

Large Phase III, open, randomized,

placebo-controlled, multicenter

nationwide Trial.

Primary combined EP: Death; Re

IMA; HF hospitalization

STEM-AMI OUTCOME TRIAL

DESIGN

Phase III, randomized, open label.

1530 Patients will be randomized to standard therapy + G-CSF or standard therapy alone in 1:1 ratio.

Accrual time 3 years. Follow-up time 2 years.

TREATMENT

FILGRASTIM 5 µ/kg will be administered subcutaneously bis in die for 6 days (from Day 0 to Day 5), starting within

24 h after PCI and reperfusion.


PRIMARY EFFICACY END POINT

Clinical outcome will be assessed by the composite endpoint of:

• Death or

• Recurrence of MI or

• hospitalization due to Heart Failure

SAFETY ENDPOINTS

• Incidence and severity of Bleeding complications

• Incidence of Malignancy

• Incidence and intensity of AEs and SAEs


STem cElls Mobilization

in Acute Myocardial Infarction Outcome Trial

A national, multicentre, randomised,

open-label, Phase III study Principal Investigator

Dr. Felice Achilli

46 Cardiologie Italiane

532 Pazienti con STEMI anteriore

arruolati ad oggi

FEVSx media 39%

Sottoprogetto RMN

per studio endpoint surrogati

LOV 2016



• Drugs




ESC 2012

Motovska Z et al. Circulation 2016; in press

PRAGUE 18

ESC 2012

Valgimigli M et al. NEJM 2015; DOI: 10.1056

..

Coprimary composite endpoint of all cause

mortality, myocardial infarction, or stroke

Cu

mu

lati

ve i

nci

den

ce (

%)

Leonardi S et al. BMJ 2016; in press

Cu

mu

lati

ve i

nci

den

ce (

%)

Leonardi S et al. BMJ 2016; in press

Coprimary composite endpoint of all

cause mortality,myocardial infarction,

stroke, or BARC type 3 or 5 bleeding*

Eparina Inibitori GpIIb/IIIA

(enoxaparina)

Bivalirudina

L’ uomo vive di avanzamenti delle

conoscenze scientifiche

ovvero l’ evoluzione della terapia antitrombotica delle

SCA negli ultimi 20 anni

EPIC, etc

1993

2001

ACUITY,

HORIZON, etc HEAT-pPCI

MATRIX 2015

LOV 2016

LOV 2016



• Drugs




Jernberg T et al. EurHJ 2015; 36:1163-1170

CARDIOLOGI CLINICI:

CARDIOLOGI INTERVENTISTI:

CARDIOLOGI RIABILITATORI:

MEDICI DI MEDICINA GENERALE:

GESTIONE QUALITA’:

dr.ssa Roberta Rossini, Bergamo

dr. Luigi Oltrona Visconti, Pavia

dr. Marco Campana, Brescia

dr. Arturo Raisaro, Pavia

dr. Daniele Nassiacos, Saronno

dr. Michele Senni, Bergamo

dr. Giuseppe Musumeci, Bergamo

dr. Corrado Lettieri, Mantova

dr.ssa Francesca Buffoli, Mantova

dr.ssa Battistina Castiglioni, Varese

dr.ssa Paola Colombo, Milano

dr. Stefano De Servi, Legnano

dr. Ugo Limbruno, Grosseto

dr. Marco Ferlini, Pavia

dr.ssa Emanuela Piccaluga, Milano

dr.ssa Daniela Trabattoni, Milano

dr. Roberto Pedretti, Tradate (VA)

dr. PierFranco Ravizza, Merate

dr. Alessandro Filippi, Bergamo

dr. Erminio Tabaglio, Brescia

dr. Alessandro Zadra, Brescia

dr.ssa Maria Grazia Cattaneo, Bergamo

Italian Consensus Document

“Post-PCI Follow-up”

GISE Lombardia, ANMCO Lombardia,

LombardIMA, SIMG Lombardia,

GICR Lombardia

To increase the degree of

appropriateness according

to a standard of quality

PCI in patients with :

1)ACS and LVEF≤45%, or

2)recent finding of low LVEF, or

3)symptoms/signs of heart failure

No

STRATEGY A

FOLLOW-UP

PCI in patients with :

1) ACS with LVEF>45%, or

2) multivessel disease and/or LM and/or

proximal LAD, or

3) incomplete and/or suboptimal

revascularization, or

4) diabetes mellitus

Yes No

STRATEGY C

FOLLOW-UP

STRATEGY B

FOLLOW-UP

Follow-up strategies

Yes

mese

PCI

MMG: Aderenza terapeutica Target lipico Target pressorio Target Hb glicata Sintomi

Cardiologo +ECG Es. ematici*

Ecocardio Test provocativo

0 1 3 6 9 12

TEST PROVOCATIVO ROUTINARIO NON INDICATO NEL PAZIENTE ASINTOMATICO

*: emocromo, glicemia, assetto lipidico, creatinina, esami mirati alla terapia in atto (es. CPK e transaminasi per uso statine, ecc.)

C

FOLLOW-UP PRESSO MMG

GISE Lombardia, ANMCO Lombardia, LombardIMA, SIMG Lombardia, GICR Lombardia

mese

PCI




0 1 3 6 9 12

- Rivascolarizzazione incompleta - Risultato subottimale

A CADENZA BIENNALE

*: emocromo, glicemia, assetto lipidico, funz renale, esami mirati a copatologie (HbA1c, eGFR, ecc), esami mirati terapia in atto (CPK e transaminasi per uso statine). Controlli successivi in funzione dei risultati ottenuti e dei target raggiunti.

ACS

Multivessel CAD

Left main disease

Proximal LAD

Suboptimal/

Incomplete revasc.

Diabetes

Da valutare in base a necessità clinica


A CADENZA ANNUALE


mese

PCI




*: emocromo, glicemia, assetto lipidico, funz renale, esami mirati a copatologie (HbA1c, eGFR, ecc), esami mirati terapia in atto (CPK e transaminasi per uso statine, N-K per anti-aldosteronici). Controlli successivi in funzione dei risultati ottenuti e dei target raggiunti.

0 1 3 6 9 12

Eventualmente biennale, specie in caso di rimodellamento VS

Da valutare in base a percorso B

Annuale nei pazienti in cui persiste disfunzione VS




Simulazione dell’applicazione del protocollo post-PCI (2 anni)

Impatto potenziale sulle liste di attesa

Numero prestazioni cardiologiche di routine/paziente dopo angioplastica coronarica (2 anni)

Prestazioni

effettuate

Prestazioni

previste

∆

prestazioni

Percorso A 5.26 6 - 0.74

Percorso B 4.18 3 + 1.18

Percorso C 4.39 1 + 3.39

Courtesy C. Lettieri

Post-PCI

Registro prospettico multicentrico dei pazienti dimessi dalle Cardiologie della Lombardia

rivascolarizzati con angioplastica coronarica

Società Italiana di Cardiologia Interventistica - GISE

Luigi Oltrona Visconti - Roberta Rossini - Corrado Lettieri - Giuseppe Musumeci

Disegno dello Studio

• Registro osservazionale prospettico

• Multicentrico 38 Cardiologie della Lombardia

• Numero di pazienti da includere 1600

• Durata della partecipazione dalla data della PCI ai 12 mesi

successivi

• Follow-up visita ambulatoriale o contatto telefonico a 12

mesi ± 15 giorni dall’arruolamento

Raccolta dati : Dal 15 Gennaio al 15 Febbraio 2017

EYESHOT (EmploYEd antithrombotic therapies

in patients with acute coronary Syndromes

HOspitalized in iTaly)

Post-MI Registry

200 centers

3 months duration

The EYESHOT Post-MI

Snapshot

LOV 2016

• Reperfusion and outcome to be refined

• New therapeutic solutions (?) ??

• Drugs no news

• Follow-up management a lot to do



attualità in tema di infarto miocardico acuto stemi - … oltrona heartline... · attualità in...

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