campagna educazionale anmco sindromi coronariche acute: dalle linee guida europee al paziente del...

Campagna educazionale ANMCO

SINDROMI CORONARICHE ACUTE: DALLE LINEE GUIDA EUROPEE AL PAZIENTE DEL MONDO

REALE

Opzioni terapeutiche nelle SCA tra nuove linee guida e nuove evidenze

Overview

• Nuove linee guida e strategie

• Anticoagulanti

• Antiaggreganti

• STEMI complicato da shock

STEMI: 2012 ESC guidelines


Componenti del ritardo nella riperfusione dello STEMI


Il trattamento ottimale dello STEMI deve essere basato sull’implementazione della rete per l’infarto miocardico acuto. Le caratteristiche essenziali della rete risiedono nelle necessita’ che i suoi componenti:1.abbiano una chiara definizione dell’area geografica di responsabilita’2.Condividano protocolli di diagnosi , trasporto e trattamento, incluso l’eventuiale personale sanitario non medico coinvolto3.Siano in grado di effettuare uina diagnosi pre-H di STEMI per privilegiare il trasposrto verso centri dotati di Emodinamica h24

Si sottolinea inoltre che il pz indirizzato ad un centro che esegue la PCI primaria venga portato direttamente in Emodinamica (saltando il PS)

Overview


• Anticoagulanti

• Antiaggreganti


Primary PCI Strategy

Aspirin, thienopyridine

3,000 pts eligible for stent randomisation

Bare metal stent paclitaxel-eluting stent

Clinical FU at 30 days, 1 year Clinical FU at 30 days, 1 year

HORIZONS AMI Trial Design• Open-label, randomised, prospective, multicenter trial

FU=follow-up; pts=patients; R=randomised; UFH=unfractionated heparin.

Stone GW. NEJM 2008;358:2218-30.

UFH + GP IIb/IIIa inhibitor(abciximab or eptifibatide)

Bivalirudin monotherapy(± provisional GP IIb/IIIa)

3,602 pts with STEMI with symptom onset ≤12 hours

R 1:3

R 1:1

30-day Clinical Outcomes3

0-d

ay

eve

nt r

ate

s (%

)

NACE Major Bleeding† MACE‡

P=0.005

P<0.001

P=0.95

*In HORIZONS AMI, 93% of bivalirudin patients received monotherapy, without provisional GP IIb/IIIa.

†Not related to CABG.

‡MACE=all-cause death, reinfarction, ischaemic TVR, or stroke.

Stone GW. NEJM 2008;358:2218-30:

15

5

0 300

5 10 15 20 25

2

4

Mo

rta

lity

(%)

Time (d)

Bivalirudin alone (n=1,800)*

Heparin + GP IIb/IIIa inhibitor (n=1,802)

1.8%

2.9%3

1

CardiacHR 0.62 [95% CI 0.40-0.96] P=0.03

Noncardiac

Cardiac

NoncardiacP=NS


Stone GW. NEJM 2008;358:2218-30

0.2%0.3%

30-day Mortality• 30-Day Cardiac and Noncardiac Mortality

1-year Outcomes1

-ye

ar

eve

nt r

ate

s (%

)

NACE Major Bleeding† MACE‡


†Not related to CABG.

‡MACE=all-cause death, reinfarction, ischaemic TVR, or stroke.

Stone GW. NEJM 2008;358:2218-30:

HR 1.00 [0.83-1.21] P=0.95

HR 0.61 [0.48-0.78] P<0.0001

HR 0.84 [0.71-0.98]P=0.03

17

Overview


• Anticoagulanti

• Antiaggreganti


Impaired bioavailability of clopidogrel in STEMI patients

Impaired bioavailability of clopidogrel in STEMI patients

Heestermans T, et al Thrombosis Research 2008;122:776-781

Montalescot G et al. Lancet 2009; 373:723-31

TRITON TIMI 38 -STEMI Cohort – N=3534

TRITON-TIMI 38: Study Design – Distribution of Patients in STEMI Cohort

ACS = acute coronary syndrome; LD = loading dose; MD = maintenance dose; NSTEMI = non-ST-segment elevation myocardial infarction; PCI = percutaneous coronary intervention; STEMI = ST-segment elevation myocardial infarction; UA = unstable angina

Double-blind, double-dummy, parallel, randomised controlled trial

All ACS/PCI patientsN = 13608

All ACS/PCI patientsN = 13608

UA/NSTEMIn = 10074

UA/NSTEMIn = 10074

Randomised patients with STEMI N = 3534

Randomised patients with STEMI N = 3534

Prasugrel 60 mg LD/10 mg MDn = 1769

Prasugrel 60 mg LD/10 mg MDn = 1769

Clopidogrel 300 mg LD/75 mg MDn = 1765

Clopidogrel 300 mg LD/75 mg MDn = 1765

2 patients did not receive study drug or undergo PCI

2 patients did not receive study drug or undergo PCI

Primary PCI n = 2438

Primary PCI n = 2438

Secondary PCI n = 1094

Secondary PCI n = 1094

Clopidogreln = 1235

Clopidogreln = 1235

Prasugreln = 1203

Prasugreln = 1203

Clopidogreln = 530

Clopidogreln = 530

Prasugreln = 564

Prasugreln = 564

Montalescot G et al. Lancet 2009;373(9665):723-731

Montalescot Lancet 2009; 373: 723–31

Stent thrombosis

51 % RRR

42 % RRR

TRITON-TIMI 38: STEMI Cohort (N=3534)

Montalescot Lancet 2009; 373: 723–31

TIMI major bleeding unrelated

to CABG surgery

TRITON-TIMI 38: STEMI Cohort (N=3534)

www.fda.gov/advisoryCommitees/CommitteesMeetingMaterials//Drugs/CardiovasculandRenalDrugAdvisoryCommitte

Hierarchical testing of major efficacy endpoints

All patients*Ticagrelor(n=9,333)

Clopidogrel(n=9,291)

HR for ticagrelor(95% CI) P Value†

Primary objective, n (%)

CV death + MI + stroke 864 (9.8) 1,014 (11.7) 0.84 (0.77–0.92) <0.001

Secondary objectives, n (%)

Total death + MI + stroke

CV death + MI + stroke + ischaemia + TIA + arterial thrombotic events

Myocardial infarction

CV death

Stroke

901 (10.2)

1,290 (14.6)

504 (5.8)

353 (4.0)

125 (1.5)

1,065 (12.3)

1,456 (16.7)

593 (6.9)

442 (5.1)

106 (1.3)

0.84 (0.77–0.92)

0.88 (0.81–0.95)

0.84 (0.75–0.95)

0.79 (0.69–0.91)

1.17 (0.91–1.52)

<0.001

<0.001

0.005

0.001

0.22

Total death 399 (4.5) 506 (5.9) 0.78 (0.69–0.89) <0.001

*The percentages are K-M estimates of the rate of the endpoint at 12 months. Patients could have had more than one type of endpoint. Death from CV causes included fatal bleeding and only traumatic fatal bleeds were excluded from the CV death category; †By Cox regression analysis

Wallentin L et al. N Engl J Med. 2009 Sep 10;361(11):1045-57

Studio PLATO

Overview


• Anticoagulanti

• Antiaggreganti


STEMI e IABP: raccomandazioni precedenti

Thrombolytic therapy vs pPCI ± IABP

NEJM 2012. DOI 10.1056/NEJMoa1208410

campagna educazionale anmco sindromi coronariche acute: dalle linee guida europee al paziente del...

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