Gp iib iiia inhibition in stemi growing clinical trial evidence
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GP IIb/IIIa Inhibition in STEMI: Growing Clinical Trial Evidence. PCI vs fibrinolysis in STEMI patients: Short-term clinical outcomes. Meta-analysis of 23 trials; N = 7739. 25. 20. Frequency (%). 15. 10. 5. 0. Recur ischemia. Death. Death no SHOCK data. ReMI. Total stroke.

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GP IIb/IIIa Inhibition in STEMI: Growing Clinical Trial Evidence

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Gp iib iiia inhibition in stemi growing clinical trial evidence

GP IIb/IIIa Inhibition in STEMI: Growing Clinical Trial Evidence


Pci vs fibrinolysis in stemi patients short term clinical outcomes

PCI vs fibrinolysis in STEMI patients: Short-term clinical outcomes

Meta-analysis of 23 trials; N = 7739

25

20

Frequency

(%)

15

10

5

0

Recur ischemia

Death

Death

no SHOCKdata

ReMI

Total stroke

Hem stroke

Major bleed

Death, MI, stroke

PCI

Fibrinolysis

Antman EM et al. Circulation. 2004;110:588-636.

Modified from Keeley EC et al. Lancet. 2003;361:13-20.


Pci vs fibrinolysis in stemi patients long term clinical outcomes

PCI vs fibrinolysis in STEMI patients: Long-term clinical outcomes

Meta-analysis of 23 trials

35

30

25

Frequency

(%)

20

15

10

5

0

Death MI stroke

Death

Death, no SHOCK data

RecurMI

Recur ischemia

PCI

Fibrinolysis

Antman EM et al. Circulation. 2004;110:588-636.

Modified from Keeley EC et al. Lancet. 2003;361:13-20.


Acc aha stemi guidelines assessing reperfusion options

Early presentation (≤3 hours from symptom onset)

Invasive strategy not an option

Delay to invasive strategy

Door-to-balloon exceeds door-to-needle time by >1 hour

>90 minutes to balloon time

High-volume lab with surgical backup

High risk from STEMI

Fibrinolysis contraindicated (excessive bleeding/ICH)

Late presentation

Symptoms >3 hours prior

STEMI diagnosis in doubt

ACC/AHA STEMI guidelines: Assessing reperfusion options

Fibrinolysis

Primary PCI

ICH = intracranial hemorrhage

Antman EM et al. Circulation. 2004;109:2480-6.


Timi flow grade

TIMI flow grade

TIMI 0 Complete occlusion

TIMI 1 Penetration of obstruction by contrast but no distal

perfusion

TIMI 2 Perfusion of entire artery but delayed flow

TIMI 3 Full perfusion, normal flow

Mortality is reduced with better flow

Chesebro JH et al. Circulation. 1987;76:142-54.


Mortality benefit of primary pci declines with pci related time delay

Mortality benefit of primary PCI declines with PCI-related time delay

Meta-regression analysis of 21 trials

15

Circle sizes reflect study sample size Solid line = weighted meta-regression

10

Absolute risk difference in death (%)

P = 0.006

5

62 minutes

Benefit:Favors PCI

0

Harm:Favors lytics

–5

0

20

40

60

80

100

PCI-related time delay (minutes)

Nallamothu BK, Bates ER. Am J Cardiol. 2003;92:824-6.


Major considerations for pharmacologic approaches to facilitate primary pci

Major considerations for pharmacologic approaches to facilitate primary PCI

  • Delay between presentation with STEMI and primary PCI vs progressive nature of ischemia-related necrosis

  • Inverse relationship between time-to-reperfusion and extent of salvaged myocardium and survival

  • Relationship between restoration of coronary flow and recovery of contractility and survival after STEMI

  • Facilitated PCI strategy utilizing GP IIb/IIIa inhibition or fibrinolytic therapy provides a degree of coronary reperfusion when PCI is not immediately available

Beygui F, Montalescot G. Eur Heart J. 2005;7(suppl):110-4.


Intami pilot trial early eptifibatide improves timi 3 flow before pci for stemi

INTAMI pilot trial: Early eptifibatide improves TIMI 3 flow before PCI for STEMI

INTegrilin in Acute Myocardial Infarction

80

67.4

70

P = 0.01

58.4

60

50

Patency (%)

40

34.0

30

22.4

20

10.2

7.6

10

0

TIMI 3

TIMI 2

TIMI 0/1

Early administration (n = 53)

Late or no administration (n = 49)

Zeymer U et al. Eur Heart J. 2005;26:1971-7.


Timi 3 patency before pci in trials of early vs late no gp iib iiia inhibitors in stemi

TIMI 3 patency before PCI in trials of early vs late/no GP IIb/IIIa inhibitors in STEMI

40

Abciximab

Tirofiban

Eptifibatide

30

TIMI 3patency before PCI (%)

20

10

0

Zorman

Reo-Mobile

ERAMI

ReoPro-bridging

ADMIRAL

Cutlip

TIGER-PA

On-TIME

INTAMI

TITAN

N = 109100695530060100487102 316

Early

Late or no GP IIb/IIIa inhibitor

Zeymer U et al. Eur Heart J. 2005;26:1971-7.

www.timi.org


Gp iib iiia inhibitors for primary pci

GP IIb/IIIa inhibitors for primary PCI

30-day death, recurrent MI, or urgent revascularization

P = 0.01

16

14.6

P = 0.03

14

P = 0.02

P = 0.04

11.2

12

10.5

10.5

10

%

8

6

5.8

5

6

4.5

4

2

0

RAPPORT

ISAR-2

ADMIRAL*

ACE

N =

483

401

300

400

Placebo

GP IIb/IIIa inhibitor

Brener SH et al. Circulation. 1998;98:734-41.

Neumann FJ et al. J Am Coll Cardiol. 2000;35:915-21.

Montalescot G et al. N Engl J Med. 2001;344:1895-1903.

Antoniucci D et al. J Am Coll Cardiol. 2003;42:1879-85.

*Outcome also includes stroke


Facilitated pci in stemi

Facilitated PCI in STEMI

  • Early administration of GP IIb/IIIa inhibitors is associated with significant flow restoration, potentially better myocardial reperfusion, and no significant increase in major bleeding

  • Early GP IIb/IIIa facilitation strategy may be recommended in STEMI patients who are candidates for primary PCI

  • Benefits of GP IIb/IIIa therapy in primary PCI for STEMI demonstrated in large clinical trials include improvement in pre-PCI coronary flow, angiographic parameters, and ischemic outcomes and mortality

  • More data from large-scale clinical trials are needed to determine the risks and benefits of facilitated PCI with GP IIb/IIIa inhibitors + fibrinolytics

Beygui F, Montalescot G. Eur Heart JSuppl. 2005;7(suppl I):I10-4.


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