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Stent Parameters Predict Major Adverse Clinical Events and the Response to Platelet Glycoprotein IIb/IIIa Blockade Findings of the ESPRIT Trial.

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Stent Parameters Predict Major Adverse Clinical Events and the Response to Platelet Glycoprotein IIb/IIIa BlockadeFindings of the ESPRIT Trial

James E. Tcheng, MD; Ing Haan Lim, MBBS; Shankar Srinivasan, PhD; Joseph Jozic, MD; C. Michael Gibson, MS, MD; J. Conor O’Shea, MD; Joseph A. Puma, MD; Daniel I. Simon, MD

Circulation Cardiovascular Interventions. 2009;2:43-51


Stent parameters and mace
Stent Parameters and MACE the Response to Platelet Glycoprotein IIb/IIIa Blockade

Post-hoc analysis of the 1983 pts in ESPRIT receiving a stent

MACE (48 hr, 1 yr) by nominal stent parameters

Number of stents implanted (1, 2, >3)

Total length of stent (quartiles of mm)

Stent diameter (<2.5, >2.5-<3.5, >3.5 mm)

Stented vessel area (quartiles of mm2)

Analysis by randomization

Placebo versus eptifibatide

Tcheng JE et al. Circ Cardiovasc Intervent; 2009; 2:43-51


Study design
Study Design the Response to Platelet Glycoprotein IIb/IIIa Blockade

1999-2000

placebo

(bailout permitted)

+

heparin60 U/kg bolus(ACT 200-300 sec)

eptifibatide180+180 µg/kg bolus

(boluses 10 min apart)2.0 µg/kg-min infusion x18-24°

+

heparin60 U/kg bolus(ACT 200-300 sec)

vs.

ASA, thienopyridine pre-rx; randomization in cath lab

elective (non-urgent) stent PCI

48 hour, 30 day, 6 month, 1 year follow-up

primary endpoint: 48° death, MI, urg revasc, thrombotic bailout

O’Shea JC et al., Am Heart J. 2000;140:834–839


Primary Endpoint Analysis the Response to Platelet Glycoprotein IIb/IIIa BlockadeEvents to 48 Hours

37%

p=0.0015

40%

p=0.0015

n=2064

33%

p=0.064

40%

p=NS

52%

p=0.029

50%

p=NS

(MB >5x)

ESPRIT Investigators. Lancet. 2000;356:2037–2044


Efficacy by Clinical Syndrome the Response to Platelet Glycoprotein IIb/IIIa Blockade30 Day death, MI, urgent TVR, bailout IIb/IIIa

44%

p=NS

NNT=11

50%

p=0.034

NNT=14

41%

p=0.028

NNT=18

31%

p=NS

23%

p=0.30

n=794 (38%) n=664 (32%) n=279 (14%) n=93 (5%) n=187 (9%)

Puma JA et al. J Am Coll Cardiol. 2006;47:715–718.


MACE at the Response to Platelet Glycoprotein IIb/IIIa Blockade48ºby Number of Stents

40%

Eptifibatide

Placebo

30%

P=0.001

Death, MI, urgent TVR

20%

10%

0

1

2

≥3

Number of stents

Tcheng JE et al. Circ Cardiovasc Intervent; 2009; 2:43-51


MACE at the Response to Platelet Glycoprotein IIb/IIIa Blockade48ºby Stent Length

40%

Eptifibatide

Placebo

30%

P=0.003

Death, MI, urgent TVR

20%

P=0.030

10%

0

<15

15 to <18 mm

18 to <30 mm

≥30 mm

Total length of implanted stent(s)

Tcheng JE et al. Circ Cardiovasc Intervent; 2009; 2:43-51


MACE at the Response to Platelet Glycoprotein IIb/IIIa Blockade48ºby Stent Diameter

40%

Eptifibatide

Placebo

30%

Death, MI, urgent TVR

20%

P=0.002

10%

0

≤2.5 mm

>2.5 to <3.5 mm

≥3.5 mm

Stent diameter

Tcheng JE et al. Circ Cardiovasc Intervent; 2009; 2:43-51


MACE at the Response to Platelet Glycoprotein IIb/IIIa Blockade48ºby Stented Vessel Area

40%

Eptifibatide

Placebo

30%

P=0.002

Death, MI, urgent TVR

20%

P=0.039

10%

0

<141

141 to <188

188 to <292

≥292

Stented vessel area (mm2)

Tcheng JE et al. Circ Cardiovasc Intervent; 2009; 2:43-51


Mean stent diameter (mm) the Response to Platelet Glycoprotein IIb/IIIa Blockade

20

40

60

80

100

120

Total stent length (mm)

Stent Diameter vs. Length

6

5

4

3

2

1

0

Tcheng JE et al. Circ Cardiovasc Intervent; 2009; 2:43-51


MACE at 1 year the Response to Platelet Glycoprotein IIb/IIIa Blockadeby Number of Stents

40%

Eptifibatide

Placebo

30%

Death, MI, TVR

20%

P=0.005

10%

0

1

2

≥3

Number of stents

Tcheng JE et al. Circ Cardiovasc Intervent; 2009; 2:43-51


MACE at 1 year the Response to Platelet Glycoprotein IIb/IIIa Blockadeby Stent Length

40%

Eptifibatide

Placebo

P=0.024

30%

P=0.034

Death, MI, TVR

20%

10%

0

<15

15 to <18 mm

18 to <30 mm

≥30 mm

Total length of implanted stent(s)

Tcheng JE et al. Circ Cardiovasc Intervent; 2009; 2:43-51


MACE at 1 year the Response to Platelet Glycoprotein IIb/IIIa Blockadeby Stent Diameter

40%

Eptifibatide

Placebo

30%

P=0.005

Death, MI, TVR

20%

10%

0

≤2.5 mm

>2.5 to <3.5 mm

≥3.5 mm

Stent diameter

Tcheng JE et al. Circ Cardiovasc Intervent; 2009; 2:43-51


MACE at the Response to Platelet Glycoprotein IIb/IIIa Blockade48ºby Stented Vessel Area

40%

Eptifibatide

Placebo

P=0.023

30%

Death, MI, TVR

20%

10%

0

<141

141 to <188

188 to <292

≥292

Stented vessel area (mm2)

Tcheng JE et al. Circ Cardiovasc Intervent; 2009; 2:43-51


Odds Ratios of MACE at the Response to Platelet Glycoprotein IIb/IIIa Blockade48º

Eptifibatide Better

Placebo Better

  • Number of Stents

    • 1

    • 2

    • ≥3

  • Stent Length (mm)

    • <15

    • 15 – <18

    • 18 – <30

    • ≥30

  • Stent Diameter (mm)

    • ≤2.5

    • >2.5 – <3.5

    • ≥3.5

  • Stented Vessel Area (mm2)

    • <141

    • 141 – <188

    • 188 – <292

    • ≥292

1

10

0.1

Tcheng JE et al. Circ Cardiovasc Intervent; 2009; 2:43-51


Odds Ratios of MACE at 1 year the Response to Platelet Glycoprotein IIb/IIIa Blockade

Eptifibatide Better

Placebo Better

  • Number of Stents

    • 1

    • 2

    • ≥3

  • Stent Length (mm)

    • <15

    • 15 – <18

    • 18 – <30

    • ≥30

  • Stent Diameter (mm)

    • ≤2.5

    • >2.5 – <3.5

    • ≥3.5

  • Stented Vessel Area (mm2)

    • <141

    • 141 – <188

    • 188 – <292

    • ≥292

1

10

0.1

Tcheng JE et al. Circ Cardiovasc Intervent; 2009; 2:43-51


Stent parameters and mace1
Stent Parameters and MACE the Response to Platelet Glycoprotein IIb/IIIa Blockade

In the placebo group, MACE rates increased as the number of stents increased, with increasing total length of stent, and with total stented vessel area

relationship nearly linear with total stented vessel area

Risk gradient significantly flattened by eptifibatide

Eptifibatide had significant efficacy with:

>2 stents

>18 mm total stent length


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