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Adjunctive Therapy for PCI. Neal Uren MD MRCP Department of Cardiology Royal Infirmary of Edinburgh. Determinants of Successful PCI. CLINICAL STATUS LV function Stable vs. unstable angina vs. MI LESION COMPLEXITY AHA/ACC class OPERATOR VOLUME ADJUNCTIVE THERAPY

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Adjunctive Therapy for PCI


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adjunctive therapy for pci
Adjunctive Therapy for PCI

Neal Uren MD MRCP

Department of Cardiology

Royal Infirmary of Edinburgh

determinants of successful pci
Determinants of Successful PCI

CLINICAL STATUS

  • LV function
  • Stable vs. unstable angina vs. MI

LESION COMPLEXITY

  • AHA/ACC class

OPERATOR VOLUME

ADJUNCTIVE THERAPY

  • Stenting (BENESTENT, STRESS)
  • Anti-thrombotic and anti-platelet agents
rationale
Rationale

“Although it is not yet possible to pharmacologically modify the risk of balloon-mediated intimal and medial disruption, it is possible to modify chemically the platelet-fibrin response to vascular injury in order to influence the outcome of the procedure”

pharmacological adjunctive therapy
Pharmacological Adjunctive Therapy
  • Heparin
  • Aspirin
  • Clopidogrel
  • Glycoprotein IIb/IIIa inhibitors
uk interventional practice 1999
UK Interventional Practice 1999
  • Structured questionnaire
  • 68% response over 4 months
  • 53% ≥10,000 U heparin
  • 8.3% abciximab use
  • 82% clopidogrel use

Swanson N et al, Int J Cardiol 2001;79:119-125

heparin
Heparin
  • Lower incidence of complications in unstable angina patients pre-treated with iv heparin

Lukas MA et al, JACC 1988;11:132A(abstr)

  • Close temporal relationship between discontinuation of anticoagulation after PTCA and coronary occlusion Gabliani G et al, AHJ 1988;116:696-700
  • 10,000 U iv heparin = ACT <300s in 5% of stable and 15% of unstable patients Dougherty KG et al, CCD 1992;26:260-3
defining the optimal act with uf heparin
Defining the Optimal ACT with UF Heparin
  • Meta-analysis of 6 trials with UFH as control
  • n=5216, with patients in 25 s intervals
  • Endpoint of 7 day MACE + major/minor bleeds
  • ACT 350-375 s 6.6% vs ACT 171-295 s 8.8% (p<0.01)
  • ACT should be substantially higher than currently appreciated

Chew DP et al, Circulation 2001;103:961-6

low dose heparin 30 u kg
Low Dose Heparin (30 U/kg)
  • n=418 patients
  • Mean age 63±11 years
  • 2253±1056 U/l with a final ACT of 174±69 s
  • Manual compression for 7.7±3 minutes
  • Average procedure time of 25±16 minutes
  • MACE 2.9% at discharge
  • 0.24% serious vascular complications

Godon P et al, Arch Mal Coeur Vaiss 2001;94:984-8

low molecular weight heparin
Low Molecular Weight Heparin
  • Elective PCI
  • NICE 1 = enoxaparin 1.0 mg/kg iv
  • NICE 4 = enoxaparin 0.75 mg/kg iv with standard abciximab
  • Comparable incidence of bleeding and ischaemic complications in NICE 4 compared with UFH + abciximab

Kereiakes DJ et al, J Invas Cardiol 2001;13:272-8

low molecular weight heparin 2 doses of dalteparin abciximab n 57
Low Molecular Weight Heparin 2 doses of Dalteparin + abciximab (n=57)

12

10

8

40 U/kg

6

60 U/kg

4

2

0

Procedural thrombosis

Major bleeding

Kereiakes DJ et al, Am Heart J 2001;141:348-52

aspirin
Aspirin
  • No difference in outcome between 80 mg and 1500 mg started 24 h pre-PCI

Mufson L et al, JACC 1988;11:236A(abstr)

  • No additional benefit of dipyridamole

Lembo NJ et al, AJC 1990;65:422-6

  • No benefit from single dose ASA pre-PCI

Patrono C et al, Circulation 1985;72:1177-84

ticlopidine study trial
Ticlopidine Study Trial

Ischaemic complications after 4-5 days pre-treatment

Placebo

14

ASA 325mg2 +Persantin 75 mg3

12

Ticlopidine 250 mg3

10

8

Percentage

6

4

2

0

White CW et al, Circulation 1987;76:IV-400

platelet aggregability post pci
Platelet Aggregability Post-PCI

* p=0.06

p=0.06

120

p=0.03

*

Greater

aggregability

100

*

80

Time to occlusion (s)

60

40

ASA+Ticlid PTCA

20

ASA Coronary angio

0

Pre

Post

Fischetti D et al, J Thromb Thrombolysis 2001;10:265-9

de evolution of stent thrombosis
De-evolution of Stent Thrombosis

1986-91 Serruys et al/Schatz et al ~25%

1991 10 pooled studies 4.5%

1993 Stress/Benestent/TASC 1 3.7%

1994 Colombo et al 0.9%

1995 MUST Registry 1.6%

1996 MUSIC Registry 0.6%

1997 Moussa et al 1.9%

slide15

Risk of MACE After Successful Stenting

Age

n=2894

105 events

Diabetes

Acute MI (<72h)

Unstable angina

Impaired LV

Stented length

Residual dissection

Stent overlap

Use of ticlopidine*

0.1

1.0

10

20

0.1

1.0

10

20

Hazard Ratio & 95% CI

Hazard Ratio & 95% CI

* 80% ASA+Ticlidopine

Schülen et al, Circulation 1998;98:104-111

slide16

Risk of a Procedural Failure

Procedure failure = MACE 42.6%, procedure success = MACE 3.6%

CFX or SVG

Vessel size

Stenosis grade

Stenosis length

Acute occlusion pre-stent

Experience (yrs)

0.1

1.0

10

20

0.1

1.0

10

20

Odds Ratio & 95% CI

Odds Ratio & 95% CI

Schülen et al, Circulation 1998;98:104-111

the stars trial
The STARS Trial

1965 patients

50 centres

84% angio. success

7

6

5

Percentage

4

Aspirin

3

Aspirin+Warfarin

*

Aspirin +Ticlopidine

2

*

1

0

Stent Thrombosis

at 30 days

Haemorrhagic

* p<0.001 vs. others

complications

Leon MB et al, NEJM 1998;339:1702-4

the stars trial suboptimal stent registry
The STARS Trial Suboptimal Stent Registry

265 patients

16% vs.27% 9/12 CRS

*

9

8

7

Multiple stents

Low final MLD

No ticlopidine

6

5

Percentage

*

4

Optimal (<10%DS)

3

Suboptimal

*

2

1

0

30 day stent

thrombosis

30 day

Peri-

* p<0.01

mortality

procedure

NQWMI

Cutlip DE et al, JACC 1999;34:698-706

clopidogrel vs ticlopidine post pci
Clopidogrel vs. Ticlopidine Post-PCI
  • No one trial large enough to demonstrate comparability
  • n=13,995 meta-analysis
  • 1° endpoint of MACE at 30 days after stenting
  • MACE clopidogrel = 2.1% vs MACE ticlopidine = 4.0%
  • Death clopidogrel = 0.48% vs death ticlopidine = 1.1%
  • Bhatt Dl et al, JACC 2002;39:9-14
mace post stenting
MACE Post-Stenting

Bhatt Dl et al, JACC 2002;39:9-14

30 day mortality post stenting
30 Day Mortality Post-Stenting

Bhatt Dl et al, JACC 2002;39:9-14

duration of therapy
Duration of Therapy
  • Retrospective analysis of ticlopidine post-stent
  • n=5678
  • 2.0% stent failure at 2 weeks + 0.5% at 2-4 weeks
  • Risk factors for late events (2.5% if all 3 present)

- age

- reduced LV function

- hypertension

  • 4 weeks theinopyridine therapy preferable

Schülen H et al, JACC 37:2066-73

timing of therapy
Timing of Therapy
  • Ticlopidine >24 h pre-PCI cause significant platelet inhibition
  • Maximum effect at 3-5 days

van de Loo A et al, Eur Heart J 1998;19:96-102

  • Ticlopidine pre-treatment duration ~ reduced NQWMI

Steinbuhl S et al, JACc 1998;32:1366-70

  • Clopidogrel induces platelet inhibition within 30 min
  • MACE ~ no pre-treatment (T / C) [OR 3.5]

Steven P et al, JACC 2001;38:648A (abstr)

glycoprotein iib iiia receptor inhibition 30 day mace with abciximab

Placebo

Reopro B+I

Glycoprotein IIb/IIIa Receptor Inhibition30 day MACE with Abciximab

EPICEPILOGCAPTURE

High-risk PCIRefractory USA pre-PCI

14

20

12.8%

12

35%

11.7%

29%

15

15.9%

10

8

Percentage

8.3%

55%

10

11.3%

6

5.3%

4

5

2

0

0

n=2099 n=2972 n=1265

NEJM1994;330:957 NEJM 1997;336:1689 Lancet 1997;349:1429

slide25

EPILOG & Bleeding Risk

Low dose heparin = 70 U/kg for ACT≥200 s

Stnadard dose heparin = 100 U/kg for ACT≥300 s

slide27

MACE in the CAPTURE trial by TnT

Hamm CW et al, NEJM 1999;340:1623

slide28

The EPISTENT Trial

  • 63 centres in North America
  • 2399 patients undergoing PCI
  • 36% unstable angina <48h
  • 57% unstable angina <6 months
  • 16% recent MI (<7 days)
  • 20% diabetics
  • Reopro 60 min pre-PCI, 12 h post-PCI

Lancet 1998;352:87

slide29

EPISTENT at 30 Days and 12 Months

Death/MI/Urgent Revascularisation

*

20

Stent + placebo

15

51%

52%

Stent + abciximab

%

Balloon + abciximab

10

°

*

*

*

* p<0.01, ° p<0.05

5

0

30

day

MACE

Death/MI

TVR

1 year

Lancet 1998;352:87

slide30

EPISTENT Subgroup Analysis

Lancet 1998;352:87

slide31

EPISTENT Subgroup Analysis

Reduction of Non-Q wave MI

Lancet 1998;352:87

conclusions
Conclusions
  • Heparin - lower doses acceptable (?<5000 U)
  • Pre-treatment with aspirin essential
  • Clopidogrel pre- & post-stenting
  • GpIIb/IIIa receptor inhibitors - Reopro™ reduces CK release in stable angina
  • No substitute for optimal stent deployment