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Who should we rescue ?. A H Gershlick University Hospital of Leicester UK. AA 2008 . Tissue Plasminogen activator. Thrombolysis . Thrombolysis studied in 45 000 pt 20-30 lives saved / 1000. 150 000 patients 53% early reperfusion 52% thrombolysis. Is P-PCI deliverable everywhere .

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slide1

Who should we rescue ?

A H Gershlick

University Hospital of Leicester UK

AA 2008

slide3

Thrombolysis studied in 45 000 pt

20-30 lives saved / 1000

150 000 patients

53% early reperfusion

52% thrombolysis

slide4

Is P-PCI deliverable everywhere

Acute MI Catchments

Tertiary PCI Catchments

slide5

Failure ? :

“TIMI 3”

In the real world

?ST segment resolution @ 60/ 90 min

X

Normal Flow

60% 40%

While there is still lysis, there will be lytic failure

slide6

Who should we Rescue ?

  • D - ? markers of lytic failure
        • Pain - insensitive
          • - MERLIN 43% R-PCI (ECG) pain free
          • - TAMI -5 – clinical variables not predictive
        • Biomarkers –sensitivity 92%
        • specificity 56%
        • Stewart JACC 1998 31 1499
slide9

Peak CK values in relation to the sum of ST-segment resolution

(100%, 70% or 30% cut-offs) 3 hours following start of thrombolytic therapy

Schroder R et al. JACC 1995;26:1657-1664

cumulative event free survival following r pci versus conservative therapy
REACT

MERLIN

Cumulative Event-free Survival following R-PCI versus Conservative Therapy

Gershlick AH et al NEJM 2005;353:2758-2768

Sutton AGC et al JACC 2004;44:287-296

differing methodology react versus merlin
Centres 35 5

ST Resolution 50% at 90mins 50% at 60 mins

10% had TIMI III at angios 40% TIMI III at angio

SK 58% 96%

Stents 69% 50%

GP IIb-IIIa use 43% 3%

PCI arm- PCI mandatednot mandated

completed in 96.5% completed in 66%

PCI within 30 days 2% of conservative group 20% conservative group

Recruitment 3.3 patients /centre/ year 30.7 patients/centre/year

Heart failure “NYHA III or IV” Diuretics

Differing Methodology: REACT versusMERLIN
slide16

Outcome

MERLIN versus REACT @ 1 year

slide17

REACT Trial

12 month

&

Long term

slide20

death

death/reAMI

rescue pci how do the outcomes from real world patients compare to the published trials
RESCUE PCI – HOW DO THE OUTCOMES FROM ‘REAL-WORLD’ PATIENTS COMPARE TO THE PUBLISHED TRIALS ?
  • 185 Consecutive Rescue PCI patients April 2005-August 2007 @ glenfield
  • Clinical follow-up via PCI database, case-note review and ONS, at a mean of 4.5months
  • Mean (SD) delay from symptom onset to PCI =501 (229) minutes [8.35 hours], range 145-2240 min

Kelly DJ, Siddiqui N, Holt M, Gershlick AH-Submitted to BCS

2007 r pci registry vs react trial

15.3

16

14

12

10.3

Death

10

Re-AMI

7

%

8

CVA

6.2

Heart Failure

6

4.9

MACE

4

2.2

2.1

2

0.5

0

2007 Registry*

REACT Trial**

2007 R-PCI Registry vs REACT Trial

* Mean 4.5month Follow-up **6/12 Follow-up

local vs transfer patients
Local vs Transfer Patients

p=0.322

p=0.42

11.5

12

9.3

10

8.4

8

%

6

Mortality

3.7

MACE

4

2

0

Local PCI

Transferred

Centre Patients

Patients

Mean Delay 438min

Mean Delay 525min

Mean Delay S-B

7.3 hrs 8.75 hrs

slide26

GRACE REGISTRY- Relationship between door-to-needle time and

6-month mortality among1786 patients undergoing fibrinolytic therapy for AMI

Nallamothu B et al Heart 2007;93:1552-5

mortality versus tertile of delay symptom onset to r pci

13.1

14

12

10

All-cause

8

Mortality

4.8

6

(%)

3.2

4

2

0

Shortest 290

Mid tertile

Longest 694

min*

485 min

min

Registry

Mortality versus Tertile of Delay (Symptom onset to R-PCI)

p=0.09

*Mean Delay from Symptom Onset to R-PCI (all patients)

slide30

Rescue PCI :

        • All failed lytic (25%-30%)
  • failure to resolve max St D to > 50% at 90 mins
      • As soon as possible (Sympt - balloon < 3hrs)

Who not to “rescue”

slide31

1082 PCI 1084 OMT

3–28 days post AMI

slide33

22/27

(82%) sheath

MAJOR ( > 3g/dl)

%

OVERT Bld No OVERT Bld

18.7

20

3 HPericard

1 Death

15

1 H thorax

1 Death

10

8.4

8.5

5

4.9

3.5

2.1

LysisCRPCI Lysis C RPCI

REACT –

Bleeding Outcomes

“Mm… shall I give repeat thrombolysis ?”

slide35

Pre-Hospital Lysis @ 4.30 am

ECG @ 6 am

Angio @ 6.45

slide36

RESCUE–PCI should be mandated

& be part of AMI protocols

Repeat lytic may be dangerous

slide38

*1st anterior ‘failed reperfusion’

**1st anterior ‘occluded LAD’

Adapted from Kunadian B, et al. J Invasive Cardiol 2007 Sep;19(9):359-68

slide39

MERLIN: 30-day Mortality according to ST-segment resolution 6 hours after

initiation of fibrinolytic therapy

Sutton et al JACC 2004;44:287-96

slide41

Absolute Reduction in 35-day Mortality versus Delay from Symptom Onset

to Randomization Among 45000 Patients with ST-segment elevation or LBBB

Fibrinolytic Therapy Trialists’ Collaborative Group. Lanct 1994;343:311-322

slide42

Use of reperfusion therapy in 376,753 patients from NRMI-4

with STEMI or LBBB within 12 hours of symptom onset

Curtis JP et al JACC 2006;47:1544-52

slide43

GRACE REGISTRY- Relationship between door-to-needle time and

6-month mortality among 2173 patients undergoing Primary PCI for AMI

Nallamothu B et al Heart 2007;93:1552-5

slide44

Mortality versus NRMI-4 Risk Index following AMI

Wiviott SD et al JACC 2004;44:783-9)

slide48

Denmark

Czech Republic

slide50

REACT

(REscue Angioplasty v Conservative treatment or repeat Thrombolysis )

ECG90 minpost (any incl SK) thrombolytic

ST < 50 % resolution (with or without pain)

CONSENT & RANDOMISE

Conservative2 nd thrombolyticCoronary Angio24 iv heparinAccelerated tPA or +/- PCI Reteplase

primary end point: 6/12 ~death/re-infarction/severe HF/CVA

2000

inclusion criteria
Inclusion Criteria
  • Acute Myocardial Infarction
  • Aspirin + Thrombolytic within 6 hours
  • Age 21yrs - 85 yrs
  • Ability to perform intervention within 12hrs of onset symptoms
  • Failed reperfusion (ECG < 50% resolved)
slide52

Exclusion Criteria

Safety pre-requisites pre randomisation (thrombolytic)

a. Hb, Hct & platelet count

b. Weight (< 65 kg)

c. Age (> 85 y)

d. Any evidence bleeding

e. Hypertension during admission(after administration first lytic; age )

f. CGS

{g. LMW heparin}

slide53

REACT Trial

6 month data

slide54

N=142 R-LYSIS

N=141 Conservative

N=144 R-PCI

Primary composite endpoint:

(death and non-fatal re-AMI, CVA , Severe HF)

44

(31.0%)

42

(29.8%)

22

(15.3%)

RESULTS No. of subjects with a component of the Composite Primary End Point @ any time within 6 months

R-PCI v Repeat lytic p< 0.001

R-PCI v Conservative p< 0.01

Repeat lytic v Conservative NS

slide55

R-PCI

C

R-lysis

slide57

R-PCI

Rpt Lysis

Conser

91% F-up

slide58

Re-vasc

33 5

29 14

19 5

0-6 months 6-12 months

3 0

4 0

1 0

21 3

22 2

13 1

0-6 months 6-12 months

18 2

18 3

9 2

18 2

14 0

4 1

slide59

R-PCI

Rpt Lysis

Conser

NS

slide60

REACT Trial

Mortality

slide62

Hazard Ratios and 95% CI of Mortality at 6 Months

Comparative Group vs Reference Group

Repeat Lysis vs

HR=1.00

Conservative

95% 0.52 to 1.92

n=283

p= 0.07

R-PCI vs

HR=0.48

Repeat Lysis

95% CI 0.21 to 1.06

n=286

R-PCI vs

p=0.07

HR=0.48

Conservative

95% CI 0.21 to 1.06

n=285

0

0.2

0.4

0.6

0.8

1

1.2

1.4

1.6

1.8

2

Favours Comparative Favours Reference

Group Group

Hazard Ratio

slide63

Longer term mortality

ONS

Patient specific NHS No.

slide66

REACT trial Longer term outcome

  • Events and difference in outcome happens early
  • Benefit is maintained out to 12 months
  • Late (4.4) year data indicates longer termmortality benefit
  • In general R-PCI
  • Where lysis is still a reperfusion strategy
  • Failed lysis(< 50% ST segment resolution @ 90mins) should be treated with Rescue – PCI
  • R-PCI should be part mandated reperfusion protocols
  • timing issues are unresolved ASAP(within 3 hours of ECG D)
slide67

MERLIN REACT

Time sypmt to hospital 10 6

Pain to lysis 180 mins 140 mins

ECG 6o mins 90 mins

SK 96% 60%

Stents 50.3% 68.5%

GP IIbIIIa 3.3% 43.4%

Pain to cath lab 320 mins 420 mins

Local v National

Definitions (HF)

slide68

10.6

7.8

2.1

12.1

14.9

47.5

4.9

0.7

1.4

7.6

8.3

22.9

MERLIN 30 day JACC 2004,4, 287-96

REACT 30 day

Conservative Rescue p value

(n=154) (n=153)

Death 11.09.8 0.7

Re-AMI 10.4 7.2 0.3

Stroke 0.6 4.6 0.03

Heart failure 29.9 24.2 0.3

Re-vasculascularisation 20.1 6.5 < 0.01

COMPOSITE 72 37.3 0.02

slide70

Achieving recommended time lines for P-PCI may be difficult

  • Thrombolysis :(+ APT) tested in 100 000 pts
      • Saves20-30 lives per thousand
      • Easy to administer
      • It is where the patients attend
      • No extra training
      • Starting to understand its limitations
      • Using pharmacology on way to cath lab not appropriate

(ASSENT 4 FINESS)

slide74

Primary Strategy

Admission

Lysis

90 min repeat ECG

Giving lytic and going to bed is not enough !!!