Myocardial Infarction AngioplastyThe Middlesbrough Experience

Rob Wright

James Cook University Hospital

Acknowledgements

Mark de Belder Jim Hall Alun Harcombe Andrew Sutton Bob Morley and the Audit Team Cath Lab Team CCU

SCH Original AMI PCI Protocol Contraindication to thrombolysis Presentation in, or early shock

(if within 12 hours of onset of symptoms) Rescue at 2 hours post onset of thrombolysis Re-infarction

Age not a contra-indication but comorbidity is

James Cook & Referring HospitalsThrombolysis 2002-2003

Bishop Auckland 92Darlington Memorial 99Friarage Northallerton 47Hartlepool 98James Cook 159North Durham 161North Tees 129Scarborough 96West Cumberland 98

South Cleveland HospitalInfarct Angioplasty 1998 - 2002

AMI cases Primary non-shock

Shock Rescue ReMI

1998 152 22 13 64 53

1999 151 20 22 78 31

2000 148 20 15 50 63

2001 171 25 16 73 57

2002 144 27 12 52 53

Mortality 9.6% 50% 9.5% 4.3%

MERLIN Sutton AGC JACC 2004;44:287-96

What to do when thrombolysis fails 307 patients with ECG failure to reperfuse Randomised to immediate angiogram or

usual care

A randomised trial of rescue angioplasty versus a conservative approach for failed fibrinolysis

in ST elevation myocardial infarction:Middlesbrough Early Revascularisation to Limit INfarction

(MERLIN) trial 

AGC Sutton MA MB MRCP, PG Campbell MB MRCP, R Graham MB MRCP, DJA Price MB MRCP, JC Gray1 BSc PhD, ED Grech MD MRCP FACC,

JA Hall MA MD FRCP, AA Harcombe MD MRCP, RA Wright MD FRCP, RH Smith2 Bsc MB FRCP, JJ Murphy3 MB BS DM FRCP,

A Shyam-Sundar2 MB BS MD DM FRCP, MJ Stewart MD FRCP, A Davies BSc MB BS FRCP, NJ Linker BSc MD FRCP FESC,

MA de Belder MA MD FRCP 

The James Cook University Hospital, Middlesbrough, UK.1University of Newcastle-upon-Tyne, UK.

2University Hospital of North Tees, Stockton-on-Tees, UK.3Darlington Memorial Hospital, Darlington, UK . 

No conflicts of interest

METHODS

Inclusion Criteria• Patients with STEMI and evidence of failure to respond to the

administration of fibrinolytic therapy • Presentation to hospital within ten hours of the onset of major

symptoms was required. • “Failure to reperfuse” was defined by a second 12-lead ECG

performed 60 minutes after the onset of fibrinolytic therapy showing: Failure of the ST segment elevation in the worst lead (the lead with maximum ST elevation) to have resolved by 50%* and the absence of an accelerated idioventricular rhythm (AIVR) at the time of the 60-minute ECG1

• Any fibrinolytic agent was allowed for trial entry *ST segment measured 80ms after the J point1Sutton et al. Heart 2000;84(2):149-56.

METHODS

Exclusion criteria• Cardiogenic shock, defined by hypotension (systolic BP

90mmHg), oliguria and poor peripheral perfusion with or without pulmonary oedema.

• Patients with confounding features on the pre-treatment ECG, e.g. the presence of bundle branch block configuration or a paced rhythm

• Patients with reinfarction in the same ECG territory within 2 months of an original infarction

• Patients without femoral arterial access• Pregnancy• Patients with significant co-existing pathology (eg. disseminated

malignancy, end-stage respiratory failure) likely to affect prognosis during the follow-up period.

Trial Flow Chart

C o nse rva tive R x

P e rs iste n t S T e lev a tionw itho u t ca rd io g en ic sho ck

C a rd iog en ic S ho ck

C o nse rva tive R x Im m ed ia te co ron ary a ng io gra phyR e scu e P C I i f in d ica ted

R a nd om isa tio n 1 :1

"F a i le d rep er fus ion " 1 h r a fte r R x in i t ia tion

R x : A ny f ib r in o ly tic a ge n tA sp ir in

S T E M IP resen ta tio n w ith in 10 hrs o f pa in

Early crossover for shock only

MERLIN Results: 30 days

0

10

20

30

40

50%

Primary endpoint Composite secondary endpoint

Rescue Conservative

p=0.7

p=0.02

0

5

10

15

20

25

30%

Dea

th

ReM

I

Str

oke

Unp

lann

ed

reva

sc CCF

P=0.7 P=0.3 P=0.03

P=0.0004

P=0.3

MERLIN Conclusions

No mortality benefit Increased risk of stroke and bleeding Reductions in

Unplanned revascularisation 6.5 v 20.1% p<0.01Reinfarction 7.2 v 10.4% ns

REACT

JCUH Shock Survival (n=113)Sutton AGC et al, Heart in press

0 50 100 150 2000

25

50

75

100

% survival

Days

SHOCK Trial - 1 year survival Hochman JS JAMA 2001

0102030405060708090

100

0 2 4 6 8 10 12

Months

% a

live ERV

IMS

Post-MERLIN Strategy

August 2002 – Operator Discretion August 2003 – “Czech Protocol” February 2004 – Open Primary PCI

Participation in Finesse and Assent 4 studies affects some patients

Prague-2 30 day Mortality Eur Heart J 2003;24:94

0

2

4

6

8

10

12

14

16

All Patients 0 - 3 Hours 3 - 12 Hours

Tx

PCI

P=0.12

P<0.02

JCUH “Czech” AMI PCI Protocol

Contraindication to thrombolysis Presentation in, or early shock (if within 12

hours of onset of symptoms) Patients with onset of chest pain >3 hours Patients with previous STEMI Rescue cases to be discussed individually Re-infarction

Age not a contra-indication but comorbidity is

JCUH “Open” AMI PCI Protocol

Patients with chest pain + ST elevation < 12hr Rescue cases to be discussed individually Re-infarction

Age not a contra-indication but comorbidity is

Post-MERLIN September 2002 – August 2004

AMI cases

Primary non-shock

Shock Rescue

(exc shock)

ReMI

Sep 02–Aug 03 113 25 12 21 55

Sep 03-Aug 04 176 84 18 9 50

Sep 03-Feb 04 80 38 11 6 25

Mar 04-Aug 04 96 61 7 3 25

AMI cases

Primary non-shock

Shock Rescue ReMI CCU

Tx

Sep 02–Aug 03 113 25 12 21 55 156

Sep 03-Aug 04 176 84 18 9 50 61

Sep 03-Feb 04 80 38 11 6 25 46

Mar 04-Aug 04 96 61 7 3 25 15

6/12 “Czech Protocol” – 6/12 Open

AMI cases

Primary PCI

Rescue ReMI ReMI Rescue

Czech 09/03-02/04

80/554(14%)

44 (55%)

9(11%)

26(33%)

1(1%)

Open PCI 03/04-08/04

96/604(16%)

66(69%)

5(5%)

22(23%)

3(3%)

09/03-08/04

176 110 14 48 4

Patient Characteristics

Czech (n=80) Open (n=96)

Previous MI 18 (23%) 28 (29%)

Previous PCI 4 (5%) 6 (6%)

Previous CABG 6 (8%) 2 (2%)

Diabetes 13 (16%) 10 (10%)

1 VD 30 (38%) 48 (50%)

2VD 30 (38%) 27 (28%)

3VD 20 (25%) 20 (21%)

Culprit Vessel

Czech Open

LAD 29 39

Cx 12 14

RCA 40 44

LMS 1 0

Grafts 4 1

Multivessel 4 2

Procedure Details

Czech (n=80) Open (n=96)

GpIIbIIIa Antagonist 61 (76%) 84 (88%)

Diagnostic Device 0 0

Thrombus suction 6 (8%) 7 (7%)

X-sizer 3 (4%) 4 (4%)

Percusurge 5 (6%) 2 (2%)

Filter 4 (5%) 1 (1%)

IABP 17 (23%) 16 (17%)

Ventilated pre 2 (3%) 1 (1%)

Complications

Czech Open

No flow/Slow flow 13 (16%) 10 (10%)

Coronary Dissection 10 (13%) 5 (5%)

Coronary Perforation 1 (1%) 3 (3%)

Temp P/M/AVblock 7 (9%) 2 (2%)

DC CV 4 (5%) 3 (3%)

Ventilated during 1 (1%) 1 (1%)

Shock induced 3 (4%) 4 (4%)

TIMI Flows

Czech % Open %

TIMI Pre Post Pre Post

0 69 5 69 3

1 7 0 7 1

2 17 9 13 6

3 7 86 11 90

Procedure Timing

Czech Open

In hours 41% 35%

Out of hours 59% 65%

JCUH AMI PCI Sep 03 – Aug 04 (n (%))

Age < 75 Shock Czech Open

Primary NS 53 (66) 69 (72)

S 7 (9) 5 (5)

Rescue NS 5 (6) 6 (6)

S 3 (4) 2 (2)

Age > 75

Primary NS 9 (11) 13 (14)

S 1 (1) 1 (1)

Rescue NS 2 (3) 0

S 0 0

JCUH AMI PCI Sep 03 – Feb 04 In-Hospital Mortality (n (%))

Age < 75 Shock Czech Death Open Death

Primary NS 53 (66) 0 (0)

S 7 (9) 2 (29)

Rescue NS 5 (6) 0 (0)

S 3 (4) 3 (100)

Age > 75

Primary NS 9 (11) 2 (22)

S 1 (1) 1 (100)

Rescue NS 2 (3) 0 (0)

S 0

JCUH AMI PCI Sep 03 – Aug 04 In-Hospital Mortality (n (%))

Age < 75 Shock Czech Death Open Death

Primary NS 53 (66) 0 (0) 69 (72) 1 (1)

S 7 (9) 2 (29) 5 (5) 1 (20)

Rescue NS 5 (6) 0 (0) 6 (6) 1 (17)

S 3 (4) 3 (100) 2 (2) 1 (50)

Age > 75

Primary NS 9 (11) 2 (22) 13 (14) 1 (8)

S 1 (1) 1 (100) 1 (1) 0 (0)

Rescue NS 2 (3) 0 (0) 0

S 0 0

Czech Protocol In-Hospital Deaths

62yr M, OOHA, Shock o/a 73yr F, Shock, IABP, Temp p/m 62yr M, Rescue shock, IABP, prev CABG 72yr F, Rescue shock, IABP, Temp p/m 70yr F, Rescue shock, IABP 76yr F, ReMI, shock, IABP 83yr M, PEA arrest day 6 76yr M, PEA arrest in CCU ?rupture

Open Protocol In-Hospital Deaths

65yr M – ReMI PCI (+prev MI) on w/l for IHU CABG. 16/5/04 LAD stent successful. 19/5/04 Cx dissection, perforation, IABP, CABG. Died 21/5/04

56yr M – OOHA Transfer occ LAD, Shock, Ventilated + IABP pre-PCI

61yr M – Rescue Shock LAD (CTO RCA) IABP, ventilated

75yr M – Facilitated RCA (3VD) VT arrest day 3 ? Rupture

77yr F – ReMI RCA (3VD), shock, IABP, VSD

JCUH AMI PCI Sep 03 – Aug 04 (n=176)

0

20

40

60

80

100

120

140

Primary -No shock

Primary -Shock

Rescue -No shock

Rescue -Shock

Age < 75Age > 75

AMI PCI Sep 03 – Aug 04 (n=176)In-Hospital Mortality (%)

0

10

20

30

40

50

60

70

80

Primary -No shock

Primary -Shock

Rescue -No shock

Rescue -Shock

Age < 75Age > 75

Conclusions

Primary PCI is feasible for local population In-hospital results are encouraging Post-Merlin practice has changed significantly Tertiary service offered for

– Shock– Reinfarction– Contraindications to thrombolysis– Rescue in selected cases

Angiographically Guided Therapy for AMI

Requirements Motivated Team Cooperation of Ambulance Service

– Telemetered ECG Anaesthetic Support Surgical Support

Questions Widening the net Facilitation Thrombus extraction – Distal protection Shock - ? LNMMA ? Pexelizumab ?Metabolic support Slow flow / No flow IABP Age – What is optimal care for the over 80s?

Audit– Times, ST resolution, Stroke, Follow Up Revasc etc