Distal Protection:

PRIDE, CAPTIVE

Symbiot III, AiMI

Dr James Cotton MD MRCP

Heart and Lung Centre

Wolverhampton

Pathology

16.3 16.5

11.6

18.6

9.6 9.9

0

5

10

15

20

EPILOG SAFER FIRE

Control

Treatment

History (SVG trials)30 D

ay M

AC

E

Ab

cix

imab

Gu

ard

wir

e

Gu

ard

wir

e

Filte

rwir

e E

X

Possible methods for embolic

protection

Trial Name Device Design

PRIDE Triactiv occlusive

distal protection

Non-inferiority

analysis vs guardwire

or filterwire

CAPTIVE Cardioshield Superiority vs nil and

Non inferiority vs

guardwire

Symbiot III Symbiot covered

stent

VS. BMS in SVG

AIMI Angiojet rheolytic

thrombectomy

Randomised vs nil in

AMI

Distal Protection UK 2003

• Distal Protection 345 (0.65%)

• Thrombectomy 347 (0.65%)

(inc. percusurg)

Pride/Captive

• Both started as superiority trials

• After FDA approval for guardwire and

filterwire, changed to non-inferiority trials.

PRIDEPRotection during saphenous vein graft

Intervention to prevent Distal Embolisation

PRIDE

SVG Lesion

>3.0<5.0 mm

Any Length

n=631

Triactiv

N=313

Guardwire n=236

Filterwire n=83

Total n=318

10 endpoint - MACE at 30 days

20 endpoint - Efficacy (final TIMI 3 flow)

- Safety

PRIDEEnd point TriActiv

(n=313)

FilterWire or

GuardWire

(n=318)

p

MACE (%) 11.2 10.1 NS

Procedure-related MACE (%) 10.2 10.1 NS

Final TIMI 3 grade (%) 99.1 97.8 NS

Myocardial infarction (%) 9.9 8.8 NS

In-hospital MACE (%) 9.9 9.1 NS

Stroke (%) 0.3 0.3 NS

Vascular/bleeding events (%) 11.8 6.6 0.02

CAPTIVE

Cardioshield Application Protects during

Transluminal Intervention of Vein grafts

by reducing Emboli

Total

N=1011

Randomised

N=847

Superiority

N=197

Non inferiority

N=652

Cardioshield

N=96

No protection

N=101

Cardioshield

N=334

Guardwire

N=318

Inclusion – Lesion <50 mm

10 endpoint: 30 day MACE

End point CardioShield

(n=96)

No

protection

(n=101)

P

MACE (%) 10.4 11.9 NS

Death (%) 1.0 1.0 NS

MI (Q- and non-Q-wave)

(%)

8.3 10.9 NS

Emergent CABG (%) 0.0 0.0 NS

Target lesion

revascularization (%)

2.1 0.0 NS

CAPTIVE: Primary end point at 30

days, superiority analysis

CAPTIVE: Primary end point at

30 days, non-inferiority analysis

End point CardioShield

(n=334)

Guardwire

(n=318)

P

MACE (%) 11.4 9.1 0.057

Death (%) 0.3 0.9 <0.001

MI (Q- and non-Q-wave)

(%)11.4 8.2 0.114

Emergent CABG (%) 0.0 0.0 NS

Target lesion

revascularization (%)0.6 0.0 <0.001

SYMBIOT III

• Symbiot PTFE coated nitinol self expanding

stent vs BMS in SVG lesions

– Up to 2 lesions

– Lesion length <41mm

– Stent length < 51mm

• Primary endpoint:

Reduction of % DS of at

least10% at 8/12 angio

compared to BMS

• (Symbiot II –

7% restenosis at 6/12)

SYMBIOT III

Randomised

N=400

BMS

199

128 150

Symbiot

201

Angiographic 8/12 FU

SYMBIOT III

Primary endpoint

34.8

40.1

Analysis segment

BMS

Symbiot

%D

S

P=0.12

26.630.6

MACE at 8/12 %

23.3

34.9

Binary restenosis (analysis segment)

P=0.43 P=0.04

SYMBIOT III

BMS

Symbiot

The AIMI Study

AngioJet Rheolytic Thrombectomy In

Patients Undergoing Primary Angioplasty

for Acute Myocardial Infarction

AIMI - Hypothesis

• Effective removal of coronary thrombus

prior to definitive angioplasty and stenting

may reduce distal embolization of

thrombus, which could improve myocardial

perfusion and salvage.

• Rheolytic thrombectomy with the AngioJet

System during PCI for all STEMI will

reduce final infarct size.

Study Design

STEMI < 12 hours

Anterior MI

Large Inferior MI

N=480

CATH LAB

Coronary Angiography

Randomization

Primary PCI

N=240

Rheolytic Thrombectomy

followed by definitive PCI

N=240

Resting Tc-99m sestamibi scan at 14-28 days (N=197 AJ/205 Control)

MACE

Clinical Follow up at 6 months

AIMI - endpoints

• Primary:

• Infarct size at 14-28 days, by Tc-99m sestamibi SPECT imaging

• Secondary:

• TIMI flow grade, TIMI blush grade, TIMI frame count (corrected)

• ST-segment resolution

• MACE (death, new Q wave MI, stroke, TLR)

• EF (SPECT)

10.2%

+/-

11.1

16.5%

+/-

13.112.5%

+/-

12.1

6.5%

+/-

8.9

15.3%

+/-

12.0

9.8%

+/-

10.9

0

5

10

15

20

All Anterior MI Inferior MI

MI siz

e (

%)

RT

Control

Final Infarct size (10 endpoint)P<0.02 P=0.58 P<0.006

6.7%

4.6%

1.7%0.8%

0

2

4

6

8

10

Death Total MACE

RT

Control

P<0.02 P<0.01

AIMI - MACE

Conclusions:

• Triactiv device is non inferior to current distal protection standards

• Cardioshield device is yet to be proven

• Symbiot stent is not superior to BMS in SVG`s

• At present rheolytic thrombectomy cannot be recommended in acute infarct angioplasty