Distal Protection:Distal Protection:PRIDE, CAPTIVEPRIDE, CAPTIVE

Symbiot III, AiMI Symbiot III, AiMI

Dr James Cotton MD MRCPDr James Cotton MD MRCP

Heart and Lung CentreHeart and Lung Centre

WolverhamptonWolverhampton

PathologyPathology

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)History (SVG trials)30

Day

MA

CE

Ab

cixi

mab

Gu

ard

wir

e

Gu

ard

wir

e

Filt

erw

ire

EX

Possible methods for embolic Possible methods for embolic protectionprotection

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 2003Distal Protection UK 2003

• Distal Protection 345 (0.65%)

• Thrombectomy 347 (0.65%)

(inc. percusurg)

Pride/CaptivePride/Captive

• Both started as superiority trials

• After FDA approval for guardwire and filterwire, changed to non-inferiority trials.

PRIDEPRIDEPRotection during saphenous vein graft Intervention to prevent Distal Embolisation

PRIDEPRIDE

SVG Lesion

>3.0<5.0 mmAny Length

n=631

TriactivN=313

Guardwire n=236Filterwire n=83

Total n=318

10 endpoint - MACE at 30 days20 endpoint - Efficacy (final TIMI 3 flow)

- Safety

PRIDEPRIDEEnd 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

CAPTIVECAPTIVE

Cardioshield Application Protects during Transluminal Intervention of Vein grafts

by reducing Emboli

TotalN=1011

RandomisedN=847

SuperiorityN=197

Non inferiorityN=652

CardioshieldN=96

No protectionN=101

CardioshieldN=334

GuardwireN=318

Inclusion – Lesion <50 mm10 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 CAPTIVE: Primary end point at 30 days, superiority analysisdays, superiority analysis

CAPTIVE: Primary end point at CAPTIVE: Primary end point at 30 days, non-inferiority analysis30 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 NSTarget lesion revascularization (%)

0.6 0.0 <0.001

SYMBIOT IIISYMBIOT 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 IIISYMBIOT III

RandomisedN=400

BMS199

128 150

Symbiot201

Angiographic 8/12 FU

SYMBIOT IIISYMBIOT IIIPrimary endpointPrimary endpoint

34.840.1

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 IIISYMBIOT III

BMS

Symbiot

The AIMI StudyThe AIMI StudyAngioJet Rheolytic Thrombectomy In

Patients Undergoing Primary Angioplasty for Acute Myocardial Infarction

AngioJet Rheolytic Thrombectomy In Patients Undergoing Primary Angioplasty

for Acute Myocardial Infarction

AIMI - HypothesisAIMI - 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 DesignStudy DesignStudy DesignStudy DesignSTEMI < 12 hours

Anterior MILarge Inferior MI

N=480

CATH LABCoronary Angiography

Randomization

Primary PCIN=240

Rheolytic Thrombectomyfollowed 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 - endpointsAIMI - 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 s

ize

(%)

RT

Control

Final Infarct size (1Final Infarct size (100 endpoint) 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 - MACEAIMI - MACE

Conclusions: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