distal protection: pride, captive symbiot iii, aimi dr james cotton md mrcp heart and lung centre...
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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
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.
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 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