Dr James Cotton MD MRCP

1
Distal ProtectionPRIDE, CAPTIVE Symbiot III,
AiMI

• Dr James Cotton MD MRCP
• Heart and Lung Centre
• Wolverhampton

2
Pathology
3
History (SVG trials)
30 Day MACE
Abciximab
Guardwire
Filterwire EX
Guardwire
4
Possible methods for embolic protection
5
(No Transcript)
6
Distal Protection UK 2003

• Distal Protection 345 (0.65)
• Thrombectomy 347 (0.65)
• (inc. percusurg)

7
Pride/Captive

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

8
PRIDE

• PRotection during saphenous vein graft
  Intervention to prevent Distal Embolisation

9
PRIDE
Triactiv N313
SVG Lesion gt3.0lt5.0 mm Any Length n631
Guardwire n236 Filterwire n83 Total n318
10 endpoint - MACE at 30 days 20 endpoint -
Efficacy (final TIMI 3 flow) - Safety
10
PRIDE
11
CAPTIVE
Cardioshield Application Protects during
Transluminal Intervention of Vein grafts by
reducing Emboli
12
Inclusion Lesion lt50 mm 10 endpoint 30 day
MACE
13
CAPTIVE Primary end point at 30 days,
superiority analysis
14
CAPTIVE Primary end point at 30 days,
non-inferiority analysis
15
SYMBIOT III

• Symbiot PTFE coated nitinol self expanding stent
  vs BMS in SVG lesions
• Up to 2 lesions
• Lesion length lt41mm
• Stent length lt 51mm

• Primary endpoint
• Reduction of DS of at
• least10 at 8/12 angio
  compared to BMS

• (Symbiot II
• 7 restenosis at 6/12)

16
SYMBIOT III
Randomised N400
BMS 199
Symbiot 201
Angiographic 8/12 FU
128
150
17
SYMBIOT IIIPrimary endpoint
P0.12
DS
18
SYMBIOT III
P0.04
P0.43
19
The AIMI Study

• AngioJet Rheolytic Thrombectomy In Patients
  Undergoing Primary Angioplasty for Acute
  Myocardial Infarction

20
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.

21
Study Design
STEMI lt 12 hoursAnterior MILarge Inferior
MIN480
CATH LABCoronary AngiographyRandomization
Rheolytic Thrombectomyfollowed by definitive
PCIN240
Primary PCIN240
Resting Tc-99m sestamibi scan at 14-28 days
(N197 AJ/205 Control)MACEClinical Follow up at
6 months
22
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)

23
Final Infarct size (10 endpoint)
P0.58
Plt0.02
Plt0.006
24
AIMI - MACE
Plt0.01
Plt0.02
25
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 SVGs
• At present rheolytic thrombectomy cannot be
  recommended in acute infarct angioplasty