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Dr James Cotton MD MRCP Heart and Lung Centre Wolverhampton

Distal Protection: PRIDE, CAPTIVE Symbiot III, AiMI . Dr James Cotton MD MRCP Heart and Lung Centre Wolverhampton. Pathology. History (SVG trials). 30 Day MACE. Abciximab. Guardwire. Filterwire EX. Guardwire. Possible methods for embolic protection. Distal Protection UK 2003.

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Dr James Cotton MD MRCP Heart and Lung Centre Wolverhampton

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  1. Distal Protection:PRIDE, 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. Distal Protection UK 2003 • Distal Protection 345 (0.65%) • Thrombectomy 347 (0.65%) (inc. percusurg)

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

  7. PRIDE PRotection during saphenous vein graft Intervention to prevent Distal Embolisation

  8. PRIDE Triactiv N=313 SVG Lesion >3.0<5.0 mm Any Length n=631 Guardwire n=236 Filterwire n=83 Total n=318 10 endpoint - MACE at 30 days 20 endpoint - Efficacy (final TIMI 3 flow) - Safety

  9. PRIDE

  10. CAPTIVE Cardioshield Application Protects during Transluminal Intervention of Vein grafts by reducing Emboli

  11. Total N=1011 Randomised N=847 Non inferiority N=652 Superiority N=197 Cardioshield N=96 No protection N=101 Cardioshield N=334 Guardwire N=318 Inclusion – Lesion <50 mm 10 endpoint: 30 day MACE

  12. CAPTIVE: Primary end point at 30 days, superiority analysis

  13. CAPTIVE: Primary end point at 30 days, non-inferiority analysis

  14. 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)

  15. SYMBIOT III Randomised N=400 BMS 199 Symbiot 201 Angiographic 8/12 FU 128 150

  16. SYMBIOT IIIPrimary endpoint P=0.12 %DS

  17. BMS Symbiot SYMBIOT III P=0.04 P=0.43

  18. The AIMI Study AngioJet Rheolytic Thrombectomy In Patients Undergoing Primary Angioplasty for Acute Myocardial Infarction

  19. 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.

  20. Study Design STEMI < 12 hoursAnterior MILarge Inferior MIN=480 CATH LABCoronary AngiographyRandomization Rheolytic Thrombectomyfollowed by definitive PCIN=240 Primary PCIN=240 Resting Tc-99m sestamibi scan at 14-28 days (N=197 AJ/205 Control)MACEClinical Follow up at 6 months

  21. 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)

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

  23. AIMI - MACE P<0.01 P<0.02

  24. 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

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