Distal Protection: PRIDE, CAPTIVE Symbiot III, AiMI Dr James Cotton MD MRCP Heart and Lung Centre Wolverhampton.

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Presentation transcript:

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

Possible methods for embolic protection

Trial NameDeviceDesign 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.

PRIDE PRotection 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= endpoint - MACE at 30 days 2 0 endpoint - Efficacy (final TIMI 3 flow) - Safety

PRIDE End pointTriActiv (n=313) FilterWire or GuardWire (n=318) p MACE (%) NS Procedure-related MACE (%) NS Final TIMI 3 grade (%) NS Myocardial infarction (%)9.98.8NS In-hospital MACE (%)9.99.1NS Stroke (%)0.3 NS Vascular/bleeding events (%)

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 1 0 endpoint: 30 day MACE

End pointCardioShield (n=96) No protection (n=101) P MACE (%) NS Death (%)1.0 NS MI (Q- and non-Q-wave) (%) NS Emergent CABG (%)0.0 NS Target lesion revascularization (%) NS CAPTIVE: Primary end point at 30 days, superiority analysis

CAPTIVE: Primary end point at 30 days, non-inferiority analysis End pointCardioShield (n=334) Guardwire (n=318) P MACE (%) Death (%) <0.001 MI (Q- and non-Q-wave) (%) Emergent CABG (%) 0.0 NS Target lesion revascularization (%) <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 Symbiot 201 Angiographic 8/12 FU

SYMBIOT III Primary endpoint %DS P=0.12

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 days (N=197 AJ/205 Control) MACE Clinical Follow up at 6 months

AIMI - endpoints Primary: Infarct size at 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)

Final Infarct size (1 0 endpoint) P<0.02 P=0.58 P<0.006

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