Abstract 2552: Preliminary Experience with the Novel MGuardTM Stent System Containing a Protection Net to Prevent Distal Embolization - Results From a Prospective, Non-Randomized, Single Center Study
Background: Disturbances of coronary flow due to distal embolization of thrombus/platelet agreggates is associated with worse immediate and long-term prognosis after PCI. Also, treatment of SVG and PCI in the setting of acute coronary syndromes (ACS) are frequently related to this complication. Although protection devices (filterwires) have been shown to reduce distal embolization, they add time and cost to PCI. The newly developed balloon-expandable MguardTM stent system (InspireMD Ltd) is a combination of an ultra-thin polymer mesh sleeve attached to the external of a bare metal stent surface designed to provide embolic protection during PCI.
Methods: Between Nov/2007-Apr/2008, 16 pts (17 lesions) were included. Lesion criteira included de novo lesions in SVG or native vessels with angiographic evidence of instability with potential to provoke flow disturbances and/or distal embolization. IVUS was perfomred immediately after the procedure and will be repeated at follow-up. Both QCA and IVUS are being analysed by independent core labs.
Results: Mean age was 63 years, 20% had diabetes, 54% were smokers, and 87% had previous MI. Overall, 47% presented with ACS, and 67% of lesions were located in a SVG. The majority of lesions had complex morphology including 76% eccentric, 29% thrombus, 35% ulcer, and 24% moderate/severe calcium. The Mguard stent was successfully delivered in all cases, there was no angiographic complications including distal embolization, and final TIMI-3/blush-3 was achieved in 100%. Preprocedural QCA data demonstrated lesion length=11.33±4.98mm, vessel size=3.58±0.58mm, and DS=76.8±14.2%; and at final procedure, residual stenosis was 7.6±5.9mm with acute gain=2.55±0.72mm. There was no cardiac enzimatic elevation postprocedural, and no MACE up to 30-day follow-up (primary endpoint).
Conclusions: In this preliminary evaluation, the MGuardTM device demonstrated excellent performance in a highly complex lesion subset (without the adjunct use of distal protection devices), including absence of angiograhpic/procedural complications, and no adverse events up to 30-day follow-up. Larger trials with long-term follow-up are warranted. Complete QCA, IVUS and clinical outcomes at 6 months will be presented at the meeting.