Abstract 17864: Final Results of the Inspire Trial With the Novel Mguard Stent for SVG and Thrombus-Containing Lesions
Background: Disturbances of coronary flow due to distal embolization of thrombus/platelet agreggates are associated with worse immediate and long-term prognosis after PCI. Treatment of SVG and PCI in the setting of acute coronary syndromes (ACS) are often 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 Mguard stent system is a combination of an ultra-thin polymer mesh sleeve attached to the external surface of a BMS designed to provide embolic protection during PCI.
Methods: A total of 30 pts were enrolled. Inclusion critiria was de novo lesions in SVG or native vessels with angiographic evidence of instability with potential to provoke flow disturbances and/or distal embolization. Primary endpoint was the incidence of MACE (composite of cardiac death, non-fatal MI and TLR) up to 30 days of the procedure. Secondary endpoints included in-stent late lumen loss (QCA), % of stent obstruction (IVUS) at 6 months and combined up to 1 year. QCA and IVUS were performed by independent corelabs.
Results: Mean population age was 63 years with 38% of diabetics. Overall, 55% presented with ACS and 57% of lesions were located in SVG. Most lesions had complex morphology including the presence of thrombus (26%) and ulceration (20%). Distal/proximal protection devices were not used. Preprocedural QCA data showed lesion length and reference vessel diameter of 12.0±4.3mm and 3.0±0.5mm. The MGuard stent was successfully delivered in all cases and final TIMI-3 was achieved in 100% with a single non Q wave MI to 30 days (3.3%). At 6 months, in-stent late loss and % of stent obstruction were 0.99 ± 0.7mm and 31±15.6%. Up to one year clinical follow-up there was no case of cardiac death, one more case of MI (total 6.6%) and 6 cases of ischemia-driven TLR (20%). Notably, there was no stent thrombosis during this period of follow-up.
Conclusions: The MGuard stent demonstrated excellent acute performance in a highly complex lesion subset with very low rate of adverse events up to 30 days. No further safety concerns were observed up to the 1st year of the procedure.
- © 2010 by American Heart Association, Inc.