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Preliminary results of the INSPIRE trial with the novel MGuard™ stent system containing a protection net to prevent distal embolization
Author(s) -
Maia Felipe,
Ribamar Costa J.,
Abizaid Alexandre,
Feres Fausto,
Costa Ricardo,
Staico Rodolfo,
Siqueira Dimytri,
Esteves Vinicius,
Sousa Amanda,
Eduardo Sousa J.
Publication year - 2010
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.22473
Subject(s) - medicine , timi , conventional pci , mace , stent , percutaneous coronary intervention , myocardial infarction , embolization , surgery , cardiology , thrombus , radiology
Objective : To assess the efficacy of the MGuard TM stent combining a polymer‐mesh sleeve attached to the external surface of a bare‐metal stent in preventing distal embolization during percutaneous coronary intervention (PCI). Background : Distal embolization of thrombus/platelet agreggates is associated with worse immediate and long‐term prognosis after PCI. Treatment of saphenous vein graft (SVG) and PCI in the setting of acute coronary syndromes (ACS) is often related to this complication. Although protection and aspiration devices have been shown to reduce distal embolization, they add time and cost to PCI. Methods : A total of 30 patients were included. Inclusion criteria were 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 included the incidence of major adverse cardiac events (MACE) (composite of cardiac death, non‐fatal myocardial infarction and TLR) up to 30 days of the procedure and TIMI flow right after the PCI. Results : Mean population age was 60.8 years with 36.7% of diabetes. Overall, 53.3% presented with ACS, and most lesions were located in SVG (16 of 30). The majority of lesions had complex morphology including the presence of thrombus (30%) and ulcer (33.3%). The MGuard stent was successfully deployed in all cases with no angiographic/clinical complications including distal embolization. Final TIMI‐3/blush‐3 were achieved in all cases with no MACE up to 30 days of the procedure. Conclusions : In this preliminary evaluation, the MGuard device demonstrated excellent performance in a highly complex lesion subset, including absence of angiograhpic/procedural complications, and no adverse events up to 30‐day FU. © 2010 Wiley‐Liss, Inc.