Preliminary results of the INSPIRE trial with the novel MGuard stent system containing a protection net to prevent distal embolization.
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 aggregates 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 angiographic/procedural complications, and no adverse events up to 30-day FU.
Maia
Felipe
F
Instituto Dante Pazzanese de Cardiologia, Av. Dr. Dante Pazzanese 500, Ibirapuera, CEP, São Paulo, Brazil.
Costa
J Ribamar
JR
Abizaid
Alexandre
A
Feres
Fausto
F
Costa
Ricardo
R
Staico
Rodolfo
R
Siqueira
Dimytri
D
Esteves
Vinicius
V
Sousa
Amanda
A
Sousa
J Eduardo
JE
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D001938:Brazil; D017023:Coronary Angiography; D001026:Coronary Artery Bypass / Q000009:adverse effects; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D003326:Coronary Circulation; D004617:Embolism / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D005240:Feasibility Studies; D005260:Female; D005374:Filtration / Q000295:instrumentation*; D006083:Graft Occlusion, Vascular / Q000175:diagnosis / Q000209:etiology / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D008297:Male; D008670:Metals; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D011474:Prosthesis Design; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional
D008670:Metals