INITIAL EXPERIENCE WITH THE NOVEL MGUARD STENT SYSTEM FOR PERCUTANEOUS CORONARY INTERVENTION AT AFIC – NIHD

Abstract

Objective: To assess the efficacy of the MGuard Stent in Percutaneous Coronary Intervention (PCI) in the setting of acute coronary syndromes.
Study Design: Interventional case series.
Introduction: Distal embolisation during PCI occurs in acute coronary syndrome from the thrombus occluding the artery. The consequences can vary from a simple sluggish flow to myocardial infarction and death. A number of protective devices reduce distal embolisation, but they add complexity and cost to the procedure. The balloon expandable MGuard stent is a unique innovation to counter the phenomenon. We sought to study its efficacy in the proposed indications.
Patients and methods : The study was conducted in AFIC – NIHD. Between April and July 2010, 18 patients were included and a total of 21 MGuard stents were deployed. Inclusion criteria were de novo lesions in saphenous vein grafts or native vessels with angiographic evidence of thrombus activity or lesion instability and a potential for distal embolisation in the setting of acute coronary syndromes. Use of filter wires or other proximal or distal protective devices was not allowed in the study. Primary end point included the incidence of MACE (composite if cardiac death, non-fatal MI and need for TLR) up to 30 days after the procedure. Secondary endpoints included restoration of TIMI grade 3 flow and myocardial blush grade 3 at the end of the procedure.
Results: All patients were male. Mean age was 45.61 years (range 32-70 years). All were admitted with acute coronary syndrome. Most lesions had complex morphological features and all had some thrombus activity. The MGuard stent was deployed successfully in all cases and without any complications. Secondary endpoints (TIMI – grade III flow and myocardial blush grade 3) were met in all cases. There was no elevation of cardiac enzymes post procedure in any patient, and no MACE was reported at 30 days (primary end point).
Conclusions: These preliminary results show that the MGuard stent is a safe option for patients undergoing PCI in the setting of acute coronary syndrome with thrombus burden and saphenous vein graft stenosis.