Coronary stenting with MGuard: extended follow-up of first human trial.

OBJECTIVES To evaluate feasibility and safety of MGuard based percutaneous coronary interventions (PCI) in vein grafts (VG) and native coronaries (NC). BACKGROUND Distal embolization is a frequent complication of PCI of VG and NC during acute coronary syndromes (ACS). MGuard was a stent designed to reduce embolization. METHODS Prospective, single arm, two-center trial assessing the feasibility and safety of MGuard-based PCI with post-PCI clinical and laboratory monitoring including: cardiac biomarkers, ECG and 6-month angiography. RESULTS Forty-one patients with mean age of 68.2±10.1 years were enrolled. Mean VG age (n=23) was 14.4±4.3 years. All patients received heparin, clopidogrel and aspirin; while none received glycoprotein IIb/IIIa inhibitors, or embolic protection device (EPD). Device and procedural success were 100% and 95.1% respectively. Two patients (4.9%) experienced procedure-related creatinine phosphokinase rise. At 6 months one patient had myocardial infarction and 19.5% had target vessel revascularization (TLR). Late follow up (12-27 months) revealed one additional TLR. CONCLUSION MGuard based PCI of NC and VG appears encouraging especially in view of unfavorable patient and lesion characteristics. Efficacy needs to be further established in larger randomized trials.