Coronary stenting with MGuard: first-in-man trial.
MGuard is a bare-metal stent covered by an ultrathin polymer mesh sleeve on its external surface, designed to reduce embolization during coronary, cerebrovascular and peripheral interventions.


OBJECTIVE
To evaluate the feasibility and safety of MGuard-based percutaneous coronary interventions (PCIs) of human native coronary arteries (NCs) and coronary vein grafts (VGs).


METHODS
MGuard-based PCI executed by 2 centers with postprocedural clinical and laboratory monitoring; including creatinine phosphokinase (CPK), troponin, electrocardiography and 6-month angiographic follow up. The primary endpoint was 30-day major adverse cardiac events (MACE) including cardiac death, myocardial infarction, stent thrombosis and repeat target lesion revascularization. The secondary endpoint was device and procedural success.


RESULTS
Twenty-nine patients with a mean age of 68.1 +/- 12 years were enrolled. The mean VG age (n = 17) was 12.6 years (range 8-19). All patients received heparin, clopidogrel and aspirin, while none received bivalirudin, glycoprotein IIb/IIIa inhibitors (GPIs) or an embolic protection device (EPD). Device and procedural success were 100% and 96.5%, respectively. One patient experienced a procedure-related CPK rise. No MACE were reported at 1 month.


CONCLUSIONS
MGuard-based PCI of NCs and VGs appears encouraging, especially in view of unfavorable patient and lesion characteristics. Both efficacy and safety need to be further established in larger-scale studies with longer follow-up periods.
Kaluski
Edo
E
Department of Cardiology, University of Medicine and Dentistry of New Jersey, Newark, NJ 07101, USA. kalusked@umdnj.edu
Hauptmann
Karl Eugen
KE
Müller
Ralf
R
Tsai
Steve
S
Klapholz
Marc
M
Grube
Eberhard
E
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects* / Q000295:instrumentation / Q000379:methods; D003324:Coronary Artery Disease / Q000601:surgery / Q000628:therapy; D003328:Coronary Thrombosis / Q000209:etiology* / Q000517:prevention & control; D003331:Coronary Vessels / Q000473:pathology* / Q000601:surgery / Q000637:transplantation; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D010975:Platelet Aggregation Inhibitors; D011446:Prospective Studies; D015607:Stents; D019737:Transplants
D010975:Platelet Aggregation Inhibitors