Coronary stenting with MGuard: first-in-man trial.

Abstract

UNLABELLED:

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.

AIM:

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.

CONCLUSION:

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.

• Authors: Edo Kaluski, Karl Eugen Hauptmann, Ralf Müller, Steve Tsai, Marc Klapholz, Eberhard Grube
• Journal: The Journal of invasive cardiology (J Invasive Cardiol) Vol. 20 Issue 10 Pg. 511-5 (Oct 2008) ISSN: 1557-2501 [Electronic] United States
• PMID: 18829994 (Publication Type: Clinical Trial, Journal Article, Multicenter Study)

Chemical References

• Platelet Aggregation Inhibitors

Topics

• Aged
• Angioplasty, Balloon, Coronary (adverse effects, instrumentation, methods)
• Coronary Artery Disease (surgery, therapy)
• Coronary Thrombosis (etiology, prevention & control)
• Coronary Vessels (pathology, surgery, transplantation)
• Feasibility Studies
• Female
• Humans
• Male
• Platelet Aggregation Inhibitors
• Prospective Studies
• Stents
• Transplants