Coronary stenting with MGuard: First-in-man trial

Edo Kaluski, Karl Eugen Hauptmann, Ralf Müuller, Steve Tsai, Marc Klapholz, Eberhard Grube

Research output: Contribution to journalArticle

26 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)511-515
Number of pages5
JournalJournal of Invasive Cardiology
Volume20
Issue number10
StatePublished - Oct 1 2008
Externally publishedYes

Keywords

  • Embolic protection device
  • Embolization
  • Restenosis
  • Stent thrombosis

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

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    Kaluski, E., Hauptmann, K. E., Müuller, R., Tsai, S., Klapholz, M., & Grube, E. (2008). Coronary stenting with MGuard: First-in-man trial. Journal of Invasive Cardiology, 20(10), 511-515.