Coronary stenting with MGuard: first-in-man trial

Area of Science:

• Cardiovascular Medicine
• Interventional Cardiology
• Biomedical Engineering

Background:

• MGuard is a novel stent featuring an external polymer mesh sleeve designed to mitigate embolization during cardiovascular interventions.
• Percutaneous coronary interventions (PCI) are standard procedures, but embolization remains a concern, particularly in complex cases involving native coronary arteries (NCs) and coronary vein grafts (VGs).

Purpose of the Study:

• To assess the feasibility and safety of utilizing the MGuard stent in PCI procedures for human NCs and VGs.
• To evaluate the clinical outcomes and device performance of MGuard-based PCI.

Main Methods:

• A prospective study involving 29 patients undergoing MGuard-based PCI at two centers.
• Patients received standard antiplatelet therapy (aspirin, clopidogrel, heparin); no glycoprotein IIb/IIIa inhibitors or embolic protection devices were used.
• Outcomes included 30-day major adverse cardiac events (MACE), device success, procedural success, and 6-month angiographic follow-up.

Main Results:

• Device and procedural success rates were high at 100% and 96.5%, respectively.
• No major adverse cardiac events (cardiac death, myocardial infarction, stent thrombosis, repeat revascularization) were reported within 30 days post-procedure.
• One patient experienced a minor, procedure-related increase in creatinine phosphokinase (CPK).

Conclusions:

• MGuard-based PCI demonstrates encouraging feasibility and safety in native coronary arteries and vein grafts, even in patients with challenging characteristics.
• Larger studies with extended follow-up are necessary to definitively establish the long-term efficacy and safety profile of the MGuard stent.