Final 1-Year MASTER Trial Results of InspireMD's MGuard Published

February 2, 2015—Final 1-year clinical and angiographic results from the MASTER trial of the MGuard (InspireMD, Inc.) for acute ST-elevation reperfusion were published online ahead of print by Dariusz Dudek, MD, et al in Circulation: Cardiovascular Interventions.

The MGuard is a bare-metal stent covered with a polymer mesh that is designed to reduce distal embolization during percutaneous coronary intervention (PCI) in ST-segment–elevation myocardial infarction (STEMI). In the MASTER trial, the primary endpoint of complete ST-segment resolution was significantly improved with the MGuard compared with control.

As summarized in Circulation: Cardiovascular Interventions, the MASTER trial was an evaluation of the 1-year clinical and angiographic results. Patients with STEMI ≤ 12 hours undergoing primary PCI of a single de novo native lesion were randomized to the MGuard versus any commercially available metallic stent (39.8% drug-eluting stents). Clinical follow-up was performed through 1 year, and angiography at 13 months was planned in 50 MGuard patients.

The MASTER investigators found that in patients with STEMI undergoing primary PCI, a trend toward reduced 1-year mortality was present in patients treated with the MGuard stent. Target lesion revascularization and major adverse cardiac events rates during follow-up were higher in the MGuard group than in the control stent group, and angiographic late loss of the MGuard was consistent with that expected from bare-metal stents.

On December 14, 2014, InspireMD announced that principal investigator Gregg Stone, MD, presented results from the MASTER II trial of the company’s MGuard Prime coronary embolic protection system at the International Conference for Innovations in Cardiovascular Systems meeting in Tel Aviv, Israel.