InspireMD has announced new 12-month results from the MASTER (MGuard for acute ST elevation reperfusion) trial, demonstrating that the MGuard outperformed bare metal and drug eluting stents in all-cause mortality in ST segment elevation myocardial infarction (STEMI) patients. Results from the trial were presented at the TCT conference.
According to a press release, the MGuard stent uses the company’s proprietary MicroNet technology, which is a circular knitted mesh that wraps around the stent to protect patients from plaque debris flowing downstream upon deployment. The aim of this technology is to specifically address the unmet need for STEMI patients.
The MASTER trial achieved its primary endpoint (p value = 0.008) in complete ST-segment resolution at 60-90 minutes post-procedure. Secondary endpoint clinical outcomes continued to show a lower mortality rate with the MGuard EPS compared to the control (1.0% vs. 3.3%, p=0.092) at 12 months. These findings are in line with the previously announced six-month follow-up results showing that all-cause mortality with MGuard EPS was lower than bare metal and drug eluting stents used as a control (0.5% vs. 2.8%, p=0.056).
“It is very reassuring to see that the 12-month follow up data is consistent with the acute results presented at TCT last year, especially the data that shows the mortality benefit trend of using this unique technology,” states Dariusz Dudek, physician-in-Chief, 2nd Department of Clinical Cardiology and Cardiovascular Interventions at the University Hospital in Krakow. “These positive results should give clinicians the confidence to use MGuard technology as a first line of defense against distal embolization for their STEMI patients.”
The MASTER trial enrolled a total of 433 patients with STEMI presenting within 12 hours of symptom onset undergoing percutaneous coronary intervention were randomized at 50 sites in nine countries to the MGuard EPS (n = 217) or commercially available bare metal or drug-eluting stents (n = 216).