InspireMD has announced that the randomised 432-patient MASTER trial of its embolic protective MGuard Embolic Protection Coronary Stent (EPS) has been published in the 6 November print edition of the Journal of American College of Cardiology.
The online version of the paper, authored by Gregg W Stone (director of the Cardiovascular Research and Education Center for Interventional Vascular Therapy at New York-Presbyterian Hospital/Columbia University Medical Center) and others, appeared on 24 October coinciding with Stone’s presentation of the findings at the Late Breaking Clinical Trials session of the 24th Annual Transcathater Cardiovascular Therapeutics (TCT) scientific meeting (Miami, USA, 22–26 October).
The MASTER (MGuard for acute ST elevation reperfusion) trial randomised 432 patients to MGuard EPS (217) and 216 to either bare metal stents (60%) or drug-eluting stents (40%). Fifty centres in nine countries participated in the trial. Patients are being followed for one year.
The findings showed the novel MGuard EPS provided a statistically and clinically significant acute advantage and, as a result, may hold the potential to lower the incidence of adverse sequela and prolong survival of heart attack victims.
The study met its primary endpoint (proportion of patients with ST segment resolution of ≥ 70%, measured at 60 to 90 minutes post procedure), showing the MGuard EPS was significantly superior to the control arm of bare metal and drug-eluting stents in the treatment of heart attack patients.
Significantly more patients treated with the MGuard EPS achieved complete ST resolution compared to the control arm (57.8% vs. 44.7%, P=0.008), a relative improvement of 29%.
The MGuard EPS showed a significant improvement in coronary artery blood flow compared with the control, including: (1) superior rates of restoring normal blood flow (TIMI-3 flow) (91.7% vs. 82.9%, P=0.006, a relative improvement of 10.6%); and (2) significantly less incomplete blood flow (TIMI-0/1 flow) post PCI (1.8% vs. 5.6%, P=0.01, a relative improvement of 67.9%).
Although the study’s secondary endpoints were not powered for statistical significance, they showed positive trends.
The trial showed a trend toward lower mortality (0% vs. 1.9%, P=0.06) at 30 days and smaller infarct size as measured by post procedure cardiac MRI (17.1gr vs. 22.3gr, p=0.27) in the MGuard EPS arm versus control.
There was no difference between the groups in the secondary endpoint of myocardial blush grade, which is an angiographic measure of blood flow to the cardiac muscle (MBG2/3 83.9% vs. 84.7%, P=0.81).
About MGuard Embolic Protection Coronary Stent
MGuard EPS combines a coronary stent merged with an embolic protection specifically designed for acute myocardial infarction patients. The embolic protection is comprised of an ultra-thin polymer micron net that is integrated with the stent. The MGuard EPS is designed to provide outstanding and lifelong embolic protection, without affecting deliverability. MGuard EPS is CE mark approved; it is not yet approved for sale in the USA by the FDA. The company announced that plans to initiate an FDA approval study in the first quarter of 2013.