MGuard image courtesy of InspireMD
January 5, 2015 — InspireMD, Inc. announced results from two important clinical trials. Thirty-day results from the MASTER II trial, which enrolled 310 of a planned 1,114 patients were presented at a major cardiology congress in Israel in December. The trial was suspended in October 2014 as a result of a corporate shift in strategy to a next-generation MGuard drug eluting stent (DES) platform. The company also announced ipsilateral diffusion weighted magnetic resonance imaging (DW-MRI) results from the CARENET Trial for the CGuard system which successfully completed enrollment in July.
MASTER II was a global clinical trial conducted under a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) and was intended for U.S. registration of the MGuard Prime coronary EPS for use in patients presenting with ST-segment elevated myocardial infarction (STEMI). The MASTER II trial was designed to show superiority of ST segment resolution 60-90 minutes post procedure as well non-inferiority in all-cause death or recurrent target vessel myocardial infarction. While the trial was halted well short of the planned enrollment, the company elected to unblind the data and present the results on behalf of the study investigators.
Gregg Stone, M.D., professor of medicine at Columbia University and principal investigator of the trial, presented 30-day results on the 310 patients enrolled in MASTER II as well as pooled data from MASTER II and the 433-patient MASTER I trial completed and published in 2012. While in MASTER I, the primary endpoint of superiority in ST-segment resolution was achieved (57.8 percent vs. 44.7 percent, p=0.008), MASTER II did not show a difference in ST-segment resolution between MGuard and control stents (FDA-approved bare metal or drug eluting stents) 56.9 percent vs. 59.3 percent (p=0.68). Pooled data between MASTER I and MASTER II for ST resolution continued to favor MGuard 57.5 percent vs. 50.7 percent for control (p=0.07).
Impressively, 30-day mortality results for the MGuard in the MASTER II trial remained low (0.6 percent vs. 1.9 percent, p=0.62), consistent with all previous MGuard trials and registries and overall MACE (major adverse cardiac events) was favorable for MGuard (2.6 percent vs. 4.5 percent p=0.36). Pooled mortality data for MASTER I and II showed a statistically significant reduction in mortality with MGuard (0.3 percent vs. 1.9 percent, p=0.04). Infarct size, another important indicator of mortality, showed a positive trend for MGuard in MASTER II (mean 22.60 percent vs. 27.48 percent, p=0.16), as well as in the pooled analysis (mean 18.80 percent vs. 22.24 percent, p=0.26).
CARENET data was also presented by Piotr Musia?ek, Ph.D., co-principal investigator for the CARENET study, from Jagiellonian University Medical College at John Paul II Hospital, in Krakow, Poland. He reported new positive clinical data from the CGuard CARENET (CARotid Embolic protection study using microNET) trial. The CARENET trial recruited a total of 30 patients and showed exceptional safety and efficacy with 0 percent MACCE (meaning no death, stroke or myocardial infarction) at 30 days, substantially lower than in other carotid stenting trials. Additionally, the incidence of new ischemic ipsilateral lesions as assessed by DW-MRI after carotid artery stenting was 37 percent, a reduction of approximately 50 percent when compared to published historical control groups of non-mesh covered carotid stents.The CARENET trial also reported an average lesion volume per patient that was 10 times smaller than historical control groups. The reduction in both the incidence and volume of new ischemic lesions indicates therapeutic benefits of the MicroNet technology and that the benefits of using this device may extend beyond the acute procedural period.
For more information: www.inspiremd.com