Positive Trial Data For MGuard™Stent With Embolic Protection

Abstract

Israeli Stent company InspireMD, Inc.,  has announced positive clinical results from an investigator-sponsored controlled randomized trial conducted in Chile. The study showed that acute ST-elevation myocardial infarction (STEMI) patients who underwent coronary angioplasty with InspireMD’s MGuard coronary stent exhibited statistically significant improvement in microvascular reperfusion criteria compared with those treated with traditional bare metal stents (BMS).

Background

MGuard presents a novel combination of a coronary stent merged with an embolic protection specifically designed for acute MI patients. The embolic protection is comprised of an ultra-thin polymer micron net that wraps the stent. According to InspireMD, the MGuard stent provides outstanding and lifelong embolic protection, without affecting deliverability.

MGuard is CE Mark approved.

Mesh-based protection is now recommended for use in the recent Guidelines of the Task force of Myocardial Revascularization of the European Society of Cardiology (ESC).

The study

Dr. Dante Lindefjeld’s study was known as the MICAMI (MIcrovascular Coronary Flow Comparison in Acute Myocardial Infarction Angioplasty) MGuard trial. It was designed to investigate if use of MGuard could reduce distal embolization of thrombus/platelet aggregates and thereby improve coronary and myocardial reperfusion in STEMI patients.

Forty patients with STEMI referred for primary PCI were enrolled at three centres in Chile and randomised to receive either MGuard or Bare metal Stent (BMS) treatment. The endpoints, analysed by blinded experts, were TIMI flow grade, myocardial blush grade, TIMI frame count and the percentage of patients with optimal result. Baseline measurements of clinical, angiographic and procedural variables were not significantly different between groups. The elapsed time from onset of AMI was also comparable for both groups.

Lead investigator Dr. Lindefjeld presented the study findings in Washington, D.C., at the Cardiovascular Research Technologies conference.

Key findings were

  • 18 patients (90%) in the MGuard group achieved Blush grade 3 compared with 10 patients (50%) in the BMS group.
  • Median Blush grade value for MGuard patients was 3.0 (optimal result) versus 2.5 for BMS patients.
  • Measurement of corrected TIMI frame count showed a benefit in favor of MGuard.
  • 17 patients (85%) in the MGuard group achieved successful angioplasty (as defined by cTFC < 23) compared with only 6 (30%) in the BMS group.
  • Final TIMI flow grade was not significantly different between the 2 groups.
  • There were 2 cases of acute stent thrombosis (one for each group) at 30 days follow up, and no clinical events at 6 months.

Investigator comments

“Every perfusion parameter measured in our study displayed superior outcomes in the MGuard group compared to the BMS group,” said Dr. Lindefjeld when asked about his presentation. “Additional randomized trials are now appropriate to gather more data about the role of MGuard in clinical use. I’m personally pleased to be the investigator who completed the first randomized trial for MGuard.”

Company comments 

Eli Bar, CTO and Vice President of Research and Development at InspireMD, commented, “The results of this 40-patient study add to the growing body of data about MGuard’s efficacy. The continued work of independent investigators such as Dr. Lindefjeld and his colleagues is important in evaluating the value of MGuard and in creating greater awareness of the product among cardiologists. We will continue to study MGuard to generate further data about its safety and efficacy.”

Source: InspireMD