February 6, 2012 — InspireMD Inc. announced positive clinical results for its MGuard stent from a controlled randomized trial conducted in Chile. The study showed that acute ST-elevation myocardial infarction (STEMI) patients who underwent coronary angioplasty with MGuard exhibited statistically significant improvement in microvascular reperfusion criteria compared with those treated with traditional bare metal stents (BMS).
The study was presented in Washington, D.C., at the Cardiovascular Research Technologies conference by lead investigator Dante Lindefjeld, M.D. "Every perfusion parameter measured in our study displayed superior outcomes in the MGuard group compared to the BMS group," said Lindefjeld. "Additional randomized trials are now appropriate to gather more data about the role of MGuard in clinical use.”
MICAMI MGuard Trial Design and Results
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 centers in Chile and randomized to receive either MGuard or BMS treatment. The endpoints, analyzed 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.
Key findings from the trial:
- 18 patients (90 percent) in the MGuard group achieved Blush grade 3 compared with 10 patients (50 percent) in the BMS group (p = 0.006)*.
- Median Blush grade value for MGuard patients was 3 (optimal result) versus 2.5 for BMS patients (p = 0.006)*.
- Measurement of corrected TIMI frame count showed a benefit in favor of MGuard (mean cTFC: MGuard 19.65 + 4.07 vs. BMS 27.35 + 7.15, p < 0.001*, cTFC mean difference MGuard - BMS 7.7, CI 95 percent: 3.94 to 11.46).
- 17 patients (85 percent) in the MGuard group achieved successful angioplasty (as defined by cTFC < 23) compared with only six (30 percent) in the BMS group (p < 0.001)*.
- Final TIMI flow grade was not significantly different between the two groups.
- There were two cases of acute stent thrombosis (one for each group) at 30 days follow up, and no clinical events at six months.
*p values were calculated using a two-sided test
About MGuard Coronary Stent
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. 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).
MGuard is currently being investigated in the multi-center, international MASTER (MGuard for Acute ST Elevation Reperfusion) trial. This 432 patient study has been designed to evaluate the MGuard stent compared to commercially-approved BMS or DES products in STEMI patients undergoing primary angioplasty. Results are expected in the second half of 2012. Plans for a registration study in the United States are also at an advanced stage.
For more information: www.inspire-md.com