/PRNewswire/ -- InspireMD, Inc., a medical device company focusing on the development and commercialization of its proprietary stent platform technology for use in patients with Acute Myocardial Infarctions, 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 MGuardT 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 Dr. Dante Lindefjeld. "Every perfusion parameter measured in our study displayed superior outcomes in the MGuardT 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 MGuardT in clinical use. I'm personally pleased to be the investigator who completed the first randomized trial for MGuardT."
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 MGuardT and in creating greater awareness of theproduct among cardiologists. We will continue to study MGuardT to generate further data about its safety and efficacy."
MICAMI MGuardT Trial Design and Results
Dr. Lindefjeld's study was known as the MICAMI (MIcrovascular Coronary Flow Comparison in Acute Myocardial Infarction Angioplasty) MGuardT trial. It was designed to investigate if use of MGuardT 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 MGuardT 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 in the MGuardT group achieved Blush grade 3 compared with 10 patients (50 in the BMS group (p 0.006)*.
- Median Blush grade value for MGuardT patients was 3.0 (optimal result) versus 2.5 for BMS patients (p 0.006)*.
- Measurement of corrected TIMI frame count showed a benefit in favor of MGuardT (mean cTFC: MGuardT 19.65 + 4.07 vs. BMS 27.35 + 7.15, p 0.001*, cTFC mean difference MGuardT - BMS 7.7, CI 95%: 3.94 to 11.46).
- 17 patients (85 in the MGuardT group achieved successful angioplasty (as defined by cTFC < 23) compared with only 6 (30 in the BMS group (p < 0.001)*.
- 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.
*p values were calculated using a 2 sided test