Lead investigator, Dariusz Dudek, Jagiellonian University, Krakow, Poland, presented positive three-year results from the extended follow-up MAGICAL trial at a InspireMD-sponsored symposium at EuroPCR.
MAGICAL was a prospective, single arm, multicentre study conducted in 2008-09 that enrolled 60 STEMI (myocardial infarction with ST segment elevation) patients. The initial results showed that, following MGuard placement, 90% of patients achieved TIMI grade 3 flow, 73.3% achieved myocardial blush grade 3 and 61.4% achieved complete ST segment resolution. The major adverse cardiac and cerebrovascular event (MACCE) rate at six months following the procedure was 1.7%.
The three year follow-up data showed an overall 10.5% MACCE rate. Within this composite end point, the target lesion revascularisation rate (TLR) was 1.8%, cardiac death was 7%, stroke occurred at a rate of 1.8% and a subsequent myocardial infarction rate was 0%. In addition, there was no reduction in cardiac function over this three-year period, as measured by echocardiogram. LVEF (left ventricular ejection function) at three years (n= 36) was 56% + 10%, compared with 54% + 12% immediately post procedure.
“The long term follow-up results of the MAGICAL trial are very encouraging. This data support and extend the earlier positive follow-up data in this trial. This long term follow-up data, if further supported in a larger randomised study, would make MGuard a leading interventional solution for patients suffering from acute coronary syndromes and more importantly the longer term complications.”
MGuard is currently being investigated in the multicentre international MASTER (MGuard for acute ST elevation reperfusion) trial. This study has been designed to evaluate the MGuard stent compared to commercially-approved BMS or DES products in STEMI patients undergoing primary angioplasty. Preliminary top line results are expected in the third quarter of 2012. Plans for a registration study in the US are also at an advanced stage.