iMOS Prime

Objective

The objective of the iMOS Prime Registry was to evaluate the ‘Real World’ Clinical Performance of the MGuard Prime Coronary Stent System in patients with acute ST-segment elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI).

 

Study design

A total of 97 patients with STEMI were enrolled at 2 sites in the Netherlands. Patients with a clear indication for PCI and with vessel diameter at the infarct lesion was either known or expected to be 2.75-4.0 mm, without excessive tortuosity or calcification were eligible for enrollment. Exclusion criteria included jailed side branches > 2.0mm, cardiopulmonary resuscitation and cardiogenic shock. Clinical follow-up was performed at 30 days, and patients will be followed through 12 months.

 

Results

Median age was 62 years and 77% of patients were male. The infarct vessel was the LAD in 32.0% of patients, RCA in 50.5%, and the left circumflex in 15.5%; a single lesion with a single stent was treated in 84.5% of patients. Aspiration was performed in 71.1% of patients, and direct stenting was performed in 13.4%. The target lesion involved side branches in 11.3%. The MGuard stent was able to reach or cross the lesion in 97/97 cases (100.0%). TIMI-3 flow was restored in 91.8%, and ST resolution (≥70%) in 74.5%. Clinical follow-up at 30 days was completed in 90/97 patients (92.8%). Adverse clinical events were infrequent and included 1 case of non-target vessel MI and 1 case of target vessel MI. 30 day MACE was 2.2%.

 

Conclusion

12 month follow-up is on-going. This is the first report on the use of MGuard Prime in the STEMI population. In the present prospective, non-randomize, single arm, multicenter observational registry, the MGuard Prime EPS resulted in high rates of TIMI-3 flow and STR, and 30 day MACE was low in the real world setting. 12 month follow-up is ongoing at the time of this report, and it will be essential to examine the late results with the MGuard Prime after primary PCI in STEMI (1).

 

References

1. Amoroso G. The iMOS Prime Registry. International MGuard Prime Observational Study. Acute and 30 day results. Proc. EuroPCR, Paris, 2014: