Postmarket Study Published for InspireMD's MGuard Prime in STEMI Patients

September 10, 2015—In Catheterization and Cardiovascular Interventions, Giovanni Amoroso, MD, et al published the 30-day primary endpoint findings from the International MGuard Prime Observational Study (IMOS Prime), a prospective, postmarket evaluation with the InspireMD’s MGuard Prime embolic protection stent (EPS) in patients with ST-segment elevation myocardial infarction (2015;86:S28–S33). The investigators sought to evaluate the procedural and clinical performances of the MGuard Prime EPS in a real-world population with acute STEMI undergoing primary percutaneous coronary intervention (PCI).

The investigators concluded that the use of the MGuard Prime stent is feasible and safe and could be also effective in achieving myocardial reperfusion in STEMI patients undergoing primary PCI. InspireMD first announced the IMOS PRIME findings in May 2014, before they were presented at the 2014 EuroPCR conference in Paris, France.

As summarized in Catheterization and Cardiovascular Interventions, the IMOS Prime study enrolled consecutive STEMI patients meeting the inclusion criteria and undergoing primary PCI. The primary endpoint was major adverse cardiac events (MACE) at 30 days, defined as the composite of cardiac death, myocardial infarction (Q wave and non-Q wave), or target lesion revascularization (PCI or coronary artery bypass graft). Secondary endpoints included device success, lesion success, and postprocedural reperfusion outcomes: thrombolysis in myocardial infarction (TIMI) flow and ST-segment elevation resolution (STR). 

A total of 97 patients (62 years, 77% men) were included. Symptom-to-catheterization-lab time was 238 minutes. Device and lesion success were 100%. Final TIMI-3 flow was achieved in 91.8% of patients, and STR was > 50% in 87% of patients. The investigators reported that MACE at 30 days was 2.2%, which consisted of one case of target vessel myocardial infarction (TVMI) and one case of non–TVMI.