A prospective, postmarket study with the Mguard Prime Embolic Protection Stent in ST-segment elevation myocardial infarction: the International MGuard Prime Observational Study (IMOS Prime)

Catheter Cardiovasc Interv. 2015 Oct:86 Suppl 1:S28-33. doi: 10.1002/ccd.25914. Epub 2015 Mar 24.

Abstract

Aims: We sought to evaluate the procedural and clinical performances of the MGuard Prime Embolic Protection Stent (EPS) in a "real-world" population with acute ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI).

Methods and results: Consecutive STEMI patients meeting the inclusion criteria and undergoing PPCI were enrolled. 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 cathlab time was 238 min. Device and lesion success were 100%. Final TIMI-3 flow was achieved in 91.8%, and STR > 50% in 87% of the patients. MACE at 30 days was 2.2%, which consisted of one case each of target vessel (TV)-myocardial infarction (MI), and non-TV-MI.

Conclusions: The use of the MGuard Prime EPS stent is feasible and safe and could be also effective in achieving myocardial reperfusion in STEMI patients undergoing PPCI.

Keywords: BMS; STEMI; embolic protection; mesh stent; primary PCI.

Publication types

  • Observational Study

MeSH terms

  • Coronary Angiography
  • Electrocardiography*
  • Embolic Protection Devices*
  • Embolism / prevention & control*
  • Follow-Up Studies
  • Humans
  • Myocardial Infarction / diagnostic imaging
  • Myocardial Infarction / surgery*
  • Percutaneous Coronary Intervention / methods*
  • Postoperative Complications / prevention & control
  • Product Surveillance, Postmarketing / methods*
  • Prospective Studies
  • Prosthesis Design
  • Stents*
  • Treatment Outcome