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).

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.

• Authors: Giovanni Amoroso, Nicola S Vos, Jan A S Van der Heyden, Renė J van der Schaaf, Mark S Patterson, Maarten A Vink, Jean-Paul Herrman, Ton Slagboom
• Journal: Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions (Catheter Cardiovasc Interv) Vol. 86 Suppl 1 Pg. S28-33 (Oct 2015) ISSN: 1522-726X [Electronic] United States
• PMID: 25754236 (Publication Type: Journal Article, Observational Study)
• Copyright: © 2015 Wiley Periodicals, Inc.

Topics

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