title: 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: OBJECTIVE
  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).
  
  
  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.affiliation: Department of Cardiology, Onze Lieve Vrouwe Gasthuis Amsterdam, The Netherlands.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Amoroso
authors.affiliation: Department of Cardiology, Onze Lieve Vrouwe Gasthuis Amsterdam, The Netherlands.
authors.forename: Nicola S
authors.initials: NS
authors.lastname: Vos
authors.affiliation: Department of Cardiology, St. Anthonius Ziekenhuis Nieuwegein, The Netherlands.
authors.forename: Jan A S
authors.initials: JA
authors.lastname: Van der Heyden
authors.affiliation: Department of Cardiology, Onze Lieve Vrouwe Gasthuis Amsterdam, The Netherlands.
authors.forename: Renė J
authors.initials: RJ
authors.lastname: van der Schaaf
authors.affiliation: Department of Cardiology, Onze Lieve Vrouwe Gasthuis Amsterdam, The Netherlands.
authors.forename: Mark S
authors.initials: MS
authors.lastname: Patterson
authors.affiliation: Department of Cardiology, Onze Lieve Vrouwe Gasthuis Amsterdam, The Netherlands.
authors.forename: Maarten A
authors.initials: MA
authors.lastname: Vink
authors.affiliation: Department of Cardiology, Onze Lieve Vrouwe Gasthuis Amsterdam, The Netherlands.
authors.forename: Jean-Paul
authors.initials: JP
authors.lastname: Herrman
authors.affiliation: Department of Cardiology, Onze Lieve Vrouwe Gasthuis Amsterdam, The Netherlands.
authors.forename: Ton
authors.initials: T
authors.lastname: Slagboom
mesh_terms: D017023:Coronary Angiography; D004562:Electrocardiography; D057505:Embolic Protection Devices; D004617:Embolism / Q000517:prevention & control*; D005500:Follow-Up Studies; D006801:Humans; D009203:Myocardial Infarction / Q000000981:diagnostic imaging / Q000601:surgery*; D062645:Percutaneous Coronary Intervention / Q000379:methods*; D011183:Postoperative Complications / Q000517:prevention & control; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D011446:Prospective Studies; D011474:Prosthesis Design; D015607:Stents; D016896:Treatment Outcome
keywords: BMS; STEMI; embolic protection; mesh stent; primary PCI