title: Coronary stenting with MGuard: extended follow-up of first human trial.
abstract: OBJECTIVE
  To evaluate feasibility and safety of MGuard based percutaneous coronary interventions (PCI) in vein grafts (VG) and native coronaries (NC).
  
  
  BACKGROUND
  Distal embolization is a frequent complication of PCI of VG and NC during acute coronary syndromes (ACS). MGuard was a stent designed to reduce embolization.
  
  
  METHODS
  Prospective, single arm, two-center trial assessing the feasibility and safety of MGuard-based PCI with post-PCI clinical and laboratory monitoring including: cardiac biomarkers, ECG and 6-month angiography.
  
  
  RESULTS
  Forty-one patients with mean age of 68.2±10.1 years were enrolled. Mean VG age (n=23) was 14.4±4.3 years. All patients received heparin, clopidogrel and aspirin; while none received glycoprotein IIb/IIIa inhibitors, or embolic protection device (EPD). Device and procedural success were 100% and 95.1% respectively. Two patients (4.9%) experienced procedure-related creatinine phosphokinase rise. At 6 months one patient had myocardial infarction and 19.5% had target vessel revascularization (TLR). Late follow up (12-27 months) revealed one additional TLR.
  
  
  CONCLUSIONS
  MGuard based PCI of NC and VG appears encouraging especially in view of unfavorable patient and lesion characteristics. Efficacy needs to be further established in larger randomized trials.
authors.affiliation: Department of Cardiology, Helios Heart Center, Siegburg, Germany.
authors.forename: Eberhard
authors.initials: E
authors.lastname: Grube
authors.affiliation: Department of Cardiology Krankenhaus der Barmherzigen Brüder Trier, Germany.
authors.forename: Karl Eugen
authors.initials: KE
authors.lastname: Hauptmann
authors.affiliation: Department of Cardiology, Helios Heart Center, Siegburg, Germany.
authors.forename: Ralf
authors.initials: R
authors.lastname: Müller
authors.affiliation: Division of Cardiology, Columbia Presbyterian, New York, NY, USA.
authors.forename: Nir
authors.initials: N
authors.lastname: Uriel
authors.affiliation: Department of Cardiology, University Medical Center, UMDNJ, Newark, NJ, USA. Electronic address: kalusked@umdnj.edu.
authors.forename: Edo
authors.initials: E
authors.lastname: Kaluski
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D000925:Anticoagulants / Q000627:therapeutic use; D015415:Biomarkers / Q000097:blood; D017023:Coronary Angiography; D001026:Coronary Artery Bypass / Q000009:adverse effects*; D003324:Coronary Artery Disease / Q000601:surgery / Q000628:therapy*; D003402:Creatine Kinase / Q000097:blood; D004562:Electrocardiography; D004617:Embolism / Q000209:etiology; D005240:Feasibility Studies; D005260:Female; D005858:Germany; D006083:Graft Occlusion, Vascular / Q000209:etiology / Q000628:therapy*; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D011446:Prospective Studies; D011474:Prosthesis Design; D015607:Stents; D013927:Thrombosis / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants; D015415:Biomarkers; D010975:Platelet Aggregation Inhibitors; D003402:Creatine Kinase