title: MGUard versus bAre-metal stents plus manual thRombectomy in ST-elevation myocarDial infarction pAtieNts-(GUARDIAN) trial: study design and rationale.
abstract: BACKGROUND
  Distal embolization may decrease coronary and myocardial reperfusion after percutaneous coronary intervention (PCI) in ST-elevation myocardial infarction (STEMI). In this setting, manual thrombectomy (MT) resulted in better perfusion and clinical outcomes when compared with "conventional" PCI (direct stenting or stenting after predilation). MGuard net protective stent (MGS, Inspire-MD, Tel-Aviv, Israel) is a new bare-metal stent (BMS) with a polyethylene theraphthalate mesh coverage anchored to the external surface of the struts aiming to minimize distal embolization during PCI.
  
  
  OBJECTIVE
  We intend to determine whether MGS implantation is comparable with a strategy of MT pretreatment followed by BMS deployment.
  
  
  METHODS
  The MGUard versus bAre-metal stents plus manual thRombectomy in ST-elevation myocarDial Infarction pAtieNts (GUARDIAN) is a multicentre, prospective, randomized, noninferiority, open-label trial with a planned inclusion of 556 STEMI patients. Patients are assigned to treatment with MGS or MT pretreatment followed by BMS implantation in the infarct-related artery. All patients are treated medically according to current international guidelines. Randomization is performed before coronary angiography. The primary endpoint is complete (≥ 70%) ST-segment resolution at 60 min after PCI. Secondary endpoints are thrombolysis in myocardial infarction (TIMI) coronary flow grade ≥ 2, corrected TIMI frame count <23, myocardial blush grade of the infarct related area ≥ 2, and major adverse cardiac events rate at 30-day, 6-month, and 1-year follow-up. A cardiac magnetic resonance imaging substudy is planned to investigate microvascular obstruction and infarct size area reduction, at prespecified time-points, among 80 consecutive patients enrolled.
  
  
  CONCLUSIONS
  If MGS implantation is noninferior to a strategy of MT pretreatment followed by BMS deployment, it will lend support to the use of this treatment as another possible option for STEMI patients undergoing PCI.
authors: Department of Clinical Medicine, Cardiovascular Sciences and Immunology, Federico II University, Naples, Italy.
authors: Salvatore
authors: S
authors: Cassese
authors: Giovanni
authors: G
authors: Esposito
authors: Ciro
authors: C
authors: Mauro
authors: Ferdinando
authors: F
authors: Varbella
authors: Antonio
authors: A
authors: Carraturo
authors: Antonio
authors: A
authors: Montinaro
authors: Plinio
authors: P
authors: Cirillo
authors: Gennaro
authors: G
authors: Galasso
authors: Antonio
authors: A
authors: Rapacciuolo
authors: Federico
authors: F
authors: Piscione
mesh_terms: D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D003131:Combined Modality Therapy; D017023:Coronary Angiography; D003326:Coronary Circulation; D004562:Electrocardiography; D057505:Embolic Protection Devices; D004617:Embolism / Q000209:etiology / Q000517:prevention & control*; D006801:Humans; D007558:Italy; D008279:Magnetic Resonance Imaging; D008670:Metals; D008833:Microcirculation; D009203:Myocardial Infarction / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D009206:Myocardium / Q000473:pathology; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011474:Prosthesis Design; D020127:Recovery of Function; D012107:Research Design; D015607:Stents; D017131:Thrombectomy; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D008670:Metals