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. PURPOSE: We intend to determine whether MGS implantation is comparable with a strategy of MT pretreatment followed by BMS deployment. STUDY DESIGN: 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.
RCT Entities:
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. PURPOSE: We intend to determine whether MGS implantation is comparable with a strategy of MT pretreatment followed by BMS deployment. STUDY DESIGN: The MGUard versus bAre-metal stents plus manual thRombectomy in ST-elevation myocarDial InfarctionpAtieNts (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: Roberta Serdoz; Michele Pighi; Nikolaos V Konstantinidis; Ismail Dogu Kilic; Sara Abou-Sherif; Carlo Di Mario Journal: Curr Atheroscler Rep Date: 2014-08 Impact factor: 5.113
Authors: Giuseppe Giugliano; Anna Sannino; Linda Brevetti; Cinzia Perrino; Gabriele Giacomo Schiattarella; Anna Franzone; Federica Serino; Marco Ferrone; Fernando Scudiero; Andreina Carbone; Michele De Paulis; Raffaele Izzo; Bruno Amato; Bruno Trimarco; Giovanni Esposito Journal: BMC Surg Date: 2012-11-15 Impact factor: 2.102
Authors: Giuseppe Giugliano; Eugenio Laurenzano; Carlo Rengo; Giovanna De Rosa; Linda Brevetti; Anna Sannino; Cinzia Perrino; Lorenzo Chiariotti; Gabriele Giacomo Schiattarella; Federica Serino; Marco Ferrone; Fernando Scudiero; Andreina Carbone; Antonio Sorropago; Bruno Amato; Bruno Trimarco; Giovanni Esposito Journal: BMC Surg Date: 2012-11-15 Impact factor: 2.102
Authors: Giuseppe Giugliano; Cinzia Perrino; Vittorio Schiano; Linda Brevetti; Anna Sannino; Gabriele Giacomo Schiattarella; Giuseppe Gargiulo; Federica Serino; Marco Ferrone; Fernando Scudiero; Andreina Carbone; Antonio Bruno; Bruno Amato; Bruno Trimarco; Giovanni Esposito Journal: BMC Surg Date: 2012-11-15 Impact factor: 2.102