MGuard versus bAre-metal stents plus manual thRombectomy in ST-elevation myocarDial Infarction pAtieNts - (GUARDIAN) Trial: study design and rationale

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 . 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.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.