Key result
GUARDIAN evaluates noninferiority of MGuard stenting vs manual thrombectomy plus BMS in STEMI.
Why the study?
Distal embolization may reduce coronary and myocardial reperfusion after PCI in STEMI, and it is unclear if MGuard stent implantation is comparable to manual thrombectomy plus BMS deployment.
Does MGuard net protective stent implantation provide noninferior reperfusion compared to manual thrombectomy followed by bare-metal stent deployment in STEMI patients?
RCT (n=556)
open-label
randomized
Yes
Does MGuard net protective stent implantation provide noninferior reperfusion compared to manual thrombectomy followed by bare-metal stent deployment in STEMI patients?
The GUARDIAN trial is designed to determine if the MGuard net protective stent is noninferior to manual thrombectomy followed by bare-metal stenting for achieving complete ST-segment resolution in STEMI patients.
Answers are grounded in this paper and cite their sources.
MGuard use in STEMI PCI was associated with high reperfusion rates; leaves open whether it improves clinical outcomes versus thrombectomy or standard stents.
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.
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Cassese et al. (2011) conducted an RCT in ST-elevation myocardial infarction (STEMI) (n=556). MGuard net protective stent (MGS) vs. manual thrombectomy pretreatment followed by bare-metal stent deployment was evaluated on complete (≥ 70%) ST-segment resolution at 60 min after PCI. The GUARDIAN trial is a planned randomized noninferiority study designed to evaluate whether the MGuard stent is noninferior to manual thrombectomy plus bare-metal stenting in 556 STEMI patients.
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