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MGUard versus bAre-metal stents plus manual thRombectomy in ST-elevation myocarDial infarction pAtieNts-(GUARDIAN)
Salvatore Cassese1, Giovanni Esposito, Ciro Mauro
1Department of Clinical Medicine, Cardiovascular Sciences and Immunology, Federico II University, Naples, Italy.
Insights
This study compares the MGuard net protective stent (MGS) to manual thrombectomy (MT) before bare-metal stent (BMS) deployment in ST-elevation myocardial infarction (STEMI) patients. Results will determine if MGS is a viable alternative for improving reperfusion and outcomes.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Biomedical Engineering
Background:
- Distal embolization during percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI) can impair myocardial reperfusion.
- Manual thrombectomy (MT) has shown improved outcomes compared to conventional PCI in STEMI.
- The MGuard net protective stent (MGS) is a novel bare-metal stent (BMS) designed to reduce distal embolization during PCI.
Purpose of the Study:
- To evaluate if MGS implantation is noninferior to MT pretreatment followed by BMS implantation in STEMI patients.
- To assess the efficacy of MGS in minimizing distal embolization and improving coronary reperfusion.
Main Methods:
- The GUARDIAN trial is a prospective, randomized, noninferiority study involving 556 STEMI patients.
- Patients are randomized to receive either MGS or MT followed by BMS in the infarct-related artery.
- The primary endpoint is complete ST-segment resolution (≥70%) at 60 minutes post-PCI; secondary endpoints include coronary flow, myocardial blush, and major adverse cardiac events.
Main Results:
- Primary endpoint analysis is pending.
- Secondary endpoints will assess coronary reperfusion (TIMI flow, corrected TIMI frame count, myocardial blush grade).
- Long-term clinical outcomes (30-day, 6-month, 1-year) and a cardiac MRI substudy on microvascular obstruction and infarct size are planned.
Conclusions:
- If MGS proves noninferior to MT plus BMS, it will offer a new treatment option for STEMI patients undergoing PCI.
- This could potentially reduce distal embolization and improve reperfusion in STEMI patients.
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.
