Multicentre experience with MGuard™ net protective stent in ST‐elevation myocardial infarction: Safety, feasibility, and impact on myocardial reperfusion

Piscione, Federico; Danzi, Gian Battista; Cassese, Salvatore; Esposito, Giovanni; Cirillo, Plinio; Galasso, Gennaro; Rapacciuolo, Antonio; Leosco, Dario; Briguori, Carlo; Varbella, Ferdinando; Tuccillo, Bernardino; Chiariello, Massimo

doi:10.1002/ccd.22292

Cited by 32 publications

(24 citation statements)

References 45 publications

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“…Moreover, when a LTB is present, the use of special mesh-covered stents can be useful in managing thrombi and preventing distal embolization. There are some small studies reporting on the use of the MGuard stent in STEMI setting, documented promising surrogate results, such as a better ST-resolution and a higher post-procedural TIMI 3 flow rate, when compared to standard types of stents [95][96][97][98] .…”

Section: Embolic Protection Devicesmentioning

confidence: 99%

Coronary thrombus in patients undergoing primary PCI for STEMI: Prognostic significance and management

Vecchio¹

2014

WJC

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Acute ST-elevation myocardial infarction (STEMI) usually results from coronary atherosclerotic plaque disruption with superimposed thrombus formation. Detection of coronary thrombi is a poor prognostic indicator, which is mostly proportional to their size and composition. Particularly, intracoronary thrombi impair both epicardial blood flow and myocardial perfusion, by occluding major coronary arteries and causing distal embolization, respectively. Thus, although primary percutaneous coronary intervention is the preferred treatement strategy in STEMI setting, the associated use of adjunctive antithrombotic drugs and/or percutaneous thrombectomy is crucial to optimize therapy of STEMI patients, by improving either angiographical and clinical outcomes. This review article will focus on the prognostic significance of intracoronary thrombi and on current antithrombotic pharmacological and interventional strategies used in the setting of STEMI to manage thrombotic lesions.© 2014 Baishideng Publishing Group Inc. All rights reserved. Key words: ST-elevation myocardial infarction; Intracoronary thrombosis; Primary percutaneous coronary intervention; Antithrombotic therapies; Coronary thrombectomyCore tip: Intracoronary thrombosis, is the basic pathophysiologic event in acute ST-elevation myocardial infarction (STEMI), and thrombi are very frequently detected in STEMI patients undergoing primary percutaneous coronary intervention (PPCI). Thrombus burden and components are important determinants of prognosis in STEMI, being well-known risk factors for longterm adverse cardiovascular events, distal embolization and stent thrombosis. As a result, percutaneous management of lesions with a consistent thrombotic burden is still challenging in the setting of PPCI for STEMI. Therefore, several pharmacological and interventional strategies, such as thrombectomy have been developed in order to improve PPCI's safety and efficacy, by reducing thrombus burden.

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Section: Embolic Protection Devicesmentioning

confidence: 99%

Coronary thrombus in patients undergoing primary PCI for STEMI: Prognostic significance and management

Vecchio¹

2014

WJC

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“…Feasibility and short-term efficacy of MGuard stent implantation during primary PCI for STEMI was confirmed in early studies. 17,18 Recently, the multicenter, prospective, randomized MGUARD for Acute ST Elevation Reperfusion (MASTER) trial 19 reported that among patients with STEMI, the MGuard resulted in superior rates of epicardial coronary flow and complete ST-segment resolution compared with conventional metallic stents, thus meeting its primary end point. A trend toward lower 30-day cardiac mortality was noted for patients treated with the MGuard stent.…”

Section: Mesh-covered Stent In Stemimentioning

confidence: 99%

Mesh-Covered Embolic Protection Stent Implantation in ST-Segment–Elevation Myocardial Infarction

Dudek

Dziewierz

Brener

et al. 2015

Circ: Cardiovascular Interventions

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P rimary percutaneous coronary intervention (PCI), with stent implantation when feasible, is the recommended method of reperfusion in patients with ST-segment-elevation myocardial infarction (STEMI).1,2 Although stent implantation frequently restores normal epicardial coronary flow in patients with STEMI, myocardial reperfusion is often suboptimal and results in increased infarct size and mortality.3-5 Numerous strategies have been proposed to improve microvascular perfusion, including pharmacological agents (eg, glycoprotein IIb/IIIa inhibitors, adenosine) and mechanical approaches (eg, thrombus aspiration, distal protection devices).6-10 Meta-analyses of underpowered randomized trials suggested that manual aspiration thrombectomy might be associated with reduced 30-day mortality, with underlying improvements in epicardial and myocardial perfusion.11,12 However, in the large-scale, randomized Thrombus Aspiration in ST-Elevation Myocardial Infarction in Scandinavia (TASTE) trial, a survival benefit of routine manual aspiration thrombectomy during primary PCI was not observed. Background-The MGuard, a bare metal stent covered with a polymer mesh, was designed to reduce distal embolization during percutaneous coronary intervention in ST-segment-elevation myocardial infarction. In the MGUARD for Acute ST Elevation Reperfusion trial, the primary end point of complete ST-segment resolution was significantly improved with the MGuard compared with control. We evaluated 1-year clinical and angiographic results. Methods and Results-Patients with ST-segment-elevation myocardial infarction ≤12 hours undergoing primary percutaneous coronary intervention of a single de novo native lesion were randomized to the MGuard versus any commercially available metallic stent (39.8% drug-eluting). Clinical follow-up was performed through 1 year, and angiography at 13 months was planned in 50 MGuard patients. There was no difference in major adverse cardiac events (1.8% versus 2.3%; P=0.75) at 30 days between the groups. Major adverse cardiac events at 1 year were higher with the MGuard, driven by greater ischemia-driven target lesion revascularization (8.6% versus 0.9%; P=0.0003). Conversely, mortality tended to be lower with the MGuard at 30 days (0% versus 1.9%; P=0.04) and at 1 year (1.0% versus 3.3%; P=0.09). Late lumen loss at 13 months in the MGuard was 0.99±0.80 mm, and binary restenosis was 31.6%. Conclusions-In patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention, a trend toward reduced 1-year mortality was present in patients treated with the MGuard stent. Target lesion revascularization and major adverse cardiac events rates during follow-up were higher in the MGuard group than in the control stent group, and angiographic late loss of the MGuard was consistent with that expected from bare metal stents. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01368471.(Circ Cardiovasc Interv. 2015;8:e001484.

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“…Thus, this stent may partly eliminate distal embolization, mainly in thrombus-containing lesions. [3][4][5][6] The aim of this pilot, randomized study was to evaluate the safety and efficacy of the MGuard stent as compared to other commercially available bare metal or drug eluting stents. Additionally, the study was designed to determine whether MGuard stent implantation affects the severity of biomarker release in patients with unstable angina or non-Q-wave myocardial infarction.…”

Section: 2)mentioning

confidence: 99%

“…5) Several advantages and disadvantages associated with this new stent should be emphasized. First, in contrast with proximal or distal protective devices, the MGuard stent does not require a disease-free landing zone in coronary artery/saphenous vein grafts, which is associated with the potential use in almost all proximal and "nonbifurcation" lesions.…”

Section: )mentioning

confidence: 99%

Effect of MGuard Net Protective Stent on the Release of Troponin I in Patients With Acute Coronary Syndromes A Randomized Controlled Trial

et al. 2011

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SummaryThis study was designed to determine whether the treatment of patients with unstable angina pectoris or non-Qwave myocardial infarction with a stent containing a protection net to prevent coronary microembolization affects the severity of biomarker release.The MGuard stent (InspireMD, Tel Aviv, Israel) was designed as a plaque/thrombus-trapping device, using a conventional bare metal stent covered with an ultrathin, flexible mesh net. We hypothesized that this stent would partly eliminate distal embolization and decrease subsequent troponin I (TnI) release.Forty-six acute coronary syndrome patients referred for percutaneous coronary intervention (PCI) were included and randomized in this study. Serum concentrations of TnI were measured prior to, as well as 24 and 48 hours after, the PCI procedure.Technical success was 95% and 100% in the MGuard group and non-MGuard group, respectively. A transient noreflow phenomenon was observed in one interventional procedure in each group of patients (5% versus 4%; NS). Two patients (one in each group) died during the hospital stay. There was no statistically significant difference in median postprocedural TnI levels in either group.The results suggest that coronary stenting with a stent system containing a protection net to prevent coronary microembolization (eg the MGuard stent) in patients with acute coronary syndromes does not decrease procedural myocardial injury, as measured by TnI release. It seems likely that stenting with the MGuard stent is feasible, however, its safety should be verified in larger studies. (Int Heart J 2011; 52: 203-206) Key words: Stent, Acute coronary syndrome, Coronary stenosis C oronary stenting has become a key method in the treatment of patients with acute coronary syndromes. In spite of this, there are several problems that have yet to be solved, and more focus needs to be applied for fine-tuning and understanding of the stenting technique.Continuous innovation regarding instruments used for coronary intervention (leading to low profile, flexibility and visibility of coronary stents, improvements in back-up of guiding catheters, etc.) is the basis for improvement of coronary stenting. However, the occurrence of coronary microembolization of atheromatic and thrombotic debris during coronary intervention may result in deterioration of the coronary microcirculation and subsequent myocardial necrosis. 1,2)The MGuard stent (InspireMD, Tel Aviv, Israel) was designed as a plaque/thrombus-trapping device, using a conventional bare metal stent covered with an ultrathin, flexible mesh net fabricated by circular knitting (Figure 1). During stent deployment, the net stretches and slides over the expanding stent struts, and subsequently seals the atherothrombotic material and captures it between the net and coronary artery wall. Thus, this stent may partly eliminate distal embolization, mainly in thrombus-containing lesions. [3][4][5][6] The aim of this pilot, randomized study was to evaluate the safety and efficacy of the MGuard stent as compa...

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Multicentre experience with MGuard™ net protective stent in ST‐elevation myocardial infarction: Safety, feasibility, and impact on myocardial reperfusion

Abstract: MGS might represent a safe and feasible option for PCI in STEMI patients, providing high perfusional and ECG improvement. Further randomized trials comparing this strategy with the conventional one are needed in the near future to assess the impact on clinical practice of this strategy.

Cited by 32 publications

References 45 publications

Coronary thrombus in patients undergoing primary PCI for STEMI: Prognostic significance and management

Coronary thrombus in patients undergoing primary PCI for STEMI: Prognostic significance and management

Mesh-Covered Embolic Protection Stent Implantation in ST-Segment–Elevation Myocardial Infarction

Effect of MGuard Net Protective Stent on the Release of Troponin I in Patients With Acute Coronary Syndromes A Randomized Controlled Trial

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