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MGUard versus bAre-metal stents plus manual thRombectomy in ST-elevation myocarDial infarction pAtieNts-(GUARDIAN) trial: study design and rationale.
- Source :
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Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions [Catheter Cardiovasc Interv] 2012 Jun 01; Vol. 79 (7), pp. 1118-26. Date of Electronic Publication: 2012 Mar 14. - Publication Year :
- 2012
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Abstract
- 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.<br />Purpose: We intend to determine whether MGS implantation is comparable with a strategy of MT pretreatment followed by BMS deployment.<br />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.<br />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.<br /> (Copyright © 2012 Wiley Periodicals, Inc.)
- Subjects :
- Angioplasty, Balloon, Coronary adverse effects
Combined Modality Therapy
Coronary Angiography
Coronary Circulation
Electrocardiography
Embolism etiology
Humans
Italy
Magnetic Resonance Imaging
Microcirculation
Myocardial Infarction diagnosis
Myocardial Infarction physiopathology
Myocardium pathology
Predictive Value of Tests
Prospective Studies
Prosthesis Design
Recovery of Function
Time Factors
Treatment Outcome
Angioplasty, Balloon, Coronary instrumentation
Embolic Protection Devices
Embolism prevention & control
Metals
Myocardial Infarction therapy
Research Design
Stents
Thrombectomy
Subjects
Details
- Language :
- English
- ISSN :
- 1522-726X
- Volume :
- 79
- Issue :
- 7
- Database :
- MEDLINE
- Journal :
- Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
- Publication Type :
- Academic Journal
- Accession number :
- 22105879
- Full Text :
- https://doi.org/10.1002/ccd.23405