TY - JOUR
T1 - Mesh-covered embolic protection stent implantation in ST-segment-elevation myocardial infarction
T2 - Final 1-year clinical and angiographic results from the MGUARD for acute ST elevation reperfusion trial
AU - Dudek, Dariusz
AU - Dziewierz, Artur
AU - Brener, Sorin J.
AU - Abizaid, Alexandre
AU - Merkely, Béla
AU - Costa, Ricardo A.
AU - Bar, Eli
AU - Rakowski, Tomasz
AU - Kornowski, Ran
AU - Dressler, Ovidiu
AU - Abizaid, Andrea
AU - Silber, Sigmund
AU - Stone, Gregg W.
N1 - Publisher Copyright:
© 2015 American Heart Association, Inc.
PY - 2015/2/1
Y1 - 2015/2/1
N2 - 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.
AB - 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.
KW - Acute myocardial infarction
KW - Primary angioplasty
KW - Prognosis
KW - Stents
UR - http://www.scopus.com/inward/record.url?scp=84925844217&partnerID=8YFLogxK
U2 - 10.1161/CIRCINTERVENTIONS.114.001484
DO - 10.1161/CIRCINTERVENTIONS.114.001484
M3 - ???researchoutput.researchoutputtypes.contributiontojournal.article???
C2 - 25603802
AN - SCOPUS:84925844217
SN - 1941-7640
VL - 8
JO - Circulation: Cardiovascular Interventions
JF - Circulation: Cardiovascular Interventions
IS - 2
M1 - e001484
ER -