Dariusz Dudek1, Artur Dziewierz1, Sorin J Brener1, Alexandre Abizaid1, Béla Merkely1, Ricardo A Costa1, Eli Bar1, Tomasz Rakowski1, Ran Kornowski1, Ovidiu Dressler1, Andrea Abizaid1, Sigmund Silber1, Gregg W Stone1. 1. From the Department of Interventional Cardiology, Jagiellonian University Medical College, Krakow, Poland (D.D., A.D., T.R.); Cardiovascular Research Foundation, New York, NY (S.J.B., O.D., G.W.S.); Department of Cardiology, New York Methodist Hospital, Brooklyn (S.J.B.); Department of Cardiology, Institute Dante Pazzanese of Cardiology, Sao Paulo, Brazil (Alexandre Abizaid, R.A.C., Andrea Abizaid); Department of Cardiology, Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Cardiovascular Research Center, São Paolo, Brazil (R.A.C.); InspireMD, Tel Aviv, Israel (E.B.); Department of Cardiology, Rabin Medical Center, Petach Tiqva, Israel (R.K.); Department of Cardiology, Heart Center at the Isar, Munich, Germany (S.S.); and Department of Cardiology, Columbia University Medical Center, New York Presbyterian Hospital (G.W.S.).
Abstract
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.
RCT Entities:
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 MGuardpatients. 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.