title: Mesh-covered embolic protection stent implantation in ST-segment-elevation myocardial infarction: final 1-year clinical and angiographic results from the MGUARD for acute ST elevation reperfusion trial.
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.
  
  
  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.
  
  
  BACKGROUND
  http://www.clinicaltrials.gov. Unique identifier: NCT01368471.
authors.affiliation: 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.).
authors.forename: Dariusz
authors.initials: D
authors.lastname: Dudek
authors.affiliation: 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.).
authors.forename: Artur
authors.initials: A
authors.lastname: Dziewierz
authors.affiliation: 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.).
authors.forename: Sorin J
authors.initials: SJ
authors.lastname: Brener
authors.affiliation: 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.).
authors.forename: Alexandre
authors.initials: A
authors.lastname: Abizaid
authors.affiliation: 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.).
authors.forename: Béla
authors.initials: B
authors.lastname: Merkely
authors.affiliation: 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.).
authors.forename: Ricardo A
authors.initials: RA
authors.lastname: Costa
authors.affiliation: 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.).
authors.forename: Eli
authors.initials: E
authors.lastname: Bar
authors.affiliation: 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.).
authors.forename: Tomasz
authors.initials: T
authors.lastname: Rakowski
authors.affiliation: 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.).
authors.forename: Ran
authors.initials: R
authors.lastname: Kornowski
authors.affiliation: 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.).
authors.forename: Ovidiu
authors.initials: O
authors.lastname: Dressler
authors.affiliation: 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.).
authors.forename: Andrea
authors.initials: A
authors.lastname: Abizaid
authors.affiliation: 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.).
authors.forename: Sigmund
authors.initials: S
authors.lastname: Silber
authors.affiliation: 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.).
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
mesh_terms: D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000209:etiology; D003328:Coronary Thrombosis / Q000000981:diagnostic imaging / Q000209:etiology; D057505:Embolic Protection Devices; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008670:Metals; D008875:Middle Aged; D009203:Myocardial Infarction / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011474:Prosthesis Design; D012008:Recurrence; D012307:Risk Factors; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D008670:Metals
keywords: acute myocardial infarction; primary angioplasty; prognosis; stents