title: Bioabsorbable Intracoronary Matrix for Prevention of Ventricular Remodeling After Myocardial Infarction.
abstract: Bioabsorbable cardiac matrix (BCM) is a novel device that attenuates adverse left ventricular (LV) remodeling after large myocardial infarctions in experimental models.
  
  
  
  This study aimed to analyze whether BCM, compared with saline control, would result in less LV dilation and fewer adverse clinical events between baseline and 6 months.
  
  
  
  In an international, randomized, double-blind, controlled trial, 303 subjects with large areas of infarction despite successful primary percutaneous coronary intervention (PCI) of ST-segment elevation myocardial infarction (STEMI) were randomized 2:1 to BCM or saline injected into the infarct-related artery 2 to 5 days after primary PCI. The primary outcome was mean change from baseline in LV end-diastolic volume index (LVEDVI) at 6 months. Secondary outcomes included change in Kansas City Cardiomyopathy Questionnaire score, 6-minute walk time, and New York Heart Association functional class at 6 months. The primary safety endpoint was a composite of cardiovascular death, recurrent MI, target-vessel revascularization, stent thrombosis, significant arrhythmia requiring therapy, or myocardial rupture through 6 months.
  
  
  
  In total, 201 subjects were assigned to BCM and 102 to saline control. There was no significant difference in change in LVEDVI from baseline to 6 months between the groups (mean change ± SD: BCM 14.1 ± 28.9 ml/m(2) vs. saline 11.7 ± 26.9 ml/m(2); p = 0.49). There was also no significant difference in the secondary endpoints. The rates of the primary safety outcome were similar between the 2 groups (BCM 11.6% vs. saline 9.1%; p = 0.37).
  
  
  
  Intracoronary deployment of BCM 2 to 5 days after successful reperfusion in subjects with large myocardial infarction did not reduce adverse LV remodeling or cardiac clinical events at 6 months. (IK-5001 for the Prevention of Remodeling of the Ventricle and Congestive Heart Failure After Acute Myocardial Infarction [PRESERVATION I]; NCT01226563).
authors: Duke Clinical Research Institute, Durham, North Carolina. Electronic address: sunil.rao@duke.edu.
authors: Sunil V
authors: SV
authors: Rao
authors: Herzzentrum Luwidshafen, Ludwigshafen, Germany.
authors: Uwe
authors: U
authors: Zeymer
authors: Duke Clinical Research Institute, Durham, North Carolina.
authors: Pamela S
authors: PS
authors: Douglas
authors: Duke Clinical Research Institute, Durham, North Carolina.
authors: Hussein
authors: H
authors: Al-Khalidi
authors: Duke Clinical Research Institute, Durham, North Carolina.
authors: Jennifer A
authors: JA
authors: White
authors: Bellerophon Therapeutics Inc., Hampton, New Jersey.
authors: Jingyu
authors: J
authors: Liu
authors: Bellerophon Therapeutics Inc., Hampton, New Jersey.
authors: Howard
authors: H
authors: Levy
authors: Sheba Tel Ha Shomer Hospital, Tel Ha Shomer, Israel.
authors: Victor
authors: V
authors: Guetta
authors: Beth Israel Deaconess Medical Center, Boston, Massachusetts.
authors: C Michael
authors: CM
authors: Gibson
authors: Montreal Heart Institute, Montreal, Quebec, Canada.
authors: Jean-Francois
authors: JF
authors: Tanguay
authors: Free University, Brussels, Belgium.
authors: Paul
authors: P
authors: Vermeersch
authors: Rangueil University Hospital, Toulouse, France.
authors: Jérôme
authors: J
authors: Roncalli
authors: Medical University of Lodz, Lodz, Poland.
authors: Jaroslaw D
authors: JD
authors: Kasprzak
authors: Cedars-Sinai Heart Institute, Los Angeles, California.
authors: Timothy D
authors: TD
authors: Henry
authors: Universitätsklinikum Schleswig-Holstein, Campus Kiel Klinik für Kardiologie und Angiologie, Kiel, Germany.
authors: Norbert
authors: N
authors: Frey
authors: Kaplan Medical Center, Rehovot, Israel.
authors: Oscar
authors: O
authors: Kracoff
authors: Minneapolis Heart Institute, Minneapolis, Minnesota.
authors: Jay H
authors: JH
authors: Traverse
authors: Flinders University, Adelaide, South Australia, Australia.
authors: Derek P
authors: DP
authors: Chew
authors: Hospital Universitario La Paz, Madrid, Spain.
authors: Jose
authors: J
authors: Lopez-Sendon
authors: Bellerophon Therapeutics Inc., Hampton, New Jersey.
authors: Reinilde
authors: R
authors: Heyrman
authors: Duke Clinical Research Institute, Durham, North Carolina.
authors: Mitchell W
authors: MW
authors: Krucoff
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D017023:Coronary Angiography; D003331:Coronary Vessels / Q000000981:diagnostic imaging / Q000601:surgery; D004311:Double-Blind Method; D004562:Electrocardiography; D005260:Female; D005500:Follow-Up Studies; D006352:Heart Ventricles / Q000000981:diagnostic imaging / Q000503:physiopathology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000175:diagnosis / Q000503:physiopathology / Q000601:surgery*; D062645:Percutaneous Coronary Intervention; D011183:Postoperative Complications / Q000517:prevention & control*; D011474:Prosthesis Design; D015607:Stents; D016896:Treatment Outcome; D016277:Ventricular Function, Left / Q000502:physiology; D020257:Ventricular Remodeling
keywords: alginate; congestive heart failure; deployment; echocardiography; end-diastolic volume