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Bioabsorbable Intracoronary Matrix for Prevention of Ventricular Remodeling After Myocardial Infarction.

Publication ,  Journal Article
Rao, SV; Zeymer, U; Douglas, PS; Al-Khalidi, H; White, JA; Liu, J; Levy, H; Guetta, V; Gibson, CM; Tanguay, J-F; Vermeersch, P; Roncalli, J ...
Published in: J Am Coll Cardiol
August 16, 2016

BACKGROUND: Bioabsorbable cardiac matrix (BCM) is a novel device that attenuates adverse left ventricular (LV) remodeling after large myocardial infarctions in experimental models. OBJECTIVES: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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).

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Published In

J Am Coll Cardiol

DOI

EISSN

1558-3597

Publication Date

August 16, 2016

Volume

68

Issue

7

Start / End Page

715 / 723

Location

United States

Related Subject Headings

  • Ventricular Remodeling
  • Ventricular Function, Left
  • Treatment Outcome
  • Stents
  • Prosthesis Design
  • Postoperative Complications
  • Percutaneous Coronary Intervention
  • Myocardial Infarction
  • Middle Aged
  • Male
 

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Rao, S. V., Zeymer, U., Douglas, P. S., Al-Khalidi, H., White, J. A., Liu, J., … Krucoff, M. W. (2016). Bioabsorbable Intracoronary Matrix for Prevention of Ventricular Remodeling After Myocardial Infarction. J Am Coll Cardiol, 68(7), 715–723. https://doi.org/10.1016/j.jacc.2016.05.053
Rao, Sunil V., Uwe Zeymer, Pamela S. Douglas, Hussein Al-Khalidi, Jennifer A. White, Jingyu Liu, Howard Levy, et al. “Bioabsorbable Intracoronary Matrix for Prevention of Ventricular Remodeling After Myocardial Infarction.J Am Coll Cardiol 68, no. 7 (August 16, 2016): 715–23. https://doi.org/10.1016/j.jacc.2016.05.053.
Rao SV, Zeymer U, Douglas PS, Al-Khalidi H, White JA, Liu J, et al. Bioabsorbable Intracoronary Matrix for Prevention of Ventricular Remodeling After Myocardial Infarction. J Am Coll Cardiol. 2016 Aug 16;68(7):715–23.
Rao, Sunil V., et al. “Bioabsorbable Intracoronary Matrix for Prevention of Ventricular Remodeling After Myocardial Infarction.J Am Coll Cardiol, vol. 68, no. 7, Aug. 2016, pp. 715–23. Pubmed, doi:10.1016/j.jacc.2016.05.053.
Rao SV, Zeymer U, Douglas PS, Al-Khalidi H, White JA, Liu J, Levy H, Guetta V, Gibson CM, Tanguay J-F, Vermeersch P, Roncalli J, Kasprzak JD, Henry TD, Frey N, Kracoff O, Traverse JH, Chew DP, Lopez-Sendon J, Heyrman R, Krucoff MW. Bioabsorbable Intracoronary Matrix for Prevention of Ventricular Remodeling After Myocardial Infarction. J Am Coll Cardiol. 2016 Aug 16;68(7):715–723.
Journal cover image

Published In

J Am Coll Cardiol

DOI

EISSN

1558-3597

Publication Date

August 16, 2016

Volume

68

Issue

7

Start / End Page

715 / 723

Location

United States

Related Subject Headings

  • Ventricular Remodeling
  • Ventricular Function, Left
  • Treatment Outcome
  • Stents
  • Prosthesis Design
  • Postoperative Complications
  • Percutaneous Coronary Intervention
  • Myocardial Infarction
  • Middle Aged
  • Male