Bioabsorbable Intracoronary Matrix for Prevention of Ventricular Remodeling After Myocardial Infarction

Sunil V. Rao, Uwe Zeymer, Pamela S. Douglas, Hussein Al-Khalidi, Jennifer A. White, Jingyu Liu, Howard Levy, Victor Guetta, C. Michael Gibson, Jean Francois Tanguay, Paul Vermeersch, Jérôme Roncalli, Jaroslaw D. Kasprzak, Timothy D. Henry, Norbert Frey, Oscar Kracoff, Jay H. Traverse, Derek P. Chew, Jose Lopez-Sendon, Reinilde HeyrmanMitchell W. Krucoff

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40 Citations (Scopus)

Abstract

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/m2 vs. saline 11.7 ± 26.9 ml/m2; 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)

Original languageEnglish
Pages (from-to)715-723
Number of pages9
JournalJournal of the American College of Cardiology
Volume68
Issue number7
DOIs
Publication statusPublished - 1 Aug 2016

Keywords

  • alginate
  • congestive heart failure
  • deployment
  • echocardiography
  • end-diastolic volume

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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