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)
Bibliographical noteFunding Information:
The PRESERVATION I trial was funded by Bellerophon Therapeutics Inc. Three former Bellerophon employees participated as coauthors (Drs. Liu, Levy, and Heyrman). Dr. Rao has received research funding from Bellerophon Therapeutics Inc. Dr. Zeymer has received honoraria for participation at steering committee meetings of PRESERVATION I. Dr. Douglas has received research funding from Bellerophon Therapeutics Inc. Dr. Levy is a contractor for and was a consultant to Bellerophon Therapeutics Inc. during the conduct of this study; and owns stock options in the company. Dr. Gibson has received research funding from Bellerophon Therapeutics Inc. Dr. Tanguay’s institution received payment from the Duke Clinical Research Institute for the PRESERVATION I trial; and he has received funding as a steering committee member; and has received a research grant from Ikaria-Bellerophon. Dr. Kasprzak has received investigator fees from Bellerophon Therapeutics Inc. Dr. Henry is a steering committee member for the PRESERVATION I study. Dr. Chew has received speaker honoraria from Medscape and AstraZeneca. Dr. Lopez-Sendon has received research grants from Daiichi-Sankyo, GSK, Servier, Sanofi, Novartis, the Menarini Group, Pfizer, Merck, and AstraZeneca; and has been an advisor for or received honoraria from Amgen, the Menarini Group, Merck, Servier, Sanofi, Novartis, and AstraZeneca. Dr. Heyrman was an employee of Ikaria-Bellerophon at the time of the study; and owns stock in Bellerophon Therapeutics Inc. Dr. Krucoff has received research grant support from Bellerophon Therapeutics Inc. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
© 2016 American College of Cardiology Foundation
- congestive heart failure
- end-diastolic volume