Sunil V Rao1, Uwe Zeymer2, Pamela S Douglas3, Hussein Al-Khalidi3, Jennifer A White3, Jingyu Liu4, Howard Levy4, Victor Guetta5, C Michael Gibson6, Jean-Francois Tanguay7, Paul Vermeersch8, Jérôme Roncalli9, Jaroslaw D Kasprzak10, Timothy D Henry11, Norbert Frey12, Oscar Kracoff13, Jay H Traverse14, Derek P Chew15, Jose Lopez-Sendon16, Reinilde Heyrman4, Mitchell W Krucoff3. 1. Duke Clinical Research Institute, Durham, North Carolina. Electronic address: sunil.rao@duke.edu. 2. Herzzentrum Luwidshafen, Ludwigshafen, Germany. 3. Duke Clinical Research Institute, Durham, North Carolina. 4. Bellerophon Therapeutics Inc., Hampton, New Jersey. 5. Sheba Tel Ha Shomer Hospital, Tel Ha Shomer, Israel. 6. Beth Israel Deaconess Medical Center, Boston, Massachusetts. 7. Montreal Heart Institute, Montreal, Quebec, Canada. 8. Free University, Brussels, Belgium. 9. Rangueil University Hospital, Toulouse, France. 10. Medical University of Lodz, Lodz, Poland. 11. Cedars-Sinai Heart Institute, Los Angeles, California. 12. Universitätsklinikum Schleswig-Holstein, Campus Kiel Klinik für Kardiologie und Angiologie, Kiel, Germany. 13. Kaplan Medical Center, Rehovot, Israel. 14. Minneapolis Heart Institute, Minneapolis, Minnesota. 15. Flinders University, Adelaide, South Australia, Australia. 16. Hospital Universitario La Paz, Madrid, Spain.
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/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).
RCT Entities:
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).
Authors: Kevin L Sack; Eric Aliotta; Jenny S Choy; Daniel B Ennis; Neil H Davies; Thomas Franz; Ghassan S Kassab; Julius M Guccione Journal: Acta Biomater Date: 2020-05-16 Impact factor: 8.947
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