Bioabsorbable Intracoronary Matrix for Prevention of Ventricular Remodeling After Myocardial Infarction
| Autor: | Pamela S. Douglas, Jay H. Traverse, Jarosław D. Kasprzak, Victor Guetta, Reinilde Heyrman, Jerome Roncalli, Jennifer A. White, Timothy D. Henry, Uwe Zeymer, C. Michael Gibson, Oscar H. Kracoff, Jingyu Liu, Howard Levy, Derek P. Chew, Sunil V. Rao, Norbert Frey, Mitchell W. Krucoff, Paul Vermeersch, Jose Lopez-Sendon, Hussein R. Al-Khalidi, Jean Francois Tanguay |
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| Přispěvatelé: | Cardio-vascular diseases, Clinical sciences |
| Rok vydání: | 2016 |
| Předmět: |
0301 basic medicine
Male medicine.medical_specialty medicine.medical_treatment Heart Ventricles Myocardial Infarction Infarction 030204 cardiovascular system & hematology Myocardial rupture Coronary Angiography Prosthesis Design Ventricular Function Left 03 medical and health sciences Electrocardiography 0302 clinical medicine Percutaneous Coronary Intervention Postoperative Complications Double-Blind Method Internal medicine Absorbable Implants medicine Humans Myocardial infarction Ventricular remodeling Aged Ventricular Remodeling business.industry Percutaneous coronary intervention Middle Aged medicine.disease Coronary Vessels 030104 developmental biology Treatment Outcome Heart failure Cardiology End-diastolic volume Female Stents Cardiology and Cardiovascular Medicine business TIMI Follow-Up Studies |
| Zdroj: | Journal of the American College of Cardiology. 68(7) |
| ISSN: | 1558-3597 |
| Popis: | 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 ) |
| Databáze: | OpenAIRE |
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