Intracoronary Delivery of Injectable Bioabsorbable Scaffold (IK-5001) to Treat Left Ventricular Remodeling After ST-Elevation Myocardial Infarction: A First-in-Man Study

• Published in: Circulation. Cardiovascular interventions Vol. 7; no. 6; pp. 806 - 812
• Main Authors: Frey, Norbert, Linke, Axel, Süselbeck, Tim, Müller-Ehmsen, Jochen, Vermeersch, Paul, Schoors, Danny, Rosenberg, Mark, Bea, Florian, Tuvia, Shmuel, Leor, Jonathan
• Format: Journal Article
• Language: English
• Published: United States American Heart Association, Inc 01.12.2014
• Subjects: Absorbable Implants - adverse effects; Adult; Aged; Alginates - administration & dosage; Alginates - adverse effects; Belgium; Calcium Gluconate - administration & dosage; Calcium Gluconate - adverse effects; Feasibility Studies; Female; Germany; Glucuronic Acid - administration & dosage; Glucuronic Acid - adverse effects; Heart Function Tests; Hexuronic Acids - administration & dosage; Hexuronic Acids - adverse effects; Humans; Hydrogels; Injections, Intra-Arterial; Male; Middle Aged; Myocardial Infarction - diagnosis; Myocardial Infarction - physiopathology; Myocardial Infarction - therapy; Pilot Projects; Predictive Value of Tests; Regenerative Medicine - methods; Surveys and Questionnaires; Time Factors; Tissue Engineering - methods; Tissue Scaffolds - adverse effects; Treatment Outcome; Ventricular Dysfunction, Left - diagnosis; Ventricular Dysfunction, Left - physiopathology; Ventricular Dysfunction, Left - therapy; Ventricular Function, Left; Ventricular Remodeling; Belgium; Germany; ventricular remodeling; coronary disease; heart failure; myocardial infarction
• ISSN: 1941-7640; 1941-7632
• DOI: 10.1161/CIRCINTERVENTIONS.114.001478

BACKGROUND—We aimed to test, for the first time, the feasibility of intracoronary delivery of an innovative, injectable bioabsorbable scaffold (IK-5001), to prevent or reverse adverse left ventricular remodeling and dysfunction in patients after ST-segment–elevation myocardial infarction. METHODS AND RESULTS—Patients (n=27) with moderate-to-large ST-segment–elevation myocardial infarctions, after successful revascularization, were enrolled. Two milliliters of IK-5001, a solution of 1% sodium alginate plus 0.3% calcium gluconate, was administered by selective injection through the infarct-related coronary artery within 7 days after myocardial infarction. IK-5001 is assumed to permeate the infarcted tissue, cross-linking into a hydrogel and forming a bioabsorbable cardiac scaffold. Coronary angiography, 3 minutes after injection, confirmed that the injection did not impair coronary flow and myocardial perfusion. Furthermore, IK-5001 deployment was not associated with additional myocardial injury or re-elevation of cardiac biomarkers. Clinical assessments, echocardiographic studies, 12-lead electrocardiograms, 24-hour Holter monitoring, blood tests, and completion of Minnesota Living with Heart Failure Questionnaires were repeated during follow-up visits at 30, 90, and 180 days after treatment. During a 6-month follow-up, these tests confirmed favorable tolerability of the procedure, without device-related adverse events, serious arrhythmias, blood test abnormalities, or death. Serial echocardiographic studies showed preservation of left ventricular indices and left ventricular ejection fraction. CONCLUSIONS—This first-in-man pilot study shows that intracoronary deployment of an IK-5001 scaffold is feasible and well tolerated. Our results have promoted the initiation of a multicenter, randomized controlled trial to confirm the safety and efficacy of this new approach in high-risk patients after ST-segment–elevation myocardial infarction. CLINICAL TRIAL REGISTRATION—URLhttp://www.clinicaltrials.gov. Unique identifierNCT01226563.