Abstract 1894: 5 Years Follow-Up Indicate Safety and Sustained Improvement of Cardiac Function in the TOPCARE-AMI Trial
Currently, there are no data investigating the long-term clinical effects (> 2 years) and safety of intracoronary progenitor cell therapy in patients with acute myocardial infarction (AMI). The TOPCARE-AMI trial was the first randomized clinical study investigating the effects of intracoronary infusion of circulating (CPC) or bone marrow-derived progenitor cells (BMC) in 59 patients with successfully reperfused AMI. Therefore, we assessed the clinical course and NT-proBNP serum levels as objective markers of cardiac function of the TOPCARE-AMI patients at 5 years follow-up. 5 years follow-up data were completed in 54 patients, 4 patients were lost to follow-up. One patient died (during the initial hospital stay at 19 days after cell administration), no patient was rehospitalized for heart failure and 16 patients underwent target vessel revascularization (TVR; all patients initially received bare metal stents), without differences between the 2 cell groups. Only 2 TVRs occurred later than 1 year after cell administration making it very unlikely that the infused progenitor cells accelerate atherosclerotic disease progression. In addition, 1 patient had successful operation of a solid bowel carcinoma after 4 years. Echocardiographic analysis in all 54 patients and cardiac MRI imaging in 36 patients excluded intramyocardial calcification in all patients at 5 years follow-up. Serum levels of NT-proBNP were significantly reduced from 902±1006pg/ml at baseline prior to cell administration to 274±250pg/ml at 4 months follow-up (p<0.001), and further decreased to 210±288pg/ml at 5 years follow-up (p<0.001 vs. baseline, p = 0.05 vs. 4 months follow-up). There were no differences between both groups. 5 years follow-up analysis of patients treated with intracoronary infusion of CPC or BMC after AMI demonstrates an excellent clinical long-term safety profile, excludes the induction of intramyocardial calcification, and documents sustained improvement of cardiac function as evidenced by persistently normal NT-proBNP serum levels demonstrating absence of overt heart failure. Complete analysis of echocardiographic and cardiac MRI assessment at 5 years follow-up will be presented.