Abstract 15644: The NHLBI and Cardiovascular Cell Therapy Research Network (CCTRN) TIME Trial: Two-Year Results
Background: The NHLBI-sponsored TIME Trial of the CCTRN investigated if the timing of stem cell delivery affects recovery of LV function following STEMI. It was a randomized, placebo-controlled trial of 120 patients with anterior STEMI randomized (2:1) to either 150 million autologous bone marrow mononuclear cells (BMCs) or cell-free placebo with intracoronary delivery on Day 3 or Day 7 following reperfusion with PCI in patients with LV dysfunction (LVEF ¬< 45%). The primary endpoints were changes in global (LVEF) and regional (infarct and border zone), LV function between baseline and 6 months by cardiac MRI. Overall, no benefit of cell therapy was observed on recovery of LV function compared to placebo at any time point. This report provides the 1 and 2 year results.
Methods and Results: 85 patients (BMC=58; Placebo=27) returned for pre-specified 1 and 2-year follow-up MRIs. Data are presented as the aggregate of the Day 3 and Day 7 groups (means). While LVEF and regional wall motion increased in both groups between baseline and 6 months (p < 0.01), no further interval changes were observed at 1 and 2 years. Infarct size significantly decreased in both groups between baseline and 6-mo (p < 0.01), with a small additional decrease to 2-years. LV volumes remained stable in both groups following a significant increase between Day 3 and 6-months. There were 3 deaths and 43 major adverse events with no significant difference in number of events between the 2 treatment groups over 2-years of follow-up (p=0.865).
Conclusion: A significant reduction in infarct size and LV mass occurs during the initial six months following reperfused STEMI that is unaffected by BMC administration. After two years, the initial improvement in LV function remained stable in both groups but is accompanied by a small, non-significant increase in LV volumes. No safety concerns were observed in this high-risk STEMI cohort with moderate LV dysfunction.
ClinicalTrials.gov Number, NCT00684021
Author Disclosures: J.H. Traverse: Research Grant; Modest; NHLBI. Research Grant; Significant; modest. T.D. Henry: None. C.J. Pepine: None. J.T. Willerson: None. D.X. Zhao: None. S.G. Ellis: None. D. Lai: None. E.C. Perin: None. M.S. Penn: None. A.K. Hatzopoulos: None. J. Chambers: None. K.W. Baran: None. G. Raveendran: None. C. Lambert: None. A. Lerman: None. D.I. Simon: None. A.P. Gee: None. J.R. Forder: None. D.A. Taylor: None. C.R. Cogle: None. R.F. Ebert: None. L. Moye': None. R.D. Simari: None.
- © 2014 by American Heart Association, Inc.