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TIME: Stem cell delivery did not improve LV function at 1 year

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DALLAS — One-year data from the TIME trial show no association in patients with STEMI between administration of intracoronary bone marrow mononuclear stem cells at 3 or 7 days after primary angioplasty and stenting and improvement of left ventricular function, according to a presentation at AHA 2013.

The results are unchanged from the 6-month findings, which were presented last year at AHA. The primary endpoint was difference in change in LV ejection fraction at 6 months.

At 6 months, there was no difference in LVEF in the group assigned cell therapy (45.2% to 48.3%) compared with the group assigned placebo (44.5% to 47.8%; P=.96), Jay H. Traverse, MD, of Minneapolis Heart Institute, said at the presentation.

 

Jay H. Traverse

At 1-year follow-up, which included 95 of the study’s 120 participants who had an analyzable MRI at that time, the results did not change. Both groups continued to show similar improvement in EF (cell therapy group, 49.5%; placebo group, 49.6%), Traverse said.

There was also no difference between the groups in changes in LV mass or infarct size at 1 year, with almost no change in either group from 6 months to 1 year. Mean LV mass was 180.4 g^b (95% CI, 168.6-192.2) at baseline, 156.8 g^b (95% CI, 146.7-166.9) at 6 months and 148.9 g^b (95% CI, 138.6-159.2) at 1 year in the cell therapy group vs. 180.4 g^b (95% CI, 168.6-192.2) at baseline, 156.8 g^b (95% CI, 146.7-166.9) at 6 months and 148.9 g^b (95% CI, 138.6-159.2) at 1 year in the placebo group. Mean infarct size was 44.7 g^b (95% CI, 39-50.4) at baseline, 30.7 g^b (95% CI, 26.9-34.5) at 6 month and 28.8 g^b (95% CI, 25-32.6) at 1 year for the cell therapy group and 46.3 g^b (95% CI, 36.5-56.1) at baseline, 31.7 g^b (95% CI, 24.5-38.9) at 6 months and 27.7 g^b (95% CI, 21.5-33.9) at 1 year for the placebo group.

Adverse event rates at 1 year were also similar. Events occurred in 22.8% of the cell therapy group and 22% of the placebo group. “Between 6 months and 1 year, there were three additional ICD placements, two reinfarctions and four repeat revascularizations, but there was no significant difference between the cell therapy and placebo groups,” Traverse said.

“We found that the recovery of [LV] function in [STEMI] was not enhanced by bone marrow mononuclear cell administration at any time point,” he said. “The improvement in global and regional function was nearly complete by 6 months.” – by Erik Swain

For more information:

Traverse JH. CS.01: Application of cell-based therapies to treat cardiac and peripheral diseases. Presented at: the American Heart Association Scientific Sessions; Nov. 16-20, 2013; Dallas.

Traverse JH. JAMA. 2013;doi:10.1001/jama.2013.282674.

Disclosure: Traverse reports no relevant financial disclosures.