Most studies on intracoronary bone marrow mononuclear cell (BMC) transplantation for acute myocardial infarction (AMI) involve treatment 3-7 days after primary percutaneous coronary intervention (PCI); however, the optimal timing is unknown. The present study assessed the therapeutic effect at different times after ST-elevation myocardial infarction (STEMI).
The present trial was not blinded. A total of 104 patients with a first STEMI and a left ventricular ejection fraction (LVEF) below 50%, who had PCI of the infarct-related artery, were randomly assigned to receive intracoronary infusion of BMC within 24 hours (Group A, n = 27), 3 to 7 days after PCI (Group B, n = 26), or 7 to 30 days after PCI (Group C, n = 26), or to the control group (CON, n = 25), which received saline infusion performed immediately after emergency PCI. All patients in Group A, B and C received an injection of 15 ml of cell suspension containing approximately 4.9 × 10(8) BMC into the infarct-related artery after successful PCI.
Compared to CON and group C patients, Group A and B patients had a significantly higher absolute increase in left ventricular ejection fraction (LVEF) from baseline to 12 months (the change of LVEF: 3.4% ± 5.7% in CON, 7.9% ± 4.9% in Group A, 6.9% ± 3.9% in Group B, 4.7% ± 3.7% in Group C), a greater decrease in left ventricular end-systolic volumes (LVESV) (the change of LVESV: -6.4 ± 15.9ml in CON, -20.5 ± 13.3ml in Group A, -19.6 ± 11.1ml in Group B, -9.4 ± 16.3ml in Group C), and significantly greater myocardial perfusion (change from baseline: -4.7 ± 5.7% in CON, -7.8 ± 4.5% in Group A, -7.5 ± 2.9% in Group B, -5.0 ± 4.0% in Group C). Group A and B patients had similar beneficial effects on cardiac function (p = 0.163) and LV geometry (LVEDV: p = 0.685; LVESV: p = 0.622) assessed by echocardiography, whereas Group C showed similar results to those of the CON group. Group B showed more expensive care (p < 0.001) and longer hospital stays during the first month after emergency PCI (p < 0.001) than Group A, with a similar improvement after repeat cardiac catheterization following emergency PCI.
Cell therapy in AMI patients that is given within 24 hours is similar to 3-7 days after the primary PCI.
(TRN: NCT02425358 , 30 April 2015).