Strengthening effects of bone marrow mononuclear cells with intensive atorvastatin in acute myocardial infarction.
OBJECTIVE
To test whether intensive atorvastatin (ATV) increases the efficacy of transplantation with autologous bone marrow mononuclear cells (MNCs) in patients suffering from anterior ST-elevated myocardial infarction (STEMI).


METHODS
This clinical trial was under a 2×2 factorial design, enrolling 100 STEMI patients, randomly into four groups of regular (RA) or intensive ATV (IA) with MNCs or placebo. The primary endpoint was the change of left ventricular ejection fraction (LVEF) at 1-year follow-up from baseline, primarily assessed by MRI. The secondary endpoints included other parameters of cardiac function, remodelling and regeneration determined by MRI, echocardiography, positron emission tomography (PET) and biomarkers.


RESULTS
All the STEMI patients with transplantation of MNCs showed significantly increased LVEF change values than those with placebo (p=0.01) with only in the IA+MNCs patients group demonstrating significantly elevation of LVEF than in the IA+placebo group (+12.6% (95%CI 10.4 to 19.3) vs +5.0% (95%CI 4.0 to 10.0), p=0.001), pointing to a better synergy between ATV and MNCs (p=0.019). PET analysis revealed significantly increased viable areas of myocardium (p=0.015), while the scar sizes (p=0.026) and blood aminoterminal pro-B-type natriuretic peptide (p<0.034) reduced. All these above benefits of MNCs were also attributed to IA+MNCs instead of RA+MNCs group of patients with STEMI.


CONCLUSIONS
Intensive ATV treatment augments the therapeutic efficacy of MNCs in patients with anterior STEMI at the convalescent stage. The treatment with the protocol of intensive ATV and MNC combination offers a clinically essential approach for myocardial infarction.


TRIAL REGISTRATION NUMBER
NCT00979758.
['Yang|Yue-Jin|YJ|0000-0002-1309-2667', 'Qian|Hai-Yan|HY|', 'Song|Lei|L|', 'Geng|Yong-Jian|YJ|', 'Gao|Run-Lin|RL|', 'Li|Na|N|', 'Wang|Hong|H|', 'Tian|Xia-Qiu|XQ|', 'Huang|Ji|J|', 'Huang|Pei-Sen|PS|', 'Xu|Jun|J|', 'Shen|Rui|R|', 'Lu|Min-Jie|MJ|', 'Zhao|Shi-Hua|SH|', 'Wu|Wei-Chun|WC|', 'Wu|Yuan|Y|', 'Zhang|Jun|J|', 'Qian|Jie|J|', 'Xu|Jun-Yan|JY|', 'Xiong|Yu-Yan|YY|']
D000328:Adult D000368:Aged D000069059:Atorvastatin D000068476:Beijing D016026:Bone Marrow Transplantation D003131:Combined Modality Therapy D004311:Double-Blind Method D005260:Female D006801:Humans D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors D008297:Male D008875:Middle Aged D020127:Recovery of Function D000072657:ST Elevation Myocardial Infarction D013318:Stroke Volume D013997:Time Factors D014182:Transplantation, Autologous D016896:Treatment Outcome D016277:Ventricular Function, Left D020257:Ventricular Remodeling
acute coronary syndrome myocardial perfusion statins